The ANPRM’s Intersection with Boston College’s Oral History Study

Josh Glickenhaus, Swarthmore College senior and PRIM&R intern The U.S. Department of Health and Human Services recently released an Advance Notice of Proposed Rulemaking (ANPRM), which outlines major proposed changes to the ‘Common Rule’ regulations for human subjects research. The ANPRM proposes changes across a broad range of issues, including a proposal to excuse all survey/interview-based research from IRB review. Part of its justification for this move is the ANPRM’s creation of new standards for data security that would minimize the risk of informational breaches, which compose the main source of risk to subjects in such studies. But the document also implies that most research of this sort poses only minimal risk to subjects, and thus full IRB review to consider protections above and beyond the new data security standards would be unnecessary. The authors of the ANPRM then seek confirmation on this point, asking, “Are there survey instruments or specific types of questions that should be classified as greater than minimal risk?”This article in the Chronicle of Higher Education suggests that the answer is a resounding “yes.” It describes an oral history study conducted at Boston College that featured interviews with former members of the Provisional Irish Republican Army (PIRA), who discussed in frank detail their time as paramilitary fighters in Northern Ireland. Because of the highly sensitive nature of the matter—broad disclosure of the facts could endanger the interviewees—Boston College gave a confidentiality pledge not to disclose any of the research materials until after the subjects’ deaths. Now that pledge is in jeopardy, as the interview tapes have been subpoenaed by the U.S. Department of Justice on behalf of the British government. BC is currently fighting the subpoenas, arguing that its confidentiality pledge—and the consequences of breaking it—applies even to the Department of Justice. The outcome of the fight is yet to be determined in court.What do you think about this example of how interview-based research can present greater-than-minimal risk? How can IRBs mitigate such risks? Should future studies with high-stakes informational risks merit some degree of oversight beyond the routine data protections called for by the ANPRM? Please share your thoughts in our comments section.