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Thousands of faculty, staff, and postdoctoral scholars must regularly disclose their outside professional activities to satisfy federal regulations and Stanford policies. This summer, the Office of the Vice Provost and Dean of Research (VPDoR) launched a Research Compliance Project in response to faculty feedback, with initiatives spanning five key areas – processes, strategy, systems, training, and culture.

The Research Compliance Project follows a university-wide assessment of the policies, procedures, and systems that researchers rely on. The assessment brought together leadership from schools, departments, and many research support offices across campus. It also included numerous interviews and a faculty survey to gather feedback and improvement ideas.

The initiatives also build on enhancements made over the last five years to strengthen Stanford policies and help faculty comply with the changing regulatory requirements while continuing to foster a culture of academic freedom in research and scholarship. Under the leadership of Kathryn “Kam” Moler, vice provost and dean of research, these enhancements have helped strengthen systems and processes at the central level and across schools.

“Our researchers collaborate across disciplines, institutions, and international borders,” said Moler. “The Research Compliance Project initiatives will make it easier for researchers to make appropriate disclosures and comply with other rules so that they can maintain those collaborations and develop cutting-edge ideas that can benefit scholarship and the experience of our students.”

Ten working groups will shepherd the initiatives, along with a steering group led by senior associate deans from four schools. The project aims to make it easier for faculty and other researchers to understand and meet compliance obligations and enhance staff capacity and knowledge in schools and administrative units. In the coming years, the initiatives will:

• Streamline processes across the sponsored research lifecycle to ensure university-wide offices and schools can help researchers adapt to new regulatory requirements and provide better support in the areas of disclosures at the time of grant submission, export control rules, research security, and conflict of interest/commitment procedures.
• Improve systems to update the university’s Outside Professional Activities Certification System (OPACS), making it more user-friendly and better integrated with other Stanford IT systems.
• Align university-wide strategy with a coordinated research risk management approach that clarifies how roles and responsibilities are shared between the VPDoR and schools.
• Enhance training to ensure current and new staff are up-to-date and positioned to support researcher disclosures.
• Strengthen a culture of transparency and communications to foster greater clarity of compliance-related policies and practices among faculty, staff, and researchers.

Five years of growth and progress in research compliance

The Research Compliance Project builds upon ongoing efforts by the VPDoR over the past five years to strengthen and bring greater clarity to processes for the academic community. These efforts have included a suite of new programs, services, and training opportunities, such as the following:

• Facilitated international agreements across borders: In 2019, the VPDoR created the Global Engagement Review Program (GERP) to advise faculty and the administration on foreign influence risks associated with certain types of engagements, gifts, affiliations, and visitors. GERP, a program that faculty may elect to use, has implemented a tiered review process to guide and advise faculty by evaluating risk and leveraging university resources to manage an appropriate resolution.
• Expanded guidance for human subject research: To strengthen the university’s accountability in relation to research involving human subjects, the VPDoR and Office of General Counsel added internal and external independent experts to the university’s Institutional Conflict of Interest Committee .
• Established data governance and management support for pre- and post-award: In 2021, the VPDoR hired a Research Data Governance and Privacy officer to assist researchers in navigating issues of privacy, openness in research, and data management. The role has been instrumental in helping faculty respond to various new data-related rules, including the new data-sharing requirements from the National Institutes of Health (NIH). In addition, a dedicated Data Use Agreement team was established in the Office of Research Administration in 2021 in an attempt to improve the efficiency with which these agreements are negotiated and executed.
• Leveraged technology to improve export control processes : The VPDoR invested in new technology to support export control practices, allowing teams to streamline the identification of parties the federal government classifies as “restricted.” The updated processes ensure more robust compliance while reducing the burden on researchers and administrators.
• Updated guidance, tools, and training in response to new federal requirements: To boost understanding of and compliance with growing lists of federal requirements, the VPDoR has continually updated guidance by introducing new templates for faculty use with disclosures, conducted education and awareness outreach sessions and this year introduced a new COI/COC training course for researchers.

To achieve these changes over the past five years, the VPDoR leadership team collaborated broadly to gain consensus on strategies, explore iterative solutions, and, most importantly, gain faculty and other researcher buy-in. As Moler’s tenure ends, the success of this approach has set up the community for success and continual improvement.

“Over the past five years, our goal has been to ensure that faculty are aware of their responsibilities and to make it as easy as possible for them to meet those responsibilities when they work beyond campus,” said Moler. “In collaboration with our partners across campus, we try to have clear policies, smart practices, and accessible training programs for our faculty and staff.”

Continuing commitment to promote openness, engagement, and collaboration

Stanford’s history of innovation and discovery is rooted in upholding the values of openness, international engagement, and collaboration with external partners. Many Stanford research policies are designed to protect these values.

Over the past decade, the federal government has increased its focus on issues related to improper foreign influence over research, conflicts of interest, and theft of technology and intellectual property. The result has been more robust guidelines and the introduction of new rules. For example, in early 2021, an important White House security memorandum directed all federal agencies to redouble their efforts to boost research security. Key funding agencies, including the National Institutes of Health and the National Science Foundation, responded with new regulations.

Moler will pass the baton to the incoming vice provost and dean of research this fall to continue steering the balance between meeting Stanford’s obligations and making compliance as smooth as possible.

“Overhauling our conflict of interest and conflict of commitment policies last Spring was a critical step,” said incoming Vice Provost and Dean of Research David Studdert. “There was a good deal of faculty, staff, and student involvement in that process, as there should be because this is more nuanced than just adopting new rules dictated to us by the government. Many of the requirements reflect or intersect with our longstanding policies and principles, some of which were developed by the Faculty Senate many decades ago.”

In the coming years, maintaining the highest degree of integrity and compliance while striving to keep the rules and processes transparent and easy to follow and increasing support for faculty research will remain major priorities.

“Fostering a state-of-the-art compliance culture is not about simply placing more requirements on busy researchers,” said Studdert. “It’s about presenting a clear path for someone to fulfill their obligations and explaining why it matters.”

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Research Compliance News and Resources

Latest news, new & revised research policies.

To e nsure that research policies reflect current procedures, objectives, and functions, policies are reviewed at least every 3 to 5 years or as needed depending on regulatory changes. Each policy follows a standard approval process including review by the Office of the Provost and the President's Office. 

The most recently approved policies are as follows:

2.126 Effort Reporting

7.25 Use of Controlled Substances and Dangerous Drugs in Research

7.7 Financial Conflicts of Interest in Research

7.9 Responsible Conduct of Research Training Policy

Preventing Research Misconduct

The use of generative artificial intelligence technologies is prohibited for the nih peer review process (not-od-23-149).

Find the detailed policy and implementation guidance at  https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-149.html

New requirements for NIH data sharing

NIH Scientific Data Sharing

Please click this image to go to the NIH Data Management & Sharing Plans page

The National Institutes of Health (NIH) currently requires grants with $500,000 per year or more in direct costs to explain how and when data resulting from the grant will be disseminated. Beginning in 2023, the NIH will require all grant applications or renewals that generate scientific data to include a robust and detailed plan for data sharing and management during the entire funding period. This information will need to be provided in a data management and sharing plan (known as a DMSP). 

The DMSP will be assessed by NIH program staff members, and the approved plan is considered a Term and Condition of the Notice of Award. Researchers must submit a DMSP as part of their funding application for all new and competing proposals/renewals that generate scientific data on or after January 25, 2023.

What you need to do:

• Know that help is available! The Research Compliance and Regulatory Affairs office is collaborating with the Emory Libraries and the Office of Information Technology to support faculty as they comply with this new policy. This newly appointed team is exploring and benchmarking options for tools that will allow administrators and researchers to meet multiple requirements—including those within NSPM-33—to minimize redundancy for Emory researchers and research teams.
• https://sharing.nih.gov/
• https://sharing.nih.gov/faqs#/data-management-and-sharing-policy.htm
• http://researchdata.emory.edu/plan/nih-dmsp.html

Policy Briefs

Policy 7.8 - Policy on Research Misconduct

Policy 7.12 - Policy for Visiting Scholars & Visiting Students

Policy 7.25 - Controlled Substances & Dangerous Drugs

Infographics

Animal care and use, conflict of interest and commitment, export control.

EEI Filing Requirements

Use of Technology Control Plans, Briefing & Certifications, Letter of Agreement, and Biological Control Plans

Program Effectiveness

AI Authorship, Cppyright, & Plagiarism

Investigations Workshop Key Takeaways

Research Integrity and Compliance

Authorship  

Tips for Controlled Substances  

Research Security

Research Security Travel Recommendations

ORCID iDs @ Emory

Why is Research Compliance Important and Where Can I Learn More?

Blog February 28, 2024

This is a sponsored message.

Department of Justice (DOJ) officials have made it clear in the last few years that investigation and enforcement of clinical research misconduct is an increasing priority. Investigations can occur in a variety of areas, from misuse of funds to the falsification of data and failure to disclose ties to foreign governments.

Recent DOJ enforcement indictments and charges include:

• Three Florida medical clinic owners for fabricating clinical trial data by enrolling ineligible subjects in the trial, falsifying laboratory results and medical records, and falsely representing subjects were taking the study drug ( United States v. Montalvo Villa, et al. )
• A biotech company CEO for disseminating misleading information about the efficacy of a particular drug (DOJ: “Former InterMune CEO Sentenced for False & Misleading Statements Related to Pulmonary Fibrosis Drug’s Clinical Tests”)
• A New York researcher who misused grant funds for personal travel and entertainment purposes ( United States ex rel. English v. Parsons-Kietikko, et al. )
• Several researchers who failed to disclose relationships with Chinese universities on their grant applications ( United States v. Mingqing Xiao )

Clearly, there are a multitude of regulations that impact clinical research, and it’s vital to stay up to date on the latest industry developments.

To get the latest information and insights on a broad spectrum of topics, Health Care Compliance Association® (HCCA®) invites you to join us for our 28th Annual Compliance Institute , April 14–17. This year’s Compliance Institute features more than 100 educational sessions across 14 unique learning tracks, as well as the valuable opportunity to connect with an expected 1,500 healthcare professionals from a wide variety of organizations and roles, with whom you can share knowledge, experiences, and insights.

General sessions at this year’s Compliance Institute will cover many emerging and important healthcare compliance topics:

Health and Human Services-Office of the Inspector General Enforcement and Compliance Update Robert K. DeConti , Chief Counsel to the Inspector General, HHS-OIG

An Update on the Office for Civil Rights’ 2024 Priorities Melanie Fontes Rainer , Director of The Office for Civil Rights, Department of Health and Human Services

AI in Healthcare Brett Short , Chief Compliance Officer, University of Kentucky Christine Moundas , Partner, Co-Lead – Digital Health Initiative, Ropes & Gray John Nash , Associate Professor, Educational Leadership Studies, University of Kentucky Sherrine Eid , Global Head of Real-World Evidence and Epidemiology, SAS

The Art of Collaboration Charles Esten , Singer/Songwriter and Actor

Educational sessions are categorized into 14 topic tracks:

• Auditing & Monitoring
• Behavioral Health
• Case Studies
• Compliance Law
• Discussion Group
• General Compliance/Hot Topics
• Investigations
• Physician Compliance
• Post-Acute Care
• Privacy & Security
• Professional Skills
• Risk Management
• Technology & Innovation

For a look at the full selection of educational sessions, view the agenda .

The city of Nashville, Tenn., will provide a vibrant backdrop for the 2024 Compliance Institute, and we’re excited to not only provide you with first-class education and networking, but also encourage you to take full advantage of the in-person conference experience and discover Nashville’s charm.

For those unable to travel, a virtual attendance option is available April 15–17, with access to more than 50 live-streamed sessions. Those who attend the virtual conference option can network with an anticipated 1,000 virtual attendees. Save your spot today – Learn more and sign up.

Established in 1996, Health Care Compliance Association® (HCCA®) supports healthcare compliance professionals as part of the overarching mission of SCCE & HCCA, a member-based professional association with more than 19,000 members in more than 100 countries.

SCCE & HCCA is dedicated to enabling the lasting success and integrity of organizations worldwide by promoting high standards in compliance and ethics programs, nurturing a community of compliance and ethics practitioners, and offering knowledge-rich educational opportunities. Additionally, we offer professional certification through the Compliance Certification Board (CCB®), an independent body which recognizes individuals with competence in the practice of compliance and ethics.

Learn more about HCCA

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An Easy-to-Understand Clinical Research Glossary to Support Participants and Professionals

ACRP Journal Article Focuses on Clinical Research in Transgender and Gender Diverse Populations

Did You Know?: Certificates and Certification Are Not the Same

Jobs in the acrp career center.

