‘The Ends Never Justify the Means’: Assuring Participant Safety a Team Effort

The “rights, safety and well-being of the participants are the most important considerations, and should prevail over the interest of science and society.” In other words, “the ends never justify the means.” These are the principles that should guide human subjects research, according to Currien MacDonald, M.D., chair of an institutional review board (IRB) at WCG Clinical.

In discussing the topic at a recent WCG webinar,[1] MacDonald began by explaining there are three components in research studies, and each plays a role in ensuring the safety of research participants—the study site, including investigators and institutions; the sponsor, perhaps in collaboration with a clinical research organization; and lastly, the institutional review board (IRB), research ethics board, if involved, an institutional biosafety committee, the Food and Drug Administration (FDA), and the HHS Office for Human Research Protections.

“The first responsibility of the sponsor is for ensuring that FDA and all participating investigators are promptly informed of significant new adverse events or risks with respect to the drug or important safety information,” said MacDonald, who also contributes to biosafety reviews for WCG’s institutional biosafety committee.

Second, “if the sponsor determines that its investigational drug presents an unreasonable and significant risk to subjects, [it] shall discontinue those investigations that present that risk…notify the FDA, all institutional review boards and all investigators…of this discontinuation,” he said.

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