case study ethics committee

Annual Review of Ethics Case Studies

What are research ethics cases.

For additional information, please visit Resources for Research Ethics Education

Research Ethics Cases are a tool for discussing scientific integrity. Cases are designed to confront the readers with a specific problem that does not lend itself to easy answers. By providing a focus for discussion, cases help staff involved in research to define or refine their own standards, to appreciate alternative approaches to identifying and resolving ethical problems, and to develop skills for dealing with hard problems on their own.

Research Ethics Cases for Use by the NIH Community

Theme 23 – Authorship, Collaborations, and Mentoring (2023)
Theme 22 – Use of Human Biospecimens and Informed Consent (2022)
Theme 21 – Science Under Pressure (2021)
Theme 20 – Data, Project and Lab Management, and Communication (2020)
Theme 19 – Civility, Harassment and Inappropriate Conduct (2019)
Theme 18 – Implicit and Explicit Biases in the Research Setting (2018)
Theme 17 – Socially Responsible Science (2017)
Theme 16 – Research Reproducibility (2016)
Theme 15 – Authorship and Collaborative Science (2015)
Theme 14 – Differentiating Between Honest Discourse and Research Misconduct and Introduction to Enhancing Reproducibility (2014)
Theme 13 – Data Management, Whistleblowers, and Nepotism (2013)
Theme 12 – Mentoring (2012)
Theme 11 – Authorship (2011)
Theme 10 – Science and Social Responsibility, continued (2010)
Theme 9 – Science and Social Responsibility - Dual Use Research (2009)
Theme 8 – Borrowing - Is It Plagiarism? (2008)
Theme 7 – Data Management and Scientific Misconduct (2007)
Theme 6 – Ethical Ambiguities (2006)
Theme 5 – Data Management (2005)
Theme 4 – Collaborative Science (2004)
Theme 3 – Mentoring (2003)
Theme 2 – Authorship (2002)
Theme 1 – Scientific Misconduct (2001)

For Facilitators Leading Case Discussion

For the sake of time and clarity of purpose, it is essential that one individual have responsibility for leading the group discussion. As a minimum, this responsibility should include:

Reading the case aloud.
Defining, and re-defining as needed, the questions to be answered.
Encouraging discussion that is “on topic”.
Discouraging discussion that is “off topic”.
Keeping the pace of discussion appropriate to the time available.
Eliciting contributions from all members of the discussion group.
Summarizing both majority and minority opinions at the end of the discussion.

How Should Cases be Analyzed?

Many of the skills necessary to analyze case studies can become tools for responding to real world problems. Cases, like the real world, contain uncertainties and ambiguities. Readers are encouraged to identify key issues, make assumptions as needed, and articulate options for resolution. In addition to the specific questions accompanying each case, readers should consider the following questions:

Who are the affected parties (individuals, institutions, a field, society) in this situation?
What interest(s) (material, financial, ethical, other) does each party have in the situation? Which interests are in conflict?
Were the actions taken by each of the affected parties acceptable (ethical, legal, moral, or common sense)? If not, are there circumstances under which those actions would have been acceptable? Who should impose what sanction(s)?
What other courses of action are open to each of the affected parties? What is the likely outcome of each course of action?
For each party involved, what course of action would you take, and why?
What actions could have been taken to avoid the conflict?

Is There a Right Answer?

Acceptable solutions.

Most problems will have several acceptable solutions or answers, but it will not always be the case that a perfect solution can be found. At times, even the best solution will still have some unsatisfactory consequences.

Unacceptable Solutions

While more than one acceptable solution may be possible, not all solutions are acceptable. For example, obvious violations of specific rules and regulations or of generally accepted standards of conduct would typically be unacceptable. However, it is also plausible that blind adherence to accepted rules or standards would sometimes be an unacceptable course of action.

Ethical Decision-Making

It should be noted that ethical decision-making is a process rather than a specific correct answer. In this sense, unethical behavior is defined by a failure to engage in the process of ethical decision-making. It is always unacceptable to have made no reasonable attempt to define a consistent and defensible basis for conduct.

This page was last updated on Friday, July 7, 2023

Case report

BMC Medical Ethics welcomes well-described reports of cases that include the following: • Unreported or unusual side effects or adverse interactions involving medications. • Unexpected or unusual presentations of a disease. • New associations or variations in disease processes. • Presentations, diagnoses and/or management of new and emerging diseases. • An unexpected association between diseases or symptoms. • An unexpected event in the course of observing or treating a patient. • Findings that shed new light on the possible pathogenesis of a disease or an adverse effect.

Case reports submitted to BMC Medical Ethics should make a contribution to medical knowledge and must have educational value or highlight the need for a change in clinical practice or diagnostic/prognostic approaches. BMC Medical Ethics will not consider case reports describing preventive or therapeutic interventions, as these generally require stronger evidence. We will not consider reports on topics that have already been well characterised or where other, similar, cases have already been published.

Authors should describe how the case report is rare or unusual as well as its educational and/or scientific merits in the covering letter that will accompany the submission of the manuscript. Case report submissions will be assessed by the Editors and will be sent for peer review if considered appropriate for the journal.

Case reports should include relevant positive and negative findings from history, examination and investigation, and can include clinical photographs, provided these are accompanied by a statement that written consent to publish was obtained from the patient(s). Case reports should include an up-to-date review of all previous cases in the field. Authors should follow the CARE guidelines and the CARE checklist should be provided as an additional file.

Authors should seek written and signed consent to publish the information from the patient(s) or their guardian(s) prior to submission. The submitted manuscript must include a statement that this consent was obtained in the consent to publish section as detailed in our editorial policies .

Professionally produced Visual Abstracts BMC Medical Ethics will consider visual abstracts. As an author submitting to the journal, you may wish to make use of services provided at Springer Nature for high quality and affordable visual abstracts where you are entitled to a 20% discount. Click here to find out more about the service, and your discount will be automatically be applied when using this link.

Preparing your manuscript

The information below details the section headings that you should include in your manuscript and what information should be within each section.

Please note that your manuscript must include a 'Declarations' section including all of the subheadings (please see below for more information).

Title page

The title page should:

"A versus B in the treatment of C: a randomized controlled trial", "X is a risk factor for Y: a case control study", "What is the impact of factor X on subject Y: A systematic review, A case report etc."
or, for non-clinical or non-research studies: a description of what the article reports
if a collaboration group should be listed as an author, please list the Group name as an author. If you would like the names of the individual members of the Group to be searchable through their individual PubMed records, please include this information in the “Acknowledgements” section in accordance with the instructions below
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The Abstract should not exceed 350 words. Please minimize the use of abbreviations and do not cite references in the abstract. The abstract must include the following separate sections:

Background: why the case should be reported and its novelty
Case presentation: a brief description of the patient’s clinical and demographic details, the diagnosis, any interventions and the outcomes
Conclusions: a brief summary of the clinical impact or potential implications of the case report

Keywords

Three to ten keywords representing the main content of the article.

The Background section should explain the background to the case report or study, its aims, a summary of the existing literature.

Case presentation

This section should include a description of the patient’s relevant demographic details, medical history, symptoms and signs, treatment or intervention, outcomes and any other significant details.

Discussion and Conclusions

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List of abbreviations

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Declarations

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Ethics approval and consent to participate

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Authors' information (optional)

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If any of the sections are not relevant to your manuscript, please include the heading and write 'Not applicable' for that section.

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include a statement on ethics approval and consent (even where the need for approval was waived)
include the name of the ethics committee that approved the study and the committee’s reference number if appropriate

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See our editorial policies for more information.

If your manuscript does not report on or involve the use of any animal or human data or tissue, please state “Not applicable” in this section.

If your manuscript contains any individual person’s data in any form (including any individual details, images or videos), consent for publication must be obtained from that person, or in the case of children, their parent or legal guardian. All presentations of case reports must have consent for publication.

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Authors are also encouraged to preserve search strings on searchRxiv https://searchrxiv.org/ , an archive to support researchers to report, store and share their searches consistently and to enable them to review and re-use existing searches. searchRxiv enables researchers to obtain a digital object identifier (DOI) for their search, allowing it to be cited.

Data availability statements can take one of the following forms (or a combination of more than one if required for multiple datasets):

The datasets generated and/or analysed during the current study are available in the [NAME] repository, [PERSISTENT WEB LINK TO DATASETS]
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
All data generated or analysed during this study are included in this published article [and its supplementary information files].
The datasets generated and/or analysed during the current study are not publicly available due [REASON WHY DATA ARE NOT PUBLIC] but are available from the corresponding author on reasonable request.
Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.
The data that support the findings of this study are available from [third party name] but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of [third party name].
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BMC Medical Ethics

ISSN: 1472-6939

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The Functioning of Hospital Ethics Committees: A Multiple-Case Study of Four Canadian Committees

Published: 05 May 2011
Volume 23 , pages 225–238, ( 2011 )

Cite this article

Alice Gaudine 1 ,
Marianne Lamb 2 ,
Sandra M. LeFort 1 &
Linda Thorne 3

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A multiple-case study of four hospital ethics committees in Canada was conducted and data collected included interviews with key informants, observation of committee meetings and ethics-related hospital documents, such as policies and committee minutes. We compared the hospital committees in terms of their structure, functioning and perceptions of key informants and found variation in the dimensions of empowerment, organizational culture of ethics, breadth of ethics mandate, achievements, dynamism, and expertise.

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Acknowledgments

This study was funded by the Canadian Institutes of Health Research. Thanks to Thomas Hart, Meredith Harvey, Peggy Sheppard, Heather Hunt Smith, and Daphne Whalen-Brake for their research assistance and to Joanne Smith-Young for coordinating the study.

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School of Nursing, Memorial University of Newfoundland, St. John’s, Newfoundland, Canada

Alice Gaudine & Sandra M. LeFort

School of Nursing, Queen’s University, Kingston, Ontario, Canada

Marianne Lamb

Schulich School of Business, York University, Toronto, Ontario, Canada

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Gaudine, A., Lamb, M., LeFort, S.M. et al. The Functioning of Hospital Ethics Committees: A Multiple-Case Study of Four Canadian Committees. HEC Forum 23 , 225–238 (2011). https://doi.org/10.1007/s10730-011-9151-z

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Published : 05 May 2011

Issue Date : September 2011

DOI : https://doi.org/10.1007/s10730-011-9151-z

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The Structure and Function of Research Ethics Committees in Africa: A Case Study

* To whom correspondence should be addressed. E-mail: [email protected]

Adnan Ali Hyder,
Ademola Ajuwon,
John Appiah-Poku,
Nicola Barsdorf,
Dya Eldin Elsayed,
Mantoa Mokhachane,
Bavon Mupenda,
Paul Ndebele,
Godwin Ndossi,
Bornwell Sikateyo,
Godfrey Tangwa,
Paulina Tindana
Nancy E Kass,
Adnan Ali Hyder,
Ademola Ajuwon,
John Appiah-Poku,
Nicola Barsdorf,
Dya Eldin Elsayed,
Mantoa Mokhachane,
Bavon Mupenda,
Paul Ndebele,

Published: January 23, 2007

https://doi.org/10.1371/journal.pmed.0040003
Reader Comments

Citation: Kass NE, Hyder AA, Ajuwon A, Appiah-Poku J, Barsdorf N, Elsayed DE, et al. (2007) The Structure and Function of Research Ethics Committees in Africa: A Case Study. PLoS Med 4(1): e3. https://doi.org/10.1371/journal.pmed.0040003

Copyright: © 2007 Kass et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Funding: This project was funded, in part, by a grant from the Fogarty International Center, National Institutes of Health R25 TW01604.

Competing interests: The authors have declared that no competing interests exist.

Abbreviations: FWA, Federal Wide Assurance; IRB, institutional review board; JHU, Johns Hopkins University; REC, research ethics committee; WHO, World Health Organization

According to international guidelines [ 1 , 2 ] and several nations' laws [ 3–5 ], research with humans requires independent ethics committee review. In the United States, committees are called institutional review boards (IRBs) [ 6 ]; elsewhere they generally are called research ethics committees (RECs). Committees are designed to: provide third party review, thereby minimizing conflicts of interest; protect the welfare of research participants through attention to risks, benefits, and informed consent; and avoid exploitation of vulnerable individuals and populations.

Most literature examining RECs comes from wealthier countries. One US study found “serious concerns” with the quality of 14% of IRB reviews [ 7 ]. Another found that IRBs focused predominantly on consent documentation, spending less time examining voluntariness, selection of participants, and risk [ 8 ]. Many US [ 9–15 ] and international [ 16–18 ] studies have found that different research ethics committees reach different conclusions when reviewing the same study.

Several scholars and advisory bodies have made recommendations to address challenges facing US IRBs [ 19–22 ]. However, there has been little research examining procedures, strengths, and challenges of RECs in developing countries. Two case reports describe disagreements between host and sponsoring country RECs [ 23 , 24 ], and an international survey reports differences in sponsoring and host country reviews [ 25 ]. Three articles describe RECs within one country (Turkey [ 26 ], Granada [ 27 ], and Sudan [ 28 ]), and five within a larger region.

