The Feds and IRBs: Your Opportunity to Weigh in

The federal government is inviting comments (at http://www.hhs.gov/ohrp/documents/20071026.htm) on policies that lead to the intrusion of institutional review boards (IRBs) into oral history research. This provides a rare opportunity for members of our profession to register their objections. I urge every historian who conducts oral history, or is responsible for students who use oral history methods, to respond to this request and express their concerns about the inappropriate and often arbitrary way this policy has been applied to history research in many colleges and universities. You have until December 26, 2007 (send comments to the mailing and email addresses listed at the end of this post).

For those who do not follow this issue, IRBs were set up at universities and research centers to protect “human subjects” (living people) from dangerous medical and psychological experiments. Unfortunately, the federal government’s rather vague policies joined with university administrators’ instinct to avoid potential liability, caught up practices in a number of other social science and humanities fields—including oral history research in our discipline. As a result, we receive regular complaints that the degrees of history doctoral students have been withheld, the research of some faculty have been put on hold, and history teachers and students have been threatened with substantial fines, just for talking to people about past experiences.

Over the past seven years, the AHA made a number of efforts to clarify or reverse this policy of using IRBs to regulate oral history, first by working with the federal Office of Human Research Protections (OHRP) to clarify their policy, and then by encouraging departments to engage the IRBs at their home institutions to clarify these policies. Despite all these efforts, an AHA staff survey last year found a patchwork of institutional policies that belie the notion that this is a federally-mandated policy.

The proposed changes to the regulations that are now open for comment provide a good example of the problems in the way federal policies are translated into practice at the college or university level. The often oracular policies of OHRP make it hard to really estimate the potential impact of the regulatory changes that are now being proposed (which deal with the categories subject to “expedited review”). But they are specifically requesting comment on two items that have been most troubling to oral historians—category 5 (which seems to open the door to oversight of archival research) and category 7 (which specifies oral history).

As I read it (and I certainly welcome opinions to the contrary) the proposed change to category 5 could potentially bring the collection of oral histories as well as web projects like George Mason University’s September 11 Digital Archive under IRB purview. The current category applies to “research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis)” with a side note that “some research in this category may be exempt from the HHS regulations.” But the new language broadens the coverage and drops some of the clarifying language that seems to absolve oral history and the gathering of other testimonials from IRB oversight. The new proposed language would cover:

(5) Research involving materials (data, documents, records, or specimens) that (a) have previously been collected for nonresearch purposes; (b) have previously been collected for research purposes, provided the materials were not collected for the currently proposed research; or (c ) will be collected solely for nonresearch purposes. Note: Some research under section (a) or (b) of this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.

IRBs seem inclined to define these categories and their mandate quite broadly, as “anything done by faculty and students here at the university that could get us sued.” So the clarification in this language seems very troubling. The proposed language for 5c seems to bring projects that merely gather oral histories or personal testimonies for future scholarly research explicitly under IRB review, and goes a step further by excluding it from exemption (since “c” is not among those listed in the disclaimer). At the same time, this also seems to invite review of the use of materials gathered by other scholars and placed on deposit in an oral history archives.

To anyone who has not gone through the review process, this may not seem like a big deal. But as many oral historians have discovered, IRBs are generally comprised of faculty with no expertise in oral history methods, who nevertheless try to fit the square peg of history into the round hole of their scientific protocols. As a result, oral historians report that IRBs are applying rigid criteria on things like “research protocols”—insisting on specific sets of questions (as if dialogue was not a vital part of the interview process) and occasionally insisting on the confidentiality of sources (as if the interviewees particular knowledge or expertise was not the purpose of the interview). This is made all the more complex by the often vague notions of the potential harm that can be done by an oral history interview (is it the trauma of reliving a bad experience, or the potential personal or legal jeopardy their comments might expose them to?) So the possibility of further extending IRB oversight into basic collection practices should be actively resisted by anyone who cares about future research in the discipline.

The other problem in the proposed regulations is the continued inclusion of oral history in the revised language for category 7. But now the category is further expanded to include a wider array of subjects of research, including “affective states” and “interpersonal relationships.” That just seems to tie the noose even tighter around the kind of oral history topics the IRBs can review.