• Clinical Research Coordinator
• Clinical Research Coordinator - 223996

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• Directory on Mississippi State University

Research Compliance in the News

Preventing access to americans’ bulk sensitive personal data and united states government-related data by countries of concern.

March 4, 2024

CRITICAL AND EMERGING TECHNOLOGIES LIST UPDATE

February 15, 2024

Earning respect and trust (H. Holden Thorp, Editorial, Science)

February 1, 2024

NSF research security training modules now available

January 30, 2024

How big is science’s fake-paper problem?

November 6, 2023

The Multimillion-Dollar Machines at the Center of the U.S.-China Rivalry

October 20, 2023

Department of Defense Seeks to Combat Undue Foreign Influence in Higher Education Institutions with Funding Restrictions

October 16, 2023

Case Study in Research Integrity – Banned From Supervising, Can’t Go in Lab, but No Impact on NIH Funded Research?

July 17, 2023

NSF Suspends 18 Awards, Receives Repayments Related to Foreign Ties, Research Misconduct

June 23, 2023

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Research Compliance News

Memo: lab animal per diem rate changes, may 29, 2024.

May 30th, 2024 in Animal Care & Use , Announcements , Memoranda , Research Compliance

TO: Boston University Deans, Department Chairs, Principal Investigators, Department Administrators, and Grant Administrators FROM: Gloria Waters, Vice President and Associate Provost for Research Karen Antman, Provost, Medical Campus, and Dean, School of Medicine DATE: May 29, 2024 SUBJECT: Lab Animal Per Diem Rate Changes Boston University is committed to efficiently managing its animal care facilities and to reviewing costs... More

Prohibition on Participation in Malign Foreign Talent Recruitment Programs

May 17th, 2024 in Announcements , Memoranda , Research Compliance

The US government has raised concerns about foreign government interference at research institutions receiving federal funds and has issued new policies and guidance to safeguard national security. This memo outlines in detail concerns related to participation by US-based researchers in “Malign Foreign Talent Recruitment Programs" (MFTRPs), including BU’s policy on... More

Procedural Changes for Expedited Review of Human Subjects Research

April 24th, 2024 in Human Subjects , Research Compliance

The Charles River Campus Institutional Review Board (CRC IRB) is discontinuing annual progress reports for expedited research and moving instead to a triennial review cycle. For research teams, this will go into effect at the next expedited annual progress report review and will apply to all newly approved expedited research... More

RIMS will be Off-line on Sunday 3/17/24 for System Update

March 15th, 2024 in IBC , Research Compliance

Research Information Management System (RIMS) will be unavailable to all users for a System Update between 12 AM and 8 AM on Sunday, March 17, 2024. This update will involve changes in the Biological Use Authorization form (IBC application form).  This update will fix several glitches in the system and... More

BU Welcomes New Dive Safety Officer, Elizabeth McNamee

October 23rd, 2023 in Research Compliance

This month, the University welcomes Lizzie McNamee as the new Dive Safety Program Manager in BU Environmental Health & Safety and the Dive Safety Officer for the BU Scientific Diving Program. She is responsible for ensuring that all BU-sponsored scientific underwater diving activities, international and local, are carried out in... More

Changes to Responsible Conduct of Research Requirements for National Science Foundation Investigators and Key Personnel

October 17th, 2023 in Announcements , Research Compliance

TO: Boston University Faculty  FROM: Sarah Hokanson, Assistant Vice President & Assistant Provost for Research Development and PhD & Postdoctoral Affairs; Director, Responsible Conduct of Research Kathryn Mellouk, Associate Vice President for Research Compliance DATE: October 16, 2023 SUBJECT: Changes to Responsible Conduct of Research Requirements for National Science Foundation Investigators and Key Personnel The CHIPS and Science... More

BU Guidelines on Research with Potential Pandemic Pathogen Oversight Published

September 21st, 2023 in IBC , Research Compliance

In March 2023, the National Science Advisory Board for Biosecurity (NSABB), a Federal advisory committee that addresses issues related to biosecurity and dual use research, provided recommendations for the development of a more comprehensive and integrated framework for the oversight of research with pathogens and toxins that may pose significant... More

Power Outage at BUMC, October 7-9

September 20th, 2023 in Research Compliance

In preparation for the planned electrical shutdown taking place from October 7-9, 2023, Facilities Management & Operations (FMO) has been coordinating with departments and occupants of affected buildings to take proactive steps to safeguard the integrity of valuable research, ensure the continuity of essential services, and minimize any potential inconvenience... More

New Leadership for Research Security at Boston University

August 25th, 2023 in Research Compliance

We are pleased to announce Sarah Porter, JD, MS, will be serving as Boston University’s new Research Security Director. As Research Security Director, Sarah will be responsible for coordinating the University’s compliance with research security regulatory requirements under the National Security Presidential Memorandum – 33 (NSPM-33). NSPM-33 research security encompasses disclosure... More

TikTok Ban on Devices used for Federal Contracts

July 27th, 2023 in Announcements , Research Compliance

TO: Boston University Faculty with Federal Contracts and Subcontracts FROM: Kate Mellouk, Associate Vice President, Research Compliance DATE: July 27, 2023 SUBJECT: TikTok Ban on Devices used for Federal Contracts In June, the US government issued an interim rule for federal contracts prohibiting the use of the social networking service TikTok and other applications from parent company ByteDance Limited on... More

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Emory Research Administration News

• Uniform Guidance

Restructuring and Establishment of the New Research Compliance Office

On January 25, 2021, an announcement was released from the EVP for Business and Administration, Christopher Augostini, regarding the restructuring of the University Compliance Office and the establishment of a new Research Compliance Office.  The announcement in its entirety, can be found here .

After the retirement of the former leader of the Office of Compliance, Kris West, the EVP for Business and Administration retained an external firm to perform an external review of the office and delivered a formal report to leadership.

This report illuminated the need for the Office of Compliance to oversee the university’s compliance efforts more holistically, in terms of compliance coordination, oversight and monitoring. Therefore, realigning research-related compliance functions under Emory’s Office of Research Administration.

With this realignment, some of the current central compliance responsibilities, such as management of research integrity investigations and research compliance-related responsibilities will transition to the Office of Research Administration. It is important to note that the Office of Compliance will continue to have accountability for university compliance oversight and will work closely with the Office of Research Administration and Emory Healthcare compliance offices. An ORA overview of the realignment of structures can be seen in the graphic below:

While an executive search is being conducted, as of February 1, 2021, Dr. Kimberly Eck, AVP for Research, has served as Interim AVP for Research Compliance and Regulatory Affairs. In this role, Dr. Eck facilitates the development of the Office of Research Compliance and Regulatory Affairs and provides direct regulatory support and compliance services to the extensive research mission of Emory University.

Some additional functions under the Office of Research Compliance and Regulatory Affairs are:

• Research Misconduct and Non-compliance Investigations
• Research policy and procedure creation and review
• Regulatory non-compliance and sponsor reporting
• DEA and other dangerous drugs oversight
• Contract Negotiations/Terms related to compliance considerations (HIPAA, Data Use, Indemnification, risk assessment of new drugs/devices, etc.)
• New research regulations assessment
• Clinical trial agreements
• Clinical trial patient reimbursement challenges that surface
• Liaising all ORA FOIA requests
• IRB, IACUC, Biosafety, Radiological Safety, Chemical Safety support, accreditation, and compliance
• Regulatory site visits and inspections (e.g. USDA, OSHA complaints, etc.)
• Negotiating conflicts between state and federal laws (e.g. HIV testing with minors)
• Liaison with counsel and external counsel (counsel on retainer)
• Liaison with a Contract Research Organization (CRO on retainer for PI initiated multi-site clinical trials)

Some updates as of May 2021:

• The COI Office is preparing to implement a more efficient technology solution to facilitate disclosures in Fall 2021/Spring 2022.
• After an external review, the Export Control Office is partnering with multiple offices to enhance the infrastructure and protections for covered information, equipment, materials, and locations.

Research Compliance is reviewing and updating their standard operating procedures for partnering with academic units related to non-compliance and research misconduct allegations that are received.

Recent Articles for Emory’s Research Administrator

• NIH Boosts Pay for Postdocs and Graduate Students
• $1.5B in Medical Research Funding Available via Congressionally Directed Programs
• World Health Organization SARS-CoV-2 Guidance – Biosafety Updates
• Opportunity to Present at the ARPA-H Customer Experience (CX) Hub
• Emory International Travel Loaner Laptop Program
• NSF Common Forms
• NSF 24-1 Proposal and Award Policy and Procedure Guide (PAPPG) Updates
• Contracting Updates: Contracts Dashboard Overview, Progress & Plans
• Emory’s Award Closeout Plan and Roadmap
• Emory University’s Office of Research Administration Selected as Mentors for Innovative Research Analytics Program

New from NIH

• NIH All About Grants Podcast: A Focus on Researchers With Disabilities June 17, 2024 This NIH All About Grants podcast episode discusses particular challenges researchers with disabilities may experience and how NIH is working to address them. Drs. Alison Cernich, Deputy Director of the Eunice Kennedy-Shriver National Institute of Child Health and Human Development (NICHD) and Theresa Cruz, Director of the NICHD National Center for Medical Rehabilitation Research, join […] NIH Staff

News from the Office of Technology Transfer

• Data Use Agreements 101
• How to strengthen your patent
• Emory’s Biotechnology Consulting Club Transforms Lab Innovations into Market Successes

Emails from EHSO

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Research Administration & Compliance Systems - June 2024 Update

This article includes the latest updates for the following sub-set of Research Administration & Compliance Systems: Research Administration Portal, Research Administration and Compliance Reporting, ecrt, and OAIR, ESTR-IRB, Agreements-DUA, and Data Safety.

Research Administration Portal

The Research Administration Portal was recently updated to include integration with GMAS along with researcher attestation functionality, including new notification, to do item, and attestation certification for Covered Individuals, in support of compliance with new Malign Foreign Talent Recruitment Program (MFTRP) attestation requirements .

Please visit the Research AdministrationPortal help site and release notes or contact [email protected] to learn more about this upcoming release.

Research Administration and Compliance Reporting

The Research Administration and Compliance Reporting (RACR) team recently released additional features and filters for the Proposals, Awards, and Expenses dashboards, available in HART. Visit the support site for a full list of updates. We encourage you to visit and bookmark the landing page to access research administration information and try out some reports.

Questions about reporting? Please visit the  Research Administration and Compliance Reporting Releases webpage  or contact [email protected] to learn more.

• The FY24 Q4 Project Review Period opens on Tuesday, August 27.
• The Project Certification Period will begin on Tuesday, September 17.
• Project certifications will be due on Thursday, October 17.

Keep an eye on the OSP Page for additional ecrt news.

OAIR, ESTR-IRB, Agreements-DUA, and Data Safety

Summer System Update Planned

The support team is planning a suite-wide update. OAIR, ESTR-IRB, Agreements-DUA, and Data Safety will be updated over the weekend, starting on Friday, August 2, at 7:00 PM ET and concluding on Sunday, August 4, at 5:00 PM ET. This update is part of our major software update and release activities. Please visit the  Research Administration and Compliance Systems Support Site  for additional information and detailed release notes (once they are available).

Some highlights:

• ESTR-IRB, Agreements-DUA, and Data Safety are receiving a major software update from version 10 to version 10.5. This update brings exciting new features that will streamline your workflow and enhance your user experience. More information will be available in the following months.
• OAIR Minor software update and release updates. Updated links to sites. More information will be available in the following months.

The support team offers 30-minute informational sessions covering general system information, key changes associated with the upgrade, and answers to your questions. Visit the System Support Office Hours Booking page to register.

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Office of the Vice President for Research

Research compliance services news, researchmatch.

For more information, including the process for using ResearchMatch as a recruitment tool, visit our ResearchMatch webpage or contact Ellen Ciesielski in Research Integrity & Compliance.

“Human Pluripotent Stem Cells Twenty-Five Years On” Webinar

The discovery of human pluripotent stem cells just over twenty-five years ago almost immediately engendered widespread enthusiastic speculation concerning their future potential in research and medicine: a future as models for early human development, as platforms for functional human genomics, as tools for the study of disease, drug screening and toxicology, and as a renewable source of cellular therapeutics for a range of intractable diseases. In this lecture, Dr. Martin Pera, a noted expert in the pluripotent stem cell field, will assess the progress thus far and the prospects and challenge s ahead.

The UConn/UConn Health Stem Cell Research Oversight (SCRO) Committee invites you to this one-hour lecture followed by a 30-minute Q&A session! 

