DHA Home About DHA Human Resources Contact Us FOIA Site Map
 
Infinite Menus, Copyright 2006, OpenCube Inc. All Rights Reserved.

Human Research Protection Official’s (HRPO) Review of Research Protocols

Initial Submission for HRPO Review

We have the goal to complete our HRPO review of protocols within 10 business days of receipt of a complete package in IRBNet. A complete package includes each of the following documents:

  • Contact Information for PI AND Government Project Manager (please use “TMA Protocol Contact Information Template for HRPO Review” template)
  • Description of the PI’s affiliations and qualifications (CV/Biosketch)
  • Proof of HRPP Training within the past 3 years for all researchers (CITI Social and Behavioral Research Investigators Module [we do not accept refresher training]). If you have completed training provided by your institution, then you need only complete the CITI Training Module titled: Non-DoD Researcher Training Requirements
    Notes-OUSD(P&R) is under “O” for “Office.” Most will need to take the Social and Behavioral Health Investigators modules. Because of the particularly vulnerable nature of the DoD population, we do NOT accept refresher training in lieu of completing the full course
  • Signed “Researcher Responsibilities Form” for all investigators.
  • IRB Documentation:
    • Protocol, including all attachments, approved by the primary IRB for the study (including the Scientific Review for all non-exempt studies)
    • Copy of IRB approval letter(s) for the study (initial review and continuing reviews when applicable)
    • If the study did not qualify as exempt, a copy of the OASD(HA)/TMA Institutional Agreement for IRB Review (IAIR) signed by the signature authority at the primary IRB, or the DoD Addendum to the HHS FWA.
  • Data Use Agreement/Data Sharing Agreement (DUA/DSA) or DUA/DSA number provided by the TMA Privacy Office (if applicable)
  • Approval form HA/TMA Gatekeeper Review for Duplication for all TMA-sponsored studies. The Proposed Study submission form can be accessed at TMA Gatekeeper Template

Continuing Review of Previously Approved Protocols

Expiration of approvals

  • Approved human subject research protocols: one day prior to primary IRB approval expiration
  • Approved exempt human subject research protocols: three years from our initial approval

If you wish to continue work on the study beyond the expiration date, then you will need to request approval to do so from your primary IRB and this office. You should submit your request using IRBNet. We will require the following documents in order to complete our review of your request:

  • Completed Continuing Review Status Update template
  • Biosketch/CV and signed Researcher Responsibilities forms for any new investigators or key personnel
  • Copy of any new documents since previous approval (scripts, consent forms, etc.) that have also been approved by the primary IRB
  • Proof of HRPP Training within the past 3 years for all new researchers and for those whose previous training has expired since the initial approval (CITI Social and Behavioral Research Investigators Module [we do not accept refresher training]). If you have completed training provided by your institution, then you need only complete the CITI Training Module titled: Non-DoD Researcher Training Requirements
    Notes-OUSD(P&R) is under “O” for “Office.” Most will need to take the Social and Behavioral Health Investigators modules. Because of the particularly vulnerable nature of the DoD population, we do NOT accept refresher training in lieu of completing the full course
  • Copy of IRB approval letter(s) for the study to continue

Requests to Modify Ongoing Studies

If you wish to modify your approved protocol, then you must request approval for the changes from your primary IRB and this office. You should submit your request using IRBNet. We will require the following documents in order to complete our review of your request:

  • Completed Protocol Modification Request template (Please login to access from the IRBNet Forms and Templates Library)
  • Biosketch/CV and signed Researcher Responsibilities forms for any new investigators or key personnel
  • Copies of any new documents (e.g., scripts, consent forms, surveys, etc.) that are the subject of the modification (that were approved by the primary IRB)
  • Proof of HRPP Training within the past 3 years for all new researchers and for those whose previous training had expired since the initial approval (CITI Social and Behavioral Research Investigators Module [we do not accept refresher training]). If you have completed training provided by your institution, then you need only complete the CITI Training Module titled: Non-DoD Researcher Training Requirements
    Notes-OUSD(P&R) is under “O” for “Office.” Most will need to take the Social and Behavioral Health Investigators modules. Because of the particularly vulnerable nature of the DoD population, we do NOT accept refresher training in lieu of completing the full course
  • Copy of IRB approval letter(s) for the requested modifications

Approval of a modification request will not affect the initial (or continuing review) approval expiration date unless the modification request is coupled with a continuing review request.

“On October 1, 2013, the Department of Defense established the Defense Health Agency (DHA) to manage the activities of the Military Health System. These activities include those previously managed by TRICARE Management Activity (TMA), which was disestablished on the same date. During the next several months, all TMA websites will change to reflect the new DHA. We appreciate your patience during this transition."
DoD Seal
7700 Arlington Boulevard, Suite 5101, Falls Church, VA 22042-5101
The appearance of hyperlinks to external Web sites does not constitute endorsement by the TRICARE Management Activity of these Web sites or the information, products or services contained therein. For other than authorized government activities, TRICARE Management Activity does not exercise any editorial control over the information you may find at other locations. Such links are provided consistent with the stated purpose of this DoD Web site. Accessibility/Section 508