This symposium brought together a variety of experts to discuss key ethical and legal questions regarding offers of payment to research participants. Panels covered:

• Why payment is offered to research participants
• Regulatory parameters governing payment
• Whether payment to research participants should be considered exceptional, compared to payment in other contexts
• How offers of payment affect participants
• How to define coercion and undue influence with regard to paying research participants
• Which factors should be considered when evaluating proposed payments
• The problem of low payment

This event was free and open to the public.

Agenda

8:00 – 8:30am, Registration

8:30 – 8:40am, Welcome Remarks – Motivation, Open Questions, and Goals

• 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
• 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?

• Elizabeth Ripley, VCU Medical Center – What do we know about payments to research participants?
• Christine Grady, National Institutes of Health Clinical Center, Department of Bioethics – Models of conceptualizing payment
• Julie Kaneshiro, Office for Human Research Protections, U. S. Department of Health and Human Services – Federal regulations and guidance
• 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
• 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?

• Alexander Capron, USC Gould School of Law – For: Paying research subjects raises unique ethical issues
• Neal Dickert, Emory University School of Medicine – Against: Paying research subjects is similar to payment in other contexts
• Carl Elliott, Center for Bioethics, University of Minnesota – Response and Discussion
• 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?

• Jesse Ripton, Director of IRB Operations, Committee on Clinical Investigation, Beth Israel Deaconess Medical Center – What do IRBs worry about?
• Scott Halpern, Perelman School of Medicine, University of Pennsylvania – What does the data show about the influence of payment on participant perceptions and behaviors?
• 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?
• Conor O’Brien, Brigham and Women’s Hospital – What can we learn from the experience of healthy-participants?
• 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?

• 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

• 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
• 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

Slide Presentations

• Barbara Bierer and Holly Fernandez Lynch, “Introduction: Paying Research Participants: Ethical and Regulatory Parameters”
• Alexander Capron, “Paying Research Subjects Raises Unique Ethical Issues”
• Neal Dickert, “Paying Research Subjects Is Nothing (Really) Special”
• Christine Grady, “Models of conceptualizing payment”
• Scott Halpern, “What Do the Data Show about the Influence of Payment on Participant Perceptions and Behaviors?”
• Julie Kaneshiro, “Paying Research Subjects: Regulatory Perspective”
• Alex John London, “2016 CIOMS International Ethical Guidelines for Health-Related Research Involving Humans”
• Holly Fernandez Lynch and Emily Largent, “Paying Research Participants: Considerations at Both Ends of the Spectrum”
• Conor S. O’Brien, “What Can We Learn from the Experience of Healthy Participants?”
• Betsy Ripley, “What Do We Know about Payments to Research Participants?”
• Jessica Ripton, “Participant Compensation: What Do IRBs Worry about?”

Recording

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.