Steve-
You might find this of interest. There were many other posts on this thread,
but I think this one is of the most interest.

Claudia

At 08:12 AM 10/16/2002 -0500, you wrote:
>Hello-
>
>Let me add my 2 cents here.  Yes, if an institution is receiving federal
>funding, it needs an IRB (and is it is good idea to have one anyway for a
>myriad of reasons).  However, a huge dilemma is brewing, especially among
>social scientists.  Based on a few cases of GROSS failure to properly manage
>research programs that result in harm to participants, some schools have
>been heavily sanctioned by the feds, whose policies now do have some sharp
>teeth.  However, the prevailing portrait of the ORI as a predator, looking
>for any deviation of federal policy so that it can yank the institutions'
>research program is way, way, way overblown.  The fallout from the
>prevailing image is that IRBs are becoming paranoid, afraid to approve any
>study that has an ounce of potential controversy.  This hits the social
>scientists especially hard because much of what we do is controversial in
>someone's eyes.  The cycle continues.  Social scientists are increasingly
>resentful of IRBs and their members (quite a literature on this already),
>charging, among other things, arrogance, incompetence, anti-science bias,
>and the like.  And the truth is that many IRB members are neither truly "up"
>on federal policy and/or they have never, themselves, done any empirical
>research.  (At my last university one IRB chair was a history professor.)
>So, now you often hear of a real antagonism between IRBs and
>investigators--not a healthy situation for science.  I have an ORI grant to
>study this problem.  Data are still raw, but I will post a summary when
>available.  I think you will find it interesting.
>
>Patricia Keith-Spiegel, PhD
>
>
>
>on 10/15/02 10:11 PM, [EMAIL PROTECTED] at [EMAIL PROTECTED] wrote:
>
>> 
>> 
>> Marie makes a very good point about the issue of federal funding. Of
course,
>> it 
>> can be a wide issue because while a particular study which is not funded
might
>> be found in violation, if there is any federal funding AT ALL coming
into an
>> institution, it can all be frozen--that is a violation in a nonfunded study
>> can 
>> result in suspension of funds to a funded study within an institution.
>> 
>> In addition, while it's probably true that you only have to follow the CFR
to
>> maintain federal funding, I think that in our litiginous society it is
not a
>> bad idea, anyway, to follow the federal codes. It certainly provides one
with
>> a 
>> good cushion in case of legal problems! The problem, generally, is that
many
>> universities ARE being sued over what may seem like relatively innocuous
>> studies--even survey studies.
>> 
>> The whole brou ha ha, as I understand it, that nearly shut down Virginia
>> Commonwealth University, started with an objection by a relative of a
subject,
>> to a couple of survey items, from a questionnaire that was part of a larger
>> study, and from there snowballed into an avalanche.
>> 
>> So, I'd still say that to follow the federal codes is probably a smart
>> idea....
>> 
>> Annette
>> 
>> Quoting Marie Helweg-Larsen <[EMAIL PROTECTED]>:
>> 
>>> The original note from David Daniel does not indicate whether his
>>> university is receiving federal funding for human subjects research. The
>>> federal guidelines (that Annette provides a link to) only have to be
>>> followed IF the university is required to follow federal IRB guidelines
>>> which (as I understand it) they only have to do if they receive federal
>>> funding for research with human subjects. Perhaps David can expand here:
>>> are you asking what the federal guidelines require or are you asking
>>> what would be good for a voluntary IRB?
>>> Marie
>>> 
>>> Annette Taylor wrote:
>>> 
>>>> I think that federal codes ALWAYS supercede any "local" guidelines,
>>>> including APA guidelines. Note the difference between a "code"
>>>> and a "guideline".
>>>> 
>>>> You should go to
>>>> http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm
>>>> where all of the details are spelled out precisely, including the
>>>> composition of the committee.  And yes, you do need a community member...
>>>> 
>>>> annette
>>>> 
>>>> 
>>>> 
>>>> On Tue, 15 Oct 2002, David B. Daniel, Ph.D. wrote:
>>>> 
>>>> 
>>>> 
>>>>> I think this has been discussed before but:  What is the optimal
>>> membership
>>>>> make-up of a human subjects review board? We have a proposal to
include a
>>>>> community member, an administrator and several faculty.  Just wondering.
>>>>> 
>>>>> David
>>>>> 
>>>>> 
>>>>> \\|//
>>>>> (o o)
>>>>> --------oOOo-(_)-oOOo----------------
>>>>> 
>>>>> David B. Daniel, Ph.D.
>>>>> Department of Psychology                Associate Research Scientist
>>>>> University of Maine at Farmington       New England Research Institutes
>>>>> 234 Main Street
>>>>> Farmington, ME   04938
>>>>> 207-778-7411
>>>>> [EMAIL PROTECTED]
>>>>> 
>>>>> 
>>>>> 
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>>>>> 
>>>>> 
>>>>> 
>>>> 
>>>> Annette Taylor, Ph. D.
>>>> Department of Psychology  E-mail:  [EMAIL PROTECTED]
>>>> University of San Diego   Voice:   (619) 260-4006
>>>> 5998 Alcala Park
>>>> San Diego, CA  92110
>>>> 
>>>> "Education is one of the few things a person
>>>> is willing to pay for and not get."
>>>> -- W. L. Bryan
>>>> 
>>>> 
>>>> 
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>>>> 
>>> 
>>> 
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________________________________________________________

Claudia J. Stanny, Ph.D.                e-mail: [EMAIL PROTECTED]
Department of Psychology                Phone:  (850) 474 - 3163
University of West Florida              FAX:    (850) 857 - 6060
Pensacola, FL  32514 - 5751     

Web:    http://www.uwf.edu/psych/stanny.html

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