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2010-05-05 DON HRPP E-GRAM
2010-05-05 DON HRPP E-GRAM
 
To: Institutional Officials, IRB Chairs, IRB Administrators and HRPP POCs.
As a follow‐up to the DON HRPP E‐gram of 13 October 2009, "Defense Federal Regulation
Supplement‐Rule," the DON HRPP developed the following information to support Human Research
Protection Official (HRPO) processes at your commands.

Attachments provided are:
[1] HRPO Nomination Letter Template; [2] DFARS Clause Federal Register Notice; [3] Background HRPO
Briefing Slides; [4] HRPO CITI Training Directions; [5] Sample ONR Checklist Process Briefing
Slides; [6] Sample ONR HRPO Basic Checklist; [7] Sample ONR HRPO Additional Checklist; [8] Sample
ONR HRPO Letter to Contracting Officer.

Attachment [1] is used for nominating a command HRPO and HRPO training materials are provided in
Attachments [2],[3] and [4]. Attachments [5] through [8] reflect the "HRPO Model" being implemented
at the Office of Naval Research (ONR). These attachments are offered as examples to assist commands
in establishing their own HRPO review process and procedure to ensure compliance with the DFARS
252.235‐7004 and SECNAVINST 3900.39D

Three steps for implementation of a command HRPO Program are as follows:
 
STEP 1: Nominate and
Appoint the HRPO ‐ Nominate a military or government
employee(s) for appointment as the Command HRPO. The HRPO position will likely be a collateral or
additional duty for the nominee. Qualified candidates could be selected from any of several command
positions including program management, legal, financial management, or Command Human Research
Protection (HRP) office positions. Prior human research protection experience is not required. Some
Commands may already have staff assigned to Human Research Protections functions. These persons may
also be nominated for the HRPO position, but that decision is at the discretion of the Command. A
Contracting Office staff member may also be considered, but the HRPO must not be the same
Contracting Officer that is awarding the contract under HRPO review. Commands should ensure that
the selected HRPO has the ability to perform the function and has completed the required
training, described below in Step 2.2
The HRPO Nomination Letter, Attachment [1] template, should be used to submit the HRPO nomination
to the DON HRPP. Commands HRPO nominations can be sent electronically to: human.research@med.navy.mil.


The DON Surgeon General (SG) or DON HRPP Director will approve the nominee for an indefinite period
of time. If the appointed HRPO is no longer able to perform their duties the Command should submit
a new nomination package.

STEP 2: HRPO Nominee Completes Requirements ‐ Prior to nomination, the HRPO should review
Attachment [2] DFARS clause ‐ see Federal Register notice at
http://edocket.access.gpo.gov/2009/E9‐17949.htm and Attachment [3] Background HRPO Briefing Slides.
The HRPO nominee must complete the HRPO training on
the Collaborative Institutional Training Initiative (CITI) website. See Attachment [4] for
directions to access the DON HRPO learner's group module.

STEP 3: Establish a Command Process for HRPO Review ‐ Samples of the ONR‐based "HRPO Model"
documents are provided for review and information in Attachments [5] through [8].
For question concerning DFARS or the HRPO Model, please contact Ms. Ivana
Sustersic at Ivana.Sustersic@navy.mil.
Thank you

DON HRPP
Sent on behalf of



Maggie L. Richard, PhD RNC CAPT NC USN
BUREAU OF Medicine & Surgery (BUMED)
Director, Navy Human Research Protection Program Building 5, 3rd Floor; 2300 E Street NW
Washington, DC
20372‐5300
Tel: 202.762‐0113
Fax: 202 762‐0976

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