It will probably pay to be responsive to the particulars of their request, and offer some assessment of the problems evident in the two categories. But in general terms, historians should express their objections to the ambiguous and often arbitrary way these policies are implemented in a field where the risk of harm is minimal. The best solution seems to be the one recommended by the American Association of University Professors, that “research on autonomous adults whose methodology consists entirely in collecting data by surveys, conducting interviews, or observing behavior in public places, be exempt from the requirement of IRB review—straightforwardly exempt, with no provisos, and no requirement of IRB approval of the exemption.”

Please make your opinion known on this subject.

Comments can be sent to:

EXPEDITED REVIEW
Office for Human Research Protections
The Tower Building
1101 Wootton Parkway, Suite 200
Rockville, MD 20852

Comments may also be sent by e-mail to expeditedreviewohrp@hhs.gov, or faxed to 301-402-2071.

For further information, contact Mr. Glen Drew, Office for Human Research Protections, The Tower Building, 1101 Wootton Parkway, Suite
200, Rockville, MD 20852, 1-866-447-4777 or by e-mail to: glen.drew@hhs.gov.

Share on FacebookTweet about this on TwitterShare on LinkedInShare on Google+Digg thisShare on StumbleUponEmail this to someonePrint this pagePin on PinterestShare on RedditShare on Tumblr

Back to Top

Leave a Reply

Comment

* Required field

  1. john zwicky

    Some questions arise. How will someone doing research on his own find an IRB. I have done oral history research without benefit of an IRB in the past. If i ever get around to turning my dissertation on the home front in Illinois during World War II into a book, I certainly may want to do some oral history. However, if I have to use an IRB, I think I’ll pass since I do not teach. I work as an archivist. And my institution certainly will not be interested in the subject of my research. Also, how about more amateur efforts? Back in the 80’s, a group of us did oral history research for a parish. Would we be in violation of the new regulations? If so, why? Will a historical society need a government permit simply to interview senior citizens about the good old days? It’s one thing to protect privacy. It’s another to get ridiculous. It simply makes government look stupid and creates disrespect for government.

    Reply
  2. Clive Wynne

    John Zwicky need not worry – if he is not part of an “institution” (basically a University) then he is not subject to an “Institional Review board.” But his concern raises I think a core issue: why does a scholarly curiosity demand federal oversight where most other forms of curiosity do not? If I want to ask somebody about their childhood experiences I don’t have to ask for permission first. At least not if my curiosity is prurient, pointless and idle – or even with a view to making a profit (a TV documentary perhaps). Only if I am part of a University and motivated by scholarly inquiry does my research require the oversight of a federally mandated committee. Now where’s the sense in that?

    Reply
  3. Heather Munro Prescott

    As someone who has gone through the IRB process for oral history research and for anonymous survey data, I think that the problem is being overblown. Why shouldn’t historians have to follow the same ethical guidelines as other social scientists? Furthermore, if you read through the materials through HHS, you will see that they are recommending the kinds of research we do for expedited review. It seems to me that what HHS is trying to do is clarify language for IRBS.

    Finally, this might help those of us who do medical history and want to use data from clinical case records.

    Reply
  4. Rev. Scott Prinster

    Clive: Only if I am part of a University and motivated by scholarly inquiry does my research require the oversight of a federally mandated committee.

    That’s not quite correct, Clive; it’s not only universities, but I believe any institution that wants to be eligible for federal funding. IRB Brownshirts aren’t going to kick down your door if you interview someone informally, but you may not be able to secure grant support if you don’t make yourself accountable to the system that funds you.

    I serve on the IRB of a hospital that has a large research center especially well-known for cardiac studies. Believe me, we don’t think it’s in anyone’s best interest to have to jump through meaningless hoops. But we have already reviewed protocols that included psychological interviews, for example, and I agree completely on the need for the same quality of informed consent, clarity, and oversight that physical protocols require.

    Heather hits the nail right on the head—this is not about adding requirements, but about clarifying the point that many social science interviews will need only an expedited review, rather than the full process.