Date: Monday, May 13, 2024

Time:  4:00 p.m. – 5:30 p.m. EDT

Presenter:   Dr. Martin Pera

Topic:  Human Pluripotent Stem Cells Twenty-Five Years On

Registration Link:   WebEx Registration Link

Martin Pera, Ph.D., The Jackson Laboratory

Martin Pera is a Professor at the Jackson Laboratory in Bar Harbor, Maine. He is the Chair of the Steering Group of the International Stem Cell Initiative, a member of the Board of Directors of the International Society for Stem Cell Research, and Editor-in-Chief of the society’s journal, Stem Cell Reports. His laboratory when at Monash University was the second in the world to isolate embryonic stem cells from the human blastocyst, and the first to describe their differentiation into somatic cells (neurons) in vitro. His current research is focused on understanding cell state transitions in pluripotent stem cells, and on the use of pluripotent stem cells to study disorders of the central nervous system and the development of cell therapy for age-related macular degeneration. Dr. Pera’s research interests are the cell biology of pluripotency and the applications of human pluripotent stem cells in disease modeling and therapy. 

For questions, contact Ellen Ciesielski, UConn/UConn Health SCRO Coordinator, Research Integrity & Compliance.

Questions about ClinicalTrials.gov?

ClinicalTrials.gov is an online database of clinical trials. At UConn Health, Principal Investigators are responsible for registering and posting results per the federal regulations as well journal policies. That National Institutes of Health definition of a clinical trial is a  research study 1   in which one or more human subjects 2  are prospectively assigned 3  to one or more interventions 4  (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. 5  

Do you have questions about ClinicalTrials.gov registration or results posting? To schedule a virtual or in-person session with the UConn Health contact for ClinicalTrials.gov, email Ellen Ciesielski , Research Compliance Monitor in Research Integrity & Compliance in the OVPR. To learn more about ClinicalTrials.gov requirements, please see our webpages .

1 See Common Rule definition of  research  at 45 CFR 46.102(d).

2 see common rule definition of  human subject  at 45 cfr 46.102(f)., 3 the term “ prospectively assigned”  refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial., 4 an  intervention  is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints.  examples include:  drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies., 5 health-related biomedical or behavioral outcome  is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life.  examples include:  positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life., hspp-newsletter- january-february- march, 2024.

UConn Health’s HSPP Reaccreditation from the

Association for Accreditation of Human Research Protection Program (AAHRPP)

On March 27-28, 2024, UConn Health Human Subjects Protection Program (HSPP) underwent a Site Visit evaluation as part of the process of reaccreditation by the Association for Accreditation of Human Research Protection Programs (AAHRPP).  After the HSPP responds to the Site Visit report the application will be reviewed by the AAHRPP Council in June 2024.  This process required team work from many stakeholders. The Director of the Human Subjects Protection Program and the Associate Vice President for Research Integrity & Compliance extend their gratitude to the faculty, staff, IRB members and members of the Scientific Review and Conflicts of Interest Committees, Office of Clinical and Translational Research Services, Sponsored Program Services, Research Pharmacy and Research Safety, and many others who committed their time to the Site Visit and who ensure that we have an outstanding human subjects program every day.

FDA Regulated Research

Overview of Human Subjects Research with Devices

The U.S. Food and Drug Administration (FDA) regulates drugs, biologics, and devices used in the diagnosis, mitigation, treatment, or prevention of diseases.

  Investigators who will be conducting clinical investigations in which the purpose of the study is to obtain data about a medical device (e.g., data on its safety and effectiveness), should become familiar with the information provided below to determine whether: (a) the device is exempt from an investigational device application (IDE), (b) the device fulfills the requirements for an abbreviated IDE, or (c) the device needs an IDE issued by the FDA.

Investigators should only think about these determinations when research participants of a clinical investigation will become part of the group in which a medical device will be used or part of the control group, and the device is the object of the investigation/research study.

Unless the sponsor of the device has made the determination that the device is exempt from the requirements of Part 812.2 (c), the study may be conducted under an abbreviated IDE or the investigator must submit an IDE application to FDA. See Table 1 below .

An investigational device exemption (IDE) is a regulatory status granted by the FDA that allows researchers to conduct clinical investigations on medical devices that have not yet received FDA approval. However, not all device studies are required to submit an IDE application to the FDA.  If a device is determined to be a non-significant device (NSR) in concurrence with the IRB, then an IDE is not necessary.

An IRB may determine that a device is a non-significant device because it does not meet the definition for a significant risk device (SR) ( see definition of SR below ) and does not present a potential for serious risk to the health, safety, or welfare of participants.

The sections below explains when and how an investigator makes a determination that a device could be used in a clinical investigation under an abbreviated IDE or under an Investigational Device Exemption (IDE).

Abbreviated Investigational Device Exemption

The sponsor makes the initial determination of SR or NSR for the device. However, it is important to note the IRB will make the final determination for NSR devices. If the research study is investigator initiated , then the investigator is also acting as the sponsor.

NSR device studies may not require submission to the FDA providing they comply with the abbreviated requirements of the regulations described in the IRB Policy 2011-021.0 .pdf  – Investigational Device Studies 

The FDA considers an investigation of a non-significant risk device to have an approved IDE ( Abbreviated Investigational Device Exemption) when an IRB concurs with the initial non-significant risk determination of the sponsor or investigator and approves the study. See Table 1 below .

Investigational Device Exemption (IDE)

If either the investigator or the IRB has made a determination that the device is a significant risk device an IDE application is to be submitted to the FDA.

To obtain an IDE approval by the FDA, the sponsor or manufacturer of the device must properly fill out an IDE application. This application should be submitted proposing a human clinical researcher to study an unapproved significant risk device or a cleared or approved device for use other than its approved indication or intent.

The application should provide information about the investigational device, including its design, manufacturing process, and intended use. A clinical investigational protocol that outlines study objectives, methodology, patient population, and end points should also be included.  In addition, the sponsor must demonstrate in the application that there is reason to believe that the risks to human subjects from the proposed investigation are outweighed by the anticipated benefits to subjects, the importance of the knowledge to be gained, that the investigation is scientifically sound, and that there is reason to believe that the device as proposed for use will be effective.

An IDE application can be considered approved 30 days after it has been reviewed by the FDA, unless otherwise indicated. The FDA may inform the sponsor of approval, approval with conditions, or disapproval prior to 30 calendar days from the date of receipt.

Once FDA approval is granted, and the IRB has approved the study the sponsor and/or investigator may proceed with the clinical investigation. See Table 1 below .

The FDA grants permission so a device that otherwise would be required to comply with a performance standard or to have premarket approval can be shipped lawfully for the purpose of conducting investigations of that device. This FDA permission is evidenced by the assignment of an IDE number.

Additional Points to Consider About Research Studies with Medical Devices

• Studies of SR Devices require review of the convened IRB.
• NSR device studies generally will require full board review but may be approved through the expedited review procedure if the study falls within a designated approvable category and is minimal risk.
• IRB approval must be obtained before any clinical investigation can begin, and for studies with a SR Device, both FDA and IRB approval must be obtained before any subject can be enrolled.

Definitions-

  Clinical investigation means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The term does not include experiments that are subject to the provisions of part 58 of this chapter , regarding nonclinical laboratory studies.

Significant Risk (SR) Device: A device that presents a potential for serious risk to the health, safety, or welfare of a subject and 1) is intended as an implant, or 2) is used in supporting or sustaining human life, or 3) is of substantial importance in diagnosing, curing, mitigating or treating a disease, or otherwise prevents impairment of human health, or 4) otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.           

      Table 1

Resources for investigators: ReGARDD – Regulatory Guidance for Academic Research of Drugs and Devices

Device Advice: Comprehensive Regulatory Assistance | FDA

UConn Health IRB Forms and Polices Revisions

Educational Resources

The following forms have been updated:

• Instructions for Requesting Reliance Upon Advarra IRB.docx (2/13/2024, updated contacts at Advarra and consent template injury language section)
• Request for UConn Health as a Recruitment Site -Without Engagement (*new form as of 3/20/24)

The following policy has been updated:

• 2011-008.2 .pdf – Informed Consent – Waivers and Alterations (1/22/2024 ) (including the FDA final rule that allows IRBs to approve an informed consent procedure that does not include or that alters certain informed consent elements, or to waive the requirement to obtain informed consent, for certain minimal risk clinical investigations).

The following links were added to the IRB website under online resources for investigators:

• Regulatory Guidance for Academic Research of Drug and Devices 
• Is my Device Study Exempt from Investigational Device Exemption (IDE) Regulations?

Upcoming Changes in at the HSPP/IRB

Education & Development Specialist of HSPP:  As of 4/5/2024, Mayra Cagganello has transferred to a new position within UConn Health.  Mayra has worked for the HSPP for almost 13 years and her dedication and support to the HSPP and research community will be missed!

Investigators who need education, guidance on IRB submission and/or training with the IRIS submission system should contact the IRB at [email protected]

We wish Mayra the best in her new role!

  Bibliography

  2011-007.0 .pdf  – Definitions Applied to Policies

2011-021.0 .pdf  – Investigational Device Studies

Frequently Asked Questions about Medical Devices

March Remote RCR Training 3/26

The Responsible Conduct of Research (RCR) Office within Research Integrity & Compliance in the OVPR hosts monthly remote RCR training sessions. For our March remote event, we will be discussing several case studies. This 1-hour event will count towards the 8-hour in person requirement for NIH , however all those who conduct research are strongly encouraged to attend!

For more details about RCR requirements, please visit our   RCR Program website .

For questions, please contact  Research Compliance Monitor,  Ellen Ciesielski  or  Karen Moré , Director of Research Compliance.

What:  March RCR remote training session featuring case study discussions

When:   Tuesday, March 26th from 12:00 p.m. to 1:00 p.m.

Where:   Remote  WebEx Registration Link

March RCR Training

Calling All Human Subjects Research Staff!  Please join the Responsible Conduct of Research (RCR) Office for our March in-person RCR training session with a focus on clinical and social researchers!

This month, we will be highlighting the importance of appropriately protecting research participants and avoiding research misconduct. We will meet in the library to view the Office of Research Integrity’s (ORI) interactive movie: “ The Research Clinic .” Snacks will be provided!

The movie is designed as a “choose your own adventure”-type experience to allow participants to work through some common pitfalls and challenges in a low-risk environment. This 1.5-hour event will count towards the 8-hour in person requirement for NIH , but  we highly encourage anyone conducting human subjects research to join us!

Space is limited so registration is required. To register, please email Research Compliance Monitor,  Ellen Ciesielski .

What:  March RCR in-person training, “The Research Clinic”

When:  Wednesday, March 13th from 12:00 p.m. to 1:30 p.m.

Where:  Babbidge Library, Class of ’47 Classroom

For questions, please contact  Karen Moré , Director of Research Compliance. For more details about RCR requirements, please visit our  RCR Office website .

2024 Responsible Conduct of Research Training Remote Sessions

This is the last week of the 2024 Responsible Conduct of Research (RCR) training sessions! Sessions will be presented live via WebEx in a series of hour-long sessions. This week’s sessions include “ Managing Mentoring and Peer Relationships ” on Monday 2/26, “ Research Security/Export Control ” on Tuesday 2/27, “ Ethics in the Use of Human Subjects in Research ”  on Thursday 2/29.

Who should sign up?   All trainees, fellows, participants, and scholars receiving support through any NIH training grant, career development award (individual or institutional), research education grant, or dissertation research grant (specifically, the following programs: D43, D71, F05, F30, F31, F32, F33, F34, F37, F38, K01, K02, K05, K07, K08, K12, K18, K22, K23, K24, K25, K26, K30, K99/R00, KL1, KL2, R25, R36, T15, T32, T34, T35, T36, T37, T90/R90, TL1, TU2, and U2R ) are required to complete RCR training per   NIH policy . This policy also applies to any other NIH-funded programs supporting research training, career development, or research education that require instruction in responsible conduct of research as stated in the relevant funding opportunity announcements.

What kind of training is required?   Unlike NSF or USDA NIFA RCR requirements which can be satisfied by online training through the CITI program, NIH requires training to be “face-to-face.” Specifically, 8 hours of unique face-to-face presentation material are required by NIH. The February remote RCR training sessions may be utilized to satisfy this requirement.

How do I sign up?   Please visit the UConn Health RCR website for a   list of the sessions offered along with registration links .

To learn more about the NIH RCR requirement or other options to satisfy NIH’s RCR training requirement, please visit the   UConn Health RCR website .

Q uestions?  Please contact Research Compliance Monitor, Ellen Ciesielski at  [email protected] .

