Ethics and Regulatory
Overview
Co-chairs:
The advent of pragmatic clinical trials that leverage electronic health records and use research methods such as cluster randomization promises to answer critical research questions with increased sample sizes at lower costs, and could greatly increase production of the evidence needed to improve healthcare. This research, which relies on data collected as part of routine clinical care and may evaluate similar treatments in comparative effectiveness studies, poses a unique set of regulatory and ethical challenges. The Ethics and Regulatory Core identifies areas of regulatory and ethical uncertainty and works with the NIH Collaboratory Trials to navigate regulatory and ethical complexities associated with pragmatic clinical trials conducted within healthcare systems.
Presentation
Kevin Weinfurt, PhD, Duke Clinical Research Institute, and Jeremy Sugarman, MD, MPH, MA, Johns Hopkins Berman Institute of Bioethics, discuss a study comparing alternative approaches to notification and authorization of participants in pragmatic trials evaluating common medical practices.
The Core is helping to develop approaches to the ethical design and conduct of pragmatic clinical trials that are in compliance with policies and regulations. Its activities supporting this work include the following:
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Address common areas of concern for pragmatic clinical trials, such as minimal risk criteria and informed consent requirements
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Liaise with regulatory and ethical oversight bodies, including institutional review boards (IRBs), the U.S. Food and Drug Administration, and the Office for Human Research Protections
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Conduct empirical research, when needed, to inform these issues
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Document experiences and lessons learned to serve as a guide for other entities engaging in research within healthcare systems
NIH Collaboratory Trial Ethics/Regulatory Discussions: Minutes and Supplementary Materials
The Core facilitates discussions on ethical and regulatory issues relevant to each of the NIH Collaboratory Trials. These discussions typically include representation from study principal investigators and study teams, members of the Collaboratory's Ethics and Regulatory Core, NIH staff, and Collaboratory Coordinating Center personnel, with additional input sometimes provided by representatives from the Office for Human Research Protections.
Areas of Focus
The Core convened groups of stakeholders to produce academic articles on a set of 11 ethical and regulatory issues related to the conduct of pragmatic clinical trials. The papers review the issues, and where possible, identify best practices and provide guidance for future pragmatic clinical trials. The following topics are addressed:
News and Interviews
- News_New Report Sets Out Posttrial Responsibilities in Pragmatic Clinical Trials
March 7, 2024: New Report Sets Out Posttrial Responsibilities in Pragmatic Clinical Trials
- News_Living Textbook Offers Pointers for Using an sIRB
January 25, 2024: Living Textbook Offers Pointers for Using an sIRB
- News_Ethics Consultation Documents Now Available for RAMP Trial
January 23, 2024: Ethics Consultation Documents Now Available for RAMP Trial
- News_Ethics Consultation Documents Now Available for AIM-CP and MOMs Chat & Care Study
January 16, 2024: Ethics Consultation Documents Now Available for AIM-CP and MOMs Chat & Care Study
- News_Ethics Consultation Documents Now Available for iPATH Trial
January 9, 2024: Ethics Consultation Documents Now Available for iPATH Trial
- News_Ethics Consultation Documents Now Available for ARBOR-Telehealth and I CAN DO Surgical ACP
December 18, 2023: Ethics Consultation Documents Now Available for ARBOR-Telehealth and I CAN DO Surgical ACP
- News_A Year of New Insights From the NIH Pragmatic Trials Collaboratory
December 12, 2023: A Year of New Insights From the NIH Pragmatic Trials Collaboratory
- News_New Chapter of Living Textbook Explores Ethical Considerations for Artificial Intelligence and Machine Learning in Pragmatic Clinical Trials
November 13, 2023: New Chapter of Living Textbook Explores Ethical Considerations for Artificial Intelligence and Machine Learning in Pragmatic Clinical Trials
- News_Ethics Consultation Documents Now Available for BEST-ICU, Chat 4 Heart Health, and TAICHIKNEE
October 10, 2023: Ethics Consultation Documents Now Available for BEST-ICU, Chat 4 Heart Health, and TAICHIKNEE
- News_FDA’s Robert Califf and Coauthors Assert More Is Needed to Achieve Learning Health Care
August 31, 2023: FDA’s Robert Califf and Coauthors Assert More Is Needed to Achieve Learning Health Care
Products and Publications
- Morain et al Learn Health Syst 2024
Post-trial responsibilities in pragmatic clinical trials: Fulfilling the promise of research to drive real-world change
- Morain and Largent Am J Bioeth 2023
MOTIFS Publication: Think pragmatically: investigators' obligations to patient-subjects when research is embedded in care
- Morain et al Learn Health Syst 2023
Stakeholder perspectives on data sharing from pragmatic clinical trials: Unanticipated challenges for meeting emerging requirements
- Garland et al Am J Bioeth 2022
Do clinicians have a duty to participate in pragmatic clinical trials?
