Dear Domenica,

The following is a statement provided by our Oral History Director from OHRP.  There is also an article in the Chronicle about the topic.  See http://chronicle.com/prm/weekly/v50/i10/10a02501.htm, Federal Agency Says Oral-History Research Is Not Covered by Human-Subject Rules, By JEFFREY BRAINARD

******************************

> Application of the Department of Health and Human Services
> Regulations for the Protection of Human Subjects at 45 CFR Part 46,
> Subpart A to Oral History Interviewing
>
>         Most oral history interviewing projects are not subject to the
> requirements of the Department of Health and Human Services (HHS)
> regulations for the protection of human subjects at 45 CFR part 46,
> subpart A, and can be excluded from institutional review board (IRB)
> oversight because they do not involve research as defined by the HHS
> regulations.  HHS regulations at 45 CFR 46.102(D) define research as
> "a systematic investigation, including research development, testing
> and evaluation, designed to develop or contribute to generalizable
> knowledge." The Oral History Association defines oral history as "a
> method of gathering and preserving historical information through
> recorded interviews with participants in past events and ways of life."
>
>         It is primarily on the grounds that oral history interviews, in
> general, are not designed to contribute to "generalizable knowledge"
> that they are not subject to the requirements of the HHS regulations
> at 45 CFR part 46 and, therefore, can be excluded from IRB review.
> Although the HHS regulations do not define "generalizable knowledge,"
> it is reasonable to assume that they term does not simply mean
> knowledge that lends itself to generalizations, which characterizes
> every form of scholarly inquiry and human communication.  While
> historians reach for meaning that goes beyond the specific subject of
> their inquiry, unlike researchers in the biomedical and behavioral
> sciences they do not reach for generalizable principles of historical
> or social development, nor do they seek underlying principles or laws
> of nature that have predictive value and can be applied to other
> circumstances for the purpose of controlling outcomes.  Historians
> explain a particular past; they do not create general explanations
> about all that has happened in the past, nor do they predict the future.
>
>         Moreover, oral history narrators are not anonymous individuals,
> selected as part of a random sample for the purposes of a survey.  Nor
> are they asked to respond to a standard questionnaire administered to
> a broad swath of the population.  Those interviewed are specific
> individuals selected because of their often unique relationship to the
> topic at hand.  Open-ended questions are tailored to the experiences
> of the individual narrator.  Although interviews are guided by
> professional protocols, the way any individual interview unfolds
> simply cannot be predicted. An interview gives a unique perspective on
> the topic at hand; a series of interviews offer up not similar
> "generalizable" information but a variety of particular perspectives
> on the topic.
>
>         For these reasons, then, oral history interviewing, in general,does
> not meet the regulatory definition of research as articulated in 45
> CFR part 46.  The Office for Human Research Protections concurs with
> this policy statement, and it is essential that such an interpretation
> be made available to the many IRBs currently grappling with issues of
> human subject research.
>
>
> ----------
> From:         Domenica G. Pappas, CRA
> Reply To:     Research Administration Discussion List
> Sent:         Monday, October 27, 2003 9:39 AM
> To:   xxxxxx@HRINET.ORG
> Subject:      [RESADM-L] IRB - Oral History
>
> I recently heard that OHRP has stated that oral history interviewing>
> activities do not involve research as defined by 45 CFR 46, but I cannot
> find anything on their website.
>
> Does anyone know where I can find the "official word" from OHRP regarding
> oral history interviewing?
>
> Thanks,
> Domenica
> Domenica G. Pappas, CRA
> Associate Director
> Office of Sponsored Research and Programs
> Executive Officer, IRB and IACUC
> 3300 S. Federal Street
> Main Building, Room 301H
> Chicago, IL 60616-3793
>
> Phone:  (312) 567-3035
> Fax:    (312) 567-6980
> Email:  xxxxxx@iit.edu
>
> web:    www.grad.iit.edu/research/
>
>
> ======================================================================
>  Instructions on how to use the RESADM-L Mailing List, including
>  subscription information and a web-searchable archive, are available
>  via our web site at http://www.hrinet.org (click on "Listserv Lists")
> ======================================================================
>
>

======================================================================
 Instructions on how to use the RESADM-L Mailing List, including
 subscription information and a web-searchable archive, are available
 via our web site at http://www.hrinet.org (click on "Listserv Lists")
======================================================================