OCTOBER, NOVEMBER, DECEMBER, 2023 – HSPP NEWSLETTER

The HIPAA Privacy Rule & Human Subjects Research – Overview

The HIPAA Privacy Rule (the “Privacy Rule”) may impose additional requirements to the federal human subjects protection regulations applied to all human subjects research.

  The purpose of this overview is to clarify concepts and apply them to commonly seen human subjects research activities/studies. Specifically, the sections below highlight some of the main provisions of the Privacy Rule as they relate to human subjects research.

A series of questions and answers explain the scope of the Privacy Rule, the difference between an Authorization, a Waiver of HIPAA Authorization and an Alteration of HIPAA Authorization.  In addition, several sections explain how to address the Privacy Rule in recruitment activities, and when using specimens for research studies.  Examples of research activities and the appropriate HIPAA forms are included in some of those sections.

The Privacy Rule regulates the way certain organizations called covered entities under the Rule handle protected health information (PHI). Since UConn Health is a covered entity, investigators conducting research with UConn Health PHI need to address HIPAA.

Question:   How do I know if I need to address the Privacy Rule in my research study?

Answer: The Privacy Rule affects research and researchers when either:

Research creates or generates PHI, or research requires access to and/or use of PHI.

If your study involves the use of PHI you must address the Privacy Rule within your application for approval. PHI means individually identifiable health information transmitted or maintained in any form ( electronic means, on paper, or through oral communication) that relates to the past, present or future physical or mental health or condition of an individual. Health information is not considered PHI if it has been de-identified in accordance with the Privacy Rule (i.e., by expert analysis or by removing all identifiers specified in the Privacy Rule of the individual or of relatives, employers, or household members of the individual).

Examples of research studies for which the HIPAA regulations apply are :

• Studies using individually identifiable health information that is generated as part of a health care service.
• Studies gathering individually identifiable health information that is entered into a medical record.
• Studies gathering individually identifiable health information that is used to make treatment decisions.
• Retrospective or Prospective research studies involving the review of medical records.
• Research studies involving surveys, questionnaires or focus groups, which obtain PHI from patients receiving treatment.

  Question:   When does the Privacy Rule not apply to research?

Answer: Research studies that do not use, disclose or create PHI are not subject to HIPAA regulations.

Examples of studies that are not subject to HIPAA:

• Studies that use tests that do not go into the medical record because they are part of a basic research study and the results will not be disclosed to the subject.
• Studies that review de-identified health information.
• Studies that obtain data from records open to the public.
• Interviews, focus groups, and surveys studies that collect information that is not considered health information (e.g., opinions, beliefs, wants/preferences, etc.)

  Question:  What is the difference between HIPAA “Authorization” and Informed Consent?

Answer: An informed consent is the individual’s volunteer permission to participate in the research. The requirement to obtain the legally effective informed consent of individuals before involving them in research is one of the central protections provided for under the HHS regulations at  45 CFR part 46 ( AKA as the Common Rule).  The Common Rule’s focus is in protecting the safety of the individuals, their privacy, and confidentiality. To do so, the investigators need to include in the consent forms the applicable elements /information described in the Main Consent Form Checklist.doc  .

The Privacy Rule, a different regulation, focuses on protecting the privacy and security of PHI. The Privacy Rule generally requires subjects to give written Authorization before a covered entity may use or disclose patients’ PHI for research. A signed HIPAA Authorization represents an individual’s agreement to the use and disclosure of the individual’s PHI for the specified research purpose.

An authorization must contain several required elements and statements, including but not limited to a description of the PHI to be used and disclosed, the person authorized to make the use or disclosure, the  researcher may make the disclosure, an expiration date, and, in some cases, the purpose for which the information may be used or disclosed.

The IRB may approve a HIPAA authorization process which does not include, or which alters some or all of the elements of a valid written authorization, or waives the requirement for written HIPAA authorization if the IRB finds and documents that the use of the subjects’ PHI meets the criteria for a waiver.

In granting an alteration or waiver of HIPAA authorization, the IRB must determine that the alteration or waiver, in whole or in part satisfies each of the following criteria:

• The use or disclosure of PHI involves no more than minimal risk to the privacy of individuals, based on, at least, the presence of the following elements:
• an adequate plan to protect the identifiers from improper use and disclosure;
• an adequate plan to destroy the identifiers at the earliest opportunity consistent with the conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law; and
• adequate written assurances that the PHI will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research study, or for other research for which the use or disclosure of PHI would be permitted (i.e., under the HIPAA regulations).
• The research could not practicably be conducted without the waiver or alteration; and
• The research could not practicably be conducted without access to or use of the PHI.

    Question:  What is the difference between a partial and complete Waiver of HIPAA Authorization?

  Answer: A waiver of HIPAA authorization is a determination that is made by the IRB.  An IRB can waive in full or in part the individual authorization required by the Privacy Rule to use and disclose PHI for research purposes.

Example of research study for which the IRB may grant a complete waiver of the Authorization:

• A research study limited to a retrospective review of medical records (HIPAA Waiver for the entire study).

Example of research study for which the IRB may grant a partial waiver of the Authorization:

• A research study collecting information during telephone screening (HIPAA Waiver for a portion of the study).

To request a waiver of HIPAA authorization the investigator must complete pages 1 and 2 of the HIPAA Request for Alteration or Waiver of Authorization.doc  form and submit this document to the IRB for review and approval prior to using and/or disclosing PHI.

Question:  Is it possible to get a HIPAA waiver to screen patient charts without having each patient first sign an Authorization form?

Answer:  Yes. The Privacy Rule allows for certain activities regarding screening, recruiting or determining eligibility (e.g. chart reviews for determining eligibility) to occur without obtaining a HIPAA authorization.

The investigator must submit a  HIPAA Request for Alteration or  Waiver of Authorization.doc  . The waiver must be granted by the IRB  before  charts are screened.

Question:  What is a HIPAA Alteration of the Required Elements and/or Statements?

Answer:  A HIPAA Alteration of the Required Elements and/or Statements is a regulatory determination that is made by the IRB.  An IRB can approve to omit (waive), or change (alter) in part the individual authorization required by the Privacy Rule to use and disclose PHI for research purposes.

When investigators are planning to obtain an individual’s authorization to access their information, and they need to either remove (waive), or change (alter) some of the core elements or statements of an authorization, they must complete and submit Appendix A.  Appendix A is in the fourth page of the HIPAA Request for Alteration or Waiver of Authorization.doc  form   The IRB must approve this request prior to the use and/or disclosure of PHI.

Example of an alteration of the authorization:

• An authorization that requires to remove (waive) the element that describes each purpose of the requested use or disclosure because providing the purpose of the study would affect the results of the study.

Examples of studies withholding information about the study purpose and/or reason for procedures, in order to prevent biasing the results:

• Subjects are asked to take a quiz for research but they are not told that the research question involves how background noise affects their ability to concentrate.
•  To further understanding of how representations of same sex couples depicted in commercials influence consumer behavior, subjects are exposed to advertisements featuring gay couples and straight couples while their heart rate, facial muscle movement, and sweat responses are recorded. Subjects are informed that their reactions to the commercials are being studied, but not that the researchers are examining if the sexual orientation of characters in commercials influences them.

  To request to alter the HIPAA authorization, the investigator needs to submit a HIPAA Request for Alteration or Waiver of Authorization.doc   and Appendix A.

  Example of research study that requires waiving documentation/signature of the authorization:

• Research on sensitive topics, such as domestic violence or illegal activities where the only link of a subject to the study is their signature on the authorization, and there is a risk of breach of confidentiality.

  To request a waiver of the participant’s signature on the HIPAA authorization, the investigator needs to submit a HIPAA Request for Alteration or Waiver of Authorization.doc   and Appendix A.

Because the federal definition of human subjects research extends to people who are sources of biological specimens and identifiable private information, research with these materials often requires review and approval by the IRB. The  level of IRB review   is based on the level of risk the study poses.

The risks of research with specimens potentially include one or both of the following:

• The risk of harm from procedures used to obtain specimens, and/or
• The risk associated with the loss of privacy and confidentiality due to personally identifiable information that may be associated with specimens.

Common questions involving research using human specimens are summarized below.

Question:  What type of IRB review is required for a research project using existing specimens ? What HIPAA form do I need to submit?

    Answer:  It depends on whether the existing specimens are identifiable. Existing specimens means the  specimens were collected for clinical purposes or for research studies other than the proposed research study.

If the existing specimens are not identifiable, and if the investigator will make no effort to re-identify the specimens, the specimens do not meet the definition of a human subject and IRB review would not be required.

On the other hand, if the specimens are identifiable, or efforts will be made to re-identify the samples, IRB review is required.

Research that only involves the use of existing identifiable specimens may qualify for exemption if one of the following is true:

• the specimens are publicly available
• Information is recorded in such a manner that the identity of the human subject cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects. In this case, the research may qualify for exempt status under Category 4.ii.

To address HIPAA submit a HIPAA Certification of De-Identification.doc

On the other hand, research involving previously collected specimens that have identifiers associated most likely qualifies for expedited review under category 5.  Use of specimen-associated identifiers must be restricted and privacy protection measures must be in place.

To address HIPAA submit HIPAA Request for Alteration or  Waiver of Authorization.doc

Question:  What type of IRB review is required for a research project using specimens that will be collected for research purposes by noninvasive means? What HIPAA form do I need to submit?

Answer:  Research that involves the collection of specimens for research purposes by noninvasive means may qualify for Expedited review- under Category 3.

Examples of these noninvasive collections of specimens are:

• Hair and nail clippings in a non-disfiguring manner
• Deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction
• Permanent teeth if routine patient care indicates a need for extraction
• Excreta and external secretions (including sweat)
• Un cannulated saliva collected either in an unstimulated fashion or stimulated by chewing gum base or wax or by applying a dilute citric solution to the tongue
• Placenta removed at delivery
• Amniotic fluid obtained at the time of rupture of the membrane prior to or during labor
• Supra‑ and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques
• Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings
• Sputum collected after saline mist nebulization.

You will need to submit a HIPAA Authorization to Use and Disclose PHI for Research Purposes.doc

Question:  What type of IRB review is required for a research project using specimens collected for research purposes by invasive means? What HIPAA form do I need to submit?

Research that involves the collection of specimens for research purposes by invasive means/using procedures that pose greater than minimal risk to participants must undergo full committee review by the IRB.

Examples of these invasive collections of specimens are:

• Collection of specimens through  a skin Biopsy
• Collection of specimen through a bronchoscopy, amniocentesis or colonoscopy.

Question:  My research study involves collecting sputum and lung aspirates from clinical procedures involving chronic smokers that are otherwise going to be thrown away.  The specimens will be provided by the pathology department without identifiers. The pathologist will not be involved in the research.  Do I have to get IRB review?  If so, what HIPAA form do I need to submit?

  Answer: You do not need to submit an application for IRB review nor you need to submit a HIPAA form. Your research is considered secondary research that is not human subjects research because: (a) the specimens were originally collected for clinical care and not specifically for the purpose of the investigator’s current research, (b) the specimens do not come with individually identifiable information, and (c) there is no interaction or intervention done specifically for the research.

The IRB may approve a research proposal in which an investigator will obtain information for the purpose of screening, recruitment or determining the eligibility of prospective subjects without the prospective subject’s HIPAA authorization, however the following conditions must be met:

• The investigator will obtain information related to screening, recruiting or determining eligibility through oral or written communication with the prospective subject.
• The investigator will obtain identifiable information or identifiable biospecimens for screening, recruiting or determining eligibility by accessing records or stored identifiable biospecimens.
• In order to access records or specimens for such purposes, there must be an established relationship between the investigator and the individuals whose records /specimens will be reviewed.  The investigator may delegate the review to designated UConn Health research staff.

Question: At what point in recruitment may we gather information about a potential participant (e.g., if a potential participant calls our office after seeing a flyer, may we screen that person/ ask them about their history, or do we need the person to complete a written HIPAA Authorization prior to screening)?

Answer:  If the IRB has approved your recruitment plan, including a partial waiver of Authorization to permit you to collect PHI for screening without written Authorization, you may take the person’s contact and screening information.  Investigators must also submit to the IRB a phone script using the Sample Phone Script for Screening Prior to Consent.doc  . The IRB must approve the script prior to collecting information from potential participants over the phone.

The potential participant should know that in order to evaluate whether he or she is a candidate for the research, the researcher will need to share the caller’s information, and the caller may need to share information, with a limited number of others who staff the study.  If the person is deemed qualified for the study, then he/she will be asked to come in to sign an informed consent and a HIPAA Authorization. To protect the privacy of the potential participant all the information they provide will be kept only if he/she qualifies to proceed and decides to participate in the study.

    Question: HIPAA specifies18 identifiers that must be removed to “de-identify” health information.  Is any one of these identifiers, all by itself, PHI?

