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Re: Compliance to IRB Schoen, Alexander 12 Oct 2006 08:41 EST

Those faculty members should attend an education session on the IRB and
then be required to teach a lesson on the importance of IRB's and
protection of human subjects in research.

Considering that these are student projects, IRB review is more
important, as the students are most likely not so well versed with
protocol design and human subject protection.

-----Original Message-----
From: Research Administration List [mailto:xxxxxx@hrinet.org] On
Behalf Of Ruth B Smith
Sent: Thursday, October 12, 2006 8:59 AM
To: xxxxxx@hrinet.org
Subject: Re: [RESADM-L] Compliance to IRB

I agree completely with what Tracy said.  The academic hierarchy should
be made aware not just for early warning about potential IRB action but
also for the example the faculty member is setting.  The faculty member
is teaching and showing his or her students how to be researchers and
faculty members themselves.  If the students learn compliance policies
and regulations are "little rules" to be flouted, there could be serious
consequences for those individuals and their institutions in future.

Ruth

 Tracy Arwood

 <xxxxxx@CLEMSON.

 EDU>
To
 Sent by: Research         xxxxxx@hrinet.org

 Administration
cc
 List

 <xxxxxx@hrinet.
Subject
 org>                      Re: [RESADM-L] Compliance to IRB

 10/12/2006 07:58

 AM

 Please respond to

 Research

 Administration

 Discussion List

 <xxxxxx@hrinet.

 org>

Dave,
I do not think there is a simple answer to your question.  The answer
depends on how your institutional policy is written.  Does your IRB
cover only projects that meet the definition of human subjects research
in the regulations?  or does your university expand on that definition
to cover a broader range of projects?  Perhaps, some of these projects
are not "generalizable" and therefore may not meet the strict
interpretation of the regulations?  If you feel strongly that these
projects should be reviewed by the IRB and that a faculty member is
purposely ignoring the mandate to do so, I would recommend convening
your IRB to investigate and discuss the noncompliance and determine what
corrective actions would be appropriate.  Involving your IO and Provost
at this stage would be helpful so they are not blind sided when the IRB
makes its determination.  I have been involved with a similar situation
and would be happy to talk to you off-line if you'd like. Good luck,
Tracy

At 07:24 PM 10/11/2006, you wrote:
>Hello everyone - I hope this is a simple question.  What does your
>university do if professors do not require their students to pass their

>human subjects research projects (undergraduate and graduate) through
>the IRB?  I am interested in the cases where the faculty member knows
>that the projects should go through IRB but tells the students that
>they do not
need
>to do so.
>
>Thanks for your input.
>
>Cheers,
>Dave
>
>
>
>++++++++++++++++++++++++++++++++++++++++++++++
>Dr. David L. McGinnis
>Co-Director, Grants and Sponsored Programs
>Montana State University-Billings
>1500 University Avenue
>Billings, MT 59101
>email: xxxxxx@msubillings.edu
>office: 406-657-2340
>fax: 406-657-2299
>cell: 406-698-8164
>+++++++++++++++++++++++++++++++++++++++++++++
>
>
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Tracy S. Arwood
Director
Office of Research Compliance
Clemson University
223 Brackett Hall
Clemson, SC 29634-5704
Phone - 864-656-1525
Fax - 864-656-4475

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