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") ======================================================================