  Answer:  Not necessarily. PHI is information, including demographic information, which relates to (i) the individual’s past, present, or future physical or mental health or condition; (ii) the provision of health care to the individual; or (iii) the past, present, or future payment for the provision of health care to the individual, and that identifies the individual or for which there is a reasonable basis to believe can be used to identify the individual.  If the only identifier you have is a DOB and that DOB is not linked to any other health information and could not be sourced to a provider (e.g., UConn Health), the DOB alone would not be PHI.  However, if the DOB is coupled with other information, such as “a patient at UConn Health,” or “was one of 15 enrollees in a particular study,” this combination would be PHI.

  Question: What coded information or coded specimens means?

The Office of Human Research Protections ( OHRP ) has defined coded as:

•   identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., the code);
• a key to decipher the code exists , enabling linkage of the identifying information to the private information or specimens.

  OHRP considers the term  investigator  to include anyone involved in conducting the research. OHRP does not consider the act of solely providing coded private information or specimens (for example, by a tissue repository) to constitute involvement in the conduct of the research. Note that if the individuals who provide coded information or specimens collaborate on other activities related to the conduct of this research with the investigators who receive such information or specimens, then OHRP would consider such additional activities to constitute involvement in the conduct of the research.

Examples of such additional activities include, but are not limited to:

(1) The study, interpretation, or analysis of the data resulting from the coded information or specimens; and

(2) Authorship of presentations or manuscripts related to the research.

Question: Is coded information identifiable?

  Answer: The Privacy Rule considers coded information to be de-identified if the 18 specific identifiers of the individual or of relatives, employers, or household members of the individual, listed below are coded and the person cannot reasonably be identified.

However, that code needs to be assigned by someone other than the investigator.  The code cannot be derived from any identifiable piece of information or combination of pieces of identifiable information.  The key to the code cannot be accessible to the investigator or research personnel using the de-identified data.

• Address (including street address, city, county, zip code). The initial three digits of a zip code may be used if, according to the current publicly available data from the Bureau of Census: 1) the area formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and 2) the initial three digits of a zip code for a region containing 20,000 or fewer people is changed to 000;
• All elements of dates (except year) for dates directly related to an individual (birth
• date, admission date, discharge date, date of death), and all ages over 89 and all elements of dates (including year) indicative of such age, except that ages and  elements may be aggregated into a single category of age 90 or older;
• Telephone numbers;
• Fax numbers;
• Electronic mail addresses;
• Social Security numbers;
• Medical record numbers;
• Health plan beneficiary numbers;
• Account numbers (bank, retirement, credit card, etc.);
• Certificate/license numbers;
• Vehicle identifiers and serial numbers, including license plate numbers;
• Device identifiers and serial numbers;
• Web Universal Resource Locators (URLs);
• Internet Protocol (IP) address numbers;
• Biometric identifiers, including finger and voice prints;
• Full face photographic images and comparable images; and
• Any other unique identifying number, characteristic or code.

  HIPAA Privacy Rule and Its Impacts on Research (nih.gov)

• Coded Private Information or Specimens Use in Research, Guidance (2008)
• 2011-014.0 .pdf – Health Insurance Portability and Accountability Act (HIPAA) in Research 
• Use and Disclosure of Protected Health Information.pdf

HSPP – April-May-June, 2023 –Newsletter

The Association for Accreditation of Human Research Protection Programs UConn Health Human Subjects Protection Programs Preparation for Reaccreditation

The Association for Accreditation of Human Research Protection Programs (AAHRPP) is an independent, non-profit accrediting body that works to protect the rights and welfare of research participants and promotes high-quality research through an accreditation process.

AAHRPP’s accreditation standards meet or exceed U.S. federal regulatory requirements and the International Committee on Harmonisation –Good Clinical Practice (E6) guideline for protection, and are reasonable, attainable, and representative of current best practices.

UConn Health’s Human Subjects Protection Program (HSPP) achieved AAHRPP accreditation in 2006. As an accredited organization, our HSPP must periodically apply for re-accreditation every five years. This is a two-step process.

Step 1, consists of a self-evaluation of our program, followed by an AAHRPP review of our policies and procedures to ensure they meet regulatory and accreditation standards.

Step 2 is an onsite visit by AAHRP representatives to ensure that our policies and procedures are followed. Once our HSPP is scheduled for the reaccreditation visit an announcement will be sent to the research community.

To complete the reaccreditation step 1, the HSPP has revised multiple IRB policies to reflect our current practices, add required information and standards for accreditation.

In the tables below is a list of the IRB polices and forms that have been revised along with a short summary of the revisions.

If you have questions regarding those changes please send an email to either [email protected] or contact the Education Specialist at [email protected] , 860-679-8802.

2009-001.0 .pdf   – Reporting Unanticipated Problems to the Institutional Review Board:  Edited section under “Self-Reporting” to clarify that the Principal investigators are to report to the IRB any noncompliance with the protocol or directives of the IRB that was within the control of the research team within 5 business days of becoming aware of the event.

2009-003.0 .pdf   – Imposing and Lifting Suspensions of IRB Approval or Imposing Terminations of IRB approval: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2009-005.0 .pdf   – Monitoring of IRB Approved Studies: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2011-006.1 .pdf   – Additional Protections – Pregnant Women, Fetuses or Neonates:  Minor grammar changes.

2011-006.4 .pdf   – Additional Protections – Other Vulnerable Groups: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2011-006.5 .pdf   – Additional Protections – Fetal Tissue Transplants: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2011-007.0 .pdf   – Definitions Applied to Policies:  Added definition of benign behavioral intervention. Edits to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their).  Included revised common rule.

2011-008.1 .pdf   – Informed Consent – Process The general section was revised to request information about the informed consent methods and documentation and to alert the investigator that prospective IRB approval is required for any subsequent modifications made to the methods of obtaining consent or documentation of informed consent whether they are done by hard copy or electronically.

• Changes to the process of obtaining consent by Phone / Fax to include that the individual obtaining consent must be approved by the IRB to consent and that such individual should have sufficient knowledge of the study to conduct the conversation and to answer any questions,; and the consent conversation should include an in-depth review of the consent document allowing sufficient time for questions to be asked and answered.
• The process for obtaining consent via videoconference (e.g., WebEx, Zoom) was added with an explanation of how this process must be conducted.
• A section about obtaining electronic documentation of consent was added with details of compliance expectations and acceptable methods and processes to obtain electronic signatures.
• A section about electronic informed consent process when consent is not witnessed by study personnel was added to alert researchers that the investigator planning to use this method should discuss this plan with the IRB prior to submitting this method for approval to ensure this method is appropriate for the research (e.g., in compliance with applicable regulations).
• Edits to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their).

2011-008.5 .pdf   – Informed Consent – Providing and Obtaining Informed Consent: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2011-009.0 .pdf – Institutional Review Board – Membership: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2011-009.11 .pdf   – Institutional Review Board – Studies Conducted in Foreign Locations: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2011-009.14 .pdf   – Institutional Review Board – Human Subject Research Determinations: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2011-009.2 .pdf   – Institutional Review Board – Exemptions: Policy was edited to remove language related to pending adoption of the revised common rule and revisions to applicability of exemption 4(iii) at UConn Health.

2011-009.3 .pdf   – Institutional Review Board – Expedited Reviews : Policy was revised to include a complete list of the criteria for approval when conducting initial or continuing review for expedited submissions. In addition, when submissions are returned to the investigators with a status of “Approved Contingent,” the IRB reviewer can now add a deadline for the investigator to respond to the contingencies sent in a Response form.

2011-009.4 .pdf   – Institutional Review Board – Convened Meeting Operations: Policy was revised to add that when virtual IRB meetings are conducted the agenda item (inclusive of supporting documents) are shared on the screen in the videoconference.

2011-009.7 .pdf   – Institutional Review Board – Assignment of Status Codes: Policy was revised to clarify the IRB will assign the study status code “Closed by PI” to a study under oversight of an external IRB when the external IRB grants the request.  Under the status code title: “Inactive-Administratively Closed” the following was added: the IRB Administrator will assign this status code to exempt research after the anticipated completion date has passed.

2011-009.8 .pdf   – Institutional Review Board – Appeals Process: Policy was revised to indicate that when a principal investigator (PI) submits an initial appeal letter, it can be completed through a written correspondence (i.e., not limited to IRIS response).  Also, the letter sent by the IRB in response to the appeal made by the PI will contain a wet-ink or electronic signature of the IRB Chair.  In addition some edits were made to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their).

2011-009.10 .pdf   – Institutional Review Board – More Frequent Review: Policy Appendix -A was revised to remove Panel 3 and CICATS.

2011-009.12 .pdf   – Institutional Review Board – Criteria for Approval:  Policy was revised to clarify that students can be considered subjects who are likely to be vulnerable to coercion or undue influence.  In addition, policy revised to remove language indicating ‘if’ the revised common rule is implemented (see section describing limited IRB review).

2011-009.13 .pdf   – Institutional Review Board – Lapse in IRB Approval: Policy was revised to describe that investigator are notified either by email or iRIS correspondence about the need to submit a request for extension of the anticipated completion date or close the study.

2011-009.15.a .pdf   – Institutional Review Board – Reliance on UConn Health as IRB of Record: Policy was revised to indicate SMART IRB template may be used to execute reliance agreements. The Office of Human Research Protection reliance agreement template was removed as it not preferred since it does not meet AAHRPP standards.

2011-009.15.b .pdf   – Institutional Review Board – Reliance on External IRB:   Trinity Health was added as an institution with which UCONN Health has an established collaborative agreement for minimal risk studies conducted by a student, fellow or resident. Also, policy now contains that when requesting reliance on an external IRB for a student/resident/fellow project, UCONN Health IRB may request the original approval letter to ensure the research is minimal risk.

2011-011.0 .pdf   – Research Personnel: Policy revised to include principal investigator (PI) responsibility to ensure the confidentiality and security of research records and data as described to the IRB in the submission materials, and to cooperate with all aspects of internal or external audits and inspections.

2011-012.0 .pdf   – Conflict of Interest – Research Personnel: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2011-012.1 .pdf   – Conflict of Interest – IRB Members: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2011-015.0 .pdf   – Recruitment and Payment:   Policy was revised to indicate that external researchers looking to advertise recruitment in UConn Health broadcast (e.g., Lifeline) messages do not need HSPP/IRB permission. Also revised to include procedure to use UConn Health as a recruitment site when UConn Health is not engaged.   Added edits to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their).

2011-016.0 .pdf   – Scientific Review:  Policy was revised to include the Clinical Research Center and funding foundation as acceptable entities who may have conducted the scientific review of studies submitted for full board review.

2011-020.0 .pdf   – Humanitarian Use Device: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2011-022.0 .pdf   – Study Drug – General: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2011-022.2 .pdf   – Investigational Drug/Biologic – Expanded Access for Treatment Use, Including Single Emergency Use: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2011-023.0 .pdf   – Educational Requirements: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2011-025.0 .pdf   – HSPP Evaluation / Institutional Support: Policy was revised to include minor updates to title of HSPP manager, and removing executive committee.

2014-034.0 .pdf   – Additional Requirements – Department of Education (Federal): Policy was revised to include that an email confirming with all of the information included in the FERPA verification form may be acceptable, provided the email is from the person at the school with the authority to grant the permission and sent from that individual’s institutional email address.  Added edits to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their).

Application Checklist for Initial Exempt Application   .doc: Exempt submission checklist Added the following requirements:  When submitting for Exempt determination under Exempt category 4.iii a confirmation that the data will remain protected under HIPAA for 4.iii is required.   If the protocol involves sharing data with indirect identifiers such as sharing a Limited Data Set with an external investigator the UConn Health investigators should provide confirmation they have in place a Data Use Agreement.    If the protocol involves sharing coded data the UConn Health investigators should provide confirmation they have a Don’t Ask /Don’t Tell agreement in place.

Application Checklist for Initial and Continuing Review Expedited  .doc : Expedited submission checklist Added the following requirement: When using electronic informed consent (eIC) (confirmation of part 11 compliance, hard copies of materials, access to eIC platform) Application Checklist for Initial and Continuing Review Full Board.docx

Application Checklist for Initial and Continuing Review Full Board .docx : Added the following requirement : When using electronic informed consent (eIC) (confirmation of part 11 compliance, hard copies of materials, access to eIC platform).

Request for Exemption Form   .doc: Request for Exemption Category 4.iii. was revised to be less restrictive but still ensure HIPAA protection for review as required under the exemption.

