ethical considerations in research pdf 2022

Ethical consideration dilemma: systematic review of ethics in qualitative data collection through interviews

Journal of Ethics in Entrepreneurship and Technology

ISSN : 2633-7436

Article publication date: 11 August 2023

Issue publication date: 14 December 2023

Qualitative research that involves the use of human participants calls for the need to protect those participants to give their honest view during data collection. This is an important part of every primary data collection in qualitative studies using interviews. This paper aims to investigate all available ethical considerations that need to be observed by the researcher when conducting primary data collection through interview and to explore the theories that underpin the ethics in qualitative studies.

Design/methodology/approach

This paper systemically reviewed existing qualitative data on ethics and gathered information that were analysed and presented on the topic area.

The findings show that ethical considerations deal with the various approaches adopted by the researcher to make the participants feel safe to participate in any given researcher. During an interview process in qualitative research, the findings show that anonymity, voluntary participation, privacy, confidentiality, option to opt out and avoiding misuse of findings are ethical considerations that must be observed by the researcher. The outcome of the investigation also shows that deontology and utilitarianism, rights and virtue are the main theories that underpin ethical considerations in research.

Originality/value

The rights of the research participants need to be respected in qualitative research to assist in gathering accurate information to achieve the objectives of study. This and other ethical principles such as anonymity, privacy, confidentiality, voluntary participation and option to opt out guide the researcher to systematically adhere to data collection approaches that yield valid results in qualitative data collection using interviews.

• Primary data
• Qualitative research
• Ethical theory
• Informed consent
• Data collection
• Ethical approval

Nii Laryeafio, M. and Ogbewe, O.C. (2023), "Ethical consideration dilemma: systematic review of ethics in qualitative data collection through interviews", Journal of Ethics in Entrepreneurship and Technology , Vol. 3 No. 2, pp. 94-110. https://doi.org/10.1108/JEET-09-2022-0014

Emerald Publishing Limited

Copyright © 2023, Michael Nii Laryeafio and Omoruyi Courage Ogbewe.

Published by Emerald Publishing Limited. This article is published under the Creative Commons Attribution (CC BY 4.0) licence. Anyone may reproduce, distribute, translate and create derivative works of this article (for both commercial and non-commercial purposes), subject to full attribution to the original publication and authors. The full terms of this licence may be seen at http://creativecommons.org/licences/by/4.0/legalcode

1. Introduction

Qualitative research that involves human subjects should focus on using the best form of interaction to gather accurate information. The researcher is vested with the main ideas and the approach to interact with the participants during data collection. However, these human subjects have the choice of what kinds of information they provide to researchers based on the treatment that are shown to them by the researchers. Researchers such as Collis and Hussey (2014) and Smith et al. (2009) proposed that researchers must have a policy of respecting the rights and privileges given to human participants in any given qualitative studies to allow the freedom of expression and the option to opt out at any point during the data collection.

These and other privileges given to the human participants in a research aid in gathering information without fear or pressure from the participants. Saunders et al. (2016) also affirmed by saying that the accuracy of information gathered using interviews largely depends on the honesty of the participants, and this is caused by outlining the ethical considerations that needs to be observed by the researcher. Ethical considerations are fundamental in any kind of research, this provides the opportunity for the researcher to gather the most important information without causing any harm to the participants in the research ( Orb et al. , 2000 ). The aim of this paper is to present a systematic and comprehensive literature review on ethical considerations in qualitative data collection using interviews and highlighting the various theories that underpin the ethical issues in qualitative research.

2. Literature review

Research ethics considers the act of doing good and protecting the rights of participants in research, as well as avoiding any possible harm to any participants ( Kara and Pickering, 2017 ; UK Statistics Authority, 2022 ). Kara and Pickering (2017) further noted in their research study that research ethics often considers the elements which concerns primary data collection than secondary data. For example, in their research that analysed 29 published articles between 2000 and 2015, majority of the article (22) addressed ethical consideration such as anonymity, privacy, confidentiality, informed consent and formal ethical regulations that concerns primary data collection, and the rest consisted of other topics such as ethics and secondary data, ethics and data analysis, theory and life-writing. This became evident that though ethical considerations are associated with other kinds of data, it particularly concerns primary data collection than secondary data. This was also confirmed by Colnerud (2015) who also expressed that ethical considerations help in preventing or reducing any harm that could happen to the human participants during primary data collection. Thus, it becomes very important for the protection of human rights in any kind of research ( Cilliers and Viljieon, 2021 ). In the current trend of research investigation, it is illegal to violate human right under the pretence of research studies. The nature of ethical issues in qualitative research is so delicate as compared to quantitative research ( Drolet et al. , 2022 ). Researchers have the highest accountability to ensure that they notice or identify and foreseeable harm and safeguard the wellbeing of the participants ( Williams-Jones et al. , 2013 ). As such, the actions of researchers, especially those that engage in qualitative studies, have been under high scrutiny due to the likelihood of mistreating the human participants, to gain deeper findings and clarity of information generated.

As noted by Van Burg et al. (2022) , qualitative research has been vital in the development of theories on emerging techniques that helped the existence of men in recent times, such as crowdfunding ( Short et al. , 2017 ), digital technologies ( Nambisan et al. , 2019 ) and lean start-up approach ( Shepherd and Gruber, 2020 ). The relevance of qualitative research has called for the need to ensure internal coherence as noted by Howard-Grenville et al. (2021) where they pointed out that a perfect fit must exist in qualitative studies which helps to link the research question to data collection, data analysis, as well as findings and development of theory.

However, researchers that engage in qualitative studies are faced with three major challenges that raises the issue of ethics in data collection: the researcher–participants relationship, the subjective interpretation of data and findings by the researcher and the research design adopted ( Beauchemin et al. , 2021 ). There is the possibility of disclosing some damaging information under deception. The literature provides an example of researcher’s deception through Humphrey’s study of homosexuals ( Punch, 1994 ). Humphrey used participants’ observation as his data collection technique through the act of deception, and this raised major concerns and shocked American scholars who wanted to have his doctorate degree revoked. Humphrey engaged in controversial research where he observed homosexuals in a public bathroom, and under the disguise of working under a different investigation follows same homosexuals to their various homes. Though this contradicts the ethical principle, Clark (1996) expressed that deception allows the researcher to gather “uncontaminated” data. This approach of “deception” was adopted by Clark (1996) in her forensic unit research. While conducting research over a period of six weeks, Clarke pretended to be working as a nursing auxiliary to observe participants and later take notes. In other words, Clarke did not disclose her identify as a researcher, rather pretended to be a worker at the facility. Clark (1996 , p. 38) justified her approach by expressing that when “dealing with sensitive aspect of subject’s behaviour”, some degree of deception should be permitted. However, Kang and Hwang (2021) pointed out that the act of deception violates human right and exposes the participants to harm and danger.

Misconduct in research studies deeply affects the results of any investigation. While Bruhn et al. (2002) believed that the authenticity of research findings depends on data collection techniques, Davison (2004) also expressed that human participants can give their honest opinion on an investigation when they are given “convenient” environment to operate. Participants should not be manipulated under no circumstance to give any to be involved in a research data collection. Throughout the research life cycle, it is very important for researchers to consider any possible ethical challenges that could occur ( Giorgini et al. , 2016 ). Due to the difficulties associated with identifying any possible ethical issues, ethical committee acts as experts who access the research documents prior to the investigation to make sure all ethical “checklists” are met by the researcher ( Lynöe et al. , 1999 ).

3. Historical background to research ethics

There has been different school of thoughts when a historical account of the birth of ethics in research is being narrated. This approach to rightfully engage human participants in research started when people started to reflect on the best way to interact and live. To recall, history has it that the birth of research ethics in modern studies started when investigators had to protect the human participants in any kind of investigation. To this school of thought, the Doctors Trial of 1946–1947 gave way for a starting point to document regulations that should have been followed by investigators for the Nuremberg Trials for war criminals by the Nazis ( Annas and Grodin, 1992 ). To further expand on the scenario, there were a total of 23 physicians from Germany who wanted to conduct research with human subjects as the main participants in view of uncovering a scientific knowledge regarding limits of the human body as a result exposed those human participants involved in the research to high temperatures and altitudes ( Grodin, 1992 ).

The accused 23 German physicians ended up brutalising and torturing the human subjects involved, as well crippling most of them which led to the death of thousands of the research victims. During the Nazi racial purification policies, these physicians were also exploring ways to racially kill innocent people in a relatively painless manner for reasons of mercy. This was to relieve the foreigners of the racial discrimination met out to them by the Nazis, without their consent. These acts were the most destructive and gruesome experiments that led to the murder of thousands of victims in Germany by the Nazi party in 1942 ( Nuremberg Code, 1947 ).

Research participants must voluntarily consent to research participation.

Research aims should contribute to the good of society.

Research must be based on sound theory and prior animal testing.

Research must avoid unnecessary physical and mental suffering.

No research projects can go forward where serious injury and/or death are potential outcomes.

The degree of risk taken with research participants cannot exceed anticipated benefits of results.

Proper environment and protection for participants is necessary.

Experiments can be conducted only by scientifically qualified persons.

Human subjects must be allowed to discontinue their participation at any time.

Scientists must be prepared to terminate the experiment if there is cause to believe that continuation will be harmful or result in injury or death.

Clinical research must conform to the moral and scientific principles that justify medical research and should be based on laboratory and animal experiments or other scientifically established facts.

Clinical research should be conducted only by scientifically qualified persons and under the supervision of a qualified medical man.

Clinical research cannot legitimately be carried out unless the importance of the objective is in proportion to the inherent risk to the subject.

Every clinical research project should be preceded by careful assessment of inherent risks in comparison to foreseeable benefits to the subject or to others.

Special caution should be exercised by the doctor in performing clinical research in which the personality of the subject is liable to be altered by drugs or experimental procedure.

Following the DoH in 1964, the development of the “Belmont Report” in 1979 became the next set of ethical guidelines that was proposed by the National Commission for the maximum protection of human participants on Biomedical and Behavioural Research. The Belmont Report reviewed and reaffirmed three key ethical guidelines that researchers must follow when dealing with human participants in research, and these are respect for persons, beneficence and justice. The Nuremberg code, DoH and Belmont Report paved way for modern approaches to research ethics in research.

4. Ethical theories

There have been several attempts by scholars in the field of ethics to provide justifications for the need to oblige to some form of principles when engaging human participants in research ( Koski, 2009 ). In essence, it is common and appropriate to consider different ethical theories that underpin the principles of a researcher to clarify what is wrong or right during data collection that involves human participants. The following are four key ethical theories that form the philosophical position of researchers during data collection.

4.1 Deontology

This ethical theory is often associated with the works of Immanuel Kant who expressed that the rightness or wrongness of an action should not be dependent on the consequences of that action, rather on whether that action is right under a series of rules ( Beauchamp, 1991 ). This is mostly regarded as obligation or duty and thus referred to as the rule-based ethics. Under this theory, people must follow their rules and do their duty. Salzman (1995) also pointed out that deontology ethical theory exists within the domain of morality which helps to guide our choice of what is right and wrong. For example, when a computer scientist who has much knowledge in hacking systems learn that there is going to be a nuclear weapon launch that could kill lots of people. Under this circumstance, the computer scientist can hack and cancel the launch of the nuclear weapon, to avoid killing of people ( Olson, 1967 ). However, the deontic view is that it is unprofessional to break into the system of the nuclear weapon without consent or permission. Deontologist advises not to breach the professional code of conduct as a computer scientist ( Waller, 2005 ).

4.2 Utilitarianism

Unlike deontology, this theory mainly focusses on the rightness or wrongness of an action based on the outcome of that action. This is born out of consequentialism which holds that utilitarianism deals with taking actions that produces the greatest benefits to the greatest number of related people ( Shaw, 1998 ). This is a moral principle that holds that the best ethical choice is the actions that produces the best benefits to the greatest number. For example, a healthy person has a good liver, kidney, heart and lungs. Imagine there are four people at the hospital who needs organ transplant each. In this instance, a healthy person can save four people with his/her organs. Utilitarianism theory suggests that the life of one healthy person can save four people at the hospital (greatest number) and that is arguably the best choice to make ( McCloskey, 1957 ). The consequence of taking the life of just one person is saving the lives of four people, though other scholars suggest that taking the life of any person is unethical.

This is a duty-based ethical theory which explains the rights of every person, and it is the duty of another person to respect those rights, thus owing up the duty to respect the rights of another. As Traer (2009 p. 103) explains:

[…] the most widely accepted justification for moral rights relies on Kant's deontological argument that we have a duty to treat every person as an end, and not to our ends, because every person is autonomous and rational, and thus has intrinsic worth.

This theory highly judges a person based on his or her character, rather than the action or outcome of event. This deals with the moral reputation of a person that determines any ethical behaviour (Annas, 1993). As the name suggest, virtue can be expressed as a morally good tendency to act well in some aspects of life ( Hursthouse and Pettigrove, 2018 ). This mainly portrays the character traits and become central to the personality of a person.

When researchers are faced with decision-making situation or data collection when there is the need to adhere to ethical considerations, there are several ethical theories that gives the guidelines to reach a decision that is ethically correct. To reach the right decision when dealing with human participants, each ethical theory helps to adhere to the best practices that lead to taking the best decision.

5. Qualitative research

The choice of this type of research largely depends on the philosophical position of the researcher. This type of research relies on the information supplied by the human subjects in the research. They hold the idea that human subjects under any given piece of research should be given the chance to bring out their views about the topic area in the research. This should be devoid of any predetermined set of questions that gives participants less chance to express themselves. As expressed by Merriam (2009) , qualitative researchers are interested in understanding the meaning people have constructed, that is, how people make sense of their world and the experiences they have in the world. This was affirmed by Parkinson and Drislane (2011) who also expressed that qualitative research use research techniques such as case studies and participants which helps in narrative and descriptive nature of practice. The most common idea from both authors concludes that qualitative research investigates events in their natural settings and successfully attempts to make meaning to the research based on the meanings the human subjects attach to them. Simply put, qualitative research deals with the gathering and analysing of non-numerical data to explore views, experiences or opinions of others.

6. Current and emerging trends in qualitative research

The community of research in qualitative studies has gone through several changes from where the human participants are harmed to the stage where the rights of participants are highly respected and protected ( Roth and von Unger, 2018 ). Qualitative researchers tend to treat ethics as the main characteristics between the researcher and what is researched. To move further, the advancement in technology has led to the transformation of many fields of research and qualitative research is no exception. As a result, qualitative research is going through tremendous and rapid changes and any researcher interested in such investigation should know the state of development in qualitative research ( Costa and Moreira, 2019 ). These changes and other emerging trends could be seen in three main areas ( ESOMAR, 2010 ): sources of data, data collection and analysis of data.

The traditional data sources under qualitative research were mainly through interviews, observation, focus groups and recordings ( Gill et al. , 2008 ). Currently, these methods have been heavily complemented by virtual, textual, visual and other data that is gathered from social media. The introduction of Web 2.0 technologies (interactive contents) has led to the development of social media platforms that enables people all over the world to share their lives and other private information online which is accessed by people all over the world ( Sykora, 2017 ). With creativity and innovation, qualitative researchers have found ways to leverage on this trend to conduct high quality research. As such, as many people around the world creates accounts on Instagram, Facebook, Twitter and other social media platforms, there are vast amount of qualitative data streams that could be accessed by the qualitative researcher. In a nutshell, social media platforms have become an additional source of data for researchers.

The consequence of data available on social media platforms has brought about other emerging data collection tools such as data mining and web crawling techniques used in recent times. For example, software programmes such as Ncapture have been integrated into NVivo which helps to capture social media contents for fast qualitative data analysis. Ncapture is a free web-browser extension created for internet explorer and Google chrome which helps the researcher to collect contents from the web to effectively import into NVivo for qualitative data analysis ( Tom and Richards, 2003 ; Zamawe, 2015 ). This has led to the introduction of “netnography” (the combination of network and ethnography) as a new form of qualitative social media research. Netnography is a specific type of qualitative social media research that relates to data collection, analysis, representation and research ethics that is deeply rooted in research participant’s observation ( Kozinets, 2017 ). Kozinets (2002) further explained that netnography uses an interpretative research philosophy which helps to adapt participants’ observation approach of anthropology to the detail investigation of involvement and experiences which manifest through digital communications.

The traditional qualitative data analysis consists of using humans to code texts manually ( Saunders et al. , 2016 ); however, the introduction of social media research has turned efforts to using automated content analysis (ACA). This consists of techniques that are used to automatically analyse social media contents. Scholars such as Stockwell et al. (2009) and Sievert and Shirley (2014) added that ACA helps qualitative researchers to engage in large-scale data analysis and helps to produce efficient results.

7. Qualitative data collection methods and procedure

7.1 methods.

Data collection is one of the most important parts of every research investigation. It is the systematic process of gathering and collecting information on the interested variables in research to answer the research question and evaluate the outcome of a research (Collis and Hussey, 2016; Saunders et al. , 2016 ). In a qualitative research where human participants are involved, data collection translates into the various processes of gathering and collection data from the targeted participants about the topic area, through, for example, interviews. There are several methods of qualitative data collection, and it is up to the researcher to justify the methods used. The choice of data collection methods for qualitative research is highly influenced by the research philosophical positioning of the researcher ( Saunders et al. , 2016 ). The most common method of collecting qualitative data is through, interviews, group discussions or focus group, observations, surveys and note taking. It is worth mentioning that the interview could take place via telephone, online (through Skype, Zoom and Teams) or face-to-face, and be recorded for analysis. The focus of the research investigation is interviews as the main qualitative data collection methods.

