Oral history to be exempt from IRB review?
« previous post | next post »
Donald Ritchie, "Good news for scholars doing oral history! The federal government is preparing to grant them a right to be excluded from IRBs", History News Network 10/13/2015:
Here are the details according to an announcement on the website of the Oral History Association: "On September 8, 2015, the U.S. Department of Health and Human Services issued a set of recommended revisions to the regulations concerning human subject research. Specifically, it recommended that oral history be explicitly excluded from review by institutional review boards, or IRBs, and alluded to the fact that oral history already has its own code of ethics, including the principle of informed consent."
It'll be good to avoid the occasional problem of overenthusiastic biomedically-oriented IRB boards (not ours at Penn) insisting on knowing the exact wording of all questions that will be asked, and insisting that all recordings and transcripts should be destroyed as soon as the study has been published.
But I suspect that this just means that oral history projects can apply to their local IRB to be ruled exempt from review — the catch is that only the IRB can determine that a project is exempt from review, and this requires that they "review" (in a different sense) an application for the project to be exempt from review.
Anyhow, I've felt for a long time that language documentation projects should generally be recast as oral history projects, for a bunch of (I hope mostly obvious) reasons. And this might make it easier for such projects to jump through the relevant bureaucratic hoops (as well as satisfying the genuine ethical concerns).
Update — I should add, based on considerable study of IRB regulations and practices, and also on considerable experience with IRB reviews (both of submissions for exemption and of protocols to be formally reviewed), that most oral history projects are in fact now properly considered to be "exempt" under existing IRB regulations. But as I said, exemption must be determined by the local IRB, not by the investigator. And it would no doubt be helpful in getting such determinations to have a formal policy declaration that "oral history" projects, appropriately defined, are exempt — rather than educating each iteration of each local IRB for each such project.
Update #2 — as Madeleine Ball and fev point out in the comments, the proposal in fact is more favorable to investigators than the History News Network story led me to understand. Quoting from the NPRM 2015 – Summary page at HHS.gov, "A new process would allow studies to be determined to be exempt without requiring any administrative or IRB review".
and more specifically,
The result of these types of changes, as the NPRM proposes to implement them, is that some studies that currently require IRB review would now become exempt. Some that are currently exempt would specifically be declared as outside the scope of the regulations (“excluded”), and thus would not require any administrative or IRB review. Further, in terms of determining when a study is exempt, a web-based “decision tool” will be created. That decision tool will provide a determination of whether or not a study is exempt. That result, so long as the tool was provided with accurate information, will be presumed by the Common Rule agencies to be an appropriate determination of exempt status. It is expected that in many instances the tool would be used by the investigators themselves, thus obviating both the need for further review and the concern that the institution might be subjecting itself to future liability by allowing investigators to use the tool. For all of the excluded and exempt research activities, this NPRM also affirms the importance of applying the ethical principle of respect for persons, in addition to the importance of abiding by this principle in fully regulated non-exempt research involving human subjects.
It seems likely that the "excluded" category, and the use of the "decision tool" to determine membership in that category, will eventually cover quite a bit of current linguistic research.
J.F. said,
October 21, 2015 @ 10:28 am
I once heard an IRB described as 'a high volume red tape dispenser. I am a trained scientist and all for biomedical ethics when properly applied to projects, but so much red tape.
Linda Seebach said,
October 21, 2015 @ 11:08 am
I was taking a grad course in child psych once (Minnesota, c. 1990) and the professor assigned a paper that required us to go find a child and interview them and their parents. After class I told her that she needed to get IRB review (and likely exemption) and she was disbelieving. But she did check, and yes, she did need to get approval for her assignment. (Which was forthcoming, as I recall.)
Bill Benzon said,
October 21, 2015 @ 11:23 am
"…insisting that all recordings and transcripts should be destroyed as soon as the study has been published."
Yikes! Are there IRBs so stupid as not to realize that the point of oral history projects is often to create permanent records that researchers can consult?
[(myl) "…is always to create permanent records…", I'd say. This case, which I believe actually happened since I was told about it by the researcher it happened to, arose because the IRB in question was used to treating interviews in the context of biomedical trial debriefing, and had a rule of thumb that once the statistical summaries had been compiled, any original recordings and notes should be destroyed so as to preserve patient confidentiality.]
J. W. Brewer said,
October 21, 2015 @ 12:01 pm
Of course, when questions arise about whether a particular published paper is fraudulent, being able to say "gosh, I'd love to give you access to the underlying data so you could try to replicate my results, but the IRB made me destroy it" could be very useful.
