Hi Barbara,

I see you have moved back south again.  Hope all is going well.

Regarding your question, we do not have our department chairs sign off on
an IRB protocol nor would I ever request it.  The regs are very specific
that only the IRB is able to approve or disapprove a human subjects
protocol and no institutional official can override the IRB's decision.  By
requiring dept. chair signature, you are in essence giving administrative
authority over the human subjects research, particularly if the IRB and the
dept. chair disagree.  We do send a copy of the IRB's protocol approval or
disapproval letter to the dept. chair.

I think we need to be clear on what IRB review means:  that the research
either has or has not met all legal and ethical requirements for human
subjects protection.  That's it.

Hope this helps.

Lorrie

 Barbara Gray
 <xxxxxx@VALDOSTA.
 EDU>                                                       To
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 org>                      [RESADM-L] Dept Chair Signature on
 IRB Applications

 08/24/2007 04:18
 PM

 Please respond to
 Research
 Administration
 Discussion List
 <xxxxxx@hrinet.
 org>

All,

Our IRB is having a big debate about Department Chairs signing off on IRB
applications.  IRB members are concerned about academic freedom issues
(e.g., a Chair refusing to sign an application because he/she has some
personal or moral issue with the nature of the research).  Our Chairs
indicate that they want to see these applications but seem mostly concerned
with resource issues…are there funds and personnel time to do the research
proposed?   I would think that a Chair would want to be aware of human
research going on in his/her department so as not to be blindsided if
something goes wrong.  I also wonder why a Chair who would refuse to sign
off on an IRB application for personal reasons wouldn’t be run out of town
for violating the researcher’s academic freedom.  Our IRB never required
Chair signatures before and I opened this can of worms with a proposed
revision of our IRB application that included a Chair signature line.
Given that our Chairs sign-off on everything else, I never dreamed this
would be such a touchy subject.  I do believe there is some history here of
which I am unaware.  So I’m looking for some input from other institutions
to determine how we might move forward:

 1.        Does your IRB application require the Department Chair’s
 signature?
 2.       Does the application require any other signatures besides
 the PI and the Chair (like Dean, VPAA, VPR, etc.)
 3.       If you don’t require any administrative signature (e.g., you
 only require PI and perhaps Co-I signatures), do you officially
 inform at least the Chair of the protocol submission?  If so, how
 much information do you share (minimal descriptive info. Vs. full
 copy of the application)?
 4.       If you do have Chairs sign, what is the phrasing about the
 signature (acknowledgement of review, assurance of availability of
 resources, approval of the protocol, or something else)?
 5.       If Chairs must sign, what is the rationale for having them
 do so?

This will probably be a pretty interesting discussion, so please share your
responses with the entire list.

Thanks,
Barbara

Ms. Barbara H. Gray
Director of Grants & Contracts
Valdosta State University
1500 North Patterson Street
Valdosta, GA  31698-0429

Telephone:  229-333-7837
Fax:  229-245-3853
Email:  xxxxxx@valdosta.edu

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