7.2 Interviews

This is the most common form of data collection for qualitative research investigation (Collis and Hussey, 2016). This presents the great opportunity for researchers to fully interact with the participants to solicit for data about a topic area. There are several forms of interviews that are available to the researcher such as unstructured, semi-structured and structured interviews (Oats, 2016). Researchers can choose any form of interviews for the data collection based on the depth of data to be collected to answer the research questions.

7.3 Procedures

A long-standing process of conducting interviews to solicit for information from participants suggests that the researcher must have four main documents ready and to be sent to the participants (interviewee) before conducting the interview ( Denzin and Lincoln, 2011 ). These documents are as follows: consent form, information sheet, interview guide and introduction letter (when the researcher is seeking to involve organisations or institutions).

7.4 Information sheet

It is mostly called participant’s information sheet ( Creswell and Plano Clark, 2007 ). This is a written document that gives the summary of the research project and detailed out how the participants will be affected by their involvement in the data collection for the study ( Saunders et al. , 2016 ). Areas that are clearly detailed out in the information sheet are: (1) What is the study about? (2) How do I join? (3) What happens to the information? (4) Do I have to take part in the research? (5) Will I benefit from the research? and (6) What if I change my mind. These and many other information are provided on the information sheet to give the interviewee an awareness of the research investigation and how he or she will be protected.

7.5 Consent form

Having read the information sheet and become aware of the project, interviewees are given the consent form to sign to show their willingness to take part in the research. This is therefore a signed document that outlines the informed consent of an individual to partake in a research study (Collis and Hussey, 2016). In most cases, the consent form has some information with a tick box against it, asking individual to tick to agree to some key information that will take place in the research before finally signing the document. Some key information that requires a “tick” by the individual (interviewee) are (1) I confirm that I have read and understand the information sheet dated for the above study, (2) I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reason and (3) I understand that my name will not appear in any reports, articles or presentations.

7.6 Interview guide

Usually limited to a one-page document ( Menzies et al. , 2016 ), the interview guide simply lists the high-level topics that the researcher plans to cover in the interview with the high-level questions that the researcher wants the interviewee to answer under each topic. The topics and questions written on this document is guided by the research questions ( Lazar et al. , 2017 ) that is necessary and sufficient to achieve the aim of the research.

7.7 Introduction letter

This is a letter that is written to an organisation to allow members of its staff members to be involved in data collection ( Saunders et al. , 2016 ) or to seek permission to retrieve data from archives of the organisation, thus often called organisational letter.

All these documents mentioned above must be made ready to commence an interview by the researcher. The researcher through a sampling technique, selects and sends an invitation to the participants and records the number who has agreed to be interviewed. The interview is then recorded and transcribed for analysis.

8. Ethical considerations in conducting interviews

When the information sheet, consent form and interview guide has been designed by the researcher, it now time for the researcher to commence the interview process. This is the time where ethical considerations become very relevant. The following are some of the ethical considerations that must be observed by the researcher during the interview process.

8.1 Anonymity

Providing anonymity to the interviewees means that all the information collected is devoid of personal details of the interviewee such as address, email, name and other key information that could lead to the identification of the interviewee ( Crow and Wiles, 2008 ). Ensuring anonymity of information collected gives protection to the interviewees and allows them to give out key information which ensures reliability of findings ( Saunders et al. , 2015 ). This helps to protect the privacy of voluntary participants in the research investigation.

8.2 Privacy and confidentiality

The interviewer must ensure that any information collected from the interviewee must remain private and confidential; thus, ensuring that no third party has access to the raw data unless otherwise stated by the interviewee for exposure.

8.3 Voluntary participation

To gain reliable information from the interviewee, none must be forced or induced to participate in the research investigation. Forcing participant will mean that they are not willing to give out any information but for material compensation, they will take part which could lead to the collection of false information. Allowing for voluntary participation will ensure that participants understand the research area and accept to engage in the data collection ( Mumford et al. , 2021 ).

8.4 Option to opt out

The researcher must respect the rights of interviews at any point during the data collection to opt out. When this happens any already collected data about the participants must be discarded. This ensures that no interviewee is forced to engage in the research if some questions go against their virtues ( Mumford et al. , 2021 ). The researcher owes it a responsibility to respect the rights of the interviewees.

8.5 Non-maleficence/Beneficence

The ethical principle of non-maleficence and beneficence describes the researcher’s obligation to fully avoid causing any harm to the participant intentionally or be able to identify and eliminate any source of harm to the participant ( Guillemin and Gillam, 2004 ). The researcher in this instance should not over-burden the participant with more questions or create a situation where the participant feels uncomfortable. Any deliberate attempt by the researcher to cause an unwelcome environment will impact negatively to the responses that will be gathered ( Wilson et al. , 2008 ). This was initially a concern in the nursing research where a patient places full trust in the hands of a nurse or health officer, and therefore suffers a deliberate harm by the health officer which could be avoided ( Alderson, 2000 ). For example, where patients handle sensitive and private information to the health officer due to trust. Table 1 below gives a typology of ethical concerns faced by interviewers.

9. Key ethical concerns in entrepreneurship and technology

Technology and entrepreneurship are constantly developing fields that provide numerous benefits to society. However, they also bring up a few ethical concerns. The following are some of the most important ethical issues in technology and entrepreneurship:

Privacy: Personal data collection, storage and use are now easier than ever thanks to technology ( Reynolds, 2019 ). This raises concerns regarding who has access to that data and how it is being used. Technologists and entrepreneurs must respect the privacy of individuals and be open about their data practices.

Security: Cyberattacks and data breaches are becoming increasingly common as technology usage rises ( Reynolds, 2019 ). Business owners and technologists should do whatever it takes to safeguard client information.

Intellectual property: New concepts and inventions are frequently developed through technology. Intellectual property rights must be respected by technologists and entrepreneurs alike, and they must avoid violating the rights of others ( Reynolds, 2019 ).

Bias and discrimination: If technology is not designed and implemented in a way that is fair and inclusive, bias and discrimination can continue ( Van Burg et al. , 2022 ). Technologists and entrepreneurs need to be aware of the possibility of bias and discrimination and take steps to reduce it.

Social obligation: Technologists and entrepreneurs have a responsibility to think about how their products and services will affect society ( Van Burg et al. , 2022 ). They should guarantee that their developments are not unsafe to society and that they are adding to everyone's benefit.

Labour issues: Entrepreneurs and technologists must consider the effects on workers as technology alters the nature of work. They should guarantee that their advancements do not prompt work dislodging or double-dealing ( Van Burg et al. , 2022 ).

Business and innovation present numerous moral difficulties that should be tended to. It is essential for technologists and entrepreneurs to be aware of these issues and to take steps to guarantee that their innovations are socially responsible and beneficial.

10. Gaining ethical approval

Research that involves the use of human participants needs to seek for ethical approval from an ethics committee. Saunders et al. (2016) further expressed that all research that involves human tissues requires that ethical approval must be sought by the university’s research ethics committee. Obtaining ethical approval means that the researcher has adhered to the acceptable ethical standards of a reliable and genuine research study ( Bickman and Rog, 2009 ).

For the application process, the researcher must make available the research proposal, together with the data collection instrument, participants’ information sheet, consent form and then apply for ethics from the university’s ethics committee by filling the ethics form online and attaching the proposal for submission. The ethics committee has been named differently by many universities based on the country or university of application, for example, it is called the “Institutional Review Board” (IRB) in the USA. Section 9 below gives a detail overview of IRB and its composition. The ethics committee (or IRS) reviews the application and examines the proposal to meet all requirements per the ethics standards. Once all requirements are met by the applicant (researcher), ethical approval is granted for the research to commence.

11. Institutional review board

The IRB is also referred to as an independent ethics committee ( Mohamadi et al. , 2014 ) with the sole mandate of reviewing the proposed research methods by researchers to ensure that the methodological pathway is ethical. This is an officially constituted group under the FDA in the USA. This committee is called “Research Ethics Committees” in Spain. This committee assumes the central role in research by approving (or rejecting), monitoring, reviewing social science research involving human participants. The primary aim of the IRB is to conduct a high-level risk-benefit analysis to determine whether research involving humans should be allowed and thus brings no harm and other related risk to the human participants involved ( McNeil, 2014 ).

The purpose of the IRB is to ensure that various steps are taken by the committee to assist in protecting the rights and welfare of the human elements in the research. This means that by the review of the research protocols and other related materials by the IRB, any psychological or physical harm are eliminated ( Alicia, 2009 ). The review process takes the form of assessing the research methods and fully promoting informed consent and voluntary participation by all participants who can make such decisions. The composition of IRB varies among countries; however, it consists of academic scholars and other non-academic scholars which helps to bring a greater scope of understanding and helps to ensure sense of ethics in human-related research. It important to note that the IRB is often applied in health and other social science research which includes sociology, psychology and anthropology. This research often relates to social behaviour, attitude or opinions, as well as research on the quality of health care provided and means of improving the health-care practices.

The growth of research in ethical considerations and debates among qualitative researchers to adapt the IRB reviews to social science research necessitated the formation of specialised ethics committees (as called in the UK) to exclusively oversee social science research investigations. For a better review by the IRB, the specialised ethics committee tries to adequately understand research conducted by social scientists.

It is a usual practice that universities around the world publish all ethical concerns that must be addressed in respective research on their official websites. Students are expected to carefully review such principles and apply to their research. Due to differences or constant changes in culture, all ethical committee members must be subjected to constant training programme to be able to incorporate new and updated cultural changes into the ethical principles for students to be aware. This will help to improve the ethical committee processes. In addition, these ethicists must train teachers or supervisors who oversee the work of research students so that they can acquire the updated and most relevant ethical issues in qualitative research. These supervisors will also teach and explain to students how to apply all needed concerns in ethics. Because ethical concerns are mostly general in most qualitative research, through training programme organised for the students, they become aware to a more narrowed and focused ethical concerns regarding the specific human participants in research. In a cycle of approach, well knowledgeable students on specific ethical issues in qualitative research are more likely to address all ethical concerns before applying for ethical approval. This situation improves the process of the ethics committee and makes their role more effective by responding to students’ applications promptly, because of rightfully responding to all specific ethical concerns. This is illustrated in the framework below ( Figure 1 ).

12. Conclusion

Human beings are at the centre of qualitative research, and the rights of these human participants need to be respected to give out valid information. Researchers conducting a qualitative research investigation must adhere to ethical considerations such as anonymity, voluntary participation, privacy and confidentiality and freedom to walk out in a researcher. Researchers must also make sure consent forms and information sheet are given to the participants to read and agree to take part in a research investigation before conducting interviews. Adhering to ethical considerations in research demonstrate that the research investigation meets the standard of ensuring reliability and validity of findings.

13. Limitations and suggestions for future research

One limitation of this research is it focused on ensuring that the research participants are safe and can give out the right information through tape-recorded interviews. The security nature of the recording device (technology used) can however, exposed the interviewee through device hacking and other cyber-attacks. Further research is therefore recommended to examine the kinds of recording device to use during interview recording to provide data protection from the public and other cyber criminals. The study was also limited to giving a general consent form to the interviewee to sign before the researcher commences the interview. Further research is therefore suggested to explore the content of the consent form to clearly state the most relevant parts that seeks to protect the interviewee. There should also be further research to fully examine the retention and use of recording by the researcher for future studies. This will help to give a measure on how long any interview data recorded should be kept by the researcher before been discarded. In addition, the researcher relied heavily on secondary data that has been collated by other past researchers, and due to the current trends in qualitative research, it is highly suggested that future researcher should adopt the interpretative philosophy using semi-structured interview to fully interact with scholars in qualitative research to uncover any new knowledge about ethics in qualitative research. Research in qualitative studies often overlooks the cultural diversity among participants that helps to understand the worldview of participants. Future research studies should be directed towards exploring how research design in qualitative research should focus on addressing cultural issues in data recoding. This is because there are some tribes or cultures that frowns on recordings and the taking and retention of information after the person’s death. In addition, future research should focus on the effect of training programmes that are organised for the ethics committee and its effects on ethical approval process. In the words, are there any given forums or developmental programmes that are made available to the ethics committee in view of improving knowledge on current ethical concerns and how it has made their role more effective.

A typology of ethical issues in an interview

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Further reading

Annas , J. ( 2022 ), “ Virtue and duty: negotiating between different ethical traditions ”, The Journal of Value Inquiry , S2CID 143268990 – via SpringerLink , Vol. 49 No. 4 , p. 609 , doi: 10.1007/s10790-015-9520-y .

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Perrault , E.K. and Nazione , S.A. ( 2016 ), “ Informed consent – uninformed participants: shortcomings of online social science consent forms and recommendations for improvement ”, Journal of Empirical Research on Human Research Ethics , Vol. 11 No. 3 , pp. 274 - 280 .

Pope , T.M. ( 2009 ), “ Multi-Institutional healthcare ethics committees: the procedurally fair internal dispute resolution mechanism ”, Campbell Law Review , Vol. 31 , pp. 257 - 331 .

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Methodology

• Ethical Considerations in Research | Types & Examples

Ethical Considerations in Research | Types & Examples

Published on October 18, 2021 by Pritha Bhandari . Revised on May 9, 2024.

Ethical considerations in research are a set of principles that guide your research designs and practices. Scientists and researchers must always adhere to a certain code of conduct when collecting data from people.

The goals of human research often include understanding real-life phenomena, studying effective treatments, investigating behaviors, and improving lives in other ways. What you decide to research and how you conduct that research involve key ethical considerations.

These considerations work to

• protect the rights of research participants
• enhance research validity
• maintain scientific or academic integrity

Table of contents

Why do research ethics matter, getting ethical approval for your study, types of ethical issues, voluntary participation, informed consent, confidentiality, potential for harm, results communication, examples of ethical failures, other interesting articles, frequently asked questions about research ethics.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe for research subjects.

You’ll balance pursuing important research objectives with using ethical research methods and procedures. It’s always necessary to prevent permanent or excessive harm to participants, whether inadvertent or not.

Defying research ethics will also lower the credibility of your research because it’s hard for others to trust your data if your methods are morally questionable.

Even if a research idea is valuable to society, it doesn’t justify violating the human rights or dignity of your study participants.

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Before you start any study involving data collection with people, you’ll submit your research proposal to an institutional review board (IRB) .

An IRB is a committee that checks whether your research aims and research design are ethically acceptable and follow your institution’s code of conduct. They check that your research materials and procedures are up to code.

If successful, you’ll receive IRB approval, and you can begin collecting data according to the approved procedures. If you want to make any changes to your procedures or materials, you’ll need to submit a modification application to the IRB for approval.

If unsuccessful, you may be asked to re-submit with modifications or your research proposal may receive a rejection. To get IRB approval, it’s important to explicitly note how you’ll tackle each of the ethical issues that may arise in your study.

There are several ethical issues you should always pay attention to in your research design, and these issues can overlap with each other.

You’ll usually outline ways you’ll deal with each issue in your research proposal if you plan to collect data from participants.

Voluntary participation means that all research subjects are free to choose to participate without any pressure or coercion.

All participants are able to withdraw from, or leave, the study at any point without feeling an obligation to continue. Your participants don’t need to provide a reason for leaving the study.

It’s important to make it clear to participants that there are no negative consequences or repercussions to their refusal to participate. After all, they’re taking the time to help you in the research process , so you should respect their decisions without trying to change their minds.

Voluntary participation is an ethical principle protected by international law and many scientific codes of conduct.

Take special care to ensure there’s no pressure on participants when you’re working with vulnerable groups of people who may find it hard to stop the study even when they want to.

Informed consent refers to a situation in which all potential participants receive and understand all the information they need to decide whether they want to participate. This includes information about the study’s benefits, risks, funding, and institutional approval.

You make sure to provide all potential participants with all the relevant information about

• what the study is about
• the risks and benefits of taking part
• how long the study will take
• your supervisor’s contact information and the institution’s approval number

Usually, you’ll provide participants with a text for them to read and ask them if they have any questions. If they agree to participate, they can sign or initial the consent form. Note that this may not be sufficient for informed consent when you work with particularly vulnerable groups of people.

If you’re collecting data from people with low literacy, make sure to verbally explain the consent form to them before they agree to participate.

For participants with very limited English proficiency, you should always translate the study materials or work with an interpreter so they have all the information in their first language.

In research with children, you’ll often need informed permission for their participation from their parents or guardians. Although children cannot give informed consent, it’s best to also ask for their assent (agreement) to participate, depending on their age and maturity level.

Anonymity means that you don’t know who the participants are and you can’t link any individual participant to their data.

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, and videos.

In many cases, it may be impossible to truly anonymize data collection . For example, data collected in person or by phone cannot be considered fully anonymous because some personal identifiers (demographic information or phone numbers) are impossible to hide.

You’ll also need to collect some identifying information if you give your participants the option to withdraw their data at a later stage.