Rivera described 20 RECs in Latin America, finding that only 45% had standard operating procedures and that members had limited training [ 29 ]. Coker examined RECs in Central and Eastern Europe [ 30 ]. Ten countries had national committees, most committees included non-medical members, and three provided training. The World Health Organization's (WHO) Southeast Asian Regional Office, finding that only some of the 16 respondents had national RECs, called for capacity development in the area of research ethics [ 31 ].

Most literature examining research ethics committees comes from wealthier countries.

The WHO African Regional Office found that 36% of member countries had no REC. In the countries that did have RECs, most RECs met monthly, five met quarterly, and one never met [ 32 ]. Finally, Milford examined African RECs' resource needs in the context of HIV vaccine trial preparedness, finding that 97% believed African RECs had inadequate training in ethics and HIV vaccine trials and 80% believed African RECs had inadequate training in health research ethics.

Additional information on how African RECs function, including their staffing, operating procedures, strengths, and challenges would be useful for African and international researchers working within Africa, and for growing efforts to enhance ethics capacity on this vast continent. We therefore used a case study approach to shed light on the structure and functioning of RECs in Africa.

The Johns Hopkins Bloomberg School of Public Health received a training grant from the Fogarty International Center in 2000 to train three African professionals in bioethics each year [ 33 ]. Several of these professionals explicitly seek to increase the scholarly and administrative capacity of their African RECs. In 2004, program faculty and trainees created a structured questionnaire to document the history, composition, functioning, financing, strengths, and challenges of RECs with which the trainees were affiliated. Questionnaires were completed by e-mail. Follow up e-mails clarified responses. Data were entered into Microsoft Excel and tabulated. Trainees and faculty met for two days in 2005 to refine concepts and work on the manuscript.

Results of Our Case Study

Eleven of the 12 trainees who attended the program in 2001–2004 collaborated. Nine had personal experience on one or more African REC. Another trainee secured information from her institution's REC; one contributed no data. One trainee worked with two committees in his country; another worked with two committees from two countries. Twice, two trainees from the same country were affiliated with different RECs. Thus, twelve RECs were included in this case study from nine African countries: Democratic Republic of the Congo, Ghana (2), Kenya, Nigeria, South Africa (2), Sudan (2), Tanzania, Zambia, and Zimbabwe.

History of research ethics committees.

The oldest committee was from South Africa, established in 1967. The REC of the Medical Research Council of Zimbabwe was formed in 1974 but had intermittent functioning until 1992, when it became more formally established. Two RECs began in the 1980s; eight were started within the last five years, including two (Kenya and Democratic Republic of the Congo) created by the trainee the year before data collection.

Six of the 12 RECs had Federal Wide Assurances (FWAs) from the US government, an indication that the institution had received US research funds or collaborated with US institutions [ 34 ]. Two RECs were established as a requirement of international collaboration. The remaining RECs were established because of a recognized need for independent ethics review. Trainees' efforts were responsible for existing or pending FWAs of three African institutions.

Composition.

RECs ranged from nine to 31 members. One included only physicians and scientists, while most had clinicians, social scientists, economists, nutritionists, pharmacists, statisticians, pastors, and lawyers. Ten had lay or non-scientist members; two did not (see Table 1 ). One required that a third of the members should be lay persons, including a traditional chief and representatives from local organizations. Another asked the local community to nominate a community member. None required gender balance, but all consciously included both men and women.

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Composition of RECs in Case Study

https://doi.org/10.1371/journal.pmed.0040003.t001

REC meetings.

One REC recently stopped meeting in person; reviews were conducted by the chair or individual members. All other committees met in person: two met irregularly, based on need; another met twice per year or as needed; one met every two months; and seven met monthly.

All committees (except the one that did not meet) had requirements for quorum (half, or half plus one). One required two-thirds attendance. Meeting quorum, in general, was not difficult. One trainee said members were committed to duties; two said meetings were scheduled in advance or on weekends. Two said quorum was a problem. One described significant member turnover; another said busy members had problems with punctuality and attendance.

Training of REC members.

Two committees had members with no training. Six RECs had received training only since the Johns Hopkins University (JHU)–Fogarty trainee returned and provided it. Four RECs had individual members who attended external workshops; one committee conducted Good Clinical Practice courses semi-annually.

Conflicts of interest.

All RECs required that members be excused if their protocol was under review. Other potential conflicts were raised, however, which may be harder to manage. Two discussed conflicts posed when a departmental colleague had a protocol under review. One said such reviews were sent to another department, even to a department with less expertise, to avoid conflicts. Another described unease voicing objections when fellow members' protocols were reviewed, fearing being labeled unfriendly. Another believed community members were loathe to reject protocols because studies bring employment. Another said protocols bring income to the institution and sometimes questions were not raised so projects could clear quickly.

Procedural and administrative issues.

Most RECs had basic administrative capabilities, although the REC that no longer met in person lacked any administrative infrastructure. Two RECs lacked standard operating procedures. Nine had such procedures in place, five of which had been written by the trainee upon returning to Africa. All eleven RECs that met kept minutes.

All RECs had a mechanism for reviewing research project amendments to approved studies, although most did not require a review for study changes or amendments. In four RECs, the JHU–Fogarty trainee created the amendment mechanism. Of the 12 RECs, two routinely conducted annual reviews (both instituted this practice after the trainee returned to Africa); two conducted annual reviews when required by an external funder or driven by the principal investigator; and eight did not conduct annual reviews.

All trainees said REC funding was a challenge. Three had no operating funds whatsoever. For the other nine, funding came solely or in combination from government (2), foreign agencies (1), and/or fees for reviews (6). Fees for review varied greatly. One REC used a “sliding scale,” charging US$5 for proposals submitted by students, US$10 for studies submitted by post-graduate trainees, and US$20 for all other research proposals. Another did not charge for institutional applications, but required US$365 for external applications and US$585 for industry studies. Some used a “fixed fee” structure, such as US$100 for all applications or 1% of the study's budget, once funded. All RECs benefited from “in-kind” donations of institutional resources, such as space, photocopying, mail distribution, and services of staff with other responsibilities.

Eight RECs did not pay members (though some reimbursed travel); four paid a “sitting allowance.” Five RECs had paid staff; seven did not. RECs that paid staff all had budgetary allotments or charged fees.

REC review.

The number of protocols reviewed per year varied tremendously. Three RECs reviewed eight to 12 protocols per year, three reviewed 30–50, five reviewed 100–250, and one reviewed 600 per year. Two RECs with small portfolios only reviewed internally funded protocols. Most reviewed a mixture of internal and external projects.

Seven RECs required all protocols to be reviewed, although two started this policy only after the JHU–Fogarty trainee returned to the institution. The five other RECs only reviewed research when required by the funder. Review time generally corresponded to the frequency with which the REC met. Most completed reviews in one to two months, ranging from two weeks to more than three months. Four RECs looked equally at science, ethics, and budget, while another four reviewed science and ethics, but not budget. Two spent little time on ethics, while another focused almost exclusively on ethics as another committee reviewed the science.

Trainees mentioned several strengths of their RECs. First, the creation of so many new committees is a strength in itself. Also, many committees have at least a few members who received some training in ethics, through the REC, the JHU–Fogarty trainee, or external workshops. Several trainees mentioned that their REC has a reputation with sponsors for integrity and/or that the REC provides useful feedback to researchers.

Challenges.

Inadequate training and funding consistently were mentioned as the biggest challenges. These scholars acknowledged significant time and effort for member training. Reviewers were often poorly equipped to review according to ethics criteria, which led to a disproportionate focus on the science. Trainees mentioned inadequate training of staff and administrators in REC procedures; one trainee raised the issue that RECs have weak monitoring systems due to funding constraints.

Budget constraints were mentioned by nearly everyone. Running an REC is expensive, and one trainee suggested that for this reason poor countries will simply avoid the creation of a REC unless required. Another said that governments must be made aware of the importance of research ethics to convince them to fund RECs. Several mentioned that REC members had multiple responsibilities and thus, they would be more committed if they could be paid, especially since serving on the REC might actually deny them income they would otherwise have received for that time. One REC had no stationery, space, computers, or communication facilities. In another, a foreign investigator donated $200 for stationery supplies when the REC started, but there were no other funds for staff or infrastructure. An REC started by the JHU–Fogarty trainee used the trainee's personal laptop for its official business. Trainees also used their reentry grants provided by the JHU program to help enhance REC infrastructure.

Another challenge was the tendency of a few RECs to “rubber stamp” approvals in order to secure international funding. Related to this challenge, a couple of trainees raised a concern about REC independence. One said outsiders, researchers, and politicians could interfere in the REC process, and another said the “culture of corruption” is prevalent in some parts of Africa, which could affect the integrity of the committee. In some regions, investigators could engage in “IRB shopping,” whereby they could submit their protocol to a new REC if it was rejected by a first. A few trainees were concerned about possible abuse of the expedited review option in their RECs, as expedited reviews do not incur the delay and expense of convening a full committee meeting. Two specifically mentioned a lack of national guidelines and local operating procedures as a challenge to good work. Another voiced a concern that institutions would often select “top management” individuals to be members who might not have appropriate skills or time.

Suggestions.

Given the challenges raised, it was not surprising to hear trainees suggest the need for more training, funding, independence, and political commitment to improve REC functioning. In addition, innovative suggestions also emerged: training workshops on how to interpret ethics principles in light of local norms; public outreach programs about research; creation of networks of African RECs to share materials, resources, and capacity building; creation of mechanisms to facilitate communication between host and sponsor country RECs; joint meetings between REC members and investigators to brainstorm solutions to shared challenges; human rights advocacy to help enhance participants' and researchers' awareness about rights in research; and more empirical research on ethics and African research.

This case study reports on the experience of ten African professionals with 12 African RECs. These 12 RECs represent a range of experiences, from a committee formed 30 years ago to two recent ones. All, to greater or lesser extents, are functional, although one never meets as a committee. All cite the need for additional training, more attention to ethics issues, and more funding for staffing, transportation, and supplies.

Many challenges described here are not unique to African RECs. Wealthier countries, too, have heard criticism about inadequate funding, staffing, and training of committees [ 35–40 ]. Poor countries, however, inevitably feel these needs more acutely. Further, additional challenges may arise from resources being limited. We heard of institutions or community members exerting pressure to approve research that would bring jobs, infrastructure development, money, and intellectual cache to the local setting. Kilama suggested that poverty itself is a threat to independence, since poverty can blind researchers, participants, and RECs alike to any problems in studies that bring jobs, medicines, or prestige to a community [ 41 ]. Challenges to people's integrity may be more typical where individuals can expedite or bypass usual procedures through informal transfer of funds, as occurs in some countries.

External mandates often were the impetus for a committee forming and, in some cases, contributed start-up resources. While some committees still only review externally sponsored projects, others used external requirements as a catalyst to create a conscientious committee, committed to ethics review, training, and integrity. Absent the external mandate, changes may have happened more slowly.

Encouraging lessons.

Positive lessons can be drawn from this case study. First, research ethics review is increasingly routine in Africa. More African institutions require and are equipped to provide review, all but one of the committees in this case study meet in person, and membership is relatively diverse. There are growing opportunities in Africa for training in Good Clinical Practice and research methodology. Increasingly, African investigators submit to international journals that require REC review as a condition of publication; African journals now, also, generally require REC review of published studies [ 42 , 43 ], and a special meeting of the Forum for African Medical Editors in 2005 developed further guidelines for journal submission and review, including guidelines related to ethics [ 42 ]. Nonetheless, several of these committees are new, and some were created by the trainee. In the future, other researchers may start an African collaboration, find no RECs exist locally, and will need to facilitate creation of one. More guidance exists to assist in this task, but it can appear somewhat daunting [ 44 ].

Second, these experiences suggest committees become more stable, equipped, and trained over time. Thus, some challenges described may reflect how new most African RECs are. Committees with the longest history are the most established with regard to procedures, funding, and staffing. One trainee described his REC focusing almost entirely on science when first created, with community members deferring to scientific ones. Over time, members gained training and experience, and reviews began to include more ethics.

Third, this case study suggests individuals can make a difference. RECs included here were not random: a professional associated with them had just completed intensive training in research ethics. Nonetheless, with limited funds and variable institutional support, a small number of individuals created two RECs, others created and implemented standard operating procedures, review forms, and regular review where none existed, and most now provide training for members, researchers, and/or the public.

Further progress likely will involve a confluence of funders' requirements for review, institutional commitments, and individual contributions. Indeed, successful change requires systemic commitment. One individual cannot effect long-term change without institutional support, which is more likely with national requirements for review [ 45 ]. National policies are more likely to be developed when international funders, aid agencies, and journals establish that RECs are required and review must be the norm. National and institutional commitment must be set as policy and implemented through influx of resources for RECs.

To make committees' work meaningful, however, there must be a commitment, as many have suggested, to training and better resources. We join others calling for a shared library of resources, model standard operating procedures [ 46 ], model consent forms, and copies of training presentations; fortunately, such resources increasingly are available through the Internet. African professionals must find means to access continuing ethics education [ 41 , 47 ]. Challenging ethics dilemmas will always arise in research; those tasked with resolving them will need ongoing support and training to navigate reasonable solutions.