Alex said,
October 21, 2015 @ 1:11 pm
The IRB at a large research university I attended told an ethnographer she couldn't interview people about kinship relationships or sexuality, because those topics "might make people uncomfortable." This pretty much sank her proposed field project to study Mexican men's attitudes towards family planning, since doing so without asking any questions about either families or sex would be difficult to say the least.
rcalmy said,
October 21, 2015 @ 7:44 pm
From comments in the linked article, this is still a proposed rule. It is not yet finalized in the Code of Federal Regulations.
Part of my job involves monitoring and reviewing regulations from one particular government agency, so I've picked up a few things about the process. The issuance of a proposed rule with comment period is a pretty common first step. During the comment period, anyone may submit a public comment (although I suspect that being able to identify yourself as "stakeholder" probably helps get your comment taken seriously; in this case being an academic under the auspices of a U.S. institution who made use of oral history would qualify you as a stakeholder). My impression (and keep in mind this is based upon one agency) is that contents of the proposed rule are likely to make it into the final rule unless there is significant disagreement in the public comments.
If you are concerned about this issue, I would suggest the following steps:
1.) Go to the Federal Register page for the proposed rule: https://www.federalregister.gov/articles/2015/09/08/2015-21756/federal-policy-for-the-protection-of-human-subjects
2.) Read the actual relevant regulation text (Warning: bureaucratese lies ahead). The bit you want is section II. A. 2. a. ii. Oral History, Journalism, Biography, and Historical Scholarship Activities.
3.) Submit a comment. Even if it is just to register approval of the rule as written, this can be valuable. If you don't think it goes far enough, tell them that. They probably won't expand the scope of the exemption this year, but if they get enough feedback in the comments it increases the likelihood of it happening sooner rather than later. Comments are due by December 7. There is a big green button on the web page labeled "Submit a Formal Comment," or there are instructions near the top of the document on other ways to submit a comment.
Madeleine Ball said,
October 21, 2015 @ 9:24 pm
"…in terms of determining when a study is exempt, a web-based “decision tool” will be created. That decision tool will provide a determination of whether or not a study is exempt. That result, so long as the tool was provided with accurate information, will be presumed by the Common Rule agencies to be an appropriate determination of exempt status. Thus, it is expected that in many instances the tool would be used by the investigators themselves, thus obviating both the need for further review and the concern that the institution might be subjecting itself to future liability by allowing investigators to use the tool."
fev said,
October 21, 2015 @ 9:31 pm
Mark, I think it's a little more optimistic — as I'm recalling the dispute, the oral historians had asked for and (broadly) gotten a blanket "exemption" a decade or so ago. Having determined that to be a wrong move (as in, you still have to submit an exempt protocol and get the IRB to concur), they're now asking to to be excluded from the category of "research that requires federal oversight" altogether — meaning no submission to the IRB at all. If that's among the Common Rule changes that are slowly being posted over at the Federal Register, then the good guys have won a round. As rcalmy suggests, people who want a say in the matter should go have one. Really, it'll help.
KeithB said,
October 22, 2015 @ 8:23 am
When my kids were at a private grade school , any science project that involved using other students had to go through "IRB review". I was amused that they were teaching how to do real science so early.
Matt said,
October 22, 2015 @ 9:09 pm
J. R. Brewer, are you aware of the debate around the veracity of Alice Goffman's On the Run? Her critics have made much of the fact that she destroyed her original notes ("underlying data"), although I believe in her case it was because she was afraid of being subpoenaed for them (given the nature of what she studied) rather than because the IRB required it.
Adam F said,
October 23, 2015 @ 2:51 am
Coincidentally, or not, IRB is mentioned in the mouseover text in today's XKCD.
J. W. Brewer said,
October 26, 2015 @ 12:01 pm
Matt (belatedly): I had not been aware, although I guess it's unsurprising. Not sure what the "official" difference between peer-reviewed "ethnography" of this sort and ordinary long-form journalism by someone without a Ph.D. is supposed to be for this sort of purpose. There certainly have been prior sociologists who did fieldwork among subcultures of Americans engaged in various sorts of criminal activity, won the trust of their research subjects, and thus got to hear and see things of potential interest to police and prosecutors, etc., so the issue of how you publish the results w/o either saying "I've changed names and identifying details to protect people, so you just have to trust me" or exposing the subjects of the fieldwork to legal risk has arisen before and presumably been addressed or finessed in various ways.