Data pseudonymization is an alternative method where you replace identifying information about participants with pseudonymous, or fake, identifiers. The data can still be linked to participants but it’s harder to do so because you separate personal information from the study data.

Confidentiality means that you know who the participants are, but you remove all identifying information from your report.

All participants have a right to privacy, so you should protect their personal data for as long as you store or use it. Even when you can’t collect data anonymously, you should secure confidentiality whenever you can.

Some research designs aren’t conducive to confidentiality, but it’s important to make all attempts and inform participants of the risks involved.

As a researcher, you have to consider all possible sources of harm to participants. Harm can come in many different forms.

• Psychological harm: Sensitive questions or tasks may trigger negative emotions such as shame or anxiety.
• Social harm: Participation can involve social risks, public embarrassment, or stigma.
• Physical harm: Pain or injury can result from the study procedures.
• Legal harm: Reporting sensitive data could lead to legal risks or a breach of privacy.

It’s best to consider every possible source of harm in your study as well as concrete ways to mitigate them. Involve your supervisor to discuss steps for harm reduction.

Make sure to disclose all possible risks of harm to participants before the study to get informed consent. If there is a risk of harm, prepare to provide participants with resources or counseling or medical services if needed.

Some of these questions may bring up negative emotions, so you inform participants about the sensitive nature of the survey and assure them that their responses will be confidential.

The way you communicate your research results can sometimes involve ethical issues. Good science communication is honest, reliable, and credible. It’s best to make your results as transparent as possible.

Take steps to actively avoid plagiarism and research misconduct wherever possible.

Plagiarism means submitting others’ works as your own. Although it can be unintentional, copying someone else’s work without proper credit amounts to stealing. It’s an ethical problem in research communication because you may benefit by harming other researchers.

Self-plagiarism is when you republish or re-submit parts of your own papers or reports without properly citing your original work.

This is problematic because you may benefit from presenting your ideas as new and original even though they’ve already been published elsewhere in the past. You may also be infringing on your previous publisher’s copyright, violating an ethical code, or wasting time and resources by doing so.

In extreme cases of self-plagiarism, entire datasets or papers are sometimes duplicated. These are major ethical violations because they can skew research findings if taken as original data.

You notice that two published studies have similar characteristics even though they are from different years. Their sample sizes, locations, treatments, and results are highly similar, and the studies share one author in common.

Research misconduct

Research misconduct means making up or falsifying data, manipulating data analyses, or misrepresenting results in research reports. It’s a form of academic fraud.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement about data analyses.

Research misconduct is a serious ethical issue because it can undermine academic integrity and institutional credibility. It leads to a waste of funding and resources that could have been used for alternative research.

Later investigations revealed that they fabricated and manipulated their data to show a nonexistent link between vaccines and autism. Wakefield also neglected to disclose important conflicts of interest, and his medical license was taken away.

This fraudulent work sparked vaccine hesitancy among parents and caregivers. The rate of MMR vaccinations in children fell sharply, and measles outbreaks became more common due to a lack of herd immunity.

Research scandals with ethical failures are littered throughout history, but some took place not that long ago.

Some scientists in positions of power have historically mistreated or even abused research participants to investigate research problems at any cost. These participants were prisoners, under their care, or otherwise trusted them to treat them with dignity.

To demonstrate the importance of research ethics, we’ll briefly review two research studies that violated human rights in modern history.

These experiments were inhumane and resulted in trauma, permanent disabilities, or death in many cases.

After some Nazi doctors were put on trial for their crimes, the Nuremberg Code of research ethics for human experimentation was developed in 1947 to establish a new standard for human experimentation in medical research.

In reality, the actual goal was to study the effects of the disease when left untreated, and the researchers never informed participants about their diagnoses or the research aims.

Although participants experienced severe health problems, including blindness and other complications, the researchers only pretended to provide medical care.

When treatment became possible in 1943, 11 years after the study began, none of the participants were offered it, despite their health conditions and high risk of death.

Ethical failures like these resulted in severe harm to participants, wasted resources, and lower trust in science and scientists. This is why all research institutions have strict ethical guidelines for performing research.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

• Normal distribution
• Measures of central tendency
• Chi square tests
• Confidence interval
• Quartiles & Quantiles
• Cluster sampling
• Stratified sampling
• Thematic analysis
• Cohort study
• Peer review
• Ethnography

Research bias

• Implicit bias
• Cognitive bias
• Conformity bias
• Hawthorne effect
• Availability heuristic
• Attrition bias
• Social desirability bias

Ethical considerations in research are a set of principles that guide your research designs and practices. These principles include voluntary participation, informed consent, anonymity, confidentiality, potential for harm, and results communication.

Scientists and researchers must always adhere to a certain code of conduct when collecting data from others .

These considerations protect the rights of research participants, enhance research validity , and maintain scientific integrity.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe.

Anonymity means you don’t know who the participants are, while confidentiality means you know who they are but remove identifying information from your research report. Both are important ethical considerations .

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, or videos.

You can keep data confidential by using aggregate information in your research report, so that you only refer to groups of participants rather than individuals.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement but a serious ethical failure.

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• Published: 22 April 2023

Ethical considerations for researchers developing and testing minimal-risk devices

• Anna Wexler   ORCID: orcid.org/0000-0002-6723-9038 1 &
• Emily Largent 1  

Nature Communications volume  14 , Article number:  2325 ( 2023 ) Cite this article

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This comment provides an overview of ethical considerations for researchers developing and testing minimal-risk devices that interact or interface with people, such as electronic wearables and biomedical sensors. We outline the process of independent review, emphasizing that research can undergo different levels of review depending on its design and risk level. Using scenarios drawn from our own experience, we outline salient ethical considerations for research with such minimal-risk devices.

An increasing number of tools and devices that directly interact or interface with people for electronic wearable and bioengineering applications are being developed, tested, and marketed to consumers 1 . For example, wearable devices, which may record everything from skin temperature to electrical brainwave signals, enable wearers to monitor a wide range of information generated by their bodies. Part of the device development process includes prototyping and testing, as researchers must establish the reliability and validity of their wearable by having people use it. Many engineers and materials scientists may, however, not be aware that they should obtain approval from an independent review committee prior to testing their device with people. This independent oversight requirement does not merely apply to clinical trials testing novel drugs or devices in patient populations; it can also extend to researchers and engineers developing seemingly “harmless” sensors or conducting “quick” validation tests on themselves or members of their lab group.

In the process known as “independent review,” researchers submit a detailed study plan or “protocol” to a group of experts not affiliated with the research who are able to assess the protocol and ensure its compliance with ethical standards and relevant research regulations. Independent review can be a legal requirement (e.g., for government-funded research or research submitted to drug or device regulators) or an institutional one (e.g., if the research is conducted under the auspices of a university or academic medical center). Other gatekeepers may also require independent review. For example, before publication, many academic journals require authors to affirm their studies were conducted with adequate participant protections, and platforms such as Apple’s app store require evidence of independent ethics review before distributing software that collects data for research purposes 2 . Notably, compliance with such requirements cannot be achieved retrospectively; thus, researchers must address independent review prospectively or risk myriad consequences.

In this article, we provide an overview of research ethics considerations for researchers developing and testing wearable health devices with human subjects. We first review the importance of independent review. Next, we outline the process of independent review, emphasizing that research can undergo different levels of review depending on its design and risk level. Finally, using scenarios drawn from our real-word experience, we outline salient ethical considerations for research with wearables and describe the steps researchers can take to ensure compliance with ethics requirements.

Why is independent review important?

Though a researcher may simply be seeking to better understand the performance or function of their wearable device, if they are doing so by interacting with and collecting information from living individuals, they are conducting “human subjects research” (see Table  1 for definition). Multiple national and international consensus documents have set forth ethical guidelines for research conducted with human subjects 3 . There are notable commonalities across these research ethics guidelines, which have been distilled by prominent research ethicists into seven requirements for ethical research 3 . These requirements apply to human subjects research, including but not limited to research with wearable health devices. The research must be (1) socially valuable and (2) scientifically rigorous, as well as offer (3) a favorable risk–benefit ratio. Subjects must (4) be selected fairly and (5) give informed consent for their participation. Researchers must (6) demonstrate respect for potential and enrolled subjects. Finally, the research must (7) undergo independent review. As we discuss below, independent review helps to assure compliance with relevant ethical and regulatory requirements and to address additional issues as they arise.

Researchers have certain reasonable interests—such as the desire to publish, develop and market a new wearable health device, or obtain grant funding—that may not be aligned with subjects’ interests. Even well-intentioned researchers may be unable to reflect impartially on their own research. Review by individuals unaffiliated with the research provides an opportunity for impartial assessment to minimize the effects of any conflicts of interest and ensure appropriate safeguards are in place to protect and promote subjects’ wellbeing 3 .

For this reason, numerous stakeholders might require independent review. For instance, in the United States, independent review is required for clinical investigations of interventions—such as drugs, biologics, and devices—under the jurisdiction of the U.S. Food and Drug Administration, as well as for human subjects research funded by many federal agencies. Institutions engaged in federally-funded human subjects research, such as universities and academic medical centers, must comply with federal research regulations, and many elect to extend independent review requirements to all human subjects research conducted under their auspices, regardless of funding source. Similar regulations and guidelines exist across the globe 3 , 4 .

Before prototyping and testing their wearable devices, researchers should acquaint themselves with any relevant independent review requirements. This involves becoming familiar with both legal and local institutional requirements. Furthermore, even absent a legal or institutional requirement, independent review may be necessary to satisfy other stakeholders, including private funders, academic journals, or app platforms. Thus, researchers should also consider their funding source as well as how they might want to disseminate their findings or market their wearable health devices and address any oversight requirements entailed by those choices.

Who conducts independent review, and how does it proceed?

Independent review is undertaken by committees officially constituted to oversee human subjects research 5 . In the United States, these are known as institutional review boards (IRBs); elsewhere they may be known as research ethics committees or independent ethics committees 4 , 5 , 6 . Hereafter, we will use “committee” or “independent review committee” to refer to these bodies. Committee members typically have a range of expertise so that they can provide robust review. Some committees are operated by academic or other institutions, others are operated by governments or funders 7 , and still others are independent (i.e., not affiliated with an institution) and review research for a fee 8 .

While each independent review committee has different requirements, reflecting both their own policies and relevant regulations, a researcher who is conducting human subjects research typically must prepare and submit a detailed protocol that outlines the study objectives, methods, data management and analysis procedures, and plans to address ethical issues that may arise. This protocol is then reviewed by the committee, which can approve it, require modifications to it, or reject it. If a researcher has questions—for instance, regarding the need for independent review or how to prepare a protocol—many committees have websites that provide submission guidelines and resources, as well as contact information for the committee.

Protocols may undergo different levels of review depending on specific aspects of the study’s design and risk profile. For example, in the United States, there are three main designations: exempt research , expedited review , and full committee review (see Fig.  1 ). Research that involves “minimal risk” (see Table  1 ) to subjects and includes only behavioral research—such as surveys or passive observation—may be deemed exempt from federal regulations and need not undergo IRB review, though the IRB may still need to assess the protocol to confirm its exempt status. Research that involves minimal risk but does not meet the requirements for an exemption may qualify for expedited review . For example, data collected through noninvasive means, such as wearable devices and sensors, or via recordings (e.g., audio, textual, or visual) will typically qualify for expedited review. When review is expedited, the protocol may be reviewed by one or more experienced IRB members without the need to convene the full committee, which may result in faster review. All research that is deemed to involve higher levels of risk requires full committee review . Importantly, researchers themselves do not determine the appropriate level of review; this assessment is made by the committee after the protocol’s submission.

A researcher developing a new device should carefully consider whether the research must undergo independent review prior to commencing research. If independent review is necessary, the researcher must prepare a protocol and submit it to an independent review committee that will determine the appropriate level of review (i.e., exempt, expedited, or full committee review). The committee will review the protocol, and either approve it, require modifications, or reject it. Research should only begin once the protocol is approved.

Independent review committees are generally subject to legislation at the national level, with a goal of better serving local needs and addressing cultural preferences 6 . This can result in substantial variability in review procedures between and within countries and underscores the importance of familiarizing oneself with relevant laws 6 , 7 , 9 . While the details do vary, in a broad sense, most committees will look to see that the seven requirements of ethical research, described above, are satisfied.

What do independent review committees look for in a research protocol involving human subjects?

While it is not possible to cover all ethical considerations relevant to device research, here we use two scenarios of researchers developing wearable health devices to illustrate salient ethical features that researchers should consider. Note that the ethical issues highlighted here are not unique to wearable device research and must also be addressed for other kinds of research with human subjects.

Scenario 1: A university professor is developing a wet adhesive on-skin sensor that assesses both cardiac rhythms and hydration levels. The professor plans to validate the device on students enrolled in a course she teaches. She would like to collect additional data from students’ smartphones, such as location and activity data, to see if she can detect meaningful correlations between physical activity, heart rate, and hydration levels .

Fair subject selection : The proposed sample—students enrolled in the professor’s course—is a “convenience sample,” chosen for being close at hand rather than for the advancement of scientific goals. This raises questions about fair subject selection—that is, whether the subjects are chosen for scientific purposes rather than factors unrelated to the purposes of the study, like vulnerability or privilege. Indeed, this sample may differ from the general population in some way, introducing bias. Thus, in developing study methodology, researchers should ensure that their sample is fairly chosen and justified by the science.

Risk–benefit ratio : Although the research described in the above scenario would likely meet the definition of minimal risk, this will be a fact-specific determination, as wet adhesives involve chemicals that can irritate the skin or cause allergic reactions. The committee will consider physical risks as well as psychological, social, and economic risks. The professor in the scenario, like all researchers, should enumerate risks and burdens to subjects, identify and implement steps to minimize them, and—once they are minimized—weigh whether the potential benefits of the study (i.e., either direct benefits to participants or socially beneficial knowledge) outweigh the risks to subjects.

Data protection and privacy : Breaches of privacy and confidentiality pose risks to participants. In this scenario, the location data the professor proposes to collect may intrude on her students’ privacy and, if breached, reveal sensitive information like home addresses. When creating a study plan, researchers should consider the least-intrusive means of achieving their research aims and propose clear methods of data protection like encrypting data or stripping it of identifiers.

Informed consent : Prior to participating in a study, prospective participants must understand the purpose of the study as well as attendant risks and benefits so they can make an informed decision about participation. This is usually achieved through an “informed consent” process in which the researcher shares key information about a study with a prospective subject, often orally and in writing. Independent review committees often make templates or standard language available to researchers to ensure the disclosure of all necessary information, some of which may be dictated by research regulations.

It is important that consent is not only informed but voluntary, and independent review committees are charged with assuring that consent is obtained under circumstances that minimize the possibility of coercion or undue influence. (Coercion occurs when there is a threat to make an individual worse off or to deny them of something to which they are entitled, and undue influence occurs when something of extreme value is offered to individuals, leading them to make an unreasonable decision) 10 . In the above scenario, committee members may be reasonably concerned that the professor’s students will feel compelled to participate given the power imbalance in their student–teacher relationship. For example, students might worry that they will be graded more harshly if they do not enroll. When developing a study protocol, researchers should take care to consider and address potential threats to voluntariness.

Incidental findings : Previously unknown medical conditions may be unintentionally discovered in the course of research; such a discovery is known as an “incidental finding” 11 . In this scenario, it is possible that the professor might detect a heart arrythmia in one of her students that would require medical attention. Researchers should anticipate that incidental findings may arise in their studies and prospectively develop plans for managing them; this might include informing individuals of such findings or referring them to an appropriate clinician.

Scenario 2: An engineering Ph.D. student is developing a t-shirt with an integrated electrothermal heater that can be worn during cold-weather sports activities to improve athletic performance. He has comprehensively tested mechanical robustness and uniform temperatures in the lab and would like to commence testing the t-shirt on people. To avoid having to find volunteers, he plans to test on the shirt on himself and submit the results for publication in an academic journal .

Self-experimentation : Independent review may seem unnecessary when the researcher and human subject are one and the same because we think autonomous individuals can permissibly choose to impose risks and burdens on themselves, but many academic institutions have policies requiring researchers to obtain approval prior to experimenting on themselves 12 . Further, given that the Ph.D. student plans to submit his research for publication, he will likely need evidence of independent ethics review even if the source of his data is self-experimentation. This scenario illustrates the importance of being familiar with local requirements and considering downstream uses of the data to ensure compliance with independent review obligations.

Scientific rigor : Independent review committees will often assess whether the proposed research methods are valid and feasible and will answer the research question. In this scenario, the committee will likely worry that having only one research participant means that there will not be sufficient power for data analysis. Because research involves exposing subjects to risks, researchers should design their studies to have clear scientific objectives and utilize accepted methods.

Additional ethical considerations

Several additional ethical issues fall outside independent review committees’ typical purview review but are worth mentioning. First, many wearable devices that utilize biomedical sensors—such as pulse oximeters and heart rate monitors—have been shown to be less accurate for individuals with darker skin tones 13 . Researchers should take care not to test their prototypes on homogenous groups of individuals, which may introduce bias and limit generalizability.

Second, while there is a tendency to assume that more data is always beneficial, this is not necessarily the case. Consider wearable electroencephalogram (EEG) devices, which are intended to enable better at-home seizure detection and monitoring for individuals with epilepsy. While these devices are being developed with the intention of improving patients’ lives, there might be unintended negative consequences. For example, EEG devices may capture data regarding subclinical seizures (i.e., only detectable via EEG) that could limit individuals’ driving privileges 14 .

