Payments to Study Participants: Experts Discuss Potential Framework
Members of the Petrie-Flom Center's collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center at Harvard Medical School today published a new article addressing longstanding ethical and regulatory concerns about paying people to participate in clinical trials. The article, which reflects input from a diverse expert working group held at Harvard Law School in 2016, will help researchers and ethics boards navigate the regulatory and ethical boundaries of paying research participants.
From the RAPS article:
A group of researchers are proposing a framework for evaluating payments to reimburse, compensate and incentivize volunteers to participate in clinical trials and other studies involving human subjects.
The framework, detailed in an article in the New England Journal of Medicine last week, describes what investigators and institutional review boards (IRBs) should consider when proposing or reviewing payment offers with the aim of dispelling some of the confusion surrounding paying research participants.
While US regulations covering human-subjects research do not specifically discuss payment, they require IRBs to "minimize the possibility of coercion or undue influence" during the consent process and regulatory guidance from both the Office for Human Research protections (OHRP) and the US Food and Drug Administration (FDA) associate payments with the potential for undue influence.
Read the RAPS article here and the featured NEJM article here!
Read the full article
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bioethics clinical research fda health law policy holly fernandez lynch human subjects research i. glenn cohen regulation research