Paying Research Participants: Ethical and Regulatory Parameters
Couldn't make it to the event? Check out some of the speakers' slide presentations below!
Description
This symposium brought together a variety of experts to discuss key ethical and legal questions regarding offers of payment to research participants. Panels covered:
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Why payment is offered to research participants
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Regulatory parameters governing payment
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Whether payment to research participants should be considered exceptional, compared to payment in other contexts
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How offers of payment affect participants
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How to define coercion and undue influence with regard to paying research participants
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Which factors should be considered when evaluating proposed payments
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The problem of low payment
This event was free and open to the public.
Working Agenda
All sessions included time for Audience Q & A.
8:00 - 8:30am, Registration
8:30 - 8:40am, Welcome Remarks - Motivation, Open Questions, and Goals
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Barbara Bierer, Program Director of the Regulatory Foundations, Law and Ethics Program of Harvard Catalyst | the Harvard Clinical and Translational Science Center and Faculty Co-Director, the Multi-Regional Clinical Trials (MRCT) Center at Harvard and Brigham and Women's Hospital
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Holly Fernandez Lynch, Executive Director, the Petrie-Flom Center; Project Co-Lead, Regulatory Foundations, Law and Ethics Program of Harvard Catalyst | the Harvard Clinical and Translational Science Center; and Faculty, Center for Bioethics, Harvard Medical School
8:40 - 9:40am, Session 1: Why Do We Offer Payment to Research Participants, and What Are the Regulatory Parameters?
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Elizabeth Ripley, VCU Medical Center - What do we know about payments to research participants?
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Christine Grady, National Institutes of Health Clinical Center, Department of Bioethics - Models of conceptualizing payment
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Julie Kaneshiro, Office for Human Research Protections, U. S. Department of Health and Human Services - Federal regulations and guidance
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Alex John London, The Center for Ethics and Policy and the Department of Philosophy, Carnegie Mellon University - Proposed Revisions to the CIOMS International Ethical Guidelines for Biomedical Research on Human Subjects
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Moderator: I. Glenn Cohen, Professor, Harvard Law School; Faculty Director, the Petrie-Flom Center; Regulatory Foundations, Law and Ethics Program of Harvard Catalyst | the Harvard Clinical and Translational Science Center
9:40 - 10:40am, Session 2: Research Exceptionalism: Is Payment in Research Special?
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Alexander Capron, USC Gould School of Law - For: Paying research subjects raises unique ethical issues
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Neal Dickert, Emory University School of Medicine - Against: Paying research subjects is similar to payment in other contexts
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Carl Elliott, Center for Bioethics, University of Minnesota - Response and Discussion
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Moderator: Barbara Bierer, Program Director of the Regulatory Foundations, Law and Ethics Program of Harvard Catalyst | the Harvard Clinical and Translational Science Award and Faculty Co-Director, the Multi-Regional Clinical Trials (MRCT) Center at Harvard and Brigham and Women's Hospital
10:40 - 10:50am, Break
10:50 - 11:50am, Session 3: How Do Offers of Payment Affect Participants?
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Jesse Ripton, Director of IRB Operations, Committee on Clinical Investigation, Beth Israel Deaconess Medical Center - What do IRBs worry about?
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Scott Halpern, Perelman School of Medicine, University of Pennsylvania - What does the data show about the influence of payment on participant perceptions and behaviors?
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Elizabeth Cahn, Research Advocate, Dana Farber/Harvard Cancer Center Breast Cancer Advocacy Group and Program Coordinator, Cancer Connection, Inc., Northampton MA - What can we learn from the experience of patient-participants?
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Conor O'Brien, Brigham and Women's Hospital - What can we learn from the experience of healthy-participants?
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Moderator: Luke Gelinas, Fellow in Clinical Research Ethics, the Petrie-Flom Center; Regulatory Foundations, Law and Ethics Program of Harvard Catalyst | the Harvard Clinical and Translational Science Center
11:50am - 12:25pm, Session 4: Where Should We Go From Here?
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Holly Fernandez Lynch and Emily Largent, Petrie-Flom Center/Harvard Catalyst Associate (2015-2016) - Considering Payment from both Sides: Is Underpayment an Ethical Problem?
12:25 - 12:30pm, Concluding Remarks
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Barbara Bierer, Program Director of the Regulatory Foundations, Law and Ethics Program of Harvard Catalyst | the Harvard Clinical and Translational Science Award and Faculty Co-Director, the Multi-Regional Clinical Trials (MRCT) Center at Harvard and Brigham and Women's Hospital
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Holly Fernandez Lynch, Executive Director, the Petrie-Flom Center; Regulatory Foundations, Law and Ethics Program of Harvard Catalyst | the Harvard Clinical and Translational Science Center; and Faculty, Center for Bioethics, Harvard Medical School
Learn More
Slide Presentations
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Barbara Bierer and Holly Fernandez Lynch, "Introduction: Paying Research Participants: Ethical and Regulatory Parameters"
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Alexander Capron, "Paying Research Subjects Raises Unique Ethical Issues"
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Neal Dickert, "Paying Research Subjects Is Nothing (Really) Special"
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Christine Grady, "Models of conceptualizing payment"
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Scott Halpern, "What Do the Data Show about the Influence of Payment on Participant Perceptions and Behaviors?"
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Julie Kaneshiro, "Paying Research Subjects: Regulatory Perspective"
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Alex John London, "2016 CIOMS International Ethical Guidelines for Health-Related Research Involving Humans"
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Holly Fernandez Lynch and Emily Largent, "Paying Research Participants: Considerations at Both Ends of the Spectrum"
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Conor S. O'Brien, "What Can We Learn from the Experience of Healthy Participants?"
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Betsy Ripley, "What Do We Know about Payments to Research Participants?"
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Jessica Ripton, "Participant Compensation: What Do IRBs Worry about?"
This event was part of the collaboration between the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center at Harvard Medical School. Cosponsored by the MRCT Center of Brigham and Women's Hospital and Harvard.
Videos
VIDEO: Welcome Remarks, Barbara Bierer and Holly Fernandez Lynch
VIDEO: Session 1, Elizabeth Ripley, "What Do We Know about Payments to Research Participants?"
VIDEO: Session 1, Christine Grady, "Models of conceptualizing payment"
VIDEO: Session 1, Julie Kaneshiro, "Federal regulations and guidance"
VIDEO: Session 1, Audience Q&A moderated by I. Glenn Cohen
VIDEO: Session 2, Barbara Bierer, Introduction
VIDEO: Session 2, Alexander Capron, "For: Paying research subjects raises unique ethical issues"
VIDEO: Session 2, Carl Elliott, "Response and Discussion"
VIDEO: Session 2, Audience Q&A moderated by Barbara Bierer
VIDEO: Session 3, Jesse Ripton,"What do IRBs worry about?"
VIDEO: Session 3, Elizabeth Cahn, "What can we learn from the experience of patient-participants?"
VIDEO: Session 3, Conor O'Brien, "What can we learn from the experience of healthy-participants?"
VIDEO: Session 3, Audience Q&A moderated by Luke Gelinas
VIDEO: Session 4, Audience Q&A
VIDEO: Concluding Remarks, Barbara Bierer and Holly Fernandez Lynch
Tags
bioethics health law policy human subjects research regulation research funding