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Templates

HRPO Templates

  • Research Protocol Submission Template: To be used by investigators to submit a non-exempt study that has not already been reviewed and approved by an IRB.
  • Scientific Review Checklist: To be used by an independent reviewer of protocols for scientific merit.  This checklist is optional; however, it should guide reviewers and investigators on the items of interest during the mandatory scientific review process.
  • Protocol Modification Request Template: To be used when requesting a modification to a previously approved and still ongoing study.
  • Protocol Continuing Review Template: All approved studies have a corresponding approval expiration date.  If the investigator wishes to continue work beyond that expiration date, then this template must be used to request the continuation.
  • Researcher Responsibilities Form: A standard form that must be signed by each investigator (PI and Associate Investigators) attesting to their understanding of and adherence to the special protections afforded to our beneficiary population .

Exempt Determination

  • Exempt Determination Request Template: Investigators who believe that their studies qualify for one of the exemptions from IRB review found in 32 CFR 219 should use this template to request a determination from the DHA HRPP.
  • Exempt Categories: An excerpt of 32 CRF 219.101(b) that describes the Categories of research that are of minimal risk and do not require IRB review.  The investigators conducting these studies must still comply with Common Rule protections.
  • DHA Data Elements Request Summary: Used by investigators and reviewers to determine what potential individual identifiers are included among the data elements requested/required.

Human Subjects and/or Research Determinations

  • Research or Human Subjects Determination Template: Investigators who believe that their activities do not meet the regulatory definition of “human subjects” and/or “research” as defined in 32 CFR 219 should use this template to request a determination from the DHA HRPP.
  • DHA Data Elements Request Summary: Used by investigators and reviewers to determine what potential individual identifiers are included among the data elements requested/required.

Protocol Submission Guidance Documents

  • General Submission Requirements: Explains the DHA HRPP requirements for protocol submission for each type of review requested and provides timelines for the reviews.
  • HRPO Review Checklist: This should be used to confirm that you have a complete protocol package before submitting it for DHA HRPO review.

Other Templates

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