Finally, while researchers tend to assume that their wearable devices will be used in the manner intended, others may utilize devices in unexpected ways. In the realm of noninvasive brain stimulation, for instance, early prototypes of simple brain stimulation devices led to the rise of a do-it-yourself community wherein members of the public turned to investigator-published literature to inform their practices 15 , despite warnings that safety was not yet well established. Thus, even during development, researchers should be aware of how their devices and research findings may be used in unintended ways.

As researchers develop novel wearable health devices and begin testing them with people, it is crucial that they understand and comply with relevant research ethics requirements and regulations. This includes satisfying independent review requirements imposed by their institution, funder, government, or other stakeholders prior to commencing research, as ethics approval cannot be obtained retroactively. For researchers conducting research outside of institutions that have standing review committees, there are independent committees that will review protocols for a fee. Researchers can reach out to the committee reviewing their protocols to ask questions (e.g., about the level of review) and to obtain helpful resources, such as directions for protocol preparation or informed consent form templates. Furthermore, maintaining an awareness of additional ethical considerations—such as the possibility of bias, downstream implications, and unintended uses—can help researchers develop wearable health devices in a responsible manner.

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E.L. and A.W. acknowledge funding from the NIH National Institute on Aging (NIA) under award number P30-AG-073105. E.L. is supported by the Greenwall foundation and the NIA under awards K01AG064123 and R01AG077111. A.W. is supported by the NIH Office of the Director under Award Number DP5OD026420.

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• Introduction
• Conclusions
• Article Information

PRO indicates patient-reported outcome.

a See eTable 1 in the Supplement for details regarding Delphi survey and consensus meeting participant characteristics.

b Six additional stakeholders provided comments prior to or after the meeting.

Acknowledgements

eFigure. Decision Tree for Inclusion/Exclusion of Candidate Items

eTable 1. Delphi Survey and Consensus Meeting Participants Characteristics

eTable 2. Consensus Meeting Notes and Outcomes of Voting for the PRO Ethics Guidelines

eTable 3a. Eight Items (Items 2-17) Which Fulfilled the Inclusion Criteria at the Delphi Exercise Stage

eTable 3b. Nine Items Proposed for Inclusion to Discuss at the Consensus Meeting

eTable 4a. Excluded Candidate Items at the Delphi Exercise Stage

eTable 4b. Excluded Candidate Items That Were Merged With Other Items and/or Were Covered by Existing Items

• Electronic Symptom Monitoring With Patient-Reported Surveys and Outcomes Among Patients With Metastatic Cancer JAMA Original Investigation June 28, 2022 This randomized clinical trial assesses the effect of using weekly electronic patient-reported outcome surveys to monitor symptoms, compared with usual care, on physical function, symptom control, and health-related quality of life among patients receiving treatment for metastatic cancer. Ethan Basch, MD, MSc; Deborah Schrag, MD, MPH; Sydney Henson, BS; Jennifer Jansen, MPH; Brenda Ginos, MS; Angela M. Stover, PhD; Philip Carr, MPH; Patricia A. Spears, BS; Mattias Jonsson, BA; Allison M. Deal, MS; Antonia V. Bennett, PhD; Gita Thanarajasingam, MD; Lauren J. Rogak, MA; Bryce B. Reeve, PhD; Claire Snyder, PhD; Deborah Bruner, PhD; David Cella, PhD; Lisa A. Kottschade, MSN; Jane Perlmutter, PhD; Cindy Geoghegan, MA; Cleo A. Samuel-Ryals, PhD; Barbara Given, PhD; Gina L. Mazza, PhD; Robert Miller, MD; Jon F. Strasser, MD; Dylan M. Zylla, MD; Anna Weiss, MD; Victoria S. Blinder, MD; Amylou C. Dueck, PhD
• Patient-Reported Outcome Measures in Clinical Research JAMA JAMA Guide to Statistics and Methods August 2, 2022 This Guide to Statistics and Methods provides an overview of patient-reported outcome measures for clinical research, emphasizes several important considerations when using them, and points out their limitations. Kevin P. Weinfurt, PhD; Bryce B. Reeve, PhD
• Stability of Changes in Health Status JAMA Viewpoint September 13, 2022 This Viewpoint explores how patient-reported response to treatment informs understanding of clinically meaningful outcomes to help establish patient expectations, inform clinical decision-making, and ensure treatment is sound. Muhammad Shahzeb Khan, MD, MSc; Javed Butler, MD, MPH, MBA
• Sharing of Individual Patient-Level Data by Trialists of Randomized Clinical Trials JAMA Research Letter May 16, 2023 This study describes access to individual patient-level data from randomized clinical trials during the COVID-19 pandemic to determine whether the intent to share what was reported in the registry, publication, or preprint was consistent with actual data access. Laura C. Esmail, PhD; Philipp Kapp, MSc; Rouba Assi, PharmD, MSc; Julie Wood, BA; Gabriela Regan, BA; Philippe Ravaud, MD, PhD; Isabelle Boutron, MD, PhD

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Cruz Rivera S , Aiyegbusi OL , Ives J, et al. Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research : The PRO Ethics Guidelines . JAMA. 2022;327(19):1910–1919. doi:10.1001/jama.2022.6421

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Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research : The PRO Ethics Guidelines

• 1 Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom
• 2 Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, United Kingdom
• 3 DEMAND Hub, University of Birmingham, Birmingham, United Kingdom
• 4 National Institute for Health and Care Research (NIHR) Applied Research Centre West Midlands, Birmingham, United Kingdom
• 5 Centre for Ethics in Medicine, Bristol Medical School, University of Bristol, Bristol, United Kingdom
• 6 Warwick Medical School, University of Warwick, Coventry, United Kingdom
• 7 NHMRC Clinical Trials Centre, Faculty of Medicine and Health, The University of Sydney, New South Wales, Australia
• 8 School of Population and Global Health, McGill University, Montreal, Quebec, Canada
• 9 A J Hunn Associates, London, United Kingdom
• 10 PRO Center of Excellence, Global Commercial Strategy Organization, Janssen Global Services, Warrington, United Kingdom
• 11 Division of Pediatric Haematology-Oncology, IWK Health Care Centre, Dalhousie University, Halifax, Nova Scotia, Canada
• 12 Observational and Pragmatic Research Institute, Midview City, Singapore
• 13 US Food and Drug Administration, Silver Spring, Maryland
• 14 European Organization for Research and Treatment of Cancer, Brussels, Belgium
• 15 Medicines and Healthcare Products Regulatory Agency, London, United Kingdom
• 16 Health Research Authority, London, United Kingdom
• 17 Patient partner, University of Birmingham, Birmingham, United Kingdom
• 18 Fast Track Research Ethics Committee, Health Research Authority, London, United Kingdom
• 19 JAMA Network, Chicago, Illinois
• 20 RTI Health Solutions, Research Triangle, North Carolina
• 21 Aparito Limited, Wrexham, Wales, United Kingdom
• 22 MRC-Versus Arthritis Centre for Musculoskeletal Ageing Research, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom
• 23 NIHR Birmingham Biomedical Research Centre, University Hospital Birmingham and University of Birmingham, Birmingham, United Kingdom
• 24 NIHR Surgical Reconstruction and Microbiology Research Centre, University Hospital Birmingham and University of Birmingham, Birmingham, United Kingdom
• 25 Aetion, Washington, DC
• 26 Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan
• 27 Global Patient-Centred Outcomes Research & Policy, UCB, Belgium, Brussels
• 28 Nature Medicine , New York, New York
• 29 Department of Cardiology, Odense University Hospital, Odense, Denmark
• 30 Clinical Institute, University of Southern Denmark, Odense, Denmark
• 31 Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois
• 32 Menzies Institute for Medical Research, University of Tasmania, Tasmania, Australia
• 33 Department of Health Services, Policy and Practice, Brown University School of Public Health, Providence, Rhode Island
• 34 University of North Carolina at Chapel Hill
• 35 Consumer Forum, National Cancer Research Institute, London, United Kingdom
• 36 Patient Involvement Network, Health Research Authority, London, United Kingdom
• 37 Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, United Kingdom
• 38 Health Data Research United Kingdom, London, United Kingdom
• 39 UK SPINE, University of Birmingham, Birmingham, United Kingdom
• Original Investigation Electronic Symptom Monitoring With Patient-Reported Surveys and Outcomes Among Patients With Metastatic Cancer Ethan Basch, MD, MSc; Deborah Schrag, MD, MPH; Sydney Henson, BS; Jennifer Jansen, MPH; Brenda Ginos, MS; Angela M. Stover, PhD; Philip Carr, MPH; Patricia A. Spears, BS; Mattias Jonsson, BA; Allison M. Deal, MS; Antonia V. Bennett, PhD; Gita Thanarajasingam, MD; Lauren J. Rogak, MA; Bryce B. Reeve, PhD; Claire Snyder, PhD; Deborah Bruner, PhD; David Cella, PhD; Lisa A. Kottschade, MSN; Jane Perlmutter, PhD; Cindy Geoghegan, MA; Cleo A. Samuel-Ryals, PhD; Barbara Given, PhD; Gina L. Mazza, PhD; Robert Miller, MD; Jon F. Strasser, MD; Dylan M. Zylla, MD; Anna Weiss, MD; Victoria S. Blinder, MD; Amylou C. Dueck, PhD JAMA
• JAMA Guide to Statistics and Methods Patient-Reported Outcome Measures in Clinical Research Kevin P. Weinfurt, PhD; Bryce B. Reeve, PhD JAMA
• Viewpoint Stability of Changes in Health Status Muhammad Shahzeb Khan, MD, MSc; Javed Butler, MD, MPH, MBA JAMA
• Research Letter Sharing of Individual Patient-Level Data by Trialists of Randomized Clinical Trials Laura C. Esmail, PhD; Philipp Kapp, MSc; Rouba Assi, PharmD, MSc; Julie Wood, BA; Gabriela Regan, BA; Philippe Ravaud, MD, PhD; Isabelle Boutron, MD, PhD JAMA

Question   What ethical considerations should be considered by researchers, research ethics committees, and funders when conducting or reviewing patient-reported outcome (PRO) clinical research?

Findings   An international consensus Delphi process was developed according to the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodology; 14 items addressing ethical considerations were recommended for inclusion in the PRO ethics guidelines.

Meaning   Addressing the items in the PRO ethics guidelines has the potential to improve the quality of PRO in clinical research while promoting and protecting participant autonomy and protecting participant and researcher welfare.

Importance   Patient-reported outcomes (PROs) can inform health care decisions, regulatory decisions, and health care policy. They also can be used for audit/benchmarking and monitoring symptoms to provide timely care tailored to individual needs. However, several ethical issues have been raised in relation to PRO use.

Objective   To develop international, consensus-based, PRO-specific ethical guidelines for clinical research.

Evidence Review   The PRO ethics guidelines were developed following the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network’s guideline development framework. This included a systematic review of the ethical implications of PROs in clinical research. The databases MEDLINE (Ovid), Embase, AMED, and CINAHL were searched from inception until March 2020. The keywords patient reported outcome* and ethic* were used to search the databases. Two reviewers independently conducted title and abstract screening before full-text screening to determine eligibility. The review was supplemented by the SPIRIT-PRO Extension recommendations for trial protocol. Subsequently, a 2-round international Delphi process (n = 96 participants; May and August 2021) and a consensus meeting (n = 25 international participants; October 2021) were held. Prior to voting, consensus meeting participants were provided with a summary of the Delphi process results and information on whether the items aligned with existing ethical guidance.

Findings   Twenty-three items were considered in the first round of the Delphi process: 6 relevant candidate items from the systematic review and 17 additional items drawn from the SPIRIT-PRO Extension. Ninety-six international participants voted on the relevant importance of each item for inclusion in ethical guidelines and 12 additional items were recommended for inclusion in round 2 of the Delphi (35 items in total). Fourteen items were recommended for inclusion at the consensus meeting (n = 25 participants). The final wording of the PRO ethical guidelines was agreed on by consensus meeting participants with input from 6 additional individuals. Included items focused on PRO-specific ethical issues relating to research rationale, objectives, eligibility requirements, PRO concepts and domains, PRO assessment schedules, sample size, PRO data monitoring, barriers to PRO completion, participant acceptability and burden, administration of PRO questionnaires for participants who are unable to self-report PRO data, input on PRO strategy by patient partners or members of the public, avoiding missing data, and dissemination plans.

Conclusions and Relevance   The PRO ethics guidelines provide recommendations for ethical issues that should be addressed in PRO clinical research. Addressing ethical issues of PRO clinical research has the potential to ensure high-quality PRO data while minimizing participant risk, burden, and harm and protecting participant and researcher welfare.

Patient-reported outcomes (PROs) are used in clinical research and routine care to provide information on the physical, functional, and psychological effects of disease and treatment from the patient perspective. 1 PRO data can inform health care decisions, regulatory decisions, health care policy, and cost-effectiveness analyses. PROs can also be used for audit/benchmarking and monitoring of symptoms to provide timely care tailored to individual needs. 1 , 2 Notwithstanding the potential benefits of incorporating PROs in research and routine practice, ethical considerations have been highlighted. 3 For example, the PRO content of clinical trial protocols and reporting of PRO results is commonly inadequate. A 2019 evaluation of 160 cancer trials showed nearly 50 000 participants were included in studies that failed to publish their PRO data. 4

The increasing use of PROs may lead to uncertainties for patients about why data are being collected and used. There is a lack of guidance on how research personnel should manage situations in which PRO data reveal concerning levels of psychological distress or physical symptoms. 5 If concerning data are not managed appropriately, those data could lead to suboptimal participant care or biased trial results. 6 In addition, PRO research may not reflect the perspectives of underserved groups such as older individuals, socioeconomically disadvantaged populations, and racial and ethnic minority groups, which could threaten the scientific validity of results. 3 , 7

Ethical issues should be resolved with justifications that use established principles, theories, and values, as well as consider individual and societal welfare. 3 In 2018, the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials)-PRO Extension was developed to provide PRO trial protocol guidance. 8 These guidelines were not, however, developed specifically for the use of research ethics committees (RECs) and limited attention has been given to the ethical dimensions of PROs in clinical research. 7 Thus, there is a need to develop ethical guidelines to address this. The aim of this international effort was to develop consensus-based guidelines for the specific use of PROs in clinical research.

The PRO ethics guidelines were developed through an international Delphi process following the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network’s framework for guideline development ( Figure ). 9

The PRO Ethics Steering Group, formed by 11 international experts with patient and public involvement (Acknowledgements in the Supplement ), was established to oversee the design and conduct of the study.

Ethical approval was given by the University of Birmingham Ethical Review Board (ERN_21-0075).

Candidate items were identified by the steering group from the SPIRIT-PRO Extension 8 guidelines and Supplement 3 of the accompanying SPIRIT-PRO Extension article. 8 Explanation of the candidate items was derived from lay terminology of the SPIRIT-PRO Extension. 10 The candidate items were supplemented with items generated from a systematic review of articles describing the ethical implications of PROs in clinical research. The protocol for the systematic review was registered on PROSPERO (registration No. CRD42020176177). The databases MEDLINE (Ovid), EMBASE, Allied and Complementary Medicine Database (AMED), and CINAHL (Cumulative Index to Nursing and Allied Health Literature) Plus were searched from inception until March 2020 with the keywords patient reported outcome* and ethic* .

Publications were deemed eligible if they discussed ethical implications and/or guidance in the context of PRO clinical trials research, routine clinical practice, and broader PRO research. Two reviewers (SCR and OLA) independently conducted title and abstract screening before full-text screening to determine eligibility. Discrepancies were resolved through the involvement of a third reviewer (MJC). Text excerpts on ethical considerations of PRO research from the included studies were independently extracted by the 2 investigators (SCR and OLA) into a qualitative data analysis software package (NVivo 12; QSR International). Both reviewers independently generated categories and themes under the thematic analysis approach. The review identified 14 relevant articles, including qualitative reports, opinion and debate articles, and special communications that discussed the ethical implications of PRO research.

Based on the review, 6 candidate items were identified, and 17 items were drawn from the SPIRIT-PRO Extension guidelines 8 and Supplement 3 of that article.

In 2021, 201 international multidisciplinary individuals with interest in PRO research were invited to participate in the online Delphi process to vote on the candidate items and propose additional items. These participants comprised individuals responsible for developing PRO research submissions for ethical review, those undertaking ethical review, or using of data arising from PRO research. Potential participants were identified and contacted via the PRO Ethics Operations Group (S.C.R., M.J.C., O.L.A., A.P.D.) and the Health Research Authority (HRA). A snowballing technique and social media (LinkedIn and Twitter) were used to identify further participants. Participant characteristics are described in eTable 1 in the Supplement . DelphiManager software (version 5.0), developed and maintained by the COMET (Core Outcome Measures in Effectiveness Trials) Initiative, was used to undertake the 2 Delphi surveys. 11

Participants were provided with written information about the study prior to consenting to participate. Participants voted anonymously on a 9-point scale (1-3: not important; 4-6: important but not critical; and 7-9: important and critical) on the importance of the 23 items presented. Ninety-six responses were received for round 1 of the Delphi and 85 responses (89% of participants from round 1) were received for round 2. Participants were advised if they did not complete round 2, their round 1 responses would be retained. During round 1, participants had the option to suggest additional items. During round 2, 12 additional items were included. Anonymized item-level round 1 scores per participant group were presented to Delphi panelists for their consideration prior to round 2 voting.