- Living Textbook Chapter_Collateral Findings
Living Textbook Chapter: Collateral Findings
- Living Textbook Chapter_Consent, Waiver of Consent, and Notification
Living Textbook Chapter: Consent, Waiver of Consent, and Notification
- Living Textbook Chapter_Identifying Those Engaged in Research
Living Textbook Chapter: Identifying Those Engaged in Research
- Living Textbook Chapter_Privacy Considerations
Living Textbook Chapter: Privacy Considerations
- Morain et al Clin Trials 2022
Ethics challenges in sharing data from pragmatic clinical trials
- Morain et al Hastings Cent Rep 2022
Toward meeting the obligation of respect for persons in pragmatic clinical trials
- Spector-Bagdady et al Am J Bioeth 2022
Promoting ethical deployment of artificial intelligence and machine learning in healthcare
- Morain and Largent Am J Bioeth 2022
MOTIFS Publication: Think pragmatically: investigators' obligations to patient-subjects when research is embedded in care
- Federico et al Contemp Clin Trials 2022
Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials
- Ali et al Contemp Clin Trials 2022
Responding to signals of mental and behavioral health risk in pragmatic clinical trials: ethical obligations in a healthcare ecosystem
- Sandy et al Medicine (Baltimore) 2021
Leave me out: patients' characteristics and reasons for opting out of a pragmatic clinical trial involving medication adherence
- Garland et al Clin Trials 2021
Incentives and payments in pragmatic clinical trials: scientific, ethical, and policy considerations
- Morain et al Healthc (Amst) 2021
MOTIFS Publication: Identification and management of pragmatic clinical trial collateral findings: A current understanding and directions for future research
- Weinfurt et al J Gen Intern Med 2021
MOTIFS Publication: Patients' reactions to letters communicating collateral findings of pragmatic clinical trials: a national web-based survey
- PCT Data Monitoring Committees-Points to Consider
Data Monitoring in PCTs-Points to Consider
- Early Stopping in Pragmatic Clinical Trials - Workshop Summary
Early Stopping in Pragmatic Clinical Trials: Workshop Summary
- Roberts et al Ethics Hum Res 2020
Ethical and regulatory concerns in pragmatic clinical trial monitoring and oversight
- Morain et al Learn Health Syst 2020
MOTIFS Publication: Stakeholder perspectives regarding pragmatic clinical trial collateral findings
- Yang et al Stat Med 2020
Diversity Supplement Publication: Sample size requirements for detecting treatment effect heterogeneity in cluster randomized trials
- Bollinger et al J Gen Intern Med 2020
MOTIFS Publication: Patients' views about the disclosure of collateral findings in pragmatic clinical trials: a focus group study
- Sugarman and Carrithers Learn Health Syst 2020
Certificates of confidentiality and unexpected complications for pragmatic clinical trials
- Engagement in Research for PCTs-2020-03-30
Engagement in Research for Pragmatic Clinical Trials
- Morain et al Am J Bioeth 2020b
MOTIFS Publication: Response to open peer commentaries on 'Ethics and collateral findings in pragmatic clinical trials'
- Morain et al Am J Bioeth 2020a
MOTIFS Publication: Ethics and collateral findings in pragmatic clinical trials
- Starks et al PLoS One 2019
Diversity Supplement Publication: Assessing heterogeneity of treatment effect analyses in health-related cluster randomized trials: a systematic review