Limitations of our case study.

This case study has several limitations. The data are self-reported, through the lens of individuals who received intensive training in research ethics. Thus, their views may reflect more sophisticated understanding of how RECs should function than other REC members might provide. Further, the capacity of RECs, as reported, was often recently enhanced due to the efforts of the JHU–Fogarty trainee. Most new African RECs presumably are not started with these resources and intellectual capacity development, so the speed with which new RECs develop procedures and skills for ethics review may happen more slowly.

This report describes 12 RECs in Africa. It does not claim to be representative of African RECs as a whole. Further, this case study examined REC functioning but does not attempt to draw a conclusion about how ethical research is in Africa. Even the most conscientious REC review does not guarantee a well-executed study. Without study monitoring, it is impossible to know the relationship between REC quality and the quality of approved research [ 48 , 49 ].

This case study examines the history, operations, strengths, and challenges of 12 African RECs. We hope this will help researchers working in Africa better understand the landscape of ethics review and help funders target resources for capacity development in a continent where health research is so critical to development, and local responsibility for research functions is critical for research.

Supporting Information

Alternative language abstract s1. french translation of the abstract by bm.

https://doi.org/10.1371/journal.pmed.0040003.sd001

(31 KB DOC).

Acknowledgments

We are grateful for the research assistance of Rachel Harrison.

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22. Institute of Medicine (2002) Responsible research: A systems approach to protecting research participants. Washington (D. C.): National Academy Press.
31. WHO South East Asian Regional Office (2002) Ethics in health research. New Delhi: World Health Organization.
32. Kirigia JM, Wambebe C, Baba-Mousa A (2005) Status of national research bioethics committees in the WHO African region. BMC Medical Ethics 6.
33. Fogarty International Center (2005) International Bioethics Education and Career Development Award. Available: http://www.fic.nih.gov/programs/training_grants/bioethics/index.htm . Accessed 19 December 2006.
34. US Department of Health and Human Resources (2006) Office for Human Research Protections. Available: http://www.hhs.gov/ohrp . Accessed 19 December 2006.
35. Bell H, Whiton J, Connelly S (1998) Evaluation of NIH implementation of Section 491 of the Public Health Service Act. Mandating Program of Protection for Research Subjects.
37. US Department of Health and Human Resources/Office of the Inspector General (1998) Institutional review boards: A time for reform.
38. US Department of Health and Human Resources/Office of the Inspector General (2000) Protecting human research subjects: Status of recommendations.
39. Bliwise R (1999) Managing a medical makeover. Duke Magazine 85.
41. Kilama WL (2003) Equipping Africa's researchers for global collaboration. Science and Development Network.
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Ethical approval requirements for case study reports

We have noticed a lot of variety in the way that ethical approval for Case Reports are published in different journals. For example, some state that the study was determined not to require Ethics Committee (EC) or Institutional Review Board (IRB) review especially if it was a retrospective review. Others state that all procedures were carried out in accordance with approved ethical standards, giving the name and reference number of the relevant IRB. Other cases still simply state that patient consent is available and give the name of the institution which has granted approval, and the protocol ID, while a final category provide no statement about ethical approval.

Question for COPE Council:

Under what circumstances should a journal require the author(s) of a Case Report to provide ethical approval?
What does COPE advise journal editors to require from authors?

Advice on this case is from a small number of COPE Council Members. Most cases on the COPE website are presented to the COPE Forum where advice is offered by a wider group of COPE Members and COPE Council Members. Advice on individual cases is not formal COPE guidance.

There are two connected aspects to this question: whether ethics approval is required for the study, and whether consent has been given for personal details (potentially including images) to be published.

On ethics approval for case studies, there are many grey areas, though in general, we would encourage always asking for approval by an institutional review board (IRB) when a study is based on human participants. However, some IRBs, institutions or governments do not regard the reporting of single cases arising during normal practice as research, although cases involving efficacy studies or part of a trial would typically be seen as such. Some case studies are published for educational purposes rather than research, and in others, where data were collected as part of routine care, permission might be given by a hospital or research institute rather than an ethics committee. IRBs may apply a patient number cut-off (eg 3 or 5) above which a case series counts as research. Thus a case-by-case approach may be needed, with further dialogue with authors in cases where there is ambiguity. It is also worth noting, however, that IRBs are primarily concerned with the procedures concerning the study design and conduct, rather than how the reporting is carried out.

The key point from a publication ethics point of view is that journals should make their policies clear on when they expect ethics approval, as well as what declarations are needed at submission and in the paper. Examples of some comprehensive case report guidelines can be found at Dove Press (for authors) and at SAGE for editors.

Since it is beyond a journal’s scope to establish different national legal frameworks they might choose simply to ask for a declaration that national or local laws were followed, naming the ethics committee that gave approval, and the reference number if appropriate. This declaration could be a statement that the need for approval was waived, as in one of the cases cited above. Some journals go further and ask for documentation that IRB approval was waived if there are any doubts about this (for example, a project website which gives further details, or a letter from the IRB).

Proof of patient consent for publication is a separate issue, but one to which journals should pay equal attention even if it is decided that informed consent for research does not apply to case reports or case series. COPE has guidelines regarding patient consent in case reports .

It should be noted that these stipulate that journals collect proof that consent was given for any study involving humans (including its publication), no matter the size of the enquiry. Since the legal procedures underpinning patient consent may vary from one country to another journals could consider providing blank forms which follow COPE guidance. Journals should also stipulate that the information provided to the individuals in question has explained what happens if their identifying photographs are published in scientific journals under an open licence. The BMC portfolio has this as an explicit point in their consent for publication policies : authors need to have informed the subject that the publication will be open access and published under CC BY, and be made aware of the consequences.

Fundamentally, while there is no one-size-fits-all answer to the question, journals should have clear policies on what they require under what circumstances. In particular, they should ensure that the ethics statement published within the manuscript is clear both on ethics approval or its waiver, and that the patient provided proper consent for publication according to local laws and regulations.

Related resources

An NIH scoping review on publishing identifying photographs
CARE Case report guidelines
Data and reproducibility
Ethical oversight

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R Førde 1 ,
I H Vandvik 2
1 Center for Medical Ethics, University of Oslo, and the Research Institute, Norwegian Medical Association Oslo, Norway
2 Department of Paediatrics, Section for Child and Adolescent Psychiatry, Rikshospitalet Oslo, Norway
Correspondence to:  R Førde  Legeforeningens forskningsinstitutt, Postboks 1152, Sentrum, 0107 Oslo, Norway; reidun.fordelegeforeningen.no

Objectives: To summarise the types of case brought to the Clinical Ethics Committee of the National Hospital of Norway from 1996 to 2002 and to describe and discuss to what extent issues of information/communication have been involved in the ethical problems.

Design: Systematic review of case reports.

Findings: Of the 31 case discussions, (20 prospective, 11 retrospective), 19 cases concerned treatment of children. Twenty cases concerned ethical problems related to withholding/withdrawing of treatment. In 25 cases aspects of information/communication were involved in the ethical problem, either explicitly (n = 3) or implicitly (n = 22).

Conclusion: Problems related to information/communication may underlie a classic ethical problem. Identification of these “hidden” problems may be important for the analysis, and hence, the solution to the ethical dilemma.

CEC, clinical ethics committee
clinical ethics committee
withdrawing
information
communication

https://doi.org/10.1136/jme.2003.003954

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Case Study – Baby K

Print this case study here: Case Study – Baby K

Case: Baby K– Futile Treatment

Matter of Baby K. C.A. 4 1994, 16 F 3D 590

Baby K is an infant female born with anencephaly. Permanently unconscious, she has only brain stem function. Ventilator treatment was provided upon birth and for an unstated period. The hospital sought to transfer the patient but did not find a willing hospital. She was transferred to a nursing home (with the condition that the hospital would accept her back upon respiratory distress). At the time of the hearing in trial court, two episodes of respiratory distress had occurred, and ventilator treatment had been provided at the hospital.

Her condition had been diagnosed prenatally, but her unmarried mother refused an abortion, even though this was recommended by her obstetrician and her neonatologist.

During the initial hospital stay, hospital personnel “urged” the mother to permit a DNR order because: 1) no treatment existed for her condition, 2) no therapeutic or palliative purpose was served by ventilator treatment, and 3) ventilator care was medically unnecessary and inappropriate. The mother, however, insisted on the use of the ventilator.

The biological father [so-declared by a Virginia state court] was “only distantly involved” and was not initially consulted on the issue by the mother or the hospital.

The physicians requested ethics committee assistance, a subcommittee of which [composed of a family practitioner, a psychiatrist, and a minister] concluded that ventilator treatment should end and that “such care is futile” and recommended pursuit of legal action “if the family refused to follow that advice.” The mother rejected the committee’s recommendation.

Following the two additional hospital stays for temporary ventilator treatment of respiratory distress, the hospital initiated a declaratory and injunctive proceeding, requesting declaration of hospital obligations under 1) the Emergency Medical Treatment and Active Labor Act (EMTALA), 2) the Rehabilitation Act of 1973 [as to discrimination against handicapped], 3) the Americans with Disabilities Act of 1990 (ADA) [as to discrimination against disabled by “public accommodation”], 4) the Child Abuse Amendments of 1984 [which authorizes a state to bring an action to present medical neglect of disabled infants, and 5) the Virginia medical malpractice laws.

The court-appointed guardian ad litem supported the hospital’s position on withholding future ventilator treatment, as did the father.

The mother stated her personal belief that all human life has value, her Christian faith that all life should be protected, and her personal belief that only God should decide the moment of the baby’s death. The hospital stipulated that neither lack of medical resources nor inability to pay for the services were reasons for its proposal for withholding future ventilator treatment.

Refusing to authorize withholding of future ventilator care, the United States District Court ruled that:

1. under EMTALA, the hospital was obligated to provide emergency stabilizing care for respiratory distress [as an acute symptom which reasonably could be expected to result in serious impairment of bodily functions], stating that an exception as to futility was not contained in the statute;

2. under the Rehabilitation Act it would be handicapped discrimination to withhold ventilator treatment because of the anencephaly, as handicapped is. statutorily defined to include a “congenital defect;” and

3. under ADA, withholding of future ventilator treatment would be discrimination against a disabled person by denial of “equal enjoyment of. . .services, facilities, privileges, advantages, or accommodation of any place of public accommodations,” and ruling that “futility” was not an exception under ADA. Declined to rule 1) on the hospital obligations under the child abuse amendments, for lack of joinder of an indispensable party, the Virginia Child Protective Services, and 2) on the hospital obligations under Virginia Medical Malpractice laws, deferring to the state to declare malpractice standards. Also stated that the mother had a “constitutionally protected right to ‘bring up children,”‘ which extended to making medical treatment decisions. The court stated that her assertion of the child’s “explicit constitutional right to life” prevailed over “the nebulous liberty interest in refusing life-saving treatment.” The court also stated that the asserted right to treatment could only be overcome by clear and convincing evidence that treatment was so unreasonably harmful as to constitute child abuse or neglect, ruling that such was not present.

The Court of Appeals affirmed (stating that, by then, three hospital readmissions had occurred). The Court ruled that EMTALA imposed absolute treatment duty (distinguished from screening duty), requiring treatment to stabilize the infant’s condition. It ruled that Act allowed no exception as to treatment care that givers deemed “medically and ethically inappropriate.”

In October, the U.S. Supreme Court refused to hear the case “without comment.”

Article: Court Lines – The Case of Baby “K”: The Concerns of Bioethics vs. The Concerns of Law

By Vicki Michel, MA, JD Ethical Currents, June 1994

Michel is Associate Director of the Pacific Center for Health Policy and Ethics, USC, Los Angeles.

On February 10, 1994, the Fourth Circuit U.S. Court of Appeals, upholding the earlier district court decision, held that a Virginia hospital must continue to provide life-sustaining treatment for an infant with anencephaly. Many bioethicists vehemently criticized the decision, describing it as “so befuddled, so completely wrongheaded…”1 or as a “reversal of what I take to be moral and legal progress…”.2 This case, like the Wanglie case before it, demonstrates the importance of how an issue is defined and framed. Lt also illustrates how healthcare professionals and bioethicists misunderstand judicial decision making.

Baby K. was diagnosed in utero with anencephaly. Ms. H, Baby K’s mother, was counseled by her physician to terminate the pregnancy but declined to do so. Baby K was given ventilator support at birth and Ms. H insisted upon continued aggressive treatment for her baby. Neither the attending physicians nor the hospital ethics committee, all of whom believed continued treatment was futile given their view that anencephaly is incompatible with life, was able to dissuade her. The ethics committee recommended that, if Mrs. H couldn’t be, convinced to terminate treatment of Baby K, the hospital should attempt to resolve this through our legal system.”3 Ms. H was not convinced, but the hospital chose to transfer the infant to a nursing home, agreeing to accept Baby K back if she developed respiratory distress (ventilator treatment was not available in the nursing home). After several transfers, the hospital filed suit, asking the court to say that the hospital would not be in violation of four federal laws – the Emergency Medical Treatment and Active Labor Act (EMTALA), the Rehabilitation Act of 1973 (Rehab Act), the Americans with Disabilities Act (ADA), and the Child Abuse Act – if it refused to give Baby K life sustaining medical care. In order to decide the case, the court had to determine whether any of these federal laws applied and, if they did, whether refusing to treat Baby K violated any of them. The district court based its decision on the first three statutes, but the Court of Appeals relied only on EMTALA.

