Right answer, wrong citation. 45CFR46 covers humans.

--
Robert S Bienkowski, PhD
xxxxxx@att.net

 -------------- Original message ----------------------
From: "Becker, Lynne Ellen" <xxxxxx@COFC.EDU>
> Thank you so much.
>
> I appreciate the references too.
>
>
>
>
>
> Lynne Becker, MSPH
>
> Compliance Coordinator
>
> Office of Research & Grants
>
> 66 George St.
>
> Charleston, SC 29424
>
> # 843-953-7421
>
> fax# 843-953-6577
>
> ________________________________
>
> From: Research Administration List [mailto:xxxxxx@hrinet.org] On
> Behalf Of Myrick, Patricia W
> Sent: Wednesday, July 05, 2006 5:15 PM
> To: xxxxxx@hrinet.org
> Subject: Re: [RESADM-L] IACUC renewals
>
>
>
> Lots of best wishes for your success, Lynne.
>
>
>
> No such actions should disturb the continuation review date which is
> established as an annual activity by 45 CFR 46.109(e).  The approved
> modification, as well as any other modifications, adverse events, etc.,
> once approved, become integral components of the protocol and as such
> are included in the continuing review with each annual cycle.  The
> "renewal date" will continue to be Sept. 7, 2006.
>
>
>
> Pat Myrick, CCRP, CIP
>
> Director
>
> Office of Research Integrity & Compliance
>
> The University of Texas at Arlington
>
> 202 E. Border St., Suite 201
>
> Arlington, TX  76019
>
> T: (817) 272-0834
>
> F: (817) 272-1111
>
>
>
>
>
> ________________________________
>
> From: Research Administration List [mailto:xxxxxx@hrinet.org] On
> Behalf Of Becker, Lynne Ellen
> Sent: Wednesday, July 05, 2006 9:24 AM
> To: xxxxxx@hrinet.org
> Subject: [RESADM-L] IACUC renewals
>
>
>
> HI-
>
> I am a new listserve member & a new IACUC & IRB coordinator.
>
> I have (what I think) is a simple question. Here's the scenario.
>
> Protocol ABC is approved & renewal date is Sep 7, 2006.
>
> A minor modification was submitted and approved June 28, 2006.
>
> Here's the question.
>
> Does the modification date replace the annual review date? What do you
> do at your institution?
>
>
>
> My reason for this question is that we do not have a specific SOP
> concerning this. I realize the purpose of the continuing review form is
> to maintain an annual eview of the project & it seems that there is some
> overlap here.
>
>
>
> Thank you all for your help.
>
>
>
> Lynne Becker, MSPH
>
> Compliance Coordinator
>
> Office of Research & Grants
>
> 66 George St.
>
> Charleston, SC 29424
>
> # 843-953-7421
>
> fax# 843-953-6577
>
>
>
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>
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