Guidance on Closure of Human Subject Research Studies

A research study should be closed by the Principal Investigator (PI) once all human research activities are completed regardless of whether a study is subject to the continuing review requirement. To do so, a closure form should be submitted to the IRB through the iRIS submission system for each non-exempt human research study (e.g., studies approved under Expedited review or Full Board review). The closure form should be submitted before the expiration of IRB approval, however, the PI can also submit a closure form after they have received a notice of lapse of approval.

If the study is an exempt study, the PI may allow the IRB approval to expire. When approval of an exempt study expires, the IRB will administratively close the study, but this does not invalidate the exemption. The research, as proposed to the IRB, may continue; it is not necessary to keep the exemption actively registered with the IRB.

A closure form allows the IRB to have a summary of the following information: • the findings of the study • the final enrollment data • whether the study met the recruitment goals, and • whether any of the following events occurred since the last approval (initial or continuing review): o subject complaints o unanticipated problems involving risk to subjects or others, o unexpected profile of adverse events in terms of frequency and/or severity, o non-compliance with or deviation from the approved protocol or procedures, o audits, inspections or monitoring visits by internal or external personnel. o any publications, presentations, trademarks, patents, etc. related to the study.

This guidance explains the circumstances in which a non-exempt human research study may be closed from IRB oversight, as well as ongoing researcher responsibilities that apply to closed studies.

Things to Consider before Closing Research Studies

• Investigators should honor wishes of the sponsor or funding source to keep the study open or to close the study. Some funding entities require IRB approval for the duration of the funding, even if human research activities are complete, or they may not allow the study to close without the sponsor’s permission. It is the PI’s responsibility to be aware of, and comply with, those requirements.

• Sponsors, contract research organizations (CROs), or coordinating center personnel may need to verify or monitor individually identifiable study data at a specific site where human subjects activities have been completed. The study team should verify whether these organizations require the studies to be open when conducting their monitoring visits. IRB approval must be maintained while these activities are occurring.

• Whenever possible, prior to closing a study, data should be permanently de-identified.

When to Close a Study

• For studies requiring continuing review (e.g., some Expedited studies and all full board studies ) a requests for closure should be submitted at the time the next continuation application is due or within 30 days after the completion of all study activity involving the use of private identifiable information or biospecimens, whichever comes first.

• Moreover, a closure form should be submitted to the IRB if the if the research study was not conducted or was canceled, or if each of the following conditions exist: o The research is permanently closed to the enrollment of subjects o The subjects have completed all research-related interventions o The research is no longer active for long-term follow up of subjects o Data has been de-identified.

• When a Principal Investigator terminates employment with UConn Health, the PI may submit a closure form to the IRB. Alternatively, the PI may submit a modification form requesting transfer of the study to another eligible Principal Investigator. Retired investigators with Emeritus status at UConn Health may be permitted to keep the study open and continue as the PI with approval from the HSPP Director.

• When a student-led project is completed, the study should be closed with the IRB. This should occur prior to the student’s departure / graduation.

IRB Process of Expired studies, Lapsed Studies and Closure Forms

• Expired studies: If approval for continuation of non-exempt research is not sought, or a request to extend the expected completion date has not been received within a reasonable time frame (e.g., 30 days), IRB staff will administratively close the study and send a written notification to the Principal Investigator of the administrative closure. The research activity may not continue and a new application may be required to resume research activity.

• Lapsed studies: If approval of the study has lapsed due to lack of a response to contingencies or a request for continuing approval or to extend the completion date has not been received the study may administratively be closed. The IRB will send a written notification to the PI. Prior to closure the IRB will issue a final request for response by email to the PI and study contacts and the PI will be given a reasonable period within which to respond (e.g. one or two weeks).

• Closure forms: When a closure form is submitted, the IRB will review any new information provided in the closure form and determine whether any additional action is required on the part of the IRB or the investigator. Upon review of the closure form, the status of the study is changed in the iRIS system (e.g., “Closed by PI”) and an outcome letter is issued confirming the closure.

Principal Investigator Responsibilities with Closed Studies

The principal investigator (PI) continues to have responsibilities for a study even when IRB oversight of a study is no longer required. These responsibilities include:

• Verifying all research activities have been completed. The PI should ensure that all research-related activities, interventions or interactions with human subjects or individually identifiable data have been completed at the site(s) approved under the Principal Investigator’s IRB application at the time a closure form is submitted to the IRB or at the time of approval expiration, whichever occurs first.

If after a study is closed, the PI wishes to engage in an activity such that the criteria for closure listed above would no longer be met, the Principal Investigator must submit a new application for IRB review and approval for the use of the previously collected data.

• Record Retention Research data from the completed study should be stored and protected in the manner approved by the IRB and consented to by the research participant so as to maintain the privacy and confidentiality of the participants.

Per HSPP Policy 2011-024.0 .pdf   – File Requirements & Record Retention Requirements   , investigators must maintain research records for three years beyond the completion/termination of the study. Investigators should be aware that other laws and requirements (e.g., funding agency) may require a longer record retention period. Per the HIPAA regulation, investigators are to retain documents relating to uses and disclosures, authorization forms for 6 years from the date of creation or the date when it last was in effect, whichever is later.

Investigator should be familiar with the record retention format described in the UConn Health HSPP Policy 2015-024.1 .pdf   – Record Retention Format   .

Investigators should ensure that any specific regulatory and/or sponsor requirements are met for record retention or submission of reports.

• Confidentiality and Data Security. If the PI is maintaining identifiable private data or specimens, the protections described in the IRB application and to subjects must be maintained for the time frame described. The PI must continue to honor any commitments made to participants as part of the approved research (e.g., providing information about study results; payment for research participation).

• HIPAA authorization. The PI may have obtained HIPAA authorization from subjects to access their medical records, with an expiration date that is far in the future. If the PI still has permission to access medical records at the time they want to close the study that permission expires upon study closure.

U.S. Department of Health and Human Services Food and Drug Administration Common Inspection findings from 2017-2022

The Food and Drug Administration (FDA) has released their Bioresearch Monitoring (BIMO) Fiscal Year 2022 Metrics. Below is a partial description of the common inspection findings from 2017-2022. The full report can be found here: https://www.fda.gov/media/165853/download

Common Sponsor-Investigator Inspectional Observations: • Failure to maintain and/or retain adequate records in accordance with 21 CFR 312.57; accountability for the investigational product; Investigator Statement (FDA 1572); Financial disclosures. • Failure to select qualified investigators and/or monitors, ensure proper monitoring of the study and ensure the study is conducted in accordance with the protocol and/or investigational plan. • Failure to submit an Investigational New Drug (IND) application. • Inadequate subject protection; informed consent issues. • Failure to notify FDA of termination of investigator.

Common Sponsor/CRO Inspectional Observations: • Failure to ensure proper monitoring of the study and ensure the study is conducted in accordance with the protocol and/or investigational plan. • Failure to meet the abbreviated requirements for investigational device exemptions (IDEs). • Failure to maintain and/or retain adequate records in accordance with 21 CFR 312.57; accountability for the investigational product; Investigator Statement (Form FDA 1572); Financial disclosures. • Failure to submit an Investigational New Drug (IND) application; IND safety report. • Failure to submit current list of all participating investigators to FDA at six-month interval after FDA approval of the study.

C ommon Clinical Investigator Inspectional Observations: • Failure to comply with Form FDA 1572 requirements, protocol compliance • Failure to follow the investigational plan; protocol deviations • Inadequate and/or inaccurate case history records; inadequate study records • Inadequate accountability and/or control of the investigational product • Safety reporting; failure to report and/or record adverse events • Inadequate subject protection; informed consent issues

Difference Between De-Identified Data Sets and Limited Data Sets & Limited Data Sets and Data Use Agreements

Under the Health Insurance Portability and Accountability Act (HIPAA) de-identified data is data from which all 18 HIPAA identifiers that could be used to identify an individual or the individual’s relatives, employers, or household members have been removed.

Unlike a de-identified data set, a limited data set is still considered Protected Health Information (PHI). As defined by HIPAA, limited data sets (LDS) are data sets stripped of certain direct identifiers that are specified in the Privacy Rule. They are not de-identified information under the Privacy Rule.

A limited data set is protected health information that excludes the following direct identifiers of the individual or of relatives, employers, or household members of the individual: (1) names; (2) postal address information, other than town or city, State, and zip code; (3) telephone numbers; (4) fax numbers; (5) e-mail addresses; (6) social security numbers; (7) medical record numbers; (8) health plan beneficiary numbers; (9) account numbers; (10) certificate/license plate numbers; (11) vehicle identifiers and serial numbers; (12) device identifiers and serial numbers; (13) web URLs; (14) Internet Protocol (IP) address numbers; (15) biometric identifiers, including fingerprints and voiceprints; and (16) full-face photographic images and any comparable images.

Distinct from de-identified data, a limited data set contains protected health information that is associated with indirect identifiers as defined in the HIPAA privacy rule. Protected health information in limited data sets may include the following indirect identifiers: town, city, state and zip code, and dates directly related to an individual, including birth date, admission date, discharge date and date of death.

The table below describe in detail the HIPAA identifiers that must not be present in a de-identified data set or in a limited data set.

Limited Data Sets and Data Use Agreements

If indirect identifiers must be kept within a limited data set (LDS) in order to perform a research study and the information is to be disclosed outside of UConn Health, the principal investigator must enter into a Data Use Agreement (DUA) with the data recipient. A DUA may also be utilized when UConn Health is the  recipient of a LDS. Only after the agreement has been executed can the limited data set be used/disclosed.

This DUA is required under the HIPAA Privacy Rule. This agreement establishes the ways in which the information in the limited data set may be used, the purpose for which it was disclosed, and identifies who is permitted to use or receive the information.

Moreover, the DUA stipulates that the recipient will use appropriate safeguards to maintain the confidentiality and protect the data from further disclosures.

Since the data use agreements establish institutional obligations and bind the institution to the terms of the agreement, investigators are not authorized to execute research DUAs. UConn Health DUAs for research related activities are processed through the Office of Sponsored Programs Sponsored Program Services (SPS) or the Office of Clinical and Translational Research (OCTR). The specific contacts in these offices are listed below:

• If the DUA is related to a Clinical Trial contact: Donald Deyo, Contract Specialist ([email protected]), or the OCTR main inbox ([email protected]).

• If the DUA is unrelated to a Clinical Trial contact: Jennifer Pomales [email protected]

The table below describes whether IRB review approval is required for a de-identified data set or for a limited data set, and when a Data Use Agreement is required.

OHRP’s Common Rule Webinar

Join the introduction-level, webinar titled “Unlocking the Mysteries of the §46.111 Criteria for IRB Approval of Research.”

This presentation will explain the criteria for IRB approval of research and include case studies and interactive quizzes to demonstrate the way the criteria can be applied. Date: Tuesday, July 11, 2023, 12:00 PM EDT Spots are limited. Registration is required to attend and receive a certificate of attendance.

Register for this webinar at: https://www.zoomgov.com/webinar/register/WN_9RbRyAwjQY2N_kRxFPbT-w

New NSF Responsible Conduct of Research Requirement— Effective 7/31/23

UConn Health is committed to maintaining the highest ethical standards in the performance, reporting, reviewing and proposing of research and scholarly activity. In support of this commitment and to fulfill funder requirements, UConn Health offers Responsible Conduct of Research (RCR) training and education with the goal of engaging researchers in the exploration of best ethical practices.

A recent National Science Foundation (NSF) requirement expansion includes RCR training for faculty and other senior personnel, and will require that the training address mentor training and mentorship. These new requirements apply to NSF proposals submitted on or after  July 31, 2023 .

A list of RCR trainings at UConn Health that fulfill NSF RCR requirements can be found on our UConn Health RCR webpage . Be on the lookout for additions to the RCR offerings in the coming months!

Research Compliance Network

The RCN serves as a communication and collaboration forum, enabling its members to exchange best practices, share strategies and resources, and develop new tools.

What is the Research Compliance Network?

Established in 2014, the Research Compliance Network (RCN) is a volunteer-led national consortium of representatives primarily from academic medical centers, universities, and hospitals. RCN members are professionals whose role involves quality assurance and quality improvement activities (QA/QI) related to organization-wide human subjects research compliance, including post-approval auditing. The network currently includes over 300 members representing various institutions, large and small.

The RCN holds bi-monthly video meetings, utilizes a group email for online discussions, and saves shared resources in a secure cloud storage platform. In addition, the RCN supports topic-specific work teams, which focus on areas of particular interest and importance to members.

