Paying Research Participants image

December 9, 2016 8:00 AM - 12:30 PM
Conferences
2016-2017
Milstein East ABC (2036), Wasserstein Hall
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

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, Alex John London, "2016 CIOMS International Ethical Guidelines for Health-Related Research Involving Humans"
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, Neal Dickert, "Against: Paying research subjects is similar to payment in other contexts"
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, Scott Halpern, "What does the data show about the influence of payment on participant perceptions and behaviors?"
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, Holly Fernandez Lynch and Emily Largent, "Considering Payment from both Sides: Is Underpayment an Ethical Problem?"
VIDEO: Session 4, Audience Q&A
VIDEO: Concluding Remarks, Barbara Bierer and Holly Fernandez Lynch

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: 

  • 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.

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

  • 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

Learn More

Slide Presentations

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, Alex John London, "2016 CIOMS International Ethical Guidelines for Health-Related Research Involving Humans"
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, Neal Dickert, "Against: Paying research subjects is similar to payment in other contexts"
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, Scott Halpern, "What does the data show about the influence of payment on participant perceptions and behaviors?"
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, Holly Fernandez Lynch and Emily Largent, "Considering Payment from both Sides: Is Underpayment an Ethical Problem?"
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