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.

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One thought on “The ANPRM’s Intersection with Boston College’s Oral History Study

  1. Zachary M. Schrag

    I am sorry to repeat a point I have already made in several fora, but IRB oversight offers uncertain protection from subpoenas. Researchers at UCLA's Civil Rights Project learned this in 2010, when the University of Arizona released data from their IRB-approved study without a fight.

    As the researchers explained in August 2010,

    "As we prepare to go to trial, the AZ lawyers have demanded that the researchers turn over all confidential information associated with the studies–names of districts, officials, and survey and interview respondents, classroom teachers who were observed, everything that was supposed to be protected by the Institutional Review Board process. The lawyers at the University of Arizona have turned over information identifying the districts and schools without a fight. The AZ lawyers also sent letters threatening the researchers with contempt of court if they did not divulge all of this information by 5pm on August 10, but noted if they decided not to testify there would be no problem and they would not have to divulge any names: a blatant attempt to get this research out of the trial by making the researchers choose between going to court and putting the districts and schools at risk (we are told the AZ Dept of Education is doing a witch hunt for anyone not "towing the line" in the state, and cutting budgets of those who don't), or backing down and not testifying. Of course, if they do not testify, not only will their critical research be discounted, but they will also have no opportunity to defend the integrity of their research from the slanderous descriptions of it by the AZ lawyers. To date, the researchers have received little or no support from their campus IRB, lawyers, or administration. This will obviously have a very chilling effect on education research conducted in that state, and in other states, if they can get away with this. And, of course, it also means that there will be no evidence presented on the egregious treatment of these ELL students."

    See http://civilrightsproject.ucla.edu/legal-developments/court-decisions/horne-v.-flores-statement-of-crp-directors-about-research-integrity

    If the federal government were serious about protecting research participants from subpoenas, it would offer researchers greater access to certificates of confidentiality or some other form of shield. IRB review does not offer researchers like those at Boston College a way to gather and preserve invaluable narratives without danger of forced disclosure.