Mission Statement

The mission of the RCN is to facilitate inter-institutional networking, benchmarking, and collaboration related to human subjects research QA/QI activities. Specific objectives include:

• Serving as a communication forum for human subjects QA/QI professionals
• Identifying best-practices related to human subjects research oversight and QA/QI
• Facilitating the exchange of information, tools, and resources
• Collaborating on developing new tools and guidance, as needed to support QA/QI work

Communication

RCN members utilize a group email for online discussions. Members are encouraged to use this group email to ask questions and to consult with the network. 

The group email address is provided to new members in their welcome email. If you would like the group email address to be re-sent to you, please use the form below. For membership requests, visit our membership page.

 Our offices will be closed Wednesday, June 19 in observance of Juneteenth.  

Higher education & healthcare research compliance conference, don’t miss our annual conference devoted to higher education and research compliance.

Attend the Higher Education & Healthcare Research Compliance Conference June 10–12, 2024 and hear from experienced professionals on a broad range of compliance topics. This dual-track conference provides regulatory updates as well as guidance and insights for building a stronger compliance program in two distinct but often related spaces: higher education and healthcare research.  Both learning tracks are open to all participants.

In addition to the educational opportunities, your conference experience includes plenty of opportunities to make valuable connections with fellow compliance practitioners and professionals with higher education and/or research backgrounds.  You’ll leave New Orleans with expanded knowledge, deeper insights, and a larger network that can help you drive organizational and professional success.

Topics include:

• Name, Image and Likeness (NIL) in College Athletics
• A nimal Research
• Patient Rights
• Conflict of Interest
• Data Security
• Minors on Campus
• Investigations
• Risk Assessments
• AI and Machine Learning

Who has attended?

• Compliance and ethics officers
• Academic compliance managers
• Title IX compliance officers
• IT compliance directors and managers
• CFOs, accountants, and others in finance
• Internal auditors
• University privacy officers
• General counsel
• Audit professionals
• Research administrators
• Healthcare executives

All conference sessions are organized by knowledge level: basic, intermediate, and advanced. These levels are a guideline to help you find sessions most relevant to your role; you are welcome to attend sessions of any level.

Attendees will have the opportunity to earn continuing education units for participating. Compliance Certification Board® (CCB)® exams will be offered on-site on June 13. A separate application and registration fee apply.

Explore New Orleans! Arrive early or extend your stay to take advantage of all that New Orleans has to offer. View the city’s Visitors Guide for a list of ideas and make your plans today!

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About Research Compliance Quarterly

The Office for Research Compliance publishes the Research Compliance Quarterly to keep researchers and research staff informed about important compliance updates. Subscribe to the Research Compliance Quarterly for announcements, changes to policies and procedures, and updates to the Kuali Protocols system.

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Please note: Due to internal or external URL updates after original dates of publication, links or attachments may no longer redirect to original content. If you need assistance locating content, you may email the ORC at researchcompliance@iu.edu .

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Research Compliance

NJIT is committed to conducting research in compliance with established federal, state and regional regulations, policies and procedures.

The Research Compliance unit in the central office helps to ensure that all research activities undertaken by faculty, staff, and students at NJIT are conducted ethically and in compliance with federal, state, local, and institute regulations and policies. It also serves as a resource for the NJIT research community for regulatory analysis and interpretation, policy development, and training and education. This unit has oversight and responsibility over the following areas::

• Responsible Conduct of Research
• Human Subjects Research via IRB
• Biosafety : Recombinant DNA, BSL-3 Pathogens, Select Agents, Biohazards, Radioactive Materials, Radiation-Producing Devices, Lasers
• Care and Use of Animals in Research  (through Rutgers University-Newark Institutional Animal Care and Use Committee)
• Export Control in Research

Conflict of Interest and Outside Activities in Research

Misconduct in Research

• Federal Information Security Management Act

Responsible Conduct of Research (RCR)

All NJIT employees including students, staff, post-docs, research associates, faculty and collaborators are expected to be in compliance with NJIT and federal requirements with respect to responsible conduct of research. This training is available via the   CITI (Collaborative Institutional Training Initiative) .

Human Subjects   or associated data can only be used for research purposes after required review and institutional approval in compliance with federal requirements. Under a Federal wide Assurance with the United States Department of Health and Human Services, all research involving human subjects performed by NJIT faculty, staff, and students either on-campus or off-campus, including at other institutions, must be reviewed and approved prior to initiation by the NJIT  Institutional Review Board (IRB) .

A complete review and approval from the   Institutional Biosafety Committee (IBC)  is required for all research activities and protocols dealing with live cells, tissues, any environmental release of genetically engineered organisms, human gene therapy, and any laboratory- or greenhouse-contained experiments. The IBC also has the responsibility of reviewing a variety of experimentation that involves hazardous biological materials (e.g., human bodily fluids, cell lines, infectious agents) and other potentially hazardous agents (e.g., carcinogens). The IBC is a federally mandated review body established under the NIH Guidelines for Research Involving Recombinant DNA Molecules to provide local review and oversight of nearly all forms of research utilizing recombinant DNA.

NJIT relies on the Rutgers-Newark IACUC for review and approval of vertebrate animal research conducted by NJIT researchers in order to ensure compliance with all regulations, policies and standards that protect animal welfare.  NJIT researchers contemplating the use of animals in their research or in the early stages of preparing to use animals in their research should contact Dr. Raju Tamot ( [email protected] ), Assistant Director, Research Compliance and Integrity, and Dr. Eric Hetherington ( [email protected] ), Executive Director in the NJIT Office of Research. 

Export Control regulations are federal laws that govern the export, shipment, transmission, transfer, or sharing from the U.S. to foreign countries, persons, or entities of technology, technical data, technical assistance, and items or materials. The U.S. Department of State and the U.S. Department of Commerce each administers different export control regulations. Additionally, U.S. government sanctions restrict travel to, and financial transactions with, certain countries, individuals, and organizations, including certain foreign universities and research institutes. NJIT is committed to complying with applicable U.S. laws and regulations pertaining to exports of items, services and technology by or on behalf of the University and the Office of Research collaborates with other university offices, such as the Office of the General Counsel, to identify and manage export risks for national security and foreign policy reasons.

NJIT follows several federal, state, and University guidelines that govern the disclosure of an outside activity, relationship, or interest, and the management of personal conflict of interest (COI) and conflict of commitments (COC) in research. The Committee on Conflict of Interest is charged with identifying and addressing any potential, actual, and apparent conflicts of interest in research that result from related external interests. The Office of Research supports the Committee while working collaboratively with the NJIT community to manage, reduce, or eliminate any identified potential, actual, or perceived conflicts of interest. Every NJIT researcher must disclose and certify through Streamlyne, all professional activities outside of NJIT and any financial interests in outside entities that the researcher, and his/her immediate family members may have that are related or have the appearance of affecting, the researcher's professional judgment in exercising any university duty or responsibility.

Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. All individuals affiliated with NJIT have an ethical responsibility to foster an environment that promotes intellectual honesty and integrity as well as act if they suspect research misconduct has occurred.

Many research compliance training courses including RCR training for required certification can be accessed online through the CITI (Collaborative Institutional Training Initiative) software programs.

NJIT faculty, student, post-docs, associates and staff can access the CITI software programs and courses through the website  www.citiprogram.org .

Please register online through the website  www.citiprogram.org  and select  “New Jersey Institute of Technology” to set-up your account. Once your account is registered, you will be able to select and go through the specific courses in research compliance.

Streamlyne for Research Compliance

The Office of Research is developing the functionality of  Streamlyne , an electronic research administration software, to serve as a dynamic content management system that will aid in the oversight of NJIT’s compliance related needs. As of July 2020, Streamlyne is used for both IRB and COI administration.

FISMA - Federal Information Security Management Act What is FISMA:

The United States Federal Information Security Management Act (FISMA) defines a framework, standards, and guidelines to protect United States Government (USG) sensitive information. FISMA applies to the university research community, state agencies, entities and service providers including those who use data provided by the federal government.  Universities that have contracts with the US government need to comply with FISMA if the data is regulated.  Any noncompliance can reduce federal funding or incur other penalties.

FISMA Compliance:

FISMA defines roles and responsibilities for all agencies and related entities to protect sensitive information from compromise and ensure that compliance requirements of the federal government are met.  Specifically, FISMA requires entities and program officials to perform annual reviews of information security programs. FISMA compliance follows the guidelines and best practices laid out by the National Standards for Information Technology (NIST) standards.  

• NJIT’s Office of Research provides institutional support and services to the research community. This includes pre-award services , post-award management , and research compliance . The Office of Research has experience with FISMA compliance and can provide assistance accordingly. It is the researchers’ responsibility to be aware of FISMA requirements and seek assistance and guidance.
• FISMA is administered by the Department of Homeland Security. Changes and updates can be found at https://www.dhs.gov/fisma . 
• Questions about FISMA should be directed to the assistant director of research compliance and integrity. https://research.njit.edu/contact . 

Regulatory Reference Federal Information Processing Standards:

• FISMA Implementation Project
• NIAID Data Security Standard Operating Procedure
• NIST Risk Management Framework
• FIPS PUB 199   
• FIPS PUB 200     
• NIST SP 800-171 Rev. 2
• NIST SP 800-60 Rev. 1
• NIST SP 800-37 Rev. 2
• NIST SP 800-39
• NIST SP 800-53A Rev.  5

New state privacy laws creating complicated patchwork of privacy obligations

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State privacy patchwork — where it began

2022-2024: state patchwork expands, the straw that broke the camel’s back maryland, minnesota, and vermont, handling the patchwork, federal regulation.

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Philip N. Yannella is a partner and co-chair of the privacy, security and data protection group at Blank Rome LLP. He has counseled and represented clients in a wide array of privacy and data security litigations. He is the author of "Cyber Litigation" (Thomson Reuters 2021). He can be reached at [email protected]. He is based in Philadelphia.

Tim Dickens is an associate in the privacy, security and data protection group at the firm. He regularly counsels organizations on compliance with domestic and international privacy and data security laws. He can be reached at [email protected]. He is based in Philadelphia.

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Pew Research Center revises report about 'racial conspiracy theories' after backlash

The Pew Research Center has revised a report after it received criticism for saying a majority of Black Americans believe “racial conspiracy theories” about U.S. institutions. 

In the report released June 10 titled “Most Black Americans Believe Racial Conspiracy Theories About U.S. Institutions,” Pew detailed “the suspicions that Black adults might have about the actions of U.S. institutions based on their personal and collective historical experiences with racial discrimination.” Survey respondents highlighted issues such as discrimination in the medical field, incarceration, and guns and drugs in Black communities. 

The report’s initial title prompted swift backlash from critics who said “racial conspiracy theories” implied that Black Americans’ distrust of U.S. institutions is irrational and without historical context. The report made brief mention of the Tuskegee syphilis experiment , a medical scandal that fueled distrust in medical institutions. 

JustLeadershipUSA, a social justice organization, was one of the most vocal critics of the  report, calling it “ shockingly offensive ” for labeling Black Americans’ distrust over well-substantiated discrimination as conspiracy theories.

Two days later, Pew officials marked the report as being under revision and acknowledged that using the phrase “racial conspiracy theories” was not the best choice. 

“The comments were so thoughtful,” Neha Sahgal, vice president of research at Pew Research Center, said of the criticism. Sahgal said leaders at Pew “paid attention to what people were trying to tell us.”

“Upon reflection, we felt that this editorial shorthand detracted from the findings of this report, which we maintain are hugely important at this time in our country,” Sahgal said. “We have since revised the report. We have taken accountability for using a shorthand that was inappropriate.”

Pew released the revised report Saturday with a new title: “ Most Black Americans Believe U.S. Institutions Were Designed To Hold Black People Back .” The updated report includes a new headline, additional context and direct quotes from respondents.

“This is very important and an excellent update to correct those errors in the original version,” DeAnna Hoskins, president of JustLeadershipUSA, said. “But why didn’t you do that from the beginning?”

Before Pew’s acknowledgement and revisions, one person wrote in a post on X : “This new Pew report on Black belief in ‘conspiracy theories’ is interesting, but I take issue with the ‘CT’ label bc of how it lumps in well-substantiated truths alongside bunk like Q*Anon and flat earth.”

There are well-documented episodes of discrimination and targeting throughout the nation’s history, from the Tuskegee experiment to exclusion of Black Americans from New Deal programs and government targeting of civil rights and Black Power leaders under COINTELPRO .

“We have to ask: Why would the people at the Pew Research Center call the opinion of the vast majority of Black Americans—which is rooted in facts, history, and lived experience—a ‘conspiracy theory,’ when it is actually a reality?” Hoskins wrote in a statement on the organization’s website. 

In an interview with NBC News, Hoskins said  it was irresponsible of Pew to equate Black people’s concerns with conspiracy theories at such a politically turbulent time in the country.