Those in bioethics largely frame this case by asking whether physicians have an obligation to treat in a situation in which they believe treatment is utterly pointless. What is important to understand is that the legal analysis necessary to decide this case never had to frame the issue in that way.

EMTALA is a law that was passed to prevent hospitals from dumping poor patients without insurance who are acutely in need of care. EMTALA requires that a hospital provide stabilizing treatment to anyone who comes to an emergency room in an “emergency medical condition,” which is defined as “acute symptoms of sufficient severity… such that the absence of immediate medical attention could reasonably be expected to result in… serious impairment… or serious dysfunction…” “Stabilizing treatment” is treatment necessary to assure “that no material deterioration of the condition will result.”

When Baby K was returned to the hospital, she was in an emergency condition and needed ventilator support to be stabilized. The hospital’s attorney did not deny this contention. Rather, the hospital argued for an exemption from EMTALA when treatment is “futile” or “inhumane” as judged by the hospital physicians. The district court relied on a very basic rule of statutory construction in considering this: when the plain language of a statute is clear, there is no legal basis to go beyond it.

However, one can argue that following the plain language, in a particular instance leads to art absurd result or a result that is inconsistent with the statute’s purpose. Judge Sprouse, the one judge who dissented from the court of appeals decision made this argument. He said he did not believe that Congress intended when enacting EMTALA, for the courts to supervise decision making in the circumstances of Baby K. The statute, he argued, was directed at patient dumping and disparate treatment between emergency patients, neither of which were at issue in this case. Judge Sprouse accepted the hospital’s argument that the relevant condition for analysis under EMTALA was Baby K’s anencephaly, not her respiratory distress, and that the hospital must provide only the same treatment to all anencephalic infants, which would, of course, be comfort care only. Judge Sprouse’s argument, especially with regard to Congress’s intent when enacting EMTALA, seems quite compelling, but it did not prevail.

The hospital also argued that Virginia law explicitly allows physicians to withhold care from a patient that the “physician determines to be medially or ethically inappropriate.”4 This Virginia statute is unique in legislating a physician-determined definition of futile treatment. However, as the court points out, it is settled law that, when a state statute conflicts with a federal statute, state law is preempted, and federal law prevails. The Virginia statute is worthy of substantiate discussion, but that discussion is not relevant to the Baby K decision.

As noted above, the 4th Circuit Court of Appeals relied on EMTALA alone to decide this case, but that was possible only because the case factually involved a transfer from a nursing home to a hospital. Most cases involving the duty to provide so-called “inappropriate” treatment will not involve such a transfer, so it is important to look at the other federal statutes invoked in the District Court opinion.

Rehabilitation Act of 1973

Section 504 of the Rehab Act prohibits discrimination against an “otherwise qualified” handicapped person solely on the basis of the person’s handicap. The law applies to any program receiving federal money and hospitals that accept Medicare and Medicaid funding are subject to it. This statute was intended to prevent employment discrimination where “otherwise qualified” meant the person was capable of doing the job requirements that accounted for rejecting the person.

The “otherwise qualified” concept does not fit well when talking about medical treatment. If Baby K’s handicap is anencephaly, then it is certainly the case that the hospital wanted to deny treatment because of her handicap. But that very handicap is what causes the need for her treatment, unlike the employment situation in which the job application and the handicap are unrelated.

However, the court says that because a baby without anencephaly would be treated for respiratory distress, Baby K would have to be treated for respiratory distress under the Rehab Act. The hospital based its argument in part on two prior cases in which hospitals were not required under the Rehab Act to override parental refusal of treatment for infants with disabilities. The court says that those cases are not relevant to the Baby K case because there the parents consented to withholding treatment. This suggests that discrimination against handicapped infants is not illegal if the parents agree to it. It’s not clear what the court is saying here, but it may be suggesting that parents have a broader range of treatment choices for their children than institutions do.

Americans with Disabilities Act

The ADA prohibits discrimination against persons with disabilities by entities defined as “public accommodations.” A disability is defined as “a physical or mental impairment that substantially limits one or more of the major life activities,” of an individual.5Anencephaly is a disability and a hospital is a public accommodation under the ADA. Thus, the hospital’s request to deny treatment to Baby K because she has anencephaly falls squarely under the prohibition of the ADA according to the district court. The court’s opinion says “the Hospital’s reasoning would lead to the denial of medical services to anencephalic babies as a class of disabled individuals. Such discrimination against a vulnerable population class is exactly what the Americans with Disabilities Act was enacted to prohibit.”6

It is this reasoning that could have a major impact on future medical treatment decisions. It would seem to prohibit withholding life-sustaining treatment from a patient with PVS, if PVS is considered to be within the ADA’s definition of disability; and it certainly seems to be within the language of the statute. Almost any condition that provokes discussion of the inappropriateness or “futility” of treatment is likely to be within the definition of disability as it now stands.

Thus, the framework for legal analysis starts in a very different place than the analysis used in bioethics. The debate between expert witnesses in the Baby K case (John Fletcher for the hospital, and Robert Veatch for the mother) is about who gets to decide when treatment is inappropriate: the physicians or the patient/surrogate. Or, as Fletcher put it, “the dispute, which is complex, is about the moral weight of parental autonomy and religious liberty when conflicting with physicians’ recommendations based on standard of care.”7

But that was not the issue for either the district court or the Fourth Circuit Court of Appeals. The latter puts it this way: “It is beyond the limits of our judicial function to address the moral or ethical propriety of providing emergency stabilizing medical treatment to anencephalic infants. We are bound to interpret federal statutes in accordance with their plain language and any expressed congressional intent.”8

Where do we go from here? Will there be a U.S. Supreme Court decision on this in the future? Should court decisions determine or influence the way we carry on the conversation about difficult bioethics issues? This question seems particularly relevant at a time when many ethics committees are trying to develop policies on “futile” or “inappropriate treatment.” Such policies generally attempt to describe those circumstances in which treatment need not be offered to a patient/surrogate. But if the circumstances described refer to conditions of the patient that fall within the legal definition of disability, the policy will be vulnerable to attack under the ADA.

Although the only court so far to use the ADA this way is the trial court in Baby K, the analysis will surely be repeated. However, this should not be a reason to cut off prematurely an important ethical controversy. If health professionals and those in related fields came to a national consensus that, for example, it was ethically inappropriate to continue providing life-sustaining treatment to permanently unconscious patients, and if courts turned out generally to take the position that forgoing such treatment violated the ADA, there would then be a need to resolve the conflict between the law and the ethics of the issue. For the time being, however, we should continue the conversation, noting that the availability of the ADA as a challenge to decisions to withhold treatment requires us to think carefully about disability as a factor in those decisions.

ETHICAL CURRENTS is provided as part of membership in the Center for Healthcare Ethics, St. Joseph Health System.

Director: John Glaser, STD Editor: Judith Wilson Ross, MA Contributing Editor: Vicki Michel, MA, JD

Editorial Offices are located at the Center for Healthcare Ethics, 440 South Batavia Street, Orange, California 92668-3995.

For further information, please call the Center for Healthcare Ethics, (714) 997-7690.

C1994 Center for Healthcare Ethics, St. Joseph Health System

BABY K: Discussion Questions

1. What issues should be addressed in a discussion of a proposed policy around “futile” care?

2. How can these issues be addressed without referring to conditions that fall within the legal definition of “disability” and could thus be liable to ADA analysis?

3. If Baby K was born at your hospital, what would have been your way of handling the case?

Cases in Medical Ethics

Student-led discussions.

A selection of medical ethics cases designed to help determine whether medicine is the correct calling for pre-medical students.

I was a Hackworth Fellow for the Markkula Center for Applied Ethics at Santa Clara University. I was also a pre-medical student, and am currently attending the Loyola University Chicago Stritch School of Medicine. During my senior year at Santa Clara, I led discussions on medical ethics with students interested in medicine. The purpose of these discussions was two-fold. First, they were created to help bring current ethical issues onto our campus. Second, they were intended to help students who were interested in a career in the health sciences determine whether or not medicine is their correct calling. Most of the discussions followed a simple format. One to two cases were formulated for the students to read. Then I presented the students with various questions related to some of the ethical issues contained in the situations described. The following cases are the ones that I presented to the groups. Each case also has a short history and summary of the ethical issues being reviewed. The questions I asked of the students are included as well. These cases and questions are public domain, and can be re-used or modified for educational purposes. I hope that you find them useful, and that they spawn the same thoughtful enjoyment in you as they did in me.

Note: The cases were not based on specific events. However, it is possible that they share similarities with actual events. These similarities were not intended.

Autonomy essentially means "self rule," and it is a patient's most basic right. As such, it is a health care worker's responsibility to respect the autonomy of her patients. However, at times this can be difficult because it can conflict with the paternalistic attitude of many health care professionals. The following two cases address patient autonomy. The first involves the rights of an individual to decide her own fate, even against her physicians' judgments. The second case involves the rights of a parent to care for her child in the manner that she sees fit.

A woman enters the emergency room with stomach pain. She undergoes a CT scan and is diagnosed with an abdominal aortic aneurysm, a weakening in the wall of the aorta which causes it to stretch and bulge (this is very similar to what led to John Ritter's death). The physicians inform her that the only way to fix the problem is surgically, and that the chances of survival are about 50/50. They also inform her that time is of the essence, and that should the aneurysm burst, she would be dead in a few short minutes. The woman is an erotic dancer; she worries that the surgery will leave a scar that will negatively affect her work; therefore, she refuses any surgical treatment. Even after much pressuring from the physicians, she adamantly refuses surgery. Feeling that the woman is not in her correct state of mind and knowing that time is of the essence, the surgeons decide to perform the procedure without consent. They anesthetize her and surgically repair the aneurysm. She survives, and sues the hospital for millions of dollars. Questions for Case 1:

Do you believe that the physician's actions can be justified in any way?

Is there anything else that they could have done?

Is it ever right to take away someone's autonomy? (Would a court order make the physicians' decisions ethical?)

What would you do if you were one of the health care workers?

You are a general practitioner and a mother comes into your office with her child who is complaining of flu-like symptoms. Upon entering the room, you ask the boy to remove his shirt and you notice a pattern of very distinct bruises on the boy's torso. You ask the mother where the bruises came from, and she tells you that they are from a procedure she performed on him known as "cao gio," which is also known as "coining." The procedure involves rubbing warm oils or gels on a person's skin with a coin or other flat metal object. The mother explains that cao gio is used to raise out bad blood, and improve circulation and healing. When you touch the boy's back with your stethoscope, he winces in pain from the bruises. You debate whether or not you should call Child Protective Services and report the mother.

Questions for Case 2:

Should we completely discount this treatment as useless, or could there be something gained from it?

When should a physician step in to stop a cultural practice? (If someone answers "when it harms the child" remind that person that there is some pain in many of our medical procedures, for example, having one's tonsils removed)

Should the physician be concerned about alienating the mother and other people of her ethnicity from modern medicine?

Do you think that the physician should report the mother?

Autonomy Part 2 Maintenance of patient autonomy is one of the major ethical focuses of physicians. Therefore, a second discussion was also held that focused primarily on patient autonomy. This discussion also took a superficial look at euthanasia. For this discussion, a 58 minute video, Dax's Case (produced by Unicorn Media, for Concern for Dying ; produced by Donald Pasquella, Keith Burton ; directed by Donald Pasquella New York : Filmmakers Library, c1984) was used. The video tells the story of Dax Cowart, a man who was severely burned by an accidental propane explosion. The burns disabled Dax, and the physicians forced treatment on him. Though he survived the treatment, he still argues that he should have been allowed to refuse it so that he could die. The video is very useful; however, the videos of Dax's burn treatments are very graphic and the video should be reviewed before it is shown to a group of students.

In the video, one of the physicians says that burn patients are incompetent to make decisions when they first enter the hospital because they are in such a great deal of pain. However, patients such as Dax can be in a great deal of pain for a very long time. In such cases, what should be done to determine competence, and when should this be done?

Do you think the fact that Dax could not see a future for himself should have been taken into account when determining his competency? Could this have clouded his judgment? (He thought that he would end up on the street corner selling pencils)

Do you think that the fact that Dax was going to recover, and had the possibility of living a happy life, made not treating Dax like suicide… or murder? What if he did not have this possibility?

After his recovery, Dax attempted suicide. Should the physicians have let him die? Is it ever correct for a doctor to allow a patient to kill himself?

Do you ever think that it is correct for a physician to break a competent patient's autonomy? If so, is this one of those cases?

