In a new episode of the Rethinking Clinical Trials Podcast, Pearl O’Rourke and Dave Wendler discuss their recent publication, “Disentangling Informing Participants From Obtaining Their Consent.”
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O’Rourke and Wendler noted that IRBs will often assume nothing needs to be communicated to participants in trials that have a waiver of informed consent. But research and research oversight is poorly understood by the public, an issue compounded by a lack of transparency.
“For any research going forward, it would be information out. Even if you think about just a general notification: ‘We do research at this institution, your information may be used.’ That’s what we do. Why aren’t we telling people that?” O’Rourke said.
In the article, O’Rourke and Wendler outlined 6 goals that the research community can advance by informing participants. These include respect for persons, participant understanding of the research, and trust and trustworthiness.
O’Rourke, now retired, was the director of human research affairs at Partners HealthCare Systems in Boston and an associate professor of pediatrics at Harvard. She currently serves as cochair of the NIH Collaboratory’s Ethics and Regulatory Core. Wendler is the head of the Section on Research Ethics at the NIH Clinical Center.
This Friday’s PCT Grand Rounds will feature the next installment of our special series, Ethical & Regulatory Dimensions of Pragmatic Clinical Trials. Pearl O’Rourke, Dave Wendler, Miguel Vazquez, and Michael Ho will present