“We’re talking about election fraud, we’re talking about QAnon — you were throwing us into that,” Hoskins said of Pew. 

The report states that most Black Americans believe U.S. institutions fall short “when it comes to treating Black people fairly.” More than 60% of Black Americans surveyed cited prison, political and economic systems as just some of the institutions intentionally designed to “hold Black people back, either a great deal or a fair amount.”

“Black Americans’ mistrust of U.S. institutions is informed by history, from slavery to the implementation of Jim Crow laws in the South, to the rise of mass incarceration and more,” the updated report states. “Several studies show that racial disparities in income , wealth , education , imprisonment and health outcomes persist to this day.”

Char Adams is a reporter for NBC BLK who writes about race.

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• How Americans Get News on TikTok, X, Facebook and Instagram

X remains more of a news destination than other sites, but the vast majority of users on all four are seeing news-related content

Table of contents.

• How people get news on TikTok
• Views about news on TikTok
• How people get news on X
• Views about news on X
• How people get news on Facebook
• Views about news on Facebook
• How people get news on Instagram
• Views about news on Instagram
• Acknowledgments
• The American Trends Panel survey methodology

The Pew-Knight Initiative supports new research on how Americans absorb civic information, form beliefs and identities, and engage in their communities.

Pew Research Center is a nonpartisan, nonadvocacy fact tank that informs the public about the issues, attitudes and trends shaping the world. Knight Foundation is a social investor committed to supporting informed and engaged communities. Learn more >

Pew Research Center conducted this study to understand how TikTok users, X (formerly Twitter) users, Instagram users and Facebook users experience news on these platforms. For this analysis, we surveyed 10,287 adult internet users in the United States from March 18 to 24, 2024.

Everyone who took part in the survey is a member of the Center’s American Trends Panel (ATP), an online survey panel that is recruited through national, random sampling of residential addresses. This way, nearly all U.S. adults have a chance of selection. The survey was weighted by combining the sample of internet users with data from ATP members who do not use the internet, and weighting the combined dataset to be representative of all U.S. adults by gender, race, ethnicity, partisan affiliation, education and other categories. The analysis in this report is based on those who use the platforms of interest. For more about how this was done, refer to the survey methodology . Read more about the ATP’s methodology .

Here are the questions used for this report , along with responses, and the survey methodology .

This is a Pew Research Center report from the Pew-Knight Initiative, a research program funded jointly by The Pew Charitable Trusts and the John S. and James L. Knight Foundation. Find related reports online at https://www.pewresearch.org/pew-knight/ .

Social media platforms are an important part of the American news diet: Half of U.S. adults say they get news at least sometimes from social media in general. But specific platforms differ widely in structure, content and culture. A new Pew Research Center survey finds that the ways in which Americans encounter news on four major platforms – TikTok, X, Facebook and Instagram – vary widely.

Key findings from this study include:

• Majorities of Facebook, Instagram and TikTok users say keeping up with news is not a reason they use the sites. X (formerly Twitter) is the exception to this pattern: Most X users say that keeping up with news is either a major or minor reason they use the platform, and about half say they regularly get news there.
• Still, people are seeing news on all four platforms, especially through opinion- or humor-based content. Majorities of users on all four sites say they see people expressing opinions about current events and funny posts that reference current events. On the whole, more people see these types of posts than news articles or breaking news, although many also see that type of content (particularly on X and Facebook).
• News on each platform comes from a variety of sources. Those who regularly get news on Facebook and Instagram are more likely than those on TikTok and X to get news from friends, family and acquaintances. More news consumers get news from influencers or other people they don’t know personally on TikTok than on other platforms. And news outlets or journalists are a more common source of news on X than on any other site.
• Most news consumers on each of the platforms studied say they at least sometimes see news on the platform that seems inaccurate. This includes roughly a quarter or more on each site who say they extremely or fairly often see inaccurate news.
• In general, Democrats tend to be more skeptical than Republicans of the news they see on X, while the reverse is true on Facebook. Among those who regularly get news on X, for example, 42% of Democrats and independents who lean toward the Democratic Party say they often see news there that seems inaccurate, compared with 31% of Republicans and GOP leaners.

More about this project

This project was designed to understand how people’s experiences and views differ across social media sites and apps .

The survey covered four social media platforms : TikTok, X (formerly Twitter), Facebook and Instagram. Each platform’s questions were identical.

This report focuses on news on social media. To learn about how people engage with politics on these platforms, read the companion report .

These are some of the key findings from a new Pew Research Center survey of about 10,000 U.S. adults conducted in March 2024. This is one of two Pew Research Center reports on habits and attitudes on different social media platforms from the Pew-Knight Initiative, a research program funded jointly by The Pew Charitable Trusts and the John S. and James L. Knight Foundation.

The rest of this overview looks at these patterns and other comparisons of the four platforms in more detail. For a closer look at individual platforms, jump to chapters on TikTok , X (formerly Twitter) , Facebook and Instagram .

Aside from X, most users on each platform don’t regularly get news there, but large majorities encounter news in some form

News consumption is more common on some sites than others. A 2023 Pew Research Center survey found that Facebook outpaces all other social media sites as a news source for Americans, with 30% of U.S. adults saying they regularly get news there. Smaller shares regularly get news on Instagram (16%), TikTok (14%) or X (12%).

Some sites are more widely used in general than others. But there also are differences among users in the share who say they regularly get news on each site. According to a new Center survey, half of X users say they regularly get news there, compared with smaller shares on TikTok (40%), Facebook (37%) and Instagram (30%).

The new survey also asked users of each platform whether keeping up with the news is a major or minor reason they use the platform – or not a reason at all. X is the only platform on which a majority of users say that getting news is a reason they use it: Roughly two-thirds of X users (65%) say this is the case, including 25% who say keeping up with the news is a major reason they use X.

Fewer than half of TikTok, Facebook and Instagram users say that getting news is a major or minor reason they use the site. And just 15% of TikTok users, 7% of Facebook users and 8% of Instagram users say it’s a major reason.

People more frequently cite other reasons for using each platform. To read more about other reasons given for using each platform, read “How Americans Navigate Politics on TikTok, X, Facebook & Instagram.”

While a relatively small portion of users on these platforms say that getting news is a major reason they use them, far more on all platforms say they see news-related content there.

Opinions and humorous content related to news are common on all four platforms. Two-thirds or more of users on each site say they ever see people expressing opinions about current events or funny posts that reference current events. On Facebook, Instagram and TikTok, users are less likely to say they ever see news articles (whether posted, reposted, linked or screenshotted) or information about a breaking news event as it is happening. X is the only platform studied where at least three-quarters of users see all of these types of information.

Considering the four different types of news-related content asked about, a large majority of users on all the platforms say they ever see at least one of them. About eight-in-ten Instagram users see at least one of these types of news-related content (82%), as do 90% of TikTok users, 91% of Facebook users and 92% of X users.

X stands out as a place to see breaking news: 75% of users say they see information about breaking news in real time there, compared with smaller shares of users on Facebook (58%), TikTok (55%) and Instagram (44%).

X and Facebook users are the most likely to see news articles on each platform, with 79% of X users and 74% of Facebook users saying they do. Americans who use TikTok (57%) and Instagram (52%) are less likely to report seeing news articles.

Across sites, younger users are much more likely to see information about breaking news. On Instagram, for example, about half of users under 50 say they see breaking news about events as they’re happening (51%), compared with 29% of those 50 and older. And on X, where majorities of both age groups see breaking news on the platform, younger users are still more likely to than older users to see this (79% of users under 50 vs. 69% of those 50 and older).

What types of sources are Americans getting news from on social media sites?

Many questions on this survey were asked only of users who say they regularly get news on each site. The remainder of this overview looks through this lens to compare the experiences and opinions of these news consumers on TikTok, X, Facebook and Instagram.

Among those who regularly get news on each platform – also described as “news consumers” – the types of sources they get that news from differ from platform to platform.

Facebook news consumers are the most likely to say they’ve ever gotten news there from friends, family and acquaintances (85%). Most Instagram news consumers (72%) also say they have done this; friends and family are the most common news source for news consumers on both Facebook and Instagram. Americans who say they regularly get news on TikTok (48%) and X (26%) are much less likely to say they have gotten news there from friends, family and acquaintances. This is by far the least common source of information for X news consumers among the types of sources measured in the survey.  

Majorities of news consumers report getting news from news outlets or journalists on all four sites. X news consumers are the most likely to say this (80%), compared with about two-thirds of news consumers on Facebook (68%), TikTok (67%) and Instagram (65%) who say the same.

TikTok news consumers are more likely than those on other platforms to say they get news from influencers and celebrities, with about two-thirds (68%) saying they ever do this. A majority of those who regularly get news on Instagram (59%) say the same.

There are only modest differences across the platforms in the share who get news from advocacy or nonprofit organizations: Around half on each site say they do.

While over half of news consumers on all four sites say they ever get news from other people they don’t know personally (beyond those previously mentioned), those on TikTok (84%) and X (75%) are especially likely to say this. For TikTok news consumers, these types of accounts are the most common news source.

Some of these sources are more likely to be used by different groups regardless of what platform they are using. For example, Democratic news consumers on most sites are more likely than their Republican counterparts to get news from advocacy or nonprofit organizations.

Republicans more skeptical of information on Facebook, Democrats more skeptical toward X

Amid broader concerns about the accuracy of information on social media , most news consumers on each of the four major social media platforms studied say they at least sometimes see news on the platform that seems inaccurate. This includes roughly a quarter or more on each site who say they extremely or fairly often see inaccurate news.

News consumers on X (37%) and Facebook (33%) are the most likely to say they often see news that seems inaccurate.

Americans also largely see social media platforms as influencing which news stories they see there to at least some extent. 

About three-quarters of news consumers on Facebook (74%) and Instagram (72%) – both owned by Meta – say the platforms influence which news stories they see there at least some, including roughly three-in-ten who say the platforms have a lot of influence. On these sites, news consumers with a higher level of educational attainment are more likely to say the platforms influence which news stories they see.

Roughly two-thirds of X news consumers (66%) and 61% of TikTok news consumers say the sites influence what they are seeing at least somewhat.

Although users maintain some level of control by deciding whom they follow on each site, computer algorithms also impact users’ feeds on many social media platforms, and technology companies have a variety of policies on how they moderate content such as false information and violent imagery . Some sites allow users to  modify their settings , though previous Center research has found that very few Americans feel like they have a lot of control over what they see online .

There are notable party divides in views toward the information on some platforms. Democrats who get news on X (including those who lean Democratic) are more likely than their Republican and GOP-leaning counterparts to say they extremely or fairly often see inaccurate news there (42% vs. 31%).

Democratic news consumers on X also are far more likely than their Republican counterparts to say X influences which news stories they see at least some (80% vs. 55%).

On Facebook, the reverse is true, with 38% of Republican Facebook news consumers saying they often see inaccurate news, compared with 29% of Democratic Facebook news consumers. Republican news consumers on Facebook also are more likely than Democratic news consumers on the site to say they think Facebook influences which news stories they see there at least some (80% vs. 68%).

There is little to no partisan difference in views toward Instagram and TikTok by these two measures.

How unique is the news seen on social media sites?

The survey asked Americans who say they regularly get news on each site whether they think the news they get there is mostly news they would have gotten elsewhere, or whether it’s news they only would have found on that site.

News consumers on TikTok (35%) and X (29%) are the most likely to say that the news they get on those sites is unique – i.e., news they would not have seen elsewhere.

Smaller shares of news consumers on Instagram (21%) and Facebook (14%) hold this view. It’s more common for Instagram and Facebook news consumers to say that the news they see is mostly news they would have gotten elsewhere (34% and 36%, respectively).

On each of the four sites, about four-in-ten or more news consumers say that the news they see is an even mix of news they would have gotten elsewhere and news they would not have gotten elsewhere.

Most news consumers on Facebook, X and Instagram at least sometimes feel worn out by the news they see

More than half of news consumers on three of the four sites studied at least sometimes feel worn out by the amount of news they see on these sites. This includes roughly one-in-five news consumers on Facebook (23%), X (20%) and Instagram (17%) who say they extremely or fairly often feel this way.

TikTok news consumers are somewhat less likely to often (11%) or sometimes (36%) feel worn out by the news they see on TikTok.

Democrats who regularly get news on X report often feeling worn out by the news there at a much higher rate than Republican news consumers on the platform (31% vs. 11%).

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How Americans Navigate Politics on TikTok, X, Facebook and Instagram

Many americans find value in getting news on social media, but concerns about inaccuracy have risen, social media and news fact sheet, social media seen as mostly good for democracy across many nations, but u.s. is a major outlier, the role of alternative social media in the news and information environment, most popular, report materials.

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