The operations group mapped the 35 candidate PRO ethics items to existing HRA guidance from the UK, as an initial indicator of what may already be covered in existing ethics guidance, 12 removing duplicates and revising wording to aid clarification. The operations group presented the consensus delegates with recommendations for the inclusion or exclusion of items based on the decision tree (eFigure in the Supplement ). The COMET Initiative guidance informed the inclusion criteria (eMethods in the Supplement ). 13

An online consensus meeting took place in October 2021 hosted by the University of Birmingham, UK. Twenty-five international participants purposively selected from the Delphi survey attended the consensus meeting, comprising 7 clinical trialists/health academic researchers, 4 ethicists/members of an ethical review panel, 2 health care professionals, 3 PRO researchers from industry, 2 journal editors, 4 patients and members of the public, 1 policy maker, 1 regulator, and 1 bioethicist (eTable 1 in the Supplement ). Delegates were presented with candidate items and anonymously voted using the Zoom poll tool. Participants had the following voting options: include, exclude, or further discussion required (see the Participation in the Voting Process section, eMethods in the Supplement , for further details).

The aim of the meeting was to seek consensus on the content of the PRO ethics guidelines. Consensus panelists considered the focus of the guidelines and agreed that the guidelines covered ethical considerations when undertaking PRO clinical research. In addition, participants discussed the wording and explanatory text of each item. A threshold of 70% or more was prespecified to demonstrate consensus when voting on the items (see the Consensus Meeting section, eMethods in the Supplement , for further details). The items were presented alongside the overall Delphi score and the number of participant groups whereby 70% or more of respondents scored an item as important and critical.

Following the consensus meeting, attendees commented on the wording and agreed on the final version of the PRO ethics guidelines. Final edits were made to improve clarity and were approved by the steering group and patient partners. The eMethods section in the Supplement provides further information on methods.

The final PRO ethics guidelines identified 14 key questions that capture core ethical issues ( Table ). The items incorporated content from 14 of the 35 original candidate items, comprising 6 items that were merged during the consensus meeting and 8 items that were not modified (see eTables 2 and 3a and 3b in the Supplement ). Further details about the 21 excluded items are presented in eTables 4a and 4b in the Supplement . An explanation describing each item with supporting evidence is presented below. The items are presented in accordance with SPIRIT-PRO Extension subheadings and findings from the systematic review.

Explanation: Evidence suggests that many trials include PROs without specifying the PRO-specific research question and without a rationale or reference to PROs in related studies. 4 , 14 , 15 Researchers should carefully consider the PRO-specific research question to inform the selection of measures and methodological approach to help ensure results are meaningful. 8 In addition, patients and research personnel should understand why PRO data are being collected and how their data will be used, and this should be communicated effectively. 4 , 14 , 15 This can help build trust, particularly when participants may share potentially sensitive information. Why data are being collected and how these data will be used should be clearly explained in the information sheet, by research personnel, or both during the consent process.

Explanation: Clearly defined PRO objectives and hypotheses inform study design, including the selection of key PRO concepts and measures, time points for assessment, and analyses. 16 Poorly defined PRO objectives or hypotheses may affect the quality of research design and reporting. Poor science undermines participant consent (failing to respect autonomy) and exposes participants to unnecessary risk or burden because the results are ultimately not usable or not generalizable.

Explanation: Researchers should consider PRO-specific eligibility requirements at the design stage of the study and robustly justify excluding a subpopulation. It would undermine the principle of justice to exclude eligible people either directly or indirectly (eg, as a result of a failure to consider PRO accessibility or other equity, diversity, and inclusion issues). 17

Explanation: The PRO concept and analysis metric should be clearly outlined and aligned with the PRO objectives and hypothesis to ensure that they capture outcomes that matter to patients and other key interested groups, such as clinicians, regulators, and policy makers. Defining and justifying the selection of PRO instrument(s) are important aspects of ethical research. If possible, the PRO measure should be validated in the target population. The number of questionnaires used, acceptability of the questions, and participant burden should be considered carefully. PRO measures ideally should be used in accordance with existing user manuals to promote data quality and ensure standardized scoring. 8 When a PRO is being considered for a new population, representative patient input should be obtained about the suitability and appropriateness of the questions to determine whether the questions are relevant to the target population. 18

Explanation: Providing the schedule of PRO assessments in the study protocol and participant information sheet is the first step to ensuring potential participants understand the commitment and effort involved in taking part in the PRO study. A robust consent process includes information provision and checks on understanding. A poor process compromises respect for participant autonomy. 19 , 20

Explanation: Exposing participants to the risks and burdens of PRO research is only justifiable if these are outweighed by the potential value of the PRO data. A sample size that is too small may produce inconclusive and, therefore, not valuable results. A sample size that is too large will expose more participants than necessary to risks and burdens and incur unnecessary costs. 21 Item 14 of the SPIRIT-PRO Extension indicates that if PROs are the primary outcome of a study, a priori sample size calculation should be provided for that specific end point. If PROs are a secondary outcome, the sample size should provide enough power to test the principal PRO hypothesis. 8 This would not be required for exploratory PRO end points.

Explanation : Research personnel should understand how and where PRO data will be collected, and clear communication of this to potential participants is an essential component of a robust informed consent process. The mode(s) of administration should be influenced by the setting in which PRO data will be collected (eg, telephone or electronic completion may be more feasible from home) and the needs of the target population. 22 Ideally, participants from the target population would provide input on modes. Offering alternative modes of completion may help improve response rates and promote inclusivity and equity—all of which improve the quality of the results. 23 Item 18a(ii) of the SPIRIT-PRO Extension provides further information regarding the modes of PRO administration and setting for PRO randomized clinical trials. 8

Explanation: Responding to PRO alerts (concerning levels of psychological distress or physical symptoms that require timely response) 6 may protect the safety and welfare of participants, 17 which is an important ethical consideration. The research protocol should state whether, why, and by whom PRO data will be monitored during the study and this information should be shared with participants. 5 , 6 In low-risk studies in which alerts for concerning symptoms are not anticipated, PRO monitoring may not be necessary. Similarly, protocols should state whether research data will be shared with the patient’s care team or entered in the electronic medical record. Alternative support mechanisms (eg, 24-hour helpline) for participants should be outlined. All research personnel involved in the management of PRO alerts should receive appropriate training and have clear pathways for support. 24 , 25 Evidence suggests research personnel handle such data inconsistently, which may lead to inequitable patient care, cointervention bias, and confusion. 6 In addition, personnel in charge of collecting PRO data may feel emotional and/or ethical burden while dealing with concerning PRO data (eg, reports from trial participants of low self-esteem, depression, or risk of self-harm or suicide). 25

Explanation: PRO protocols should promote participant inclusivity while recruiting a diverse population that is representative of patients with the condition of interest. Barriers to participation, such as access to technology in rural areas, areas of socioeconomic disadvantage, or both, as well as disability, language, and cultural requirements, should be addressed to promote fairness and ensure results are as accurate and generalizable as possible. 26 For example, a clinical trial of adults receiving chemotherapy at 50 community cancer centers promoted inclusivity by offering internet and no-internet (automated telephone call) options to complete PROs remotely. Thirty-five percent of the participants chose the automated call (no-internet) option vs 65% who chose internet-based completion. 27 Without an alternative PRO mode, more than one-third of the vulnerable population may have been excluded.

Researchers may consider different modes of completion (item 7) to promote inclusivity and should be explicit about how the PRO strategy promotes or hinders the goal of recruiting a diverse sample representative of the target population. For instance, trials involving participants with different languages require the availability of validated language and culturally adapted PRO questionnaires, while some participants may need physical help or other types of assistance in responding (eg, turning pages, holding a pen, assistance with a telephone or computer keyboard). 8 , 16 , 24

Explanation: PROs should be acceptable to the population in which they will be administered, both in terms of the questions they ask and the overall burden to the patient (eg, is the completion time for the PRO measure acceptable). 28 The degree of participant burden depends on the frequency and timing of PRO assessments and on issues such as participant cognition, illness severity, treatment toxicity, and literacy. 16 Researchers should consider issues such as whether the questionnaire(s) capture important and relevant concepts to interested groups (such as overall health-related quality of life, specific domain or symptoms as described in item 4) and whether PROs include overlapping content and/or particularly sensitive questions. It is also important to consider the length, number of questionnaires, and end points, with respect to burden for subgroups of participants and if the mode of delivery (item 7) and schedule of assessments (item 5) are appropriate. If researchers demonstrate acceptable participant burden via robust involvement from representatives of the target patient population in the PRO selection process, RECs should not override the PRO strategy without strong ethical justification (eg, RECs should avoid automatically rejecting a proposal with a large number of PROs if justification is provided).

Short questionnaires minimize participant burden and assure greater completeness of PRO data while minimizing missing data. 29 However, patient input during the selection of PRO measures is key because participants may be willing to complete lengthy questionnaires if they understand the value of data collection and how the data will be used. 30 Thus, the views of the affected population are authoritative in this regard. Failure to seek participant input to core design issues, such as concepts to measure that matter most to patients, selection of questionnaires, time points, and mode of assessment, may lead to poor concordance, and therefore flawed results that cannot inform clinical practice. Poorly designed studies mislead participants who participate to help others and misuse research resources.

Explanation: It is well recognized in research governance that participants who lack capacity (eg, young children and adults who are cognitively impaired) are potentially vulnerable, and their interests in the context of research need to be protected. However, it is also important that such people are not unjustifiably excluded from relevant research. PRO research needs to meet the same well-defined standards.

These individuals may require a proxy: someone else to report the participant’s outcomes on their behalf. 8 This is different to assisting a participant to document their own answers (see item 9). 31 , 32 The correct administration of PRO tools when proxies need to be used contributes to the collection of robust and reliable data. The justification for including vulnerable participants in research is that it will either benefit them directly or it will benefit the population to which they belong. 33

In many research contexts, it is reasonable to anticipate the need for proxy response throughout all or some of the research (although the possibility can never be excluded) and this should be clearly documented in the research protocol. Researchers should be aware that proxy reporting is acceptable in some contexts and not in others. For example, the European Medicines Agency discourages proxy reporting because their data are often subject to biases and should only be used if it is the only effective means of obtaining vital information that might otherwise be lost. 28 The US Food and Drug Administration also discourages the use of proxy-reported outcomes to inform labeling claims, recommending observer reports for observable phenomenon only (eg, vomiting, but not nausea) instead. 16 However, in palliative care, collecting both proxy and observer measures is acceptable. 34

It is important to recognize that lack or loss of capacity to consent to research participation will not always be accompanied by an inability to self-complete PROs (with or without assistance), and appropriate support for such participants should be specified.

Explanation: Patient and public involvement refers to the partnership between patients, members of the public, and researchers in the codevelopment of research. 35 Patients and members of the public have unique insight derived from their lived experiences making research more relevant and enhancing the design, conduct, and quality of the research. 36 - 38 Incorporating these insights into research can make it prima facie more ethical in 2 ways: by democratizing the research agenda and/or helping to improve participant-facing documents and processes. 39

The inclusion of patient and/or public involvement should be considered best practice during the study design stage. Involvement of individuals with the disease can provide valuable insights into their lived experience and help ensure the research is relevant to their needs and acceptable, while public involvement may generate broader insights from a societal perspective. In addition, their inclusion should be integral to all the stages of research. The inclusion of patient involvement, public involvement, or both in the development of the PRO strategy may help to ensure that research measures what matters to patients, thereby maximizing its beneficial effect. It is also the best means of ensuring that PRO tools, and how they are administered, are acceptable (see item 10), and thereby may be influential in maximizing the response rate (see item 13). For example, recent patient involvement in the Therapies for Long COVID Study has led to the development of a new Symptom Burden Questionnaire because existing measures were felt to omit key symptoms experienced by those with the condition. 40

Explanation: Missing PRO data are a major problem in clinical research. 23 , 41 Missing data are normally caused by a combination of factors relating to methodology, logistic, administrative, and patient-related issues. 41 Protocols should describe how missing data will be minimized. Missing PRO data can complicate interpretation, lead to invalid conclusions, or may mean that the PRO data are not published. 4 , 42 , 43 When this occurs, it undermines the consent of participants who took part in the study and wastes research resources.

Although not all missing PRO data can be avoided, different strategies exist to mitigate this problem. 23 Specific recommendations related to data collection and management include using the minimum number of questionnaires appropriate to address the PRO research question, establishing standardized and documented PRO administration procedures, engaging and educating participants in the study by providing updates or incentives, using active quality assurance measures (such as monitoring of completion rates, reminders for upcoming or missed assessments), appointing a dedicated staff member responsible for PRO assessment at each center, training staff, and offering alternative modes of administration. 23 , 31 Reminders, notifications, or follow-up calls may be used to minimize missing data. Although different strategies exist to minimize avoidable PRO missing data, participants should be notified and provide consent, prior to accepting being part of the study, about the mechanisms the study will follow.

Explanation: The dissemination of PRO findings is essential to achieve beneficial outcomes. PRO data are, however, commonly omitted from primary and secondary publications. 4 Failing to report PRO data could limit the interpretation of the results and may hinder the translation of PRO findings into clinical practice, resulting in lost opportunities to benefit patients and the perpetuation of harmful practices. Failure to disseminate PRO findings is disrespectful of participants’ time, effort, and contribution to research. It may also undermine participants’ consent if they were misinformed about dissemination plans. 43 Sharing a summary of the PRO research results in accessible plain language for use by patients, participants, and members of the public promotes autonomy by empowering patients in shared decision-making around their care. 44

It is recommended that PRO findings should be incorporated into the main research publication or reported in a secondary publication providing a detailed explanation of the PRO data. 45 The CONSORT-PRO Extension guideline was developed to address the reporting of PRO trial data. The CONSORT-PRO provides evidence-based recommendations to improve completeness of reporting randomized clinical trials with either a primary or secondary PRO end point. 46

The Table shows an implementation tool for PRO researchers and RECs to be completed by research teams preparing PRO research or by reviewers.

The PRO ethics guidelines provide international consensus-based recommendations on questions that should be asked of a study’s design to facilitate the evaluation of its ethical acceptability. The guidelines highlight the ethical imperative to conduct robust science and the ethical issues to consider in the design and review of PRO clinical research. While a number of ethical issues identified are not unique to PROs and apply to research more widely, they raise particular challenges in the context of PROs, which is the focus of the work developed. The PRO ethics guidelines comprise 14 items to consider for use alongside the existing SPIRIT-PRO and CONSORT-PRO Extension guidelines 8 , 46 and other ethical recommendations relevant to the jurisdiction of interest. 12 , 47 , 48

The guidelines do not aim to mandate how ethical research should look, nor to mandate the correct response to the questions it asks. Instead, the guidelines aim to highlight issues that should be considered by research groups and ethics committees, including patients, research participants, and the public.

The recommendations within the PRO ethics guidelines reflect widely accepted ethical norms encapsulated in instruments such as the Declaration of Helsinki, 49 the Belmont Report, 50 and the Council for International Organizations of Medical Sciences guidelines. 51 The recommendations are in line with the 3 principles of respect of persons, concern for welfare, and justice outlined in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans 48 and the widely used 4 principles of biomedical ethics: autonomy, justice, beneficence, and nonmaleficence. 19 As such, the guiding ethical questions presented here do not set out any new ethical ideas, but rather specify widely accepted norms in the context of PROs and frame them in a way that is accessible to PRO researchers and useful for reviewers of PRO research.

The use of the PRO ethics guidelines has the potential to reduce participant risk and burden. In addition, addressing the items of the PRO ethics guidelines may help promote and protect participant autonomy and the welfare of participants and researchers. Furthermore, it may promote inclusive, equitable PRO research; the sharing of PRO research findings with participants and patients; and minimization of research waste ( Box ).

Aims of the PRO Ethics Guidelines

Maximize beneficial effect from research resources

Promote and protect participant autonomy

Protect participant research welfare

Promote accessible research

Minimize participant burden and harm

Minimize participant risk

Promote high-quality research

Disseminate PRO research

The Table provides an implementation tool for PRO researchers to reflect how each item has been addressed prior to ethical submission and for RECs to make notes on the research submitted and discuss in detail any relevant points at the ethics meeting. This tool is a starting point and can be tailored according to the users’ needs. Collaborations with national and international networks are being planned to promote the implementation of the PRO ethics guidelines.

This study has several limitations. First, the review identified only limited literature on which to base items for inclusion in the Delphi. Therefore, some relevant candidate items may not have been included; however, additional items were proposed by the steering group, and further items were informed by the SPIRIT-PRO Extension work, based on an extensive review of PRO protocol guidance. Furthermore, participants had the opportunity to propose additional items during round 1 of the Delphi process. Second, only literature available until March 2020 was considered in development of the guidelines. However, an updated search was performed on March 23, 2022; an additional 569 articles were screened and no further relevant literature was identified. Third, because participants ranked items according to their general importance, it is possible that some items might be less relevant for certain types of trials.

