Dear DIA Bioethics Community,
Our next webinar will take place on September 27 from 11:00 a.m. – 12:00 p.m. EST.
For this event, we are excited to host Barbara Bierer and Luke Gelinas (see bios below) as they share with us an ethical framework for addressing
issues related to payments to clinical trial participants. A more detailed
description of the session can also be found below.
You must register in advance via this link. After registering, you will receive a confirmation email containing information about joining the meeting.
Please join us for what is certain to be an engaging discussion on a topic of great interest!
On behalf of the DIA Bioethics Community Leadership Team,
Karla Childers
Payment for trial participation: An ethical framework to address contested issues
Despite being a common practice, payment for research participation
continues to cause ethical and regulatory uncertainty. Debate persists over foundational issues such as how best to construe the concern about payment found in US regulatory guidance (e.g., as ‘undue influence’ or ‘coercion’) and on what grounds payment may be offered (e.g., merely as reimbursement for out-of-pocket expenses, as compensation for participant time, or for other reasons), as well as over the details of payment plans, such as how to set reasonable payment amounts, the
timing of payment, and completion bonuses.
In this webinar, we seek to clarify some of these issues by (1) describing the regulatory concern with payment as rooted in its putative potential to distort decision-making and compromise informed consent; (2) advancing a framework that distinguishes three legitimate bases for payment (reimbursement for expenses; compensation for time and burdens; recruitment incentive); and (3) addressing common questions about payment in light of this framework. Along the way, we argue that payment for research participation is supported by considerations of justice and has a crucial role to play in overcoming common obstacles to participation and increasing diversity in clinical trials.
Barbara E. Bierer, MD, Professor of Medicine, Harvard Medical School, Brigham and Women’s Hospital
Barbara E. Bierer, M.D., a hematologist-oncologist, is Professor of Medicine at Harvard Medical School (HMS) and the Brigham and Women’s Hospital (BWH). Dr. Bierer co-founded and now leads the Multi-Regional Clinical Trials Center of BWH and Harvard (MRCT Center), a collaborative effort to improve standards for the planning and conduct of international clinical trials. In this capacity, she works with regulators, pharmaceutical
companies, CROs, academia and patients/patient advocates to harmonize policies and approaches for multisite, transnational trials. She is a
co-founder of COVID-19 Collaboration Platform and of the non-profit Vivli, a global clinical research data sharing platform. She is also the Director of the Regulatory Foundations, Ethics, and Law program at the Harvard Catalyst, and Director of Regulatory Policy for SMART IRB. She serves as Faculty in the Center for Bioethics, HMS, and Affiliate Faculty in the Petrie-Flom Center for Health Law at Harvard Law School. From 2003 – 2014, Dr. Bierer served as Senior Vice-President, Research, BWH where she founded the Brigham Research Institute and the Brigham Innovation Hub. She is a
past chair of SACHRP and has served or serves on the Board of Directors of
AAHRPP, PRIMR, MSH, Vivli, North Star IRB, and the Edward P. Evans Foundation. She has authored over 250 publications.
LUKE GELINAS, Chairperson at Advarra IRB, Senior Advisor, MRCT Center
Dr. Gelinas is a Chairperson at Advarra IRB where he provides analysis and guidance on complex ethical issues arising in the course of clinical research study design and human participant protection. He holds a Ph.D. in Philosophy with a concentration in Ethics from the University of Toronto and an M.A. in Religion, summa cum laude, from Yale Divinity School.
From 2015-2018, Dr. Gelinas was Senior Researcher at Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. There he led collaborative and multi-stakeholder projects addressing foundational and practical issues in research ethics, including projects on the ethical issues implicated in the use of social media for research recruitment, clinical trial priority-setting, and the ethical and regulatory parameters of paying research participants.
Between 2012-2015, Dr. Gelinas completed a Postdoctoral Fellowship in the Department of Bioethics at the Clinical Center, National Institutes of Health, as well as subsequent training in clinical ethics consultation at Alden March Bioethics Institute.
Dr. Gelinas’ written work has appeared in leading medical and bioethics journals, including New England Journal of Medicine, Hastings Center Report, and Journal of Medical Ethics. He frequently lectures and consults on various issues in research ethics and human participant protection.
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https://diaglobal.zoom.us/meeting/register/tJAsc-2urjMjHdZUWME8TpbWEhjd7AZA31H_