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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.  A complete package includes each of the following documents:

  • Description of the PI’s affiliations and qualifications (CV/Biosketch).
  • Proof of HRPP Training within the past 3 years for all researchers (CITI programs for biomedical and social/behavioral research [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: Module for Non-DoD Personnel Conducting Research Involving Human Subjects Supported by the DoD (ID: 16769).
    • Note - 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 and key study personnel.
  • IRB Documentation:
    • Protocol, including all attachments, approved by the primary IRB for the study (including the Scientific Review for all non-exempt studies) – Protocol and Scientific Review Templates available on the Templates, Forms and Guidance Documents Tab.
    • DHA Data Element Request Summary template.
    • Copy of IRB approval letter(s) for the study (initial review and continuing reviews or amendments when applicable).

Continuing Review of Previously Approved Protocols

Expiration of approvals

  • Approved human subject research protocols: one month after primary IRB approval expiration.
  • Approved exempt human subject research protocols: no expiration; however, amendments must be reviewed and approved in order to ensure that the study still meets exempt criteria.

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. Your request will include each of the following documents in order for us to complete our review of your request:

  • Completed Continuing Review Status Update template.
  • Completed DHA Data Elements Request Summary template (if applicable).
  • Biosketch/CV and signed Researcher Responsibilities Form 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 researchers (CITI programs for biomedical and social/behavioral research [we do not accept refresher training]).  If you have completed training provided by your institution, then you need only complete the CITI Training Module.
    • Note - 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/Amend 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.  Your request must include each of the following documents in order for us to complete our review of your request:

  • Completed Protocol Modification Request template.
  • Completed DHA Data Elements Request Summary template (if applicable).
  • Biosketch/CV and signed Researcher Responsibilities Form 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 researchers (CITI programs for biomedical and social/behavioral research [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: Module for Non-DoD Personnel Conducting Research Involving Human Subjects Supported by the DoD (ID: 16769).
    • Note - 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.

Exempt Determinations

The Common Rule (32 CFR 219) provides for exemptions from IRB review for certain Categories of minimal risk studies. If a protocol meets the criteria for one or more of these exempt studies, then an IRB review is not necessary. The investigators, however, must comply with all of the provisions of The Common Rule as they pertain to the protection of human subjects of their research protocol.

If, upon reviewing 32 CFR 219.101(b), you believe that your protocol meets the criteria for one or more of the exempt categories, then complete the Request for Exempt Determination Review template and the DHA Data Elements Request Summary templates and submit it, along with all supporting documents, via email.

Investigators are not permitted to begin work on a protocol under the assumption that it is exempt from IRB review until a formal determination from this office has been received.

DHA Address: 7700 Arlington Boulevard | Suite 5101 | Falls Church, VA | 22042-5101

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