The PRO ethics guidelines provide recommendations for ethical issues that should be addressed in PRO clinical research. Addressing ethical issues of PRO clinical research has the potential to ensure high-quality PRO data while minimizing participant risk, burden, and harm and protecting participant and researcher welfare.

Corresponding Author: Melanie J. Calvert, PhD, Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham B15 2TT, England ( [email protected] ).

Accepted for Publication: April 5, 2022.

Author Contributions: Drs Cruz Rivera and Calvert had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Cruz Rivera, Aiyegbusi, Ives, Mercieca-Bebber, Hunn, Bhatnagar, Bottomley, Campbell, Collis, Golub, von Hildebrand, Mahendraratnam, Wilson, Stover, Calvert.

Acquisition, analysis, or interpretation of data: Cruz Rivera, Aiyegbusi, Ives, Draper, Mercieca-Bebber, Ells, Hunn, Scott, Fernandez, Dickens, Anderson, Bottomley, Campbell, Collett, Craig, Davies, Gosden, Gnanasakthy, Haf Davies, Lord, Miyaji, Monteiro, Morel, Zwisler, Peipert, Roydhouse, Wilson, Yap, Calvert.

Drafting of the manuscript: Cruz Rivera, Draper, Hunn, Dickens, Anderson, Campbell, Collett, Collis, Davies, Gosden, Gnanasakthy, Haf Davies, Monteiro, Stover, Calvert.

Critical revision of the manuscript for important intellectual content: Aiyegbusi, Ives, Draper, Mercieca-Bebber, Ells, Hunn, Scott, Fernandez, Dickens, Anderson, Bhatnagar, Bottomley, Campbell, Craig, Golub, von Hildebrand, Lord, Mahendraratnam, Miyaji, Monteiro, Morel, Zwisler, Peipert, Roydhouse, Wilson, Stover, Yap, Calvert.

Statistical analysis: Bottomley, Haf Davies, Calvert.

Obtained funding: Mercieca-Bebber, Calvert.

Administrative, technical, or material support: Aiyegbusi, Dickens, Gosden, Haf Davies, von Hildebrand, Mahendraratnam.

Supervision: Calvert.

Other - patient partner: Collis.

Other - patient viewpoint and contributor: Wilson.

Other - statistical advice: Yap.

Other - consensus meeting participation: Roydhouse.

Other - Providing options and opinions: Haf Davies.

Other - helped with formulation of interpretation and analysis regarding ethical values/principles: Draper.

Other - Delphi panel member, reviewed and commented on the study documents and publications: Scott.

Conflict of Interest Disclosures: Dr Cruz Rivera reported receiving funding from UK SPINE and European Regional Development Fund–Demand Hub and personal fees from Merck. Dr Aiyegbusi reported receiving grants from the National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre, NIHR Applied Research Collaboration West Midlands, UK Research and Innovation (UKRI), Health Foundation, Janssen, Gilead, and GlaxoSmithKline and personal fees from Gilead Sciences Ltd, Merck, and GlaxoSmithKline outside the submitted work. Dr Draper reported receiving unrelated research funding from UK SPINE (UKRI), AHRC, and the University of Warwick and being a member of the Defence Medical Services ethics committee, Birmingham Women’s and Children’s NHS Foundation Trust clinical ethics committee, and NHS Blood and Transplant Deceased Donor Family Tissue Advisory Group. Dr Scott reported receiving a pension from Janssen and holding stock in Johnson & Johnson. Drs Ells and Fernandez are members of the Canadian Interagency Panel on Research Ethics, which is responsible for the interpretation and evolution of the Canadian Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans . Ms Anderson reported receiving funding from the Health Education England/NIHR Integrated Clinical Academic Program Clinical Doctoral Research Fellowship. Dr Haf Davies reported owning an ePRO software platform called Atom5 through Aparito. Dr Lord reported being a member of the Nuffield Bioethics Working Group on the Future of Ageing. Dr Mahendraratnam reported owning stock options at Aetion Inc. Mr Miyaji reported grants (paid to the Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo) from AC Medical, A2 Healthcare, New Age Trading, Japan Tobacco Inc, Japan Media Corp, Medidata Solutions, Ono Pharmaceutical, FMD K&L Japan, 3H Medi Solution, NOBORI, Medrio Inc, Welby Inc, Nipro Corp, and Intellim and personal fees from Pfizer Japan Inc, Takeda Pharmaceutical Co, Merck, Ayumi Pharmaceutical, and Welby Inc. Dr Morel reported owning shares of UCB Pharma. Dr Zwisler reported being chair of the national clinical coordinating group on PRO in cardiac diseases. Dr Peipert reported receiving unrelated research funding from the National Cancer Institute, the National Institutes of Health, the Food and Drug Administration, the ECOG-ACRIN Medical Research Foundation, the Peter G. Peterson Foundation, Veloxis Pharmaceuticals, Pfizer, and the Northwestern University George M. O’Brien Kidney Core Center. He has received unrelated personal fees from AstraZeneca, IMPAQ International, and FACIT.org; in addition, he is the International Society for Quality of Life Research’s psychometric special interest group chair. Through his institution, he is supported by unrelated grants and contracts from Bristol Myers Squibb, Clovis Oncology, Pfizer, and Veloxis Pharmaceuticals. Dr Roydhouse reported receiving unrelated personal fees in the last 24 months from Amgen. Through her institution, she is supported by an unrelated Select Foundation Fellowship and has received unrelated research funding from the Royal Hobart Hospital and the Food and Drug Administration. Dr Stover reported receiving unrelated consulting fees or speaking honoraria in the last 24 months from Navigating Cancer, Association of Community Cancer Centers, Genentech, Purchaser Business Group on Health, and Henry Ford Cancer Center and unrelated research funding from Sivan Innovation and UroGen Pharma Ltd. Dr Yap reported receiving unrelated consulting fees and speaking honoraria from Faron Pharmaceuticals and Celgene, respectively, and being an expert advisor for the Medicines and Healthcare products Regulatory Agency’s Clinical Trials, Biologicals and Vaccines Expert Advisory Group and a funding panel member for the Medical Research Council Experimental Medicine and Cancer Research UK Clinical Research Committee. Dr Calvert reported serving as director of the Birmingham Health Partners Centre for Regulatory Science and Innovation, director of the Centre for Patient Reported Outcome Research, and an NIHR senior investigator and receiving funding from the NIHR, UK Research and Innovation (UKRI), NIHR Birmingham Biomedical Research Centre, the NIHR Surgical Reconstruction and Microbiology Research Centre, NIHR ARC West Midlands, UK SPINE, European Regional Development Fund–Demand Hub and Health Data Research UK at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Innovate UK (part of UKRI), Macmillan Cancer Support, UCB Pharma, Janssen, GlaxoSmithKline, and Gilead. Dr Calvert has received personal fees from Astellas, Aparito Ltd, CIS Oncology, Takeda, Merck, Daiichi Sankyo, Glaukos, GlaxoSmithKline, and the Patient-Centered Outcomes Research Institute outside the submitted work. In addition, a family member owns shares in GlaxoSmithKline. No other disclosures were reported.

Funding/Support: This work was sponsored by the University of Birmingham, the NIHR Birmingham Biomedical Research Centre, UK Research and Innovation, UK SPINE, and the European Regional Development Fund.

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Several authors are employees of the University of Birmingham; however, beyond the declared author contributions, the sponsor had no additional role.

Disclaimer: The views expressed in this article are those of the author(s) and not necessarily those of national agencies (eg, the NIHR, Food and Drug Administration, Medicines and Healthcare products Regulatory Agency, Health Research Authority, Canadian Institutes of Healthcare Research, the Department of Health and Social Care, Canadian Interagency Panel on Research Ethics, or the Canadian Tri-Council Policy Statement 2. Dr Golub is Executive Deputy Editor of JAMA but was not involved in any of the decisions regarding review of the manuscript or its acceptance.

Additional Information: Dr Scott retired from Janssen Global Services in March 2021; however, she was still involved in the development of the guideline until its final stage. Coauthor Amanda Hunn, MA, died February 8, 2022.

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• Open access
• Published: 29 September 2021

Defining ethical challenge(s) in healthcare research: a rapid review

• Guy Schofield   ORCID: orcid.org/0000-0002-9055-292X 1 , 3 ,
• Mariana Dittborn   ORCID: orcid.org/0000-0003-2903-6480 2 ,
• Lucy Ellen Selman   ORCID: orcid.org/0000-0001-5747-2699 3 &
• Richard Huxtable   ORCID: orcid.org/0000-0002-5802-1870 1  

BMC Medical Ethics volume  22 , Article number:  135 ( 2021 ) Cite this article

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Despite its ubiquity in academic research, the phrase ‘ethical challenge(s)’ appears to lack an agreed definition. A lack of a definition risks introducing confusion or avoidable bias. Conceptual clarity is a key component of research, both theoretical and empirical. Using a rapid review methodology, we sought to review definitions of ‘ethical challenge(s)’ and closely related terms as used in current healthcare research literature.

Rapid review to identify peer-reviewed reports examining ‘ethical challenge(s)’ in any context, extracting data on definitions of ‘ethical challenge(s)’ in use, and synonymous use of closely related terms in the general manuscript text. Data were analysed using content analysis. Four databases (MEDLINE, Philosopher’s Index, EMBASE, CINAHL) were searched from April 2016 to April 2021.

393 records were screened, with 72 studies eligible and included: 53 empirical studies, 17 structured reviews and 2 review protocols. 12/72 (17%) contained an explicit definition of ‘ethical challenge(s), two of which were shared, resulting in 11 unique definitions. Within these 11 definitions, four approaches were identified: definition through concepts; reference to moral conflict, moral uncertainty or difficult choices; definition by participants; and challenges linked to emotional or moral distress. Each definition contained one or more of these approaches, but none contained all four. 68/72 (94%) included studies used terms closely related to synonymously refer to ‘ethical challenge(s)’ within their manuscript text, with 32 different terms identified and between one and eight different terms mentioned per study.

Conclusions

Only 12/72 studies contained an explicit definition of ‘ethical challenge(s)’, with significant variety in scope and complexity. This variation risks confusion and biasing data analysis and results, reducing confidence in research findings. Further work on establishing acceptable definitional content is needed to inform future bioethics research.

Peer Review reports

Methodological rigour within research is a cornerstone in the production of high-quality findings and recommendations. Across the range of empirical methodologies, a broad collection of protocol development tools, methodology guidelines, and reporting guidelines have been developed and evidence of their use is increasingly required by journals [ 1 , 2 , 3 , 4 , 5 , 6 ]. Within both empirical bioethics and descriptive ethics, there has been an accompanying increase in the acknowledgment of the importance of methodological rigour in the empirical elements, including within the recent consensus statement on quality standards in empirical bioethics research by Ives et al. [ 7 , 8 , 9 ]. Aligned with this aim for rigour, definitional clarity of key terms used within a research project is a component of research quality [ 10 , 11 ]. Improving the quality of empirical bioethics is also itself an ethical imperative [ 9 ].

We recently conducted a systematic review examining ‘ethical challenges’ as reported by specialist palliative care practitioners [ 12 ]. Our review, alongside our initial scoping search findings and reading of the literature, suggested that, although many authors use the term ‘ethical challenge(s)’ in empirical ethics research, there appeared to be no commonly described or accepted definition. Furthermore, papers retrieved rarely defined ‘ethical challenge(s)’ explicitly , which has also been noted by other researchers examining other topic areas [ 13 , 14 , 15 ]. Our review further suggested that authors frequently use terms closely related to ‘ethical challenge(s)’—such as ‘moral dilemmas’ or ‘ethical issues’—interchangeably with ‘ethical challenge(s)’ throughout manuscripts, rather than staying with the original term. Research shows that non-philosophers may understand these related terms in heterogeneous ways which may additionally affect understanding of texts across different readerships [ 16 , 17 ].

Without a clear definition of an ethical challenge, each researcher must use individual judgement to ascertain whether they have identified an instance of one within their dataset. This potentially generates an unnecessary source of bias, particularly if multiple researchers are involved in data collection, extraction, or analysis. This risks generating misleading ethical analyses, evaluations, or recommendations. Additionally, and more broadly, if primary studies do not define the term, then work based on these—such as systematic reviews of individual studies or those undertaking secondary data analysis—may unknowingly compare different phenomena without a mechanism for mitigating the effects this introduces.

In the hope of prompting a debate on this topic, we therefore undertook a rapid review, which aimed to explore existing definitions of “ethical challenge(s)” and the use of other closely related terms within recent empirical healthcare ethics literature.

We conducted a rapid review examining the usage of the term ‘ethical challenge(s)’ over the last 5 years in published research articles, in order to identify and summarise if, and how, the term was defined. As a secondary aim, we examined authors’ uses of closely related alternative terms within the included article texts separate to their use within any explicit definitions that may be present.

Rapid reviews use abridged systematic review methodology to understand the evidence base on a particular topic in a time and resource efficient manner [ 18 , 19 , 20 , 21 , 22 ]. Comparative reviews of topics in which both a rapid review and a systematic review had been undertaken demonstrated that the overall conclusions were similar, although rapid reviews were less likely to contain social and economic data, and systematic reviews contained more detailed recommendations [ 18 , 19 , 20 , 23 , 24 ]. The Cochrane Rapid Review Methods Group has recently released interim methodological guidelines for undertaking rapid reviews [ 6 ], advising authors to describe where their protocol deviates from a systematic review and detail any biases that these deviations may introduce [ 18 , 19 , 21 ]. We have followed the Cochrane recommended methodology [ 6 ]. A rapid review reporting guideline is currently under development [ 25 ] and this review is therefore reported based on the PRISMA 2020 statement for systematic reviews, with justifications provided where our approach deviated [ 26 ].

Prospective review protocol registration on the PROSPERO database is the current gold standard, but, at the time of writing, PROSPERO does not accept records for rapid reviews [ 27 ]. The protocol was therefore not published in advance.

Eligibility criteria

The inclusion and exclusion criteria are summarised in Table 1 . We used Strech et al.’s Methodology, Issues, Participants (MIP) structure for our eligibility criteria, which is recommended for systematic reviews in ‘empirical bioethics’ [ 28 ]. The criteria reflect three assumptions. First, that the inclusion of ‘ethical challenge(s)’ in the title would increase the likelihood that this was the authors’ preferred term for the concept under investigation, and therefore increase the probability of a definition being provided. Second, that studies aiming to describe empirical data and identify ethical challenges in real-world contexts are most likely to contain a definition to guide researchers in identifying these challenges as they collect and analyse data. Third, that structured reviews of studies of ethical challenges are likely to include a definition to allow researchers to reliably recognise an ethical challenge in retrieved records. We used a 5-year timeframe as a date restriction. This reflected a balance between adequately covering recent use of the term and time and resource restrictions of the rapid review.

Information sources

The search strategy was as follows:

‘ethical challenge’.ti OR ‘ethical challenges’.ti.

We searched Medline (Ovid interface), Philosopher’s Index (OVID interface), EMBASE (OVID interface), and CINAHL (Cumulative Index to Nursing and Allied Health Literature, EBSCO interface) for studies indexed over a five-year period between April 2016 and April 2021. These resources cover the breadth of healthcare research. Including Philosopher’s Index increased coverage of the bioethics literature. We did not search the grey literature [ 6 ]. The search strategy was tested by successfully retrieving three sentinel studies known to the research team.

Study selection

Retrieved studies were imported into Endnote X9.2 [ 29 ]. Records unavailable through institutional subscriptions were requested from corresponding authors. If unavailable 14 days after the request, the record was excluded. A random sample of 20% of records were dual screened at the title/abstract level by GS/MD. After discussion, the remainder were screened by GS. At full-text screening, a further 20% were dual screened by GS/MD and, again after discussion, the remaining studies were screened by GS.

Data extraction and analysis

Data extraction was undertaken using a pre-piloted form, with the first 5 records dually extracted by GS and MD. Data from the remaining included studies was then extracted by GS, with correctness and completeness checked by MD. We collected data on date of publication, authors, journal, country (for primary studies), methodology, definition of ‘ethical challenge(s)’ (present (yes/no)) and (where offered) the definition provided, and any closely related terms used, with counts of all terms used in each article. For closely related terms, data was extracted from the authors’ text, but not from direct quotations from qualitative research. Where definitions of ‘ethical challenge(s)’ were offered and/or related terms were identified, these were categorised and counted following the principles of summative content analysis [ 30 ]. Summative content analysis combines both the quantitative counting of specific content or words/terms with latent content analysis to identify and categorise their meanings. We identified keywords (‘ethical challenge(s)’ and closely related terms) deployed by the authors of the included papers, both prior to and during data analysis, and analysed the retrieved definitions. This approach allowed for exploration of both the content of definitions and development of insights into the use of related terms.

Risk of bias assessment

The focus of the rapid review was the definition of the term ‘ethical challenge(s)’ within retrieved records. We therefore did not undertake quality assessment for the included studies and reviews.

831 records were retrieved, reduced to 393 after de-duplication. 238 records were excluded after reviewing the title and/or abstract. 157 records were identified for full text screening, with 3 unavailable [ 31 , 32 , 33 ]. 82 records were excluded at full text stage and 72 records were included for analysis. See Fig.  1 for the PRISMA flowchart.

