Protecting Vulnerable Populations in Clinical Trials

Protecting Vulnerable Populations in Clinical Trials

IRBs, Vulnerable Populations, Informed Consent & Ethical Conflict

Within IRB considerations, all human research must be conducted in a manner which adequately protects the rights and welfare of the participants. Any trial administered in a village in Central Africa would be subject to federal regulations as if the trial was being conducted within the United States. As such this trial would need to comply with the federal regulations that are designed to protect humans with regard to informed consent and other ethical issues.

Although the procedures normally followed in Central Africa might differ than those in the United States, IRB policy is to approve the research providing that there “the procedures prescribed by the [foreign] institution afford protections that are at least equivalent to those provided in this policy” (45 CFR 46.101, 2015). In such an event, the foreign country’s procedures may be used in substitution US federal procedures and policies. However, this approval must be made by the appropriate federal agency after reviewing the foreign procedures. This outcome is different when the research is being funded by federal sources. For example, all FDA funded research must comply with FDA and with DHHS standards (DHHS, 2015).

The real issue in a trial in Central Africa is whether the research company follows the established protocols outlined in 45 CFR 46.101 and 45 CFR 46.102 (45 CFR 46.101, 2015). Whether the company is a private or public IRB should not matter as both are subject to approval by IRB. Private, for profit companies, may be more prone to ethical conflicts due to the fact that they may take advantage of vulnerable citizens who do not have another means of getting drugs and do not understand individual rights and thereby lose informed consent. Although the FDA and IRB are meant to provide oversight in this manner it is difficult to determine if requirements of informed consent are actually being met.


45 CFR 46.101. (2015). To what does this policy apply? Retrieved from Cornell Law:

DHHS. (2015). INTERNATIONAL RESEARCH. Retrieved from Department of Health and Human Services:

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Triola Vincent. Mon, Feb 01, 2021. Protecting Vulnerable Populations in Clinical Trials Retrieved from

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