Do you think that in this case, that the ends justified the means?

The word "euthanasia" draws its roots from Greek meaning "good death." As it is used in this discussion, it means "the act of ending the life of a person suffering from either a terminal illness, or an incurable disease." The AMA is against physicians assisting in euthanasia. There is currently only one state in the US that allows for euthanasia, and that is Oregon, where in 1997, the "Death With Dignity Act" went into effect. Euthanasia advocates stress that it should be allowed as an extension of a person's autonomy. Those who are against euthanasia often say that it can lead to the devaluation of human life, and to a slippery slope in which the old and disabled will be killed on the whims of healthy people. We examined one case and the Oregon law to view the ethics of euthanasia.

Case One: A woman was diagnosed with motor neurone disease (the same disease that Stephen Hawking has) 5 years ago. This is a condition that destroys motor nerves, making control of movement impossible, while the mind is virtually unaffected. People with motor neurone disease normally die within 4 years of diagnosis from suffocation due to the inability of the inspiratory muscles to contract. The woman's condition has steadily declined. She is not expected to live through the month, and is worried about the pain that she will face in her final hours. She asks her doctor to give her diamorphine for pain if she begins to suffocate or choke. This will lessen her pain, but it will also hasten her death. About a week later, she falls very ill, and is having trouble breathing.

Questions for Case 1:

Does she have a right to make this choice, especially in view of the fact that she will be dead in a short while (say six hours)? Is this choice an extension of her autonomy?

Is the short amount of time she has to live ethically relevant? Is there an ethical difference between her dying in 6 hours and dying in a week? What about a year, and how do you draw this distinction?

Is the right for a patient's self-determination powerful enough to create obligations on the part of others to aid her so that she can exercise her rights? She clearly cannot kill herself. She can't move, but should someone be FORCED to help her, or to find someone to help her?

Should the money used to care for this woman be taken into account when she is being helped? Do you think that legalizing euthanasia could create conflicts of interest for the patient/ or the doctor? Will people feel that they need to end their lives earlier to save money?

Ask each student: If you were the physician, what would you do? Note: if you would pass her off to another doctor knowing he or she would do it, does this free you from you ethical obligations?

Oregon's Death With Dignity Act: We discussed the following questions pertaining to the Death With Diginity Act.

Death With Dignity Questions:

Look at the requirements for the request. Do you see any problems with them? (The woman from case 1 would not qualify.)

Why would they put in these guidelines? Should they be there, if they keep a competent person like the woman above from living her autonomy? (Is it to protect the doctors so they will not have to GIVE the medication?)

Is there a moral difference between prescribing the drug and actually giving it to the patient? If not, why put in the rules?

Why do you think they wouldn't let a person who is terminally ill and in pain with possibly more than 6 months receive assistance in dying? Say someone is diagnosed with HIV?

Does the justification of euthanasia necessarily justify the assisted suicide of a healthy person?

Do you think a weakness of this law is the probability of patients being influenced by family members? (For example, for financial or other reasons?) Note: Approximately 60% of Oregonians in 2000 said (before they died) that they used the prescription at least in some part due to fear of being a burden on their family.

The AMA says that euthanasia is fundamentally incompatible with the physician's role as healer. What do you think about this statement? Why should a physician have to be the one who does this?

Assisted Reproduction:

This is a difficult subject because it involves reproductive issues. In our culture, reproductive liberty, the freedom to decide when and where to conceive a child is highly protected, and this can make these cases much more difficult.

Case 1: There are two types of surrogacy. One type involves a surrogate mother who uses her own egg and carries the baby for someone else. The other type is a "gestational surrogacy" in which the mother has no genetic tie to the child she carries. In the case presented, a gestational surrogate is used.

A woman, after a bout with uterine cancer had a hysterectomy (surgical removal of the uterus). Before, its removal, however, she had several eggs removed for possible fertilization in the future. Now married, the woman wishes to have a child with her husband. Obviously she cannot bear the child herself, so the couple utilizes a company to find a surrogate mother for them. The husband's sperm is used to fertilize one of the wife's eggs, and is implanted in the surrogate mother. The couple pays all of the woman's pregnancy-related expenses and an extra $18,000 as compensation for her surrogacy. After all expenses are taken into account the couple pays the woman approximately $31,000 and the agency approximately $5,000. Though the surrogate passed stringent mental testing to ensure she was competent to carry another couple's child, after carrying the pregnancy to term, the surrogate says that she has become too attached to "her" child to give it up to the couple. A legal battle ensues.

In the United States it is illegal to pay a person for non-replenishable organs. The fear is that money will influence the poor to harm their bodies for the benefit of the rich. Do you see a parallel between this case and this law? Can allowing surrogate mothers to be paid for their troubles allow poorer women to be oppressed?

Does paying the surrogate harm her and/or the child's dignity?

Is it selfish/conceited for this couple to want children of their own genetic make-up? If yes, does this change if you can "easily" have a child? (Note: Over 100,000 children in the U.S. are waiting to be adopted. However, most are older, have several siblings, or have special needs.)

On their website, the AMA says "that surrogacy contracts [when the surrogate uses her own egg], while permissible, should grant the birth mother the right to void the contract within a reasonable period of time after the birth of the child. If the contract is voided, custody of the child should be determined according to the child's best interests." Do you see any problems with this? (What's a reasonable time? In a way can you steal the surrogate's child?)

One of the main arguments against the use of surrogate mothers is that carrying and giving birth to a child is such an emotional event that it is impossible to determine if the surrogate will be able to give up the child. Though adults enter into the contract, the child could ultimately suffer if a long custody battle ensues (as it could in states where surrogacy contracts hold no legal value, such as Virginia). With the possibility of such battles, do you think it is acceptable for parents to use a surrogate mother?

Do you think that if the surrogate is awarded the baby, this could cause emotional harm to the child?

Who do you think should receive the child, and why?

A married couple wishes to have a child; however, the 32 year old mother knows that she is a carrier for Huntington's disease (HD). HD is a genetic disorder that begins showing signs at anywhere from 35-45 years of age. Its symptoms begin with slow loss of muscle control and end in loss of speech, large muscle spasms, disorientation and emotional outbursts. After 15-20 years of symptoms HD ends in death. HD is a dominant disorder which means that her child will have a 50% chance of contracting the disorder. Feeling that risking their baby's health would be irresponsible, the couple decides to use in vitro fertilization to fertilize several of the wife's eggs. Several eggs are harvested, and using special technology, only eggs that do not have the defective gene are kept to be fertilized. The physician then fertilizes a single egg, and transfers the embryo to the mother. Approximately 9 months later, the couple gives birth to a boy who does not carry the gene for the disorder.

Is this a case of eugenics? "Eugenics" is defined as "the hereditary improvement of the human race controlled by selective breeding" (dictionary.com)

Would it be acceptable for the parents to select for sex as well, or should they only select an embryo that does not have HD? How would this be different?

Is it ethical for this couple to have a baby when the mother could begin showings signs of HD when the baby is just a few years old?

With this technology possible, would it be ethical for this couple to have a child without genetically ensuring it would not have the disease? What if we did not have this technology, would it be ethical for a known carrier to have a child? (If not, how far should this carry? a carrier for cystic fibrosis ( which is recessive)? )

Weighing everything we have discussed, do you believe the couple acted ethically?

Response To Bio-Terrorism

The possibility of terrorists using biological weapons on the citizens of the United States has been a major topic in the press for the last several years. Smallpox has been speculated to be the perfect biological terror agent because of the potency of the virus, and because of the lack of herd immunity present in the US population. The following case presents a possible way in which the virus could be released in the population and a possible response. The questions following the case involve the ethics surrounding the government's response.

Smallpox Facts:

Smallpox initially has flu-like symptoms, which are recognizable 7-19 days after exposure. After 2-4 days of flu-like symptoms, the fever begins to decrease, and pox will form.

An infected person is contagious one day before the characteristic pox appear.

Approximately 30-50% of unvaccinated people exposed to smallpox will contract the disease.

The mortality rate for smallpox was approximately 20-40%.

The vaccine that was used was approximately 90% effective.

It is possible that if terrorists were to use the smallpox virus, that they would genetically modify it. If this were the case, then the vaccine may not prevent all of the disease symptoms for those vaccinated.

Facts gathered from: http://www.vbs.admin.ch/ls/e/current/fact_sheet/pocken/

Date: June 22, 2005. A 27-year-old man is brought into a New York City emergency room with a 101-degree fever, and what he believes is chickenpox (Varicella). After a brief examination, the 35-year-old physician is puzzled because the pox do not appear to be typical of the varicella-zoster virus. Worried, he calls in another physician for her opinion. She takes one look at the patient, determines he has small pox, and immediately orders him to be quarantined. She notifies the Centers for Disease Control and Prevention (CDC) and asks them what should be done. While doing background on the patient, he tells the physicians that he is a flight attendant and that he has flown to Orlando, FL, Los Angeles, CA, Chicago, IL, and Seattle, WA in the past few weeks while working. Though he is given excellent treatment, and had been in perfect health a few days earlier, the patient dies 7 hours after admittance to the hospital.

The CDC decides that mandatory small pox vaccines will be administered to all workers in the NYC hospital, and to all patients who were in the ER. His co-workers are all given mandatory vaccines as well, as are all people living in his apartment complex. They also ship stored quantities of the vaccine to all of the cities where the man had flown to for work. The vaccines are offered to citizens of these cities. Finally, all people, along with their families who had been on the man's flights in the weeks preceding the appearance of the disease are forced to receive the vaccine.

Questions: Note: The flight attendant was most likely given small pox by a bio terrorist who flew on his plane sometime during the past week/week and a half. The terrorist would have been contagious but would not have shown symptoms. Virtually every person the man came into contact with would have gotten the virus.

Is it ethical for the CDC to force people to get the vaccine?

An LA woman on the flight is religiously opposed to vaccines. Under California law she can normally refuse vaccines on religious or personal grounds. However, the government says she must receive the vaccine or face mandatory quarantine. What do you think of this?

Do you think that for more common diseases, for example measles, that it is ethical for the state to allow people to refuse vaccines (even for religious grounds)? What if their refusal can harm others who cannot have the vaccine, such as people who are immunocompromised like AIDS patients?

Is it ethical for someone to refuse the vaccine?

You had driven down to Los Angeles 5 days ago to visit a friend for the weekend. While in town, you visited many tourist attractions. You are worried and you try to get the vaccine, but are denied it because of limited resources. What do you think of this?

Citizens begin calling for the mandatory quarantining of people directly exposed to the victim, i.e those living in his apartment complex, those working in the ER, those who flew on the plane in the prior week. What do you think of this?

The smallpox vaccine, like many other vaccines (example: oral polio vaccine) can actually transmit the virus to others. In light of this, is it ethical for people to get the vaccine? (Note: they are vaccinating those who may not want to be vaccinated)

Today, should health care workers be allowed/forced to get the smallpox vaccine? What about non-health care worker citizens?

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J Med Ethics Hist Med

Challenges of hospital ethics committees: a phenomenological study

Samira raoofi.

1 PhD Student in Health Care Management, Department of Health Care Management, School of Health Management and Information Sciences, Iran University of Medical Sciences, Tehran, Iran.

Seddighe Arefi

2 PhD Student in Health Education and Health Promotion, Department of Health Education and Health Promotion, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.

Rahim Khodayari Zarnaq

3 Associate Professor, Department of Health Policy and Management, School of Management and Medical Informatics, Tabriz University of Medical Sciences, Tabriz, Iran; Tabriz Health Service Management Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.

Bashir Azimi Nayebi

4 PhD Student in Health Policy, Student Research Committee, School of Management and Medical Informatics, Tabriz University of Medical Sciences, Tabriz, Iran.

Mir Sajjad Seyyed Mousavi

5 Assistant Professor, Department of basic sciences, Faculty of Paramedicine, Tabriz University of Medical Sciences Tabriz, Iran.

Medical ethics committees play an important role in examining and resolving ethical problems in hospitals by developing ethical guidelines and making ethical decisions. This study aimed at investigating the challenges that these committees typically face.

This qualitative phenomenological study was conducted in 2020. Data was collected through semi-structured interviews with purposive sampling and participation of 19 ethics committees’ members in Tehran hospitals. Then, data were analyzed by the content analysis method using MAXQDA-10 software.

Challenges of hospital ethics committees were classified into three main themes including external factors, intra-organizational factors, and ethics committee structure, in addition to six sub-themes including inadequate supervision, lack of instructions, organizational culture, human resources, nature of the committee, and ineffectiveness of committees’ decisions.

Since many challenges are faced by ethics committees, plans should be developed and implemented to fulfill the following purposes: ( i ) strengthen the position of these committees in hospitals, ( ii ) continuous supervision over the formation and holding of the committees, ( iii ) their operation process, ( iv ) their decision-making process, and ( v ) process of sharing committees’ decisions with all hospital stakeholders and staff.