PRISMA flow diagram of record identification

Record characteristics

Of the 72 included records, 53 were empirical studies [ 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83 , 84 , 85 , 86 ], 10 non-systematic reviews [ 87 , 88 , 89 , 90 , 91 , 92 , 93 , 94 , 95 , 96 ], 7 systematic reviews [ 12 , 13 , 14 , 97 , 98 , 99 , 100 ], 1 systematic review protocol [ 101 ], and 1 non-systematic review protocol [ 102 ]. Of the 53 empirical studies, 42 (79%) were qualitative studies [ 34 , 35 , 36 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 47 , 48 , 50 , 51 , 52 , 54 , 55 , 56 , 57 , 58 , 60 , 62 , 63 , 64 , 65 , 66 , 67 , 69 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 79 , 80 , 81 , 83 , 84 , 85 , 86 ], 6 (12%) used a mixed methods approach [ 45 , 46 , 53 , 59 , 61 , 68 ], and 5 (10%) were quantitative [ 37 , 49 , 70 , 78 , 82 ]. 7/56 empirical studies, all qualitative interview studies, recruited participants internationally with no specific location stated [ 40 , 54 , 55 , 58 , 60 , 63 , 73 ]. Of the remaining studies, all but one were single-country studies: Botswana [ 75 ], Canada [ 41 , 65 ], China [ 57 ], Denmark [ 39 , 43 ], Dominican Republic [ 44 ], Germany [ 51 , 84 ], India [ 61 ], Iran [ 38 , 46 , 49 , 68 , 70 , 71 , 72 , 78 , 82 , 98 ], Italy [ 45 ], Mexico [ 87 ], the Netherlands [ 76 ], New Zealand [ 47 ], Norway [ 42 , 52 , 56 , 64 , 80 , 81 , 83 ], Saudi Arabia [ 34 , 35 , 36 , 37 ], Tanzania [ 69 , 74 ], Uganda [ 67 ], UK [ 86 ], and USA [ 50 , 53 , 59 , 62 , 66 , 77 , 79 , 85 , 85 ]. The remaining study was undertaken in both Sierra Leone and the UK [ 48 ]. See Table 2 for a summary.

12/72 (17%) of retrieved studies offered an explicit definition for ‘ethical challenge(s)’ [ 12 , 13 , 14 , 48 , 50 , 56 , 57 , 66 , 69 , 81 , 98 , 101 ]. Definitions were more likely to be found in more recent publications, with 4/12 included studies published in 2016–2018 [ 14 , 48 , 56 , 81 ], and 8/12 published in 2019–2021 [ 12 , 13 , 50 , 57 , 66 , 69 , 98 , 101 ]. The included study locations were evenly distributed, matching the overall pattern of retrieved studies, with studies from high- [ 48 , 50 , 56 , 66 , 81 ], middle- [ 57 , 98 ], and low-income settings [ 48 , 69 ]. The identified studies included eight qualitative studies [ 48 , 50 , 56 , 57 , 66 , 69 , 81 , 98 ], 3 systematic reviews [ 12 , 13 , 14 ], and 1 systematic review protocol [ 101 ]. Two of these records were the systematic review protocol and the report from our group, which accordingly contained the same definition [ 12 , 101 ], leaving 11 unique definitions. Definitions of ‘ethical challenge(s)’ identified in included studies are provided in Table 3 . Additionally, 68/72 (94%) reports used closely related terms synonymously in place of ‘ethical challenge(s)’ throughout their manuscript text, with between 1 and 8 different terms used within each report, and 32 different terms were identified. This occurred in both those reports that contained a definition and those that did not. See Table 4 for terms and frequencies.

Those records that offered explicit definitions used four approaches: (1) definition through concepts [ 12 , 57 , 66 ]; (2) reference to moral conflict, moral uncertainty or difficult choices [ 13 , 14 , 48 , 57 , 69 , 98 ]; (3) definition by study participants [ 12 , 48 , 50 , 56 ]; or (4) challenges as linked to their ability to generate emotional or moral distress within healthcare practitioners [ 14 , 14 , 66 , 81 ]. Each definition was associated with one or more of the identified elements, although none covered all four approaches. We describe these approaches below.

Approach 1: definition through concepts

This approach involves primarily defining ‘ethical challenge(s)’ in terms of related concepts. All three definitions using this approach defined ‘ethical challenge(s)’ as a summative collection of related concepts, including ‘ethical dilemmas’, ‘moral dilemmas’, ‘moral challenges’, ‘ethical issues’, and ‘ethical conflicts’ [ 12 , 57 , 66 ], for example:

‘The expression “ethical challenges” mainly refers to ethical dilemmas and ethical conflicts as well as other scenarios where difficult choices have to be made’ [ 57 ] p34

Only one went on to define the other concepts they utilised, ‘ethical dilemmas’ and ‘ethical conflicts’:

‘Ethical dilemmas are described as situations that cannot be solved; decisions made between two options may be morally plausible but are equally problematic due to the circumstances. Ethical conflicts, on the contrary, arise when one is aware of the necessity of proper actions but he or she may have trouble exercising these actions because of certain internal or external factors.’ [ 57 ] p34

Approach 2: moral conflict, moral uncertainty or difficult choices

This approach anchors an ethical challenge to the requirement for an agent to make a (difficult) choice in a situation where moral principles conflict, or there is moral uncertainty as to the ‘right’ way forward.

‘In this context, ethical challenge refers to the situation whereby every alternative is morally wrong and still one has to make a choice’ [ 69 ] p676 ‘An ethical challenge occurs when one does not know how to behave and act in the best way…’ [ 14 ] p93

Approach 3: definition by study participants

Four of the definitions involved research participants themselves defining something as an ‘ethical challenge’ [ 12 , 48 , 50 , 56 ], with three studies explicitly stating that participants would lead this definitional work [ 48 , 50 , 56 ]. Draper & Jenkins offer a starting definition, adopted from Schwartz et al. [ 103 ] with which to prime participants, while Forbes and Phillips [ 50 ] and Jakobsen and Sørlie [ 56 ] left the definition fully with their participants (Table 3 ). Finally, Schofield et al. proposed a very broad definition (Table 3 ), alongside the specific statement that either participants or researchers could nominate something as an ‘ethical challenge’ [ 12 ].

Approach 4: emotional or moral distress

This final approach was to tie ethical challenges to situations where participants feel ‘discomfort’, emotional distress or more specifically moral distress or moral residue [ 14 , 66 , 81 ]. Larkin et al. are clear that this distress must be tied to moral causes, but Hem et al. and Storaker et al. also refer more broadly to ‘discomfort’ [ 14 ] and ‘emotional stress’ [ 81 ] respectively. For example:

‘In this article, ethical challenges refer to values that entail emotional and moral stress in healthcare personnel.’ [ 81 ] p557

To the authors’ knowledge, this is the first rapid review to examine the use of the term ‘ethical challenge(s)’ in empirical healthcare research literature. Notably, only 12/72 (17%) of included studies published in the last 5 years contained a definition for ‘ethical challenge(s)’, despite this being the focus of the research being reported. The definitions identified were found in qualitative studies and systematic reviews and were evenly distributed geographically across high-, middle- and low-income settings. Definitions contained one or more of the identified approaches, although none contained elements from all four. Taken together, these findings suggest that a clear definition of ‘ethical challenge(s)’, and consistent use thereof, is currently lacking.

The four approaches indicate the diverse approaches to understanding ‘ethical challenge(s)’. Approaches 1 and 2 explore the concept from opposite viewpoints, with approach 1 looking from the conceptual perspective, through terms such as ‘dilemmas’ and ‘conflict’, and approach 2 from a participant perspective, specifically in those situations in which someone is trying to make a decision in circumstances where the preferred option is not possible or when they perceive there to be clash in values they feel are important. Within the concept-led definitions (approach 1), the use of a plurality of terms highlights a potential risk of bias, as different readers may interpret these differently. For example, some terms, such as ‘moral dilemma’, have relatively well understood specific meanings for some readers, particularly those with philosophical training [ 104 , 105 , 106 ]. The presence in the literature of specific and multiple meanings for some related terms highlights the importance of empirical studies providing a definition of these additional terms alongside their primary definition for ‘ethical challenge(s)’. This is more likely to be relevant where an a priori definition is used, but may be relevant to any prompting text for studies using a participant-led process, as in the study by Draper and Jenkins [ 48 ]. This clarity is important for both readers and future researchers who may undertake a secondary analysis of the data.

Approach 3 involves facilitating participants to nominate something as an ethical challenge [ 12 , 48 , 50 , 56 ]. This speaks to an important question about who, in a research context, is permitted to define or describe the object of interest, in this case ‘ethical challenge(s)’. Restricting the identification of ‘ethical challenge(s)’ to researchers alone may introduce bias by excluding input from those without bioethical ‘expertise’, but with important lived experience of the context under investigation. There is evidence that although clinicians can be sensitive to major ethical dilemmas, they can be less sensitive to small everyday ethical elements in clinical practice, and that ethical awareness varies between individuals [ 107 , 108 ]. Additionally, there is evidence in healthcare ethics research that patients and carers identify ethical challenges in situations that healthcare workers do not [ 109 ]. Therefore, relying entirely on a particular stakeholders’ perspectives (such as clinicians’) may risk missing important ethical challenges present in a scenario (assuming, of course, that we can settle what counts as an ‘ethical challenge(s)’).

In Approach 4, ethical challenges were linked to situations in which participants felt discomfort [ 14 ], emotional stress [ 81 ], moral distress or moral residue [ 66 ]. These concepts are themselves defined in quite varied ways (see, for example, definitions of ‘moral distress’ in a systematic review by Morley et al. [ 110 ]), potentially leading to additional conceptual confusion. Identifying triggers for moral distress is important, as high levels of moral distress are known to have negative impacts on work environments and lead to increased levels of compassion fatigue, increased staff turnover rates and poorer patient outcomes [ 110 , 111 , 112 ]. However, it is also possible that the requirement that, to be identified as an ethical challenge, the situation must invoke stress or distress might result in the under-identification of ethical challenges. We anticipate that many practitioners will daily manage multiple low-level ethical challenges, many of which will not generate moral distress or leave a moral residue. As such, the presence of moral distress may not be sufficient or even necessary in order to label a moral event an ‘ethical challenge’. However, the relationship between ‘ethical challenge(s)’ and moral distress is complex, and some might argue that the latter has an important relationship to the former. For example, moral distress, as conceived by Jameton and others [ 110 , 113 , 114 ], is linked to the after-effects of having to handle ethical challenge(s), so some researchers might view the generation of moral distress as relevant to identifying ethical challenges.

Although our review revealed these four approaches, the wider literature indicates there may be alternative approaches available. For example, other potential approaches would define ethical challenges as events that interact with moral principles, such as autonomy, beneficence, non-maleficence or justice, as proposed by Beauchamp and Childress [ 115 ], or as events in which those principles clash, for example as used by Klingler et al. in their research focusing on ethical issues in health surveillance [ 116 ]. However, these approaches were not seen amongst our included papers.

Returning to our included papers, the high rates of use of closely related terms within included manuscript texts may add to difficulties in understanding the exact object of interest if these terms are being used as synonyms for ‘ethical challenge(s)’. This may be particularly the case if terms used include those such as ‘moral dilemma’, which (as shown above) will have specific meanings for some readers. Interchangeable, undefined usage of these terms by study authors within study texts risks further exacerbating the problems caused by a lack of definitional clarity.

Strengths and limitations

This rapid review is the first systematic attempt to describe the definitions of ‘ethical challenge(s)’ available within the recent published literature.

There are, however, five limitations to note. First, the review only includes results from the past 5 years, which inevitably means that older publications, which may have contained further definitions of ‘ethical challenge(s)’, were excluded. The focus on the previous 5 years does, however, allow for an assessment of the term’s use(s) within a reasonable period of time and was felt to be appropriate given the aims and resources available to this project.

Second, our three assumptions listed in the methodology section may have excluded some records that contained a relevant definition. However, these assumptions, and the resulting focus on two search terms, allowed for a balance between retrieved record numbers and team resources.

Third, the four databases searched were chosen for their focus on the healthcare ethics literature; we may therefore may have missed relevant usage in other fields or disciplines. Similarly, we did not search the grey literature, which might have excluded relevant research.

Fourth, for resource reasons, the assessment as to whether a related term was being used interchangeably in the text was undertaken by a single researcher (GS). This subjective assessment risks miscalculating both the number of interchangeable terms identified and the frequency counts.

Finally, we did not review the theoretical literature for conceptual definitions of ‘ethical challenge(s)’, hence the definitions we identified might not match completely conceptual understandings of the term. However, our review shows how the term is currently being used in the research literature. Indeed, if there are strong conceptual definitions within the theoretical literature, then it is clear that they are currently not reaching the researchers whose work was identified by our review.

This review is the first, to our knowledge, to identify and describe definitions (and uses) of the widely-utilised concept of ‘ethical challenge(s)’ within healthcare research. Only 17% (12/72) of retrieved papers presented an explicit definition of ‘ethical challenge(s)’ before beginning to investigate this concept in context. The definitions found contained one or more of four identified approaches, with significant cross-reference to related terms and concepts which themselves have variation in their accepted meanings. We recommend that researchers define the phenomenon of interest—in this case, ‘ethical challenge(s)’—to help ensure clarity. This should either be a priori, or, if using an approach that includes participant participation in the generation of the definition, reporting their final working definition a posteriori. The choice of definition should be justified, including the decision as to whether to include participants in this process. Additionally, if a definition references other conceptual terms, then consideration should be given to defining these as well.

The results of this rapid review suggest that a common conceptual understanding of the term ‘ethical challenge(s)’ is lacking within empirical bioethical research and that there is a need for researchers in this area to consider what conceptual formulations might be most useful. Again, failure to use definitions of crucial research concepts within empirical bioethics research potentially generates confusion and avoidable bias within research outputs, risking misleading ethical analyses, evaluations, and resulting recommendations. We therefore hope this review will help stimulate debate amongst empirical bioethics researchers on possible definitional content for such a commonly used term and prompt further discussion and research. Additionally, given the central role of patient and public partnership and involvement in research, further thought should be given to who should be involved in nominating something as a challenge worthy of study.

Following on from this work, there would be value in conducting an empirical bioethical project combining a full systematic review of definitions of ‘ethical challenge(s)’ (and related terms) integrated with an exploration of the conceptual literature to generate recommendations for approaches towards the content of potential definitions, perhaps related to the identified approaches above. Such a project could also ask authors who currently use the term ‘ethical challenge(s)’ in their research how they conceptualise this. Furthermore, work to better understand the benefits of including study participants in the definition process is also important. Finally, whilst researchers should justify whatever approach they choose to take, there may be merit in examining whether anything is lost if studies lack a robust or agreed definition, or whether doing so affords a flexibility and openness that allows for a broader range of ethical challenges to be identified.

Availability of data and materials

All data is presented in this manuscript.

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Acknowledgements

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GS is supported by a Wellcome Trust Research Award for Health Professionals (208129/Z/17/Z). LES is funded by a Career Development Fellowship from the National Institute for Health Research. RH is part-funded by the Wellcome Trust (209841/Z/17/Z) and the NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol. He serves on various local, regional, and national ethics committees and related groups. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research, the Department of Health, or any of the other organisations with and for whom the authors work.

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Schofield, G., Dittborn, M., Selman, L.E. et al. Defining ethical challenge(s) in healthcare research: a rapid review. BMC Med Ethics 22 , 135 (2021). https://doi.org/10.1186/s12910-021-00700-9

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WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects

Adopted by the 18 th WMA General Assembly, Helsinki, Finland, June 1964 and amended by the: 29 th WMA General Assembly, Tokyo, Japan, October 1975 35 th WMA General Assembly, Venice, Italy, October 1983 41 st WMA General Assembly, Hong Kong, September 1989 48 th WMA General Assembly, Somerset West, Republic of South Africa, October 1996 52 nd WMA General Assembly, Edinburgh, Scotland, October 2000 53 rd WMA General Assembly, Washington DC, USA, October 2002 (Note of Clarification added) 55 th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification added) 59 th WMA General Assembly, Seoul, Republic of Korea, October 2008 64 th WMA General Assembly, Fortaleza, Brazil, October 2013

1.         The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

The Declaration is intended to be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs.

2.         Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians. The WMA encourages others who are involved in medical research involving human subjects to adopt these principles.

General Principles

3.         The Declaration of Geneva of the WMA binds the physician with the words, “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act in the patient’s best interest when providing medical care.”

4.         It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. The physician’s knowledge and conscience are dedicated to the fulfilment of this duty.

5.         Medical progress is based on research that ultimately must include studies involving human subjects.

6.         The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even the best proven interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality.

7.         Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights.

8.         While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.

9.         It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent.

10.       Physicians must consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.

11.       Medical research should be conducted in a manner that minimises possible harm to the environment.

12.       Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications. Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional.

13.       Groups that are underrepresented in medical research should be provided appropriate access to participation in research.

14.       Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.

15.       Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.

Risks, Burdens and Benefits

16.       In medical practice and in medical research, most interventions involve risks and burdens.

Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.

17.       All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation.

Measures to minimise the risks must be implemented. The risks must be continuously monitored, assessed and documented by the researcher.

18.       Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed.

