Hi,
We had a similar situation.  We had invoked our Research Misconduct
policy, and the person presenting the allegations regarding the
non-compliance was considered a "whistleblower."  Everyone involved was
very supportive of the process, the allegations were substantiated, the
Inquiry Committee made recommendations to the Research Integrity Officer
and the Deciding Official implemented the punitive recommendations.

In the end, there was greater awareness of the need for a compliant
culture, and even the accused was satisfied with the outcome of the
process.

Steve

-----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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