Introduction

Hospital committees peruse several purposes: ( i ) improving the performance and solving the problems of hospitals, ( ii ) increasing the awareness and participation in decision-making, and ( iii ) easy communication with multiple units, and ( iv ) creating development opportunities for staff at all levels and gaining experience in supervisory skills. The committees are also involved in the process of improving hospital services as well as regular and continuous evaluation of hospital activities. According to the Ministry of Health and Medical Education, hospital committees are necessary for achieving the optimal quality in healthcare service provision.

The medical ethics committee, as one of the top ten priorities of medical ethics, is among the essential hospital committees to improve medical service quality ( 2 , 3 ) and is the primary mechanism for reviewing ethical problems faced in the hospital. Ethical guidelines ( 4 , 5 ) and these committees also play an important role in regulating patient-physician relationships, maintaining their mutual rights, promoting health, and creating mutual trust between healthcare service recipients and providers. These committees provide organizational guidance to help healthcare providers against legal issues, reduce moral tensions, maintain ethical performance, and achieve patient safety ( 6 ). The latest guidelines for the ethics committee and other hospital committees are related to the fourth generation of accreditation criteria, notified to hospitals in 2019, according to which hospitals should draft internal regulations for all their committees at the beginning of the year; in addition, according to the schedule of the committees, the documents of the committees should be regularly sent to the vice-chancellor of the relevant university for supervision ( 7 ).

The Medical Ethics Committee has been referred by various titles such as "Clinical Ethics Committee", "Patient Care Advisory Committee", "Institute Ethics Committee", and "Health Care Ethics Committee", and it has been active in hospitals since the early 1980s ( 4 , 8 ). In Iran, according to the standard instructions for evaluation of public hospitals in the country from 1997, all hospitals are required to implement an ethics committee in the hospital ( 9 ). The structure and members of this committee are almost similar in different countries and include both medical and non-medical members as well as social workers, spiritual care providers, and legal advisors, whose membership is voluntary and, in some cases, appointed. The participation of various groups in the committee is required to examine all ethical aspects of the emerging problems and provide improved care to patients and their families. This committee is usually formed on a monthly basis in all hospitals, interacts closely with other hospital committees, as well as implements the standards of patient rights, controls compliance regulations, and provides facilities for religious rulings ( 10 - 12 ).

Various studies defined the functions of the ethics committee as follows: ( i ) developing guidelines, ( ii ) training healthcare providers and patients, ( iii ) counseling and commenting on controversial medical issues, ( iv ) policy development, and ( v ) developing frameworks to assist in decision-making, ( vi ) solving hospital and patient problems, ( vii ) resolving ethical problems in the hospital, ( viii ) cooperating in the investigation of medical malpractice cases, ( ix ) following patient rights and fulfilling them, and ( x ) leading studies and research ( 13 - 17 ).

Lack of knowledge about the ethics committee, duties and role of the committee in the hospital, their activity, superficial and unplanned formation of hospital committees to acquire accreditation points, reasons for the committee’s inefficiency in changing physician-patient relationship, differences in the committee's activities in various countries, discussion of different cases, as well as not reporting committee's approvals are among ethics committees’ challenges ( 9 , 18 - 21 ). These committees, as the hospital’s think tank, include advisors and decision-makers of hospitals’ heads and managers. Moreover, according to the Ministry of Health, to achieve the desired quality in providing hospital services, hospital committees are necessary and should participate in preparing the hospital’s strategic and operational plans. Additionally, each plan must be evaluated and monitored to achieve the predetermined goals and to determine the executors. Hence, this study aimed at investigating ethics committees’ challenges to improve performance or decision-making in the face of ethical issues in hospitals.

In this study, a qualitative approach with content analysis method was used and data collection was through in-depth face-to-face interviews with participants chosen through purposive sampling. The participants were key informants of the medical ethics field at private and public hospitals in Tehran as well as managers, nursing management, nurses, educational supervisors, accreditation experts, and patient safety experts. An official letter from the vice chancellor for research at Tabriz University of Medical Sciences was previously sent to the key informants’ respective organizations for interviews.

Participants’ verbal consent was initially obtained, and interviews were conducted in a relaxing atmosphere. The purpose of the interview was fully explained to the interviewees, and, in each interview session, two interviewers asked questions, took notes, and recorded audios. Each in-depth interview lasted for 50 to 90 minutes, and a semi-structured questionnaire was prepared to guide the interviews. The initial questions were developed based on the available literature and finalized through three pilot interviews. The questions were targeted at the "Explaining the Hospital Ethics Committee’ Challenges" subject. The interview questions were open-ended and mainly focused on weaknesses and challenges of ethical committee in hospitals. The interview questions are listed in Table 1 .

Interview Guide

Data processing and analysis

The interviews were transcribed verbatim, and initial content analysis was performed by inspecting transcripts and notes. After multiple reviews, three main themes were identified and entered into the MAXQDA-10 software. Then, subthemes were identified and reviewed by two experts in the field and then placed under subsets of the main themes in the MAXQDA-10 software. In case of no agreement between the two experts in the field for placing a sub-theme in a subset of the main themes, a third expert was consulted. To ensure the identification of all the sub-themes, the researchers reviewed the software implemented version. Axial coding permitted the refined sub-themes to be assembled to identify themes and relationships. During this process, the identification of the themes and sub-themes were validated by comparing the information provided by different respondents, obtained from the interviews, as well as observations and analysis of secondary documents ( 2 ). Finally, using the themes and subthemes and the researchers’ interpretations of the interviews, a framework of relations was constructed, representing the hospital ethics committee’s challenges.

To increase the consistency of the data and prevent prejudice, the researchers disregarded their presumptions about the subject during conducting interviews and data analyses ( 22 ). For the validity of the interview content and transparency of ambiguities, every interview was transcribed verbatim in the shortest possible time after the interview and then was sent to the interviewees for approval ( 23 ).

Data saturation was reached after 18 interviews ( Table 2 ) with ethics committee members, including the hospital's internal manager, nursing management staff, committee coordination experts, patient safety experts, a secretary of the medical ethics committee, and accreditation experts. Participants had doctoral, master’s, or bachelor's degrees and were working in private hospitals. The ethics committees’ challenges in hospitals were identified and classified into three main themes and six sub-themes. The main themes were categorized into external factors, internal factors, and factors related to the structure of the ethics committee ( Table 3 ).

Characteristics of the participants

Main themes, subthemes, and final codes

External factors:

Lack of integrated instructions

Lack of transparency of the raised issues was a major challenge of the ethics or other hospital committees, which confused committee members and such ambiguity did not require them to discuss key significant subjects. All topics should be considered in the committee’s regulations, including committee members’ specifications, their assigned duties, meeting time, and schedule. These regulations should be compiled at the beginning of the year for all committees and communicated to the committee members.

"The agenda of the ethics committee was wrong, and some people even think that it was accompanied by examining religious issues. But, according to the accreditation standards, the ethics committee has been used to fulfill patients’ rights, and its form has not been changed. National accreditation standards dealt with it broadly and generally, and it did not comment on

specific and well-defined tasks". (P.6)

Poor and irregular monitoring

All committee meetings’ approvals should be sent to the vice-chancellor for treatment of the covered universities in due time, but no feedback was provided by the vice-chancellor for treatment regarding the follow-ups of the committee approvals, the effectiveness of their implementation, or the corrective measures to be taken. The vice-chancellor for treatment did not supervise the holding of the committees and the implementation of their approvals.

"Records are sent to the vice chancellor for treatment and the university at the end of the month. When I sporadically did not send the committees’ records, surprisingly no one cared or complained. No one also paid attention to whether the enactment had been implemented or not". (P.5)

Intra-organizational factors:

Human Resources

Sometimes, the implementation of committee's approvals required several financial and human resources, which often led to delays in the implementation or non-implementation of the approvals.

Organizational Culture

The organizational atmosphere and commitment of senior managers were important to make necessary follow-ups and to implement the committee's approvals. Sometimes, the erring staff is a physician and should only be warned by the head of the organization or technical assistant, which was rarely done, or if it was done, the physician would not admit the mistake.

"Even in cases where the patient complains to the doctor, the relevant managers do not have necessary cooperation because they cannot say anything to the doctor. Only complaint and incident records are documents, and such complaints can be repeated by another doctor “. (P.8)

"A major challenge in hospitals, especially in private hospitals, is that, often, the judges themselves are to blame. Self-judgment is difficult for them, which rarely happens. They do not judge honestly and fairly”. (P.10)

Moreover, committee members were often unaware of their job descriptions, which led to various issues and even their absence from the committee. The committee's primary mission was to deal with complaints, errors, and punishment, and the positive aspects and characteristics of staff work were not highlighted, leading to a negative view of the committee.

"Typically, committee’s physicians do not attend the meetings. Committee members do not have a full understanding of the raised issues”. (P.2)

Structure of the ethics committee:

The nature of the committee

Hospital committees, consisting of members appointed according to accreditation criteria in hospitals, should be formed according to a specific schedule. However, committees were often held superficially, ineffective in implementing approvals, as well as inefficient in holding meetings and choosing committee members. The ethics committee's mission was often unclear to committee members and overlapped with other hospital committees, which led to non-compliance with standards in the hospital.

“Lack of regular formation of hospital committees according to a schedule can be a major problem, causing the committee' performance not to be assessed and their effectiveness not to be approved”. (P.1)

Ineffectiveness of the committee approvals

All hospital committees output approvals that should be implemented while considering the organization’s problems and their effective implementation should be monitored by the committee members, especially the committee’s secretary. Many members reported that the extent of their authority in the hospital, as a member of the committee, was not well defined for the implementation of the approvals, which discouraged them from monitoring and enforcing the approvals or had a significant impact on fulfilling the patient rights’ standards. Moreover, committee approvals were not provided to other departments or wards so that they could be used as lessons learned to avoid repetition.

"If the importance of this committee in the hospital is emphasized and its executive power is increased, like other hospital committees, it can supervise the implementation of professional ethics among the hospital staff”. (P.12)

"The physicians participating in the committee, or even some other committee members, are not aware of these standards and do not take care of their full implementation, which leads to a lack of future attention and recurrence of many cases and problems”. (P.11)

This study aimed at identifying the challenges of the medical ethics committee in hospitals, where the challenges were classified into three main categories: external factors, organizational factors, and factors related to the committee’s structure.

External factors related to the headquarters’ units and included supervisory roles and communication of integrated instructions. If such factors are communicated to the hospitals in a unified way, incoherency of the issues in the committee can be resolved. Moreover, the hospital committee’s approvals should be monthly sent to the vice chancellor for treatment, but they did not provide feedback on the implementation or non-implementation of approvals. In contrary to the present study, a study titled "Medical Ethics Committee in Norway" showed that the Ministry of Health, in addition to developing and communicating training instructions to the ethics committee, specified the priority of the committee's activities ( 24 ). Qarebaghian et al, ( 25 ) also stated that the regulations of the Blood Bank Committee were communicated to hospitals by the Ministry of Health to discuss the optimal use of blood products and their application, which led to satisfactory results. In a study by Haji Beigi et al., Blood Bank committees in private hospitals were not as much of those of the public hospitals reported to upstream organizations; in public hospitals, regulatory agencies’ role was relatively more significant ( 26 ). In that study, when public hospitals were compared against private hospitals, no significant difference was observed in the hospital committees’ performance and working conditions. Extra-organizational challenges in the functioning of ethics committees in hospitals were pervasive, regardless of the hospitals’ type and ownership, mainly related to the healthcare system’s macro-policy.

Intra-organizational factors included organizational culture and the organization’s human resources. The present study’s results showed that the organization’s atmosphere did not support performing activities as a team, and major activities were not implemented considering their real priorities. Lack of senior managers’ commitment and lack of enough budgets were the factors related to the non-implementation of the committee approvals. Moreover, the use of committee members with no training on medical ethics standards was a major committees challenge. A study by Nasiripoor and Kal in line with the present study, showed that although the Hospitals’ National Accreditation Program emphasized that the training of the ethics committee members, the number and variety of members, and the way of selecting members were not appropriately done in hospitals ( 27 ), due to a lack of attention to the importance and position of such committees in hospitals.

In line with this study, Gaudine et al. concluded that the lack of commitment of senior managers in organizations was due to the non-implementation of the ethical committee’s approvals and caused the committees not to be held seriously in hospitals ( 28 ).

Du Val et al and Larcher et al also concluded that lack of standard regulations, lack of managers’ support, incompetence of committee members, lack of committees’ documentation, and non-implementation of committees’ approvals are among ethics committees’ challenges ( 29 , 30 ).

Amini et al. ( 31 ) also pointed out that professional principles such as professional ethics of the residents of Tabriz University of Medical Sciences were not at an acceptable level, demanding further inspection, formal training, and informal training. In other words, not enough investment was made to teach professional principles in universities, and at the hospital level, training in this area was not sufficient and effective. Often, residents are involved in various ethical issues in the hospital, and in the future, they will become members of these ethics committees as physicians working in the hospital. In line with the present study, Mousavi et al. stated that lack of formal and informal support of senior managers, lack of managers’ accountability regarding the raised issues, and sometimes their unjustified involvement in the committee led to ethics committee’ challenges ( 32 ). Moreover, the uncertain position of the ethics committees in hospitals can contribute to these challenges.

