By Stacey Kusterbeck
When conducting clinical trials involving vulnerable participants, researchers are ethically and legally obligated to protect them from harm. But what policies do academic institutions have for protecting vulnerable human research subjects? “The question is important and has not been studied systematically,” says David B. Resnik, JD, PhD, a bioethicist at the National Institutes of Health.
Resnik and colleagues analyzed policies for research with vulnerable populations at the 105 top-funded academic research institutions in the United States.1 Each institution had at least two policies. Most had eight or more. “We were surprised that there were so many different types of vulnerable subjects covered by the policies — 14 in all,” says Resnik.
Most institutions had policies that covered pregnant women, fetuses, neonates, children, and prisoners. All those populations are covered by the additional protections included in the Common Rule.2 Other vulnerable groups also were well-represented in policies. Institutions had policies for students and trainees; employees; people with impaired or questionable decision-making capacity; people with disabilities; and people with limited English proficiency, including illiteracy. “Researchers should familiarize themselves with their institutions’ policies concerning vulnerable research subjects and should implement additional protections for vulnerable subjects, where appropriate,” advises Resnik.
The research community must comply with numerous federal and state regulations governing research on vulnerable populations. “In consideration of these regulations, and from the ethical perspective, IRBs (Institutional Review Boards) evaluate research protocols for adequacy of protections from harm that may accrue to the participants,” says Edward Kuczynski, director of the Human Research Protection Program at University of California, San Francisco.
The requirements apply to all human research studies, even if researchers are not specifically attempting to recruit individuals from vulnerable populations. Typically, IRBs ask investigators if they will be recruiting vulnerable individuals. If so, the IRB reminds the researchers of the additional protections that are required. “Because many studies are not focused on these populations, researchers often specifically exclude them from participation. IRBs do encourage recruitment of a diverse participant population, however,” says Kuczynski. IRB members can offer guidance on how to comply with regulations while including vulnerable individuals. IRBs consider these questions when reviewing study protocols, says Kuczynski:
- Has the study team designed adequate methods to mitigate the risks of legal, reputational, and physical harm?
- Do study protocols include adequate referral processes to protect the vulnerable participants from immediate or short-term self-harm and to prevent harm to others?
- Are there processes in place for situations where a participant’s cognitive ability to provide informed consent is questionable? “Appropriate methods for assessing cognitive state, and engaging with a legally authorized representative, must be designed into the protocol,” says Kuczynski.
References
- Jonathan I, Akers E, Shi M, Resnik DB. Vulnerable research participant policies at U.S. academic institutions. J Empir Res Hum Res Ethics. 2024;19(4-5):220-225.
- 45 CFR 46
When conducting clinical trials involving vulnerable participants, researchers are ethically and legally obligated to protect them from harm. But what policies do academic institutions have for protecting vulnerable human research subjects?
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