We give the same advice.

As for the new NIH “rule”, I have not seen a formal policy announcement, but we are getting the same consistent message across the NIH: No awards with restrictions for human/animal work pending protocol approval.

We have seen maybe one, maybe two, exceptions made when the PI can make a clear case that a) there is a compelling scientific need to wait, but for less than a full year, to get the protocol approved (and in particular, that it is not just a matter of poor planning), and b) there is a clear plan for how to move the research safely forward without the human/animal component during that waiting period.

As I recall, we had an R21 where the outcome of some short-term preliminary experiments were needed in order to complete the precise design of the animal protocol, but they needed to get IACUC approval within the first year of the award in order to complete the animal study before the conclusion of the two-year R21 award cycle.

But the NIH made it clear that this was not an exception they granted lightly, and they indicated that they would be carefully monitoring the RPPR.

-Adam

Adam Kuehn, Assistant Director

Office of Research Support

Duke University

2200 West Main Street, Suite 710

Durham, NC 27705

919-681-8689 (direct)

919-684-3030 (central)

xxxxxx@duke.edu

From: Research Administration List [mailto:xxxxxx@lists.healthresearch.org] On Behalf Of Donahue, Sherie (LLU)
Sent: Friday, August 05, 2016 12:58 PM
To: xxxxxx@lists.healthresearch.org
Subject: Re: [RESADM-L] restricted awards from NIH

Many years ago there were deadline dates on JIT notices. However, I have not seen a deadline date in the email notices for several years.

We have worked on the premise that all of the JIT information must be submitted before the proposal goes to council. We advise our PIs to start the approval process earlier if they have a complicated protocol that might take longer to get through the appropriate committees.

Sincerely,

Sherie

Sherie Donahue, MS, CRA – Electronic Research Specialist
Secretary, Institutional Biosafety Committee
LOMA LINDA UNIVERSITY | Office of the Vice President for Research Affairs
Loma Linda, CA 92350
(909) 651-5098 or (909) 558-1000, x83911· (909) 558-0244 (fax) · xxxxxx@llu.edu

The difficult we do immediately. The impossible takes a little longer. – motto of the US Army Corps of Engineers during WWII
If the facts don’t fit the theory, change the facts. – Albert Einstein

From: Research Administration List [mailto:xxxxxx@lists.healthresearch.org] On Behalf Of Davis Hamilton, Zoya
Sent: Thursday, August 04, 2016 9:13 AM
To: xxxxxx@lists.healthresearch.org
Subject: [RESADM-L] restricted awards from NIH

Dear Colleagues,

We just heard from an NIH GMS that NIH is not processing any awards with restrictions in instances where IRB or IACUC approval may take longer than the Just in Time deadline. Has any of you heard of this? Has there been some type of announcement from NIH? I went online, but couldn’t find anything.

Thank you,

Zoya

Zoya Davis-Hamilton, Ed.D., CRA / Director, Research Administration Initiatives / Tufts University /136 Harrison Ave, Boston, MA 02111 / (617) 636-6709 / http://viceprovost.tufts.edu/researchadmin/

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