The ambiguity of the committee's position in the hospital, the overlap of the ethics committee's outputs and agenda with those of other hospital committees, and the ineffectiveness of ethics committee in enforcing medical ethics standards have made ethics committees unproductive in hospitals, whereas McGee et al. emphasized that a major task of the medical ethics committee in the hospital was policy-making. Diversity in the selection of committee members is required to teach standards and ethics to the hospital staff as diverse groups of staff work at hospitals ( 33 ).

According to the present study, the main reason for the non-implementation of approvals was the ethics committee’s low executive power and inefficiency in hospital’s policy-making, whereas Younger et al. showed that the ethics committee had a positive impact on facilitating decision-making on the raised ethical problems, had been effective in providing legal protection to hospital and clinical staff, and had also shaped the hospital’s ethical policies ( 34 , 35 ).

As an advantage, the present research qualitatively studied the challenges of the professional ethics committees in public and private hospitals in Tehran. A limitation of the present study was the lack of previous studies regarding ethics committees in Iran, due to which further citation and comparison, as well as the preparation of a study guide were difficult or impossible. Moreover, all interviewees were from the employees of the hospitals in Tehran, and physicians did not participate in this study due to unwillingness and lack of time.

Given the identification of major challenges in the structure, development, and functioning of the hospital ethics committee, healthcare policymakers and senior managers should focus on the following factors: ( i ) facilitating committees’ activities, (ii) highlighting committees’ importance and purposes, (iii) strengthening committees’ position, (iv) supervising committees’ approvals, (v) obliging the implementation of committees’ approvals, and (vi) constantly monitoring committees’ activities. By promoting core tasks in organizations, organizational culture issues will be resolved. With the commitment of upstream organizations, guidelines and mechanisms can be developed to enhance the nature of ethical committees. Moreover, higher authorities should apply more control over the selection of committee members, the process of holding committees, the importance and position of committees in the hospital, and implementation of committees’ approvals, as well as training for senior hospital managers, physicians, and other stakeholders. Specific criteria should be developed and used for the selection of committee members, and an appropriate performance guarantee should be defined for the implementation of the approvals. Furthermore, the ethics committee’s outputs should be provided to the hospital staff and the target groups as learned lessons to prevent the repetition of similar issues.

Ethics approval and consent to participate

This study is part of a research project approved by the regional research ethics committee of Tabriz University of Medical Sciences; Approval

ID: IR.TBZMED.REC.1399.1167.

Acknowledgements

The authors would like to thank the participants for their invaluable time and sharing their experiences and information.

Citation to this article:

Raoofi S, Arefi S, Khodayari Zarnaq R, Azimi Nayebi B, Seyyed Mousavi MS. Challenges of hospital ethics committees: a phenomenological study. J Med Ethics Hist Med. 2021; 14: 26.

Conflicts of Interests

The authors declare no conflict of interests.

This research was funded by Tabriz University of Medical Sciences, Grant No: 66246

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Hospital ethics committees intervene when patients and providers disagree. Here’s how they work.

How did hospital ethics committees come to be?

In the early 1960s, advances in medical care meant people with failing kidneys could receive a life-saving treatment known as dialysis. Dr. Belding Scribner, a physician in Seattle who lived on a houseboat and wore a red hat , had perfected a machine that could extend patients’ lives, and in doing so he formed an “artificial kidney center” to deliver the treatment.

It worked — almost too well. The list of people wanting the treatment grew, but the center didn’t have bandwidth for everyone.

The shortfall required a decision: Who would receive the treatment? And who wouldn’t?

Scribner partnered with the local medical society, which formed a seven-person committee of providers and community members to grapple with those questions. And they did, creating a criteria that included an assessment of a candidate’s demographic details, income and “future potential,” according to the American Medical Association’s Journal of Ethics. People called it the “God Committee.” It would be one of the first groups of its kind in the U.S.

Ethics committees like this one became more present as advances in medical care outpaced hospital resources, and as providers became “better and better at keeping people alive, even if their bodies were trying to die,” said Dr. Stuart Pickell, a physician with Texas Health Physicians Group and chair of Tarrant County Medical Society’s Ethics Consortium .

In 1992, The Joint Commission , a nonprofit that evaluates patient safety and quality of care at health care organizations around the country, began requiring hospitals seeking their accreditation to “have in place a mechanism for the consideration of ethical issues arising in the care of patients.”

By the late 1990s, more than 90% of U.S. hospitals had an ethics committee.

Who can be on a hospital ethics committee?

A hospital’s bylaws govern the creation and upkeep of the committee, so no two ethics committees are perfectly alike, according to Dr. David Capper, a physician who chairs the ethics committee for Medical City Fort Worth .

Once the bylaws establish a committee, a designated leader like the hospital’s chief of staff invites employees and community members to join. People can also ask to join the committee.

“The No. 1 criteria is that they really have an interest in what they’re doing,” Capper said, though membership requires a “degree of self-education” as well.

For Medical City Fort Worth’s committee, the education is more formal: New members receive and study a book of medical ethics and then discuss their progress with Capper. Capper himself is currently in a master’s program in biomedical ethics at Trinity International University.

No guidelines govern the composition of ethics committees in Texas. A singular hospital, however, might require a certain makeup of the committee or, at the very least, that the community participates.

The committees for Baylor Scott & White All Saints Medical Center, Medical City Fort Worth, Texas Health Harris Methodist Hospital and John Peter Smith Hospital each have chaplains, Capper said. In various seasons, he’s also seen the committees include retired medical providers, people with PhDs in ethics, community attorneys, medical residents and professors. Each committee comprises about 25 people, he said, with 12-15 people who actively and consistently participate.

“There’s anything but a singular worldview or a singular perspective that’s represented,” he said.

The ethics committees report to the hospital’s medical executive committee, a leadership board that represents the medical staff: physicians, nurse practitioners and physician assistants, who typically aren’t employees of the hospital under Texas law , Capper said.

“So the hospitals cannot have their way to tell an ethics committee what to do and how to deliberate and what conclusions to make on behalf of a patient,” he said. “The ethics committee is independent of the institution itself.”

Despite how they operate on paper, they’re still heavily represented by people who work in or have connections to the hospital, Pickell said. Hospital attorneys frequently attend committee meetings, he said, so the committees can feel like a risk management tool for the hospital.

“(Hospitals) want to help people, and that’s their underlying mission,” he said. “But they also want to make sure they don’t hurt their own institution in some way.”

He, Capper and several other physicians in the community drafted a resolution asking the Texas Medical Association to study the composition of hospital ethics committees throughout Texas and, in doing so, propose guidelines for that composition in the future. The resolution passed the association’s house of delegates and a council will begin the study this fall, Pickell said.

Pickell, who leads Tarrant County Medical Society’s Ethics Consortium, a nonpartisan body of people interested in health care and ethics, said he hopes the consortium can serve as an intermediary in the meantime, one that isn’t affiliated with area hospitals.

How do hospital ethics committees work?

Although committees differ in how they operate, generally they meet regularly — once a month, once every two months, once a quarter, etc. — and as needed when ethical conflicts arise in the hospital, Capper said.

For example, a person can request an ethics consultation during a particularly difficult case and a small group of committee members convene to offer feedback. If the case warrants further discussion, the entire committee may confer.

Members of the committee then vote on a course of action. In the committee he chairs at Medical City Fort Worth, Capper works with other members to reach a consensus.

“The idea is that, if there’s a significant dissent, there’s got to be a good reason for that dissent,” he said. “If there’s a good reason for that dissent, then we all need to listen to it again.”

“If there’s a good reason for that dissent, then we all need to listen to it again.” – Dr. David Capper, chair of Medical City Fort Worth’s ethics committee

The committee presents its recommendations to the patient’s care team, as well as any general recommendations to the medical executive committee.

“I think we have a tremendous amount of power in negotiation,” Capper said.

An ethics committee’s central, codified power, however, comes from the Texas Advance Directives Act .

What is the Texas Advance Directives Act?

In the late 1990s, Dr. Kendra Belfi was invited to help write a new law that would consolidate and clarify Texas’ legislation related to advance directives, or people’s wishes for their end-of-life care. At the time, she was a geriatrician in Fort Worth, as well as chair of the Texas Medical Association’s committee on aging and long-term care.

Years before, when Belfi was a medical resident in Dallas in the ’70s, Texas hadn’t yet passed the Natural Death Act, a 1977 law that gave people the right to choose their end-of-life care. That meant no one died without medical providers trying at least once to revive them, she said.

In the years since that act passed, the prevailing philosophical wisdom surrounding a patient’s end-of-life wishes has been that “negative rights outweigh positive rights,” Belfi said.

In other words, if a patient could benefit from but doesn’t want life-sustaining treatment, they can refuse it. However, a patient has fewer rights when it comes to seeking a life-sustaining treatment their doctors think is unreasonable. For example, she said, “I cannot demand that you give me a liver transplant if I’m not a candidate for a liver transplant.”

“I cannot demand that you give me a liver transplant if I’m not a candidate for a liver transplant.” – Dr. Kendra Belfi, retired physician who helped write the Texas Advance Directives Act

The Texas Advance Directives Act, which then-Gov. George W. Bush signed in 1999, would create a dispute resolution process to help mediate conflicts between providers and patients related to end-of-life care. The law included a “legal safe harbor” component that was the first of its kind in the country, according to a 2000 article in Baylor University Medical Center Proceedings.

If someone asks a hospital to provide life-sustaining treatment a physician thinks is inappropriate, the hospital can pursue a dispute resolution path outlined in the act, which legally protects the physician, hospital and ethics committee.

This process requires the physician to convene a meeting with the hospital ethics committee. If, after listening to the physician and patient or guardians, the committee decides the physician should stop life-sustaining treatment, the patient or guardians — with the hospital’s help — have 10 days to find another physician or hospital who will treat the patient.

After the 10 days expire, the physician may withhold life-sustaining treatment and, along with the hospital and ethics committee, not face civil liability.

“Hospitals do not enter into this process lightly,” Belfi said. “They do everything they can. Usually, before there’s a meeting which results in the 10-day rule, there’s been a long time with lots of discussions and attempts to come to some kind of agreement.”

Lewis, Tinslee’s mother, has argued that this ethics committee review process did not “provide her sufficient procedural due process,” according to court documents.

Since then, a panoply of voices have weighed in, including the Texas Catholic Conference of Bishops and the Texas Medical Association, which both support the constitutionality of the law; and the attorney general of Texas, who doesn’t — specifically when it comes to the dispute resolution process.

If the law were to be deemed unconstitutional, Belfi isn’t certain what would happen — it would depend on “how much of the law was gutted,” she said.

“All of this just makes the point that people need to talk about their health care wishes — do advance directives, etc.,” she said. “Unfortunately, that does not help us with the issue of young children.”

Alexis Allison is the health reporter at the Fort Worth Report. Her position is supported by a grant from Texas Health Resources. Contact her by email or via Twitter . At the Fort Worth Report, news decisions are made independently of our board members and financial supporters. Read more about our editorial independence policy here .

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by Alexis Allison, Fort Worth Report October 18, 2021

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Alexis Allison covers health for the Fort Worth Report. When she can, she'll slip in an illustration or two. Allison is a former high school English teacher and hopes her journalism is likewise educational.... More by Alexis Allison

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Why Authorship Matters
Who Is an Author?
Non-Author Contributors
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1. Why Authorship Matters

Authorship confers credit and has important academic, social, and financial implications. Authorship also implies responsibility and accountability for published work. The following recommendations are intended to ensure that contributors who have made substantive intellectual contributions to a paper are given credit as authors, but also that contributors credited as authors understand their role in taking responsibility and being accountable for what is published.

Editors should be aware of the practice of excluding local researchers from low-income and middle-income countries (LMICs) from authorship when data are from LMICs. Inclusion of local authors adds to fairness, context, and implications of the research. Lack of inclusion of local investigators as authors should prompt questioning and may lead to rejection.

Because authorship does not communicate what contributions qualified an individual to be an author, some journals now request and publish information about the contributions of each person named as having participated in a submitted study, at least for original research. Editors are strongly encouraged to develop and implement a contributorship policy. Such policies remove much of the ambiguity surrounding contributions, but leave unresolved the question of the quantity and quality of contribution that qualify an individual for authorship. The ICMJE has thus developed criteria for authorship that can be used by all journals, including those that distinguish authors from other contributors.

2. Who Is an Author?

The ICMJE recommends that authorship be based on the following 4 criteria:

Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
Drafting the work or reviewing it critically for important intellectual content; AND
Final approval of the version to be published; AND
Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

In addition to being accountable for the parts of the work done, an author should be able to identify which co-authors are responsible for specific other parts of the work. In addition, authors should have confidence in the integrity of the contributions of their co-authors.

