REGISTER NOW (12/9)! Paying Research Participants: Ethical and Regulatory Parameters

Rolled up US paper banknote in a test tube rack representing the costs of medical research

Paying Research Participants: Ethical and Regulatory Parameters
December 9, 2016 8:00 AM – 12:30 PM
Milstein East ABC (2036), Wasserstein Hall
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Register for this event

Description

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

  • 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 is free and open to the public, but space is limited and registration is required. Register now!

Working Agenda

All sessions will include time for Audience Q & A.

8:00 – 8:30am, Registration

A continental breakfast will be provided.

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) – Pushing the Envelope: Defining Coercion and Undue Inducement, Establishing Relevant Factors for Consideration, and the Problem of Low Payment

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

Registration

This event is free and open to the public, but space is limited and registration is required. Register now!

This event is 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.