When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to continue, modify or immediately stop the study.

Vulnerable Groups and Individuals

19.       Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm.

All vulnerable groups and individuals should receive specifically considered protection.

20.       Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research.

Scientific Requirements and Research Protocols

21.       Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation. The welfare of animals used for research must be respected.

22.       The design and performance of each research study involving human subjects must be clearly described and justified in a research protocol.

The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding funding, sponsors, institutional affiliations, potential conflicts of interest, incentives for subjects and information regarding provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study.

In clinical trials, the protocol must also describe appropriate arrangements for post-trial provisions.

Research Ethics Committees

23.       The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins. This committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration.

The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No amendment to the protocol may be made without consideration and approval by the committee. After the end of the study, the researchers must submit a final report to the committee containing a summary of the study’s findings and conclusions.

Privacy and C onfidentiality

24.       Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.

Informed Consent

25.       Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees.

26.       In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information.

After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.

All medical research subjects should be given the option of being informed about the general outcome and results of the study.

27.       When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship.

28.       For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.

29.       When a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorised representative. The potential subject’s dissent should be respected.

30.       Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research  group. In such circumstances the physician must seek informed consent from the legally authorised representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research must be obtained as soon as possible from the subject or a legally authorised representative.

31.       The physician must fully inform the patient which aspects of their care are related to the research. The refusal of a patient to participate in a study or the patient’s decision to withdraw from the study must never adversely affect the patient-physician relationship.

32.       For medical research using identifiable human material or data, such as research on material or data contained in biobanks or similar repositories, physicians must seek informed consent for its collection, storage and/or reuse. There may be exceptional situations where consent would be impossible or impracticable to obtain for such research. In such situations the research may be done only after consideration and approval of a research ethics committee.

Use of Placebo

33.       The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances:

Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or

Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention

and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention.

Extreme care must be taken to avoid abuse of this option.

Post-Trial Provisions

34.       In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.

Research Registration and Publication and Dissemination of Results

35.       Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.

36.       Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.

Unproven Interventions in Clinical Practice

37.       In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorised representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.

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• Ethical Considerations in Research | Types & Examples

Ethical Considerations in Research | Types & Examples

Published on 7 May 2022 by Pritha Bhandari .

Ethical considerations in research are a set of principles that guide your research designs and practices. Scientists and researchers must always adhere to a certain code of conduct when collecting data from people.

The goals of human research often include understanding real-life phenomena, studying effective treatments, investigating behaviours, and improving lives in other ways. What you decide to research and how you conduct that research involve key ethical considerations.

These considerations work to:

• Protect the rights of research participants
• Enhance research validity
• Maintain scientific integrity

Table of contents

Why do research ethics matter, getting ethical approval for your study, types of ethical issues, voluntary participation, informed consent, confidentiality, potential for harm, results communication, examples of ethical failures, frequently asked questions about research ethics.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe for research subjects.

You’ll balance pursuing important research aims with using ethical research methods and procedures. It’s always necessary to prevent permanent or excessive harm to participants, whether inadvertent or not.

Defying research ethics will also lower the credibility of your research because it’s hard for others to trust your data if your methods are morally questionable.

Even if a research idea is valuable to society, it doesn’t justify violating the human rights or dignity of your study participants.

Prevent plagiarism, run a free check.

Before you start any study involving data collection with people, you’ll submit your research proposal to an institutional review board (IRB) .

An IRB is a committee that checks whether your research aims and research design are ethically acceptable and follow your institution’s code of conduct. They check that your research materials and procedures are up to code.

If successful, you’ll receive IRB approval, and you can begin collecting data according to the approved procedures. If you want to make any changes to your procedures or materials, you’ll need to submit a modification application to the IRB for approval.

If unsuccessful, you may be asked to re-submit with modifications or your research proposal may receive a rejection. To get IRB approval, it’s important to explicitly note how you’ll tackle each of the ethical issues that may arise in your study.

There are several ethical issues you should always pay attention to in your research design, and these issues can overlap with each other.

You’ll usually outline ways you’ll deal with each issue in your research proposal if you plan to collect data from participants.

Voluntary participation means that all research subjects are free to choose to participate without any pressure or coercion.

All participants are able to withdraw from, or leave, the study at any point without feeling an obligation to continue. Your participants don’t need to provide a reason for leaving the study.

It’s important to make it clear to participants that there are no negative consequences or repercussions to their refusal to participate. After all, they’re taking the time to help you in the research process, so you should respect their decisions without trying to change their minds.

Voluntary participation is an ethical principle protected by international law and many scientific codes of conduct.

Take special care to ensure there’s no pressure on participants when you’re working with vulnerable groups of people who may find it hard to stop the study even when they want to.

Informed consent refers to a situation in which all potential participants receive and understand all the information they need to decide whether they want to participate. This includes information about the study’s benefits, risks, funding, and institutional approval.

• What the study is about
• The risks and benefits of taking part
• How long the study will take
• Your supervisor’s contact information and the institution’s approval number

Usually, you’ll provide participants with a text for them to read and ask them if they have any questions. If they agree to participate, they can sign or initial the consent form. Note that this may not be sufficient for informed consent when you work with particularly vulnerable groups of people.

If you’re collecting data from people with low literacy, make sure to verbally explain the consent form to them before they agree to participate.

For participants with very limited English proficiency, you should always translate the study materials or work with an interpreter so they have all the information in their first language.

In research with children, you’ll often need informed permission for their participation from their parents or guardians. Although children cannot give informed consent, it’s best to also ask for their assent (agreement) to participate, depending on their age and maturity level.

Anonymity means that you don’t know who the participants are and you can’t link any individual participant to their data.

You can only guarantee anonymity by not collecting any personally identifying information – for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, and videos.

In many cases, it may be impossible to truly anonymise data collection. For example, data collected in person or by phone cannot be considered fully anonymous because some personal identifiers (demographic information or phone numbers) are impossible to hide.

You’ll also need to collect some identifying information if you give your participants the option to withdraw their data at a later stage.

Data pseudonymisation is an alternative method where you replace identifying information about participants with pseudonymous, or fake, identifiers. The data can still be linked to participants, but it’s harder to do so because you separate personal information from the study data.

Confidentiality means that you know who the participants are, but you remove all identifying information from your report.

All participants have a right to privacy, so you should protect their personal data for as long as you store or use it. Even when you can’t collect data anonymously, you should secure confidentiality whenever you can.

Some research designs aren’t conducive to confidentiality, but it’s important to make all attempts and inform participants of the risks involved.

As a researcher, you have to consider all possible sources of harm to participants. Harm can come in many different forms.

• Psychological harm: Sensitive questions or tasks may trigger negative emotions such as shame or anxiety.
• Social harm: Participation can involve social risks, public embarrassment, or stigma.
• Physical harm: Pain or injury can result from the study procedures.
• Legal harm: Reporting sensitive data could lead to legal risks or a breach of privacy.

It’s best to consider every possible source of harm in your study, as well as concrete ways to mitigate them. Involve your supervisor to discuss steps for harm reduction.

Make sure to disclose all possible risks of harm to participants before the study to get informed consent. If there is a risk of harm, prepare to provide participants with resources, counselling, or medical services if needed.

Some of these questions may bring up negative emotions, so you inform participants about the sensitive nature of the survey and assure them that their responses will be confidential.

The way you communicate your research results can sometimes involve ethical issues. Good science communication is honest, reliable, and credible. It’s best to make your results as transparent as possible.

Take steps to actively avoid plagiarism and research misconduct wherever possible.

Plagiarism means submitting others’ works as your own. Although it can be unintentional, copying someone else’s work without proper credit amounts to stealing. It’s an ethical problem in research communication because you may benefit by harming other researchers.

Self-plagiarism is when you republish or re-submit parts of your own papers or reports without properly citing your original work.

This is problematic because you may benefit from presenting your ideas as new and original even though they’ve already been published elsewhere in the past. You may also be infringing on your previous publisher’s copyright, violating an ethical code, or wasting time and resources by doing so.

In extreme cases of self-plagiarism, entire datasets or papers are sometimes duplicated. These are major ethical violations because they can skew research findings if taken as original data.

You notice that two published studies have similar characteristics even though they are from different years. Their sample sizes, locations, treatments, and results are highly similar, and the studies share one author in common.

Research misconduct

Research misconduct means making up or falsifying data, manipulating data analyses, or misrepresenting results in research reports. It’s a form of academic fraud.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement about data analyses.

Research misconduct is a serious ethical issue because it can undermine scientific integrity and institutional credibility. It leads to a waste of funding and resources that could have been used for alternative research.

Later investigations revealed that they fabricated and manipulated their data to show a nonexistent link between vaccines and autism. Wakefield also neglected to disclose important conflicts of interest, and his medical license was taken away.

This fraudulent work sparked vaccine hesitancy among parents and caregivers. The rate of MMR vaccinations in children fell sharply, and measles outbreaks became more common due to a lack of herd immunity.

Research scandals with ethical failures are littered throughout history, but some took place not that long ago.

Some scientists in positions of power have historically mistreated or even abused research participants to investigate research problems at any cost. These participants were prisoners, under their care, or otherwise trusted them to treat them with dignity.

To demonstrate the importance of research ethics, we’ll briefly review two research studies that violated human rights in modern history.

These experiments were inhumane and resulted in trauma, permanent disabilities, or death in many cases.

After some Nazi doctors were put on trial for their crimes, the Nuremberg Code of research ethics for human experimentation was developed in 1947 to establish a new standard for human experimentation in medical research.

In reality, the actual goal was to study the effects of the disease when left untreated, and the researchers never informed participants about their diagnoses or the research aims.

Although participants experienced severe health problems, including blindness and other complications, the researchers only pretended to provide medical care.

When treatment became possible in 1943, 11 years after the study began, none of the participants were offered it, despite their health conditions and high risk of death.

Ethical failures like these resulted in severe harm to participants, wasted resources, and lower trust in science and scientists. This is why all research institutions have strict ethical guidelines for performing research.

Ethical considerations in research are a set of principles that guide your research designs and practices. These principles include voluntary participation, informed consent, anonymity, confidentiality, potential for harm, and results communication.

Scientists and researchers must always adhere to a certain code of conduct when collecting data from others .

These considerations protect the rights of research participants, enhance research validity , and maintain scientific integrity.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe.

Anonymity means you don’t know who the participants are, while confidentiality means you know who they are but remove identifying information from your research report. Both are important ethical considerations .

You can only guarantee anonymity by not collecting any personally identifying information – for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, or videos.

You can keep data confidential by using aggregate information in your research report, so that you only refer to groups of participants rather than individuals.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement but a serious ethical failure.

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WHO Technical Advisory Group (TAG) on clinical and policy considerations for new Tuberculosis (TB) vaccines

The World Health Organization (WHO) is seeking experts to serve as members on Technical Advisory Group on clinical and policy considerations for new Tuberculosis (TB) vaccines.  This “Call for experts” provides information about the advisory group in question, the expert profiles being sought, the process to express interest, and the process of selection.

Tuberculosis (TB) is a leading cause of death from an infectious agent, and a major contributor to antimicrobial resistance. About a quarter of the world’s population has been infected with Mycobacterium tuberculosis, most living in low-and-middle income countries. This population is at risk of developing TB disease.  An estimated 10.6 million people fell ill with TB in 2022, an estimated 1.3 million people died.

WHO seeks to advance the development and deployment of new TB vaccines to prevent TB disease, with a focus on adolescents and adults in whom 90% of TB disease occurs.  Prevention of TB disease in these populations, responsible for most of the transmission, will significantly reduce disease and incidence in all those at risk, including unvaccinated infants, children, older adults and other key populations, such as people living with HIV. There are several vaccine candidates in the pipeline, many in late-stage development, and effort is needed now to co-ordinate and where feasible align on regulatory expectations, provide guidance on clinical aspects such as optimal clinical endpoints and on anticipated evidence needs for policy at the global, regional and national levels.  

WHO recently established the TB Vaccine Accelerator Council to facilitate the development, testing, authorization, & use of new TB vaccines.  This TAG would form part of the working groups associated with the TB Vaccine Accelerator.

Functions of the Technical Advisory Group on clinical and policy considerations for new Tuberculosis (TB) vaccines

• To provide independent evaluation of the scientific and strategic clinical, regulatory and policy aspects related to new TB vaccine candidates, including but not limited to safety, immunogenicity, efficacy, anticipated impact and effectiveness, resulting in recommendations on data requirements, study designs, clinical trial protocols and regulatory strategies.
• To advise WHO on evidence to support policy formulation, optimal programmatic delivery strategies and where appropriate implementation science to accelerate the pathway to recommendation, introduction and use of new TB vaccines at the country and global levels.
• To assist the secretariat in developing novel guidance / communication on WHO positions with respect to aspects such as clinical endpoints, case definitions, expected data and evidence needs, trade-offs, to inform investment and introduction decision-making.

Operations of the Technical Advisory Group (TAG) on clinical and policy considerations for new Tuberculosis (TB) vaccines

The TAG shall normally meet face-to-face at least once each year, and virtually up to 8 times per year. Interim teleconferences and review of draft documents may be required of the members.  The working language of the group will be English.

Who can express interest?

The Technical Advisory Group (TAG) on clinical and policy considerations for new Tuberculosis (TB) vaccines will be multidisciplinary, with members who have a range of technical knowledge, skills and experience relevant to novel TB vaccines, specifically their clinical development, regulatory approval, policy and implementation considerations to support WHO prequalification.  Approximately 20 individuals may be selected.

WHO welcomes expressions of interest from:

Scientists and healthcare professionals with expertise and/or experience in the following areas:

• Epidemiology, natural history and/or clinical experience of TB;
• Experience of TB control programme;
• Vaccine product development and regulatory strategy, particularly for vaccines targeted to adults and adolescents;
• Vaccine regulatory approval including in low- and middle-income countries;
• Vaccine related policy, particularly for vaccines targeted to adults and adolescents;
• Behavioural science
• Implementation science
• Community engagement
• Health economics and modelling in the field of TB and/or 
• Health systems and programme delivery.

Submitting your expression of interest

To register your interest in being considered for the TAG on clinical and policy considerations for new Tuberculosis (TB) vaccines, please submit the following documents by 12 July 2024  to [email protected] using the subject line “Expression of interest for the ‘Clinical and policy TAG on new TB vaccines’:

• A cover letter, indicating your motivation to apply and how you satisfy the selection criteria. Please note that, if selected, membership will be in a personal capacity. Therefore do not use the letterhead or other identification of your employer;
• Your curriculum vitae (including your nationality/ies) and
• A signed and completed Declaration of Interests (DOI) form for WHO Experts, available at https://www.who.int/about/ethics/declarations-of-interest .

After submission, your expression of interest will be reviewed by WHO.  Due to an expected high volume of interest, only selected individuals will be informed. 

Important information about the selection processes and conditions of appointment

Members of WHO advisory groups (AGs) must be free of any real, potential or apparent conflicts of interest. To this end, applicants are required to complete the WHO Declaration of Interests for WHO Experts, and the selection as a member of a AG is, amongst other things, dependent on WHO determining that there is no conflict of interest or that any identified conflicts could be appropriately managed (in addition to WHO’s evaluation of an applicant’s experience, expertise and motivation and other criteria).

All AG members will serve in their individual expert capacity and shall not represent any governments, any commercial industries or entities, any research, academic or civil society organizations, or any other bodies, entities, institutions or organizations. They are expected to fully comply with the Code of Conduct for WHO Experts ( https://www.who.int/about/ethics/declarations-of-interest ). AG members will be expected to sign and return a completed confidentiality undertaking prior to the beginning of the first meeting.

At any point during the selection process, telephone interviews may be scheduled between an applicant and the WHO Secretariat to enable WHO to ask questions relating to the applicant’s experience and expertise and/or  to assess whether the applicant meets the criteria for membership in the relevant AG.

The selection of members of the AGs will be made by WHO in its sole discretion, taking into account  the following (non-exclusive) criteria: relevant technical expertise; experience in international and country policy work; communication skills; and ability to work constructively with people from different cultural backgrounds and orientations .The selection of AG members will also take account of the need for diverse perspectives from different regions, especially from low and middle-income countries, and for gender balance.

If selected by WHO, proposed members will be sent an invitation letter and a Memorandum of Agreement. Appointment as a member of a AG will be subject to the proposed member returning to WHO the countersigned copy of these two documents.

WHO reserves the right to accept or reject any expression of interest , to annul the open call process and reject all expressions of interest at any time without incurring any liability to the affected applicant or applicants and without any obligation to inform the affected applicant or applicants of the grounds for WHO's action. WHO may also decide, at any time, not to proceed with the establishment of the AG, disband an existing TAG or modify the work of the AG.

WHO shall not in any way be obliged to reveal, or discuss with any applicant, how an expression of interest was assessed, or to provide any other information relating to the evaluation/selection process or to state the reasons for not choosing a member.

WHO may publish the names and a short biography of the selected individuals on the WHO internet.

AG members will not be remunerated for their services in relation to the AG or otherwise. Travel and accommodation expenses of AG members to participate in AG meetings will be covered by WHO in accordance with its applicable policies, rules and procedures.

The appointment will be limited in time as indicated in the letter of appointment.

If you have any questions about this “Call for experts”, please write to [email protected] well before the applicable deadline.

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