Federal interpretation and enforcement of protections for vulnerable participants in human research

REGULATIONS AND POLICIES GOVERNING research, codes of ethics, and the research ethics literature reflect the need to provide special protections to vulnerable research participants. Nevertheless, there is disagreement about who is vulnerable and why, what protections are appropriate, and when to disallow research involving vulnerable persons. The Common Rule (CR) governs much of the human research conducted in the United States and the Office for Human Research Protections (OHRP) oversees much of this research. The CR requires special protections for pregnant women, fetuses, neonates, prisoners, and children. Although it also requires that researchers employ "additional safeguards" to protect other vulnerable persons, it does not define vulnerability or identify appropriate "safeguards." Very little is known about how OHRP interprets the "additional safeguards" requirement. We examined all letters of determination posted on the OHRP website between July 1, 2000 and December 31, 2006 (n = 636) to study the extent to which OHRP addressed, in its audits and investigations, the requirement to protect vulnerable persons. The letters did not reveal guidance on understanding vulnerability, determining whether a study includes vulnerable persons or protecting vulnerable participants. If institutions and investigators are to fulfill the ethical obligation to provide appropriate safeguards when conducting research on vulnerable persons, they must develop and implement mechanisms to identify and address vulnerability.