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Review Requirements

Investigators must obtain approval from a Department of Defense IRB, Human Protections Administrator or Exemption Determinations Official prior to initiating their activity.  Failure to do so might constitute a regulatory non-compliance that can result in sanctions.

Requirement for Scientific Review

In accordance with DoD Instruction 3216.02 (Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research), Enclosure 3 (Procedures), Section 3.a.(2), “The DoD institution shall have policies and procedures to require scientific review of non-exempt research involving human subjects and to ensure this review is considered during the IRB review process.” Within the DHA, activities that involve information collections (e.g., surveys) that have been reviewed by the Report Control Symbol process for internal information collections, or the Office of Management and Budget licensing process for information collections from the general population satisfies the requirement for scientific review.

Types of Reviews and Services Provided

The OASD(HA) and DHA Human Research Protection Program Office provides the following services toward carrying out our oversight responsibilities. All non-exempt human subjects research originating within the OASD(HA) and DHA must be reviewed by the Walter Reed National Military Medical Center’s Institutional Review Board (IRB):

  1. Human Research Protection Official’s (HRPO) Review of Research Protocols: review of studies that have been approved by a duly constituted IRB with a Federal-wide Assurance from HHS and an agreement with DHA attesting to its understanding of and adherence to DoD-specific protections.  For the sake of brevity, we have included among the HRPO Reviews the Continuing Review of ongoing activities extending beyond the original approval expiration date and the Review of Modifications to existing studies;
  2. Exemption Determinations: review of protocols to determine if criteria for exemption from IRB review are met as codified in 32 CFR 219 (HHS Regulation: 45 CFR 46 Protection of Human Subjects). “Exempt” protocols must still adhere to the ethical standards articulated in The Common Rule;
  3. Human Subject and/or Research Determinations: Federal Regulations define “human subject” and “research.” Our office will review protocols to determine if the studies meet these definitions; and
  4. Guidance and Assistance: our office provides guidance and advice to investigators during all stages of their study (including protocol development) in order to facilitate reviews and compliance.

Submission Requirements

All documents requiring review must be submitted using the Electronic IRB (EIRB) system.  Information on accessing and using the system can be found at the DHA EIRB page.

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

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