There's a whole series of replies to this first message which was
posted on the IRB Discussion forum.  I think you have to have a
password to access the Chronicle article mentioned, tho.  I also find
nothing at the OHRP site.

Date: Tue, 21 Oct 2003 16:00:01 -0500
From: "IRB Discussion" <xxxxxx@irbforum.org>
Subject: [IRB Discussion] digest #659 (10 messages)
To: xxxxxx@irbforum.org
Sender: xxxxxx@irbforum.org
Reply-To: "IRB Discussion" <xxxxxx@irbforum.org>
Reply-to: xxxxxx@irbforum.org
X-Bulkmail: 3.09

IRB Discussion digest, issue number 659.

If replying via email (xxxxxx@irbforum.org), do not include the contents
of this digest.

Today's topics:

 1 Re:   Existence of accepted therapy precluding    placebo     controls
 2 Re:   fining researchers
 3 Re:   Healthy Scepticism
 4 No Harm, No Foul? (2 replies)
 5 Protocols per PI
 6 Follow-up to excessive deviations
 7 Oral-history interviews and research
 8 Chronicle Article: "Oral History" Maybe Not Research, per OHRP?

Message: 7
From:    Howard Mann <xxxxxx@hsc.utah.edu>
Date:    2003-10-21 11:04:25
Subject: Oral-history interviews and research

FYI :

"The federal office that oversees human volunteers in research has decided
that oral-history interviews generally do not fall under the government's
definition of research and thus need not be regulated by institutional review
boards
. "

Additional details :  http://chronicle.com/prm/daily/2003/10/2003102101n.htm

Letter from OHRP :

http://chronicle.com/extras/2003/10/20031021_hhs.pdf

Excerpt :

"It is primarily on the grounds that oral history interviews, in general, are
 *not designed
*

[emphasis mine. This notion of "intention-through-design" is interesting: ?
relevant to distinctions between research, QA, program evaluation, etc
. ]

to contribute to "generalizable knowledge"  that they are not subject to the
requirements of the HHS regulations at 45CFR 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 the term does not
simply mean knowledge that lends itself to generalizations, which
characterizes every form of scholarly enquiry 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 or laws of nature that have predictive
value and can be applied to other circumstances for the purpose of controlling
 outcomes
."

Regards,

Howard

[ source / reply - http://www.irbforum.org/forum/read/3/15376/15376#15376 ]
___________________________________________________________________________

Message: 8
From:    Norma Edwards <xxxxxx@uci.edu>
Date:    2003-10-21 13:51:34
Subject: Chronicle Article: "Oral History" Maybe Not Research, per OHRP?

I guess I will reserve my comments/questions (with an annoyed tone) until I
actually see some guidance from OHRP. I would love to have less work for our
social/behavioral IRB committee
!

--Norma
UC Irvine

This article is available online at this address:

http://chronicle.com/daily/2003/10/2003102101n.htm

 Tuesday, October 21, 2003

 Federal Agency Says Oral History Is Not Subject to Rules on
 Human Research Volunteers

 By JEFFREY BRAINARD

 The federal office that oversees human volunteers in research
 has decided that oral-history interviews generally do not fall
 under the government's definition of research and thus need
 not be regulated by institutional review boards.

 The decision follows complaints from oral historians and other
 social scientists . . .

[ source / reply - http://www.irbforum.org/forum/read/3/15379/15379#15379 ]
___________________________________________________________________________

>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/
>
--

Carrie Gregory
Compliance Division
The Research Office
University of RI
(401) 874-2526

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