- Weinfurt et al Clin Trials 2019
Empirical Ethics Supplement Publication: Public views regarding the responsibility of patients, clinicians, and institutions to participate in research in the United States
Presentations
- AcademyHealth D&I Workshop 2023_Ethics_Regulatory_Slides
AcademyHealth D&I Workshop 2023 - Ethics & Regulatory
- 2023 AcademyHealth Workshop_Day 2_Morain
Ethical and Regulatory Oversight Considerations
- 2023 NIH Workshop_Panel 3_O'Rourke
2023 NIH Workshop Panel 3: O'Rourke
- IMPACT Annual Meeting Breakout Session_Data Safety Monitoring Final 3.28.22
Data Monitoring for PCTs
- SC-Mtg-2023-Day2-Morain-HEAL Bioethics
Stephanie Morain Presentation 2023 Steering Committee Meeting
- SC-Mtg-2023-Day2-O'Rourke
Pearl O'Rourke Presentation 2023 Steering Committee Meeting
- GR-Video-02-10-23
Informing and Consenting: What Are the Goals? (GR Video 2023)
- GR-Slides-02-10-23
Informing and Consenting: What Are the Goals? (GR Slides 2023)
- GR-Video-01-13-23
Ethical Considerations When Vulnerable Populations are Subjects in Pragmatic Trials (GR Video 2023)
- GR-Slides-01-13-23
Ethical Considerations When Vulnerable Populations are Subjects in Pragmatic Trials (GR Slides 2023)
- GR-Video-12-09-22
The Stepped Wedge Cluster Randomized Trial: Friend or Foe? (GR Video 2022)
- GR-Slides-12-09-22
The Stepped Wedge Cluster Randomized Trial: Friend or Foe? (GR Slides 2022)
- GR-Video-11-11-22
Data Sharing and Pragmatic Clinical Trials: Law & Ethics Amidst a Changing Policy Landscape (GR Video 2022)
- GR-Slides-11-11-22
Data Sharing and Pragmatic Clinical Trials: Law & Ethics Amidst a Changing Policy Landscape (GR Slides 2022)
- GR-Video-10-14-22
Responding (or Not) to Signals of Potential Clinical Significance in Pragmatic Clinical Trials (GR Video 2022)
- GR-Slides-10-14-22
Responding (or Not) to Signals of Potential Clinical Significance in Pragmatic Clinical Trials (GR Slides 2022)
- Collab_Ethics-GR Flyer_05aug2022
Ethical and Regulatory Dimensions of Pragmatic Clinical Trials
- 2022 NIH Workshop_Panel 1
2022 NIH Workshop Panel 1 Presentation
- SC-Mtg-2022-Day-1-Sugarman
Dr. Sugarman's Presentation at 2022 Steering Committee Meeting
- SC-Mtg-2022-Day-2-Morain
Bioethics Supplement Activities Presentation at 2022 Steering Committee Meeting
- Managmement of Collateral Findings in PCTs (ASBH 2020)
Management of Collateral Findings in PCTs (ASBH 2020)
- GR-Video-04-06-18
Legal and Ethical Architecture for PCOR Data (GR Video 2018)
- Presentation_Ethics_PRIMER_2019_c
Management of Incidential Findings in PCTs (PRIM&R 2019)
- Presentation_Ethics_UMich_2018_c
Lingering and Emerging Ethical Issues for PCTs and Learning Health Systems (U Michigan 2018)
- Presentation_Ethics_ASBH_2018_c
Panel Presentation: Uncertain Times Call for Empirical Bioethics (ASBH 2018)
- Presentation_Ethics_SOCRA_2018_c
Rethinking Research and Research Ethics: PCTs (SOCRA 2018)
- Panel-5-Combined
A vs B Workshop Panel 5: Ethical and IRB Approaches for a Successful Embedded A vs. B Pragmatic Trials Moderator: David Wendler, PhD
- 8.-Adrian_Lesley_Ethics-Core_FINAL
NIH Collaboratory Regulatory and Ethics Core Lessons Learned
- GR-Slides-04-06-18
Legal and Ethical Architecture for PCOR Data (GR Slides 2018)
- Topic 5-Regulatory+Ethics
ePCT Workshop Topic 5: Regulatory and Ethics