2015-10-21 DON HRPP E-GRAM
From: USN NCR BUMED FCH VA Mailbox DON-HRPP
Sent: Wednesday, October 21, 2015 1:46 PM
To: USN NCR BUMED FCH VA Mailbox DON-HRPP
Subject: DON HRPP Clarification of Memo Issued by Assistant Secretary of Defense (Research & Engineering) dtd 1 June 2015
Attachments: ASD(R&E) Memo dtd 1 June 2015.pdf; HRPO Nomination Letter Template - 08 Feb 2013.doc
DON HRPP has received questions regarding the interpretation and possible implementation of the attached memo entitled "Reducing Administrative Burden on a non‐DoD institution relying on a DoD Institutional Review Board (IRB)".
At this time, when a non‐DoD institution is conducting Department of the Navy (DON)‐ supported human subject research under a written agreement, and
is relying on a DoD IRB via an approved Institutional Agreement for IRB Review, the responsibilities of the Human Research Protection Official (HRPO) as defined within Defense Federal Acquisition Regulation Supplement 48 CFR 252.235‐7004 and DoD Instruction 3216.02 may be met by a member of
the DoD IRB who is reviewing the research concurrent with that IRB review,IF that IRB member is properly designated as an HRPO. DON institutions wishing to nominate one or more of their IRB members to serve as an HRPO must complete the nomination letter (attached) and submit to usn.ncr.bumedfchv.mbx.don‐email@example.com for approval by the Director, DON
Additional information is available on DON HRPP's website:
If you have any questions, please contact your DON HRPP POC or email DON HRPP at usn.ncr.bumedfchv.mbx.don‐firstname.lastname@example.org.
Sent on behalf of
CAPT William Deniston, MSC, USN, Ph.D.
Department of the Navy Human Research Protection Program
Bureau of Medicine and Surgery
7700 Arlington Blvd, Suite 5160
Falls Church VA 22042‐5160