A dark cloud lurks behind the silver lining of the recent federal proposal to overhaul rules covering institutional review boards (IRBs) and their oversight of research. While the proposal offers a tantalizing opportunity to free some history research from the ham-handed review of IRBs, it also raises a significant and substantial risk that large swaths of data could be closed to future historians under a new category of “information risk”—potentially even extending their restrictions into the archives.
The proposal recommends extending current federal guidelines for medical records (under the Health Insurance Portability and Accountability Act or HIPAA) to cover all information on research subjects. They mention the HIPAA guidelines 51 times, and clearly state that they want to establish “mandatory data security and information protection standards for all studies that involve identifiable or potentially identifiable data.” The particulars about how this might be implemented remain a bit vague. But the emphasis on “uniformity” in the application of these rules and tendency among IRBs to define their mandates broadly could impose the same standards of confidentiality on history research that currently apply to your medical records. To make matters worse, the responsibilities for administering these policies would also be handed over to a new and as yet undefined entity outside the IRBs. Based on the description in the proposal and practical experience with IRBs, it seems fair to assume that the new privacy boards would be heavily dominated by the interests of biomedical research and impose criteria entirely inappropriate to history research.
The proposal recommends that all work subject to IRB review (even in its mildest form, under a proposed new “Excused” category of research) should follow the HIPAA standards. Since those standards generally bar the reporting of any identifiable information about the research subject, any history work that seeks information on specific or particular experiences or events would become much more difficult. They also place substantial restrictions on anyone possessing identifiable research data, down to the passwords on computers holding “identifiable information.”
If these new restrictions were implemented in a uniform way to encompass all research subject to IRB review, they could extend even to archival research and effectively make those restrictions permanent. For a number of years now, former AHA Council member Linda Shopes has been warning that the rules could lead to regulations on archival research “simply because they deal with the activities of human beings.” The new proposal makes that possibility quite explicit, by encompassing “researchers’ use of pre-existing data (i.e. data that were previously collected for purposes other than the currently proposed research study)” and insists that a researcher acquire “written consent” if he or she “obtains information that identifies the subjects.” The proposal is not clear about whether consent agreements obtained by the original interviewer or host archive would be adequate for subsequent research, but the general tendency in these regulations to seek “one size fits all” solutions makes this deeply worrisome.
The proposal suggests at one point that they are “considering” only applying these rules prospectively, not retrospectively; but that would only address any immediate concerns for the discipline. It would still present a substantial problem for historians going forward. These rules could present a significant long-term danger for future historians trying to look back on the present, since the restrictions on information covered by the HIPAA rules have no expiration date. This is not an idle problem, as demonstrated last year, when a historian had to go to court in Connecticut to obtain access to treatment records of veterans of the Civil War (see Thomas Scheffey, “A Legal Skirmish Over Civil War Records, Connecticut Law Tribune, April 26, 2010).
The information risk provisions in the proposal pose two significant challenges for historians. First, they make it all the more important to insist on excluding oral history research from these federal regulations. For years oral historians have complained about absurd mandates from IRBs to destroy their tapes and keep the names of their interviewees secret—requirements that are fundamentally at odds with the canons for most oral history research. The substantial elevation of new privacy concerns under the proposed regulations, even for research otherwise categorized as “Excused” from IRB oversight, would increase those sorts of challenges to oral history work in ways that would make such work untenable.
But more generally, historians should stand up to assert the value of all forms of data to future historical research. The other social science organizations I have consulted are quite up in arms about this part of the proposal, and believe it could seriously affect their work. And unlike most historians, they generally expect to work within a framework of privacy and confidentiality protections for their research subjects. For large areas of history work, where getting at the particular aspects of a specific moment in time is the primary focus of research and confidentiality can undermine the credibility of the results, the potential concerns from a new privacy regime will be significantly higher.
Members of the discipline with an interest in these issues should remind the regulators that information exists in a time horizon that extends beyond the typical one- to five-year life cycle of a biomedical research study, and that these materials should be protected in a way that still makes them available to serve as a source for future historical research. At the very least, the regulations should allow for some sort of sunset provision—similar to those for U.S. census data—to assure that someday historians will be able to make use of the information collected in the present.
As before, we encourage you to write HHS with your own thoughts and observations on the issues raised by the proposal. The comment period has been extended to October 26, 2011, and can be submitted online (click on “Submit a Comment” follow the instructions, and just ignore the item at the top that comments are closed) or by mail to Jerry Menikoff at firstname.lastname@example.org or Office of Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.
Thanks to Zachary Schrag and Linda Shopes for their review and advice on this report. Please note, however, that the final conclusions are entirely those of the author.