    Reply
  5. Jon M. Harkness

    I am a historian of medicine who has done considerable work on the history of biomedical research ethics, so I am well aware of the possibilities of abuse in clinical research (etc.). I believe, however, that the “mission creep” of IRBs is a trend that is restraining scholarship in the humanities and social sciences while offering protection against largely imaginary harms. Or—even worse—they are protecting against harms that are inherently, inescapably, and properly part of society committed to the free exchange of ideas.
    Also, IRB oversight of information gathering interviews runs up against the possibility of infringement on First Amendment “Freedom of the Press” rights. As Jane Kirtley, U of MN media ethics and law expert, has recently written (in a piece put out by the State Department as part of an effort to help the rest of the world understand how a “free” society operates) the precise membership in “the press” has not been clearly defined by the courts—and it is getting more murky in the internet age:
    “But who is a “journalist”? This has been a question that American courts have been loath to answer. After all, if the government can define who is entitled to act as a journalist, it can control who gathers and disseminates news. Yet, with the advent of the Internet, which allows anyone with access to a computer and a modem to publish his or her opinions to the world, how will the law determine who is entitled to claim those rights? The Internet is a medium that crosses borders instantaneously, enabling information and ideas to be disseminated in the twinkling of an eye. Determining whose standards and laws will apply to the speech and the speakers who use it to communicate will be one of the major jurisprudential challenges of the 21st century.” (the whole article can be found at http://usinfo.state.gov/journals/itgic/0203/ijge/gj03.htm)
    For an excellent article on the scholarly and constitutional perils surrounding IRB oversight of scholars (including historians) using “journalistic research methods” (including oral history interviews), I strongly urge others to read a recent piece by Robert L. Kerr, Assistant Professor, Gaylord College of Journalism and Mass Communication, University of Oklahoma,in Communication Law & Policy, Vol. 11, Summer 2006, pp. 393-447:
    “UNCONSTITUTIONAL REVIEW BOARD?
    CONSIDERING A FIRST AMENDMENT
    CHALLENGE TO IRB REGULATION
    OF JOURNALISTIC RESEARCH METHODS”
    Among many (many) excellent points, Kerr asserts that even “expedited” IRB reviews can be quite slow and needlessly cumbersome. Kerr begins and ends his article by pointing to an exquisite irony in this situation. I quote here from his conclusion (p. 446):
    “Lost in the approach now in place is the fact that the abuses of the Tuskegee syphilis experiments were made public through the use of journalistic research methods—in great part through interviews that posed uncomfortable but vital questions to their subjects.”
    According to Jean Heller (the journalist who exposed Tuskegee in the early 1970s), her best sources were scientists she interviewed at the Public Health Service. If Heller happened to work in an academic department in the early 21st century, her IRB might not have allowed her to conduct these sensitive and painful interviews, which definitely held the potential to damage the reputations the interviewees!

    Reply
  6. Jon Bergstrom

    Academica is not the only place burdened with this stuff. Many industries are now required to hold safety or SLAM (Stop, Look Analyze Manage) meetings before starting the simplest jobs. These have to be documented, and the employs have to sign off that they had the meeting. Alas, the foolishness of these is so obvious that they are not taken at all seriously. The committee head is usually a “senior” manager that has been parked there to get them out of the way, and boy do they love to tell the peons where to go. It’s sad, for these things could fill real need at times, but once things get bureaucratic it becomes nothing but a great time waster.

    Reply
  7. Jon Bergstrom

    I could not access H.M Prescott’s the link as it’s behind a subscription firewall, but I still will make one more comment.

    I am not an academic but I have a great interest in the history of technology. In our business, I saw the results of losing two men who had been with the company forever. They were not the type to write things down.

    In one month we lost 75 years of intuitional memory, and it cost us a heck of a lot to recreate it. Some was simple, “there is a steam trap in the forth floor men’s room that needs to be drained every week”, and some that was not, “Leroy’s anniversary would have been on June xx, someone has to take him to the mausoleum”.

    If we had taken notes in all the bull sessions at the end of work, or better yet, taped them, so much information would have been preserved. Not just the technical details, but the feel of the time.

    I’m sorry, but the idea of throwing up a barricade to saving this sort of oral history seems just foolish. This is worlds apart from preventing dubious injections given to uninformed folks. Frankly, it seems just a way to provide life support for a committee of dinosaurs in the name of correctness.

    Reply