All those designated as authors should meet all four criteria for authorship, and all who meet the four criteria should be identified as authors. Those who do not meet all four criteria should be acknowledged—see Section II.A.3 below. These authorship criteria are intended to reserve the status of authorship for those who deserve credit and can take responsibility for the work. The criteria are not intended for use as a means to disqualify colleagues from authorship who otherwise meet authorship criteria by denying them the opportunity to meet criterion #s 2 or 3. Therefore, all individuals who meet the first criterion should have the opportunity to participate in the review, drafting, and final approval of the manuscript.

The individuals who conduct the work are responsible for identifying who meets these criteria and ideally should do so when planning the work, making modifications as appropriate as the work progresses. We encourage collaboration and co-authorship with colleagues in the locations where the research is conducted. It is the collective responsibility of the authors, not the journal to which the work is submitted, to determine that all people named as authors meet all four criteria; it is not the role of journal editors to determine who qualifies or does not qualify for authorship or to arbitrate authorship conflicts. If agreement cannot be reached about who qualifies for authorship, the institution(s) where the work was performed, not the journal editor, should be asked to investigate. The criteria used to determine the order in which authors are listed on the byline may vary, and are to be decided collectively by the author group and not by editors. If authors request removal or addition of an author after manuscript submission or publication, journal editors should seek an explanation and signed statement of agreement for the requested change from all listed authors and from the author to be removed or added.

The corresponding author is the one individual who takes primary responsibility for communication with the journal during the manuscript submission, peer-review, and publication process. The corresponding author typically ensures that all the journal’s administrative requirements, such as providing details of authorship, ethics committee approval, clinical trial registration documentation, and disclosures of relationships and activities are properly completed and reported, although these duties may be delegated to one or more co-authors. The corresponding author should be available throughout the submission and peer-review process to respond to editorial queries in a timely way, and should be available after publication to respond to critiques of the work and cooperate with any requests from the journal for data or additional information should questions about the paper arise after publication. Although the corresponding author has primary responsibility for correspondence with the journal, the ICMJE recommends that editors send copies of all correspondence to all listed authors.

When a large multi-author group has conducted the work, the group ideally should decide who will be an author before the work is started and confirm who is an author before submitting the manuscript for publication. All members of the group named as authors should meet all four criteria for authorship, including approval of the final manuscript, and they should be able to take public responsibility for the work and should have full confidence in the accuracy and integrity of the work of other group authors. They will also be expected as individuals to complete disclosure forms.

Some large multi-author groups designate authorship by a group name, with or without the names of individuals. When submitting a manuscript authored by a group, the corresponding author should specify the group name if one exists, and clearly identify the group members who can take credit and responsibility for the work as authors. The byline of the article identifies who is directly responsible for the manuscript, and MEDLINE lists as authors whichever names appear on the byline. If the byline includes a group name, MEDLINE will list the names of individual group members who are authors or who are collaborators, sometimes called non-author contributors, if there is a note associated with the byline clearly stating that the individual names are elsewhere in the paper and whether those names are authors or collaborators.

3. Non-Author Contributors

Contributors who meet fewer than all 4 of the above criteria for authorship should not be listed as authors, but they should be acknowledged. Examples of activities that alone (without other contributions) do not qualify a contributor for authorship are acquisition of funding; general supervision of a research group or general administrative support; and writing assistance, technical editing, language editing, and proofreading. Those whose contributions do not justify authorship may be acknowledged individually or together as a group under a single heading (e.g. "Clinical Investigators" or "Participating Investigators"), and their contributions should be specified (e.g., "served as scientific advisors," "critically reviewed the study proposal," "collected data," "provided and cared for study patients," "participated in writing or technical editing of the manuscript").

Because acknowledgment may imply endorsement by acknowledged individuals of a study’s data and conclusions, editors are advised to require that the corresponding author obtain written permission to be acknowledged from all acknowledged individuals.

Use of AI for writing assistance should be reported in the acknowledgment section.

4. Artificial Intelligence (AI)-Assisted Technology

At submission, the journal should require authors to disclose whether they used artificial intelligence (AI)-assisted technologies (such as Large Language Models [LLMs], chatbots, or image creators) in the production of submitted work. Authors who use such technology should describe, in both the cover letter and the submitted work in the appropriate section if applicable, how they used it. For example, if AI was used for writing assistance, describe this in the acknowledgment section (see Section II.A.3). If AI was used for data collection, analysis, or figure generation, authors should describe this use in the methods (see Section IV.A.3.d). Chatbots (such as ChatGPT) should not be listed as authors because they cannot be responsible for the accuracy, integrity, and originality of the work, and these responsibilities are required for authorship (see Section II.A.1). Therefore, humans are responsible for any submitted material that included the use of AI-assisted technologies. Authors should carefully review and edit the result because AI can generate authoritative-sounding output that can be incorrect, incomplete, or biased. Authors should not list AI and AI-assisted technologies as an author or co-author, nor cite AI as an author. Authors should be able to assert that there is no plagiarism in their paper, including in text and images produced by the AI. Humans must ensure there is appropriate attribution of all quoted material, including full citations.

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COMMENTS

Ethics Committees: Structure, Roles, and Issues
Abstract. An Ethics Committee (EC) is an independent body composed of members with expertise in both scientific and nonscientific arenas which functions to ensure the protection of human rights and the well-being of research subjects based on six basic principles of autonomy, justice, beneficence, nonmaleficence, confidentiality, and honesty.
Hospital Ethics Committees, Consultants, and Courts
George Annas, JD, MPH is the Warren Distinguished Professor at the schools of public health, medicine, and law at Boston University, where he is also the director of the Center for Health Law, Ethics & Human Rights. He has authored or edited 20 books on health law and bioethics, including The Rights of Patients (New York University Press, 2004), Worst Case Bioethics (Oxford University Press ...
Annual Review of Ethics Case Studies
Research Ethics Cases for Use by the NIH Community. Theme 23 - Authorship, Collaborations, and Mentoring (2023) Theme 22 - Use of Human Biospecimens and Informed Consent (2022) Theme 21 - Science Under Pressure (2021) Theme 20 - Data, Project and Lab Management, and Communication (2020) Theme 19 - Civility, Harassment and ...
Cases
James B. Cutrell, MD and James M. Sanders, PhD, PharmD. This commentary on a case describes need for clinician collaboration to optimize therapeutic use of antimicrobials in clinical settings. AMA J Ethics. 2024;26 (6):E441-447. doi: 10.1001/amajethics.2024.441. Case and Commentary. May 2024.
Case report
Manuscripts reporting studies involving human participants, human data or human tissue must: include a statement on ethics approval and consent (even where the need for approval was waived) include the name of the ethics committee that approved the study and the committee's reference number if appropriate
Ethics Committees in Health Care Institutions
Ethics committees, or similar institutional mechanisms, offer assistance in addressing ethical issues that arise in patient care and facilitate sound decision making that respects participants' values, concerns, and interests. In addition to facilitating decision making in individual cases (as a committee or through the activities of ...
In Pursuit of Ethical and Inclusive Research: What Ethics Committees
Co-authored by a multi-disciplinary research team and the former chair of a Human Research Ethics Committee, this reflexive case study identified three key tensions which arose in the ethical review of research involving this purportedly marginalised population, which reflected the wider importance of trust. ... Ethics committees have a big ...
Why Did Hospital Ethics Committees Emerge in the US?
American Hospital Association. Guidelines: hospital committees on biomedical ethics. January 27, 1984. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research.Deciding to Forego Life-Sustaining Treatment: A Report on the Ethical, Medical, and Legal Issues in Treatment Decisions
Evaluating the effectiveness of clinical ethics committees: a
Clinical Ethics Committees represent one of the most common explicit forms of CESS, together with facilitation of Moral Case Deliberation (MCD) and individual ethics consultants (Molewijk et al. 2015 ). CECs deliver ethics support in many ways, by undertaking a variety of tasks that, over time, scientific literature has categorized as follows ...
The Functioning of Hospital Ethics Committees: A Multiple-Case Study of
A multiple-case study of four hospital ethics committees in Canada was conducted and data collected included interviews with key informants, observation of committee meetings and ethics-related hospital documents, such as policies and committee minutes. We compared the hospital committees in terms of their structure, functioning and perceptions of key informants and found variation in the ...
PDF Reviewing Clinical Trials: A Guide for the Ethics Committee
ICH GCP E6 Guideline. The final chapter includes about 50 ethics committee scenarios covering most ethical areas in human research. Many of those scenarios have been utilised in educational activities for ethics committee members and have proven exceptionally helpful in translating theory into practice, especially for novice clinical
Clinical ethics committees in nursing homes: what good can they do
Clinical ethics support services (CESS) aid in the handling of ethical challenges in healthcare. 1-3 The clinical ethics committee (CEC) is a kind of CESS which has been established in many hospitals in many Western countries. 4 Nursing homes (residential long-term care), however, are seldom served by CECs. The United States is an exception; here, CECs have a long history in nursing homes. 5 ...
PDF Establishing an Ethics Committee
ethics topics. Discuss case studies found in the literature or developed by committee members. (See Training Tools included at the end of this document). Step Five: Identify Guiding Principles Your committee needs to identify guiding principles and an ethics analysis framework to inform the committee's deliberations. Ethics codes provide
The Structure and Function of Research Ethics Committees in ...
Positive lessons can be drawn from this case study. First, research ethics review is increasingly routine in Africa. More African institutions require and are equipped to provide review, all but one of the committees in this case study meet in person, and membership is relatively diverse.
Ethical approval requirements for case study reports
Some case studies are published for educational purposes rather than research, and in others, where data were collected as part of routine care, permission might be given by a hospital or research institute rather than an ethics committee. IRBs may apply a patient number cut-off (eg 3 or 5) above which a case series counts as research.
Ethics Cases
The importance of academic institutions in shaping the societal narrative is increasingly showcased by constant media exposure and continuous requests for social commentary. This case study outlines effective methodologies of leadership, ethics, and change management within an organization, for the purpose of motivating and engaging ...
Clinical ethics, information, and communication: review of 31 cases
R Førde 1, ; I H Vandvik 2; 1 Center for Medical Ethics, University of Oslo, and the Research Institute, Norwegian Medical Association Oslo, Norway; 2 Department of Paediatrics, Section for Child and Adolescent Psychiatry, Rikshospitalet Oslo, Norway; Correspondence to: R Førde Legeforeningens forskningsinstitutt, Postboks 1152, Sentrum, 0107 Oslo, Norway; reidun.fordelegeforeningen.no
PDF Ethical Statement Templates
1. Ethical approval for this study/case/case series was obtained from *NAME OF ETHICS COMMITTEE OR INSTITUTIONAL REVIEW BOARD (APPROVAL NUMBER/ID)*. 2. Ethical approval for this study was waived by *NAME OF ETHICS COMMITTEE OR INSTITUTIONAL REVIEW BOARD* because *REASON FOR WAIVER*. 3. Ethical approval was not sought for the present study ...
Case Study
Print this case study here: Case Study - Baby K. Case: Baby K- Futile Treatment. Matter of Baby K. C.A. 4 1994, 16 F 3D 590. Summary . ... The physicians requested ethics committee assistance, a subcommittee of which [composed of a family practitioner, a psychiatrist, and a minister] concluded that ventilator treatment should end and that ...
Cases in Medical Ethics: Student-Led Discussions
We examined one case and the Oregon law to view the ethics of euthanasia. Case One: A woman was diagnosed with motor neurone disease (the same. disease that Stephen Hawking has) 5 years ago. This is a condition that destroys motor nerves, making control of movement impossible, while the mind is virtually unaffected.
Challenges of hospital ethics committees: a phenomenological study
Medical ethics committees play an important role in examining and resolving ethical problems in hospitals by developing ethical guidelines and making ethical decisions. This study aimed at investigating the challenges that these committees typically face. This qualitative phenomenological study was conducted in 2020.
Hospital ethics committees intervene when patients and providers
An ethics committee's central, codified power comes from the Texas Advance Directives Act. ... Lewis filed a restraining order against the hospital, and in the months since, multiple court proceedings have kept her case afloat and Tinslee alive. ... New members receive and study a book of medical ethics and then discuss their progress with ...
Pediatric Collections: Ethics Rounds: A Casebook in Pediatric Bioethics
Ethics Rounds Ethical Issues With Patient-Provider Interactions in an Evolving Social Media Landscape Imogen Clover-Brown, MD; Bryanna Moore, PhD; Christina G. Andrews, MPA, MEd; Armand H. Matheny Antommaria, MD, PhD, FAAP
Defining the Role of Authors and Contributors
The corresponding author typically ensures that all the journal's administrative requirements, such as providing details of authorship, ethics committee approval, clinical trial registration documentation, and disclosures of relationships and activities are properly completed and reported, although these duties may be delegated to one or more ...

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The Structure and Function of Research Ethics Committees in Africa: A Case Study

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Case Study – Baby K

Case: Baby K– Futile Treatment

Cases in Medical Ethics

Challenges of hospital ethics committees: a phenomenological study

Seddighe Arefi

Rahim Khodayari Zarnaq

Bashir Azimi Nayebi

Mir Sajjad Seyyed Mousavi

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Ethics approval and consent to participate

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Pediatric Collections: Ethics Rounds: A Casebook in Pediatric Bioethics