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Review Requirements

Requirement for Scientific Review

NOTE: 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.”

Types of Reviews and Services Provided

The OASD(HA) and TMA Human Research Protection Program Office provides the following services toward carrying out our oversight responsibilities:

  1. Human Research Protection Official’s (HRPO) Review of Research Protocols: review of studies that have been approved by a competent Institutional Review Board (IRB) with a Federal-wide Assurance from HHS and an agreement with TMA 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. Exempt Determination: 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.

Review Requirements

Protocols are to be submitted for review in IRBNet. At this time, access to IRBNet requires a Common Access Card (CAC) for credential verification. We do not accept protocol submissions via email.

Resources



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