HRPP Manual Section 12-10

U.S. Department of Defense Requirements: U.S. Air Force

The Air Force has issued DODI3216.02_AFI40-402, Protection of Human Subjects and Adherence to Ethical Standards in Air Force Supported Research which implements and extends the instructions of the DoD Instruction 3216.02. In addition, the  Air Force Guidance Memorandum to DODI3216.02_AFI40-402, Protection of Human Subjects and Adherence to Ethical Standards in Air Force Supported Research, immediately implements changes to DODI3216.02_AFI40-402.  The Air Force Guidance Memorandum becomes void after one year has elapsed from 15 July 2021, or upon incorporation by interim change to, or rewrite of DODI3216.02_AFI40-402, whichever is earlier.

This guidance provides Air Force requirements in addition to the DoD Instruction. Relevant sections of the AFI40-02 are included below; however, see AFI40-02 for full requirements. When AFI40-02 applies to an IRB submission, the IRB Administrator will also work with the PI to assure requirements specific to the Air Force are met.

Applicability

The AFI40-402 applies to U.S. Air Force, which includes the Air Reserves Components (encompassing the Air National Guard and Air Force Reserve).

DoD Supported Research

Under the AFI40-02, an activity is not considered to be DoD-supported when a DoD employee either has been formally authorized to pursue an outside activity separate from their DoD position, or is in an off-duty status or otherwise not working in a DoD capacity, and if the activity does not otherwise involve the DoD.

In addition, under the AFI40-02, legal transfer (e.g., through sale or donation) of equipment from the DoD to non-DoD institution, when not done by the DoD for the purpose of enabling specific research involving human subjects, severs the relationship with the DoD, and the transfer is not considered DoD support

Research in Foreign Countries

Before the IRB approves research involving human subjects conducted in a foreign country whose laws and regulations apply to the research, the following requirements must be met:

  • Confirm all applicable national laws and requirements of the foreign country have been met

  • IRB shall consider the cultural sensitivities in the setting where the research will take place

  • IRB must document the source of information about the foreign research context in writing and maintain this with the research records (e.g., via letters from consultants and/or IRB minutes of meeting discussions in which consultants participated).

DoD Component Level Review for Non-Exempt Human Subject Research

DoD Instruction 3216.02 identifies conditions that require the DoD Component to conduct a component-level administrative review of all non-exempt human subject research.

In addition, when the AFI40-42 is applicable, the following conditions also require a component-level administrative review:

  • Research involves biological or chemical warfare agents or weapons and is not prohibited by 50 U.S.C. 1520a

  • Activity is either exempt or non-exempt research involving human subjects, and involves collection of statistical information under a promise of confidentiality per the Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA) and section 512 of Public Law 107-347.

HRPO Review

Successful completion of human research protection official (HRPO) review is required prior to initiation of Air Force supported research involving human subjects. The non-DoD institution shall ensure receipt of confirmation that the HRPO review is complete and that the activity is compliant prior to initiation of the research.

When documentation is provided to the HRPO, the HRPO has authority to concur, require modifications in (to secure concurrence), or nonconcur with non-DoD institutions’ determinations. When unable to concur with the non-DoD institution’s determination, HRPO will provide written documentation of its decision, which shall include the decision’s rationale, relevant regulatory citations, and, if appropriate, modifications required to support a finding of compliance and thus, HRPO concurrence.

Reporting

In addition to the reporting required in DoD Instruction 3216.02, the non-DoD institution shall promptly notify the HRPO when significant changes to the research protocol are approved by the IRB.

A significant change means an amendment to a non-DoD conducted activity that requires prompt notification to HRPO. This includes all substantive changes (see definition below), major non-administrative amendments (e.g., changes in protocol design) and administrative changes that affect HRPO’s ability to adequately oversee the activity (e.g., a change in the institution’s PI).

A substantive change means an amendment to an approved item which changes it to the extent it requires new review prior to initiation. Substantive changes are a sub-set of significant changes.

  • Examples of substantive changes to Air Force Issued DoD Assurances requiring Air Force Medical Service Agency Research Oversight and Compliance Division (AFMSA/SGE-C) approval prior to start include, but are not limited to, changes in signatory officials or in the description of an institution.

  • Examples of substantive changes to non-DoD conducted activities requiring HRPO acceptance prior to start include, but are not limited to:

    • Addition of specific conditions identified in AFI40-402

    • Addition of any condition that may impact issues initially reviewed by the HRPO, e.g.

      • Addition of personnel of institutions not identified upon initial HRPO review;

      • Change in the IRB’s determination of review procedure or risk level (e.g., from expedited to exempt, expedited to convened board, etc.);

      • Addition of subjects who cannot consent; or

      • Addition of a foreign research site including non-U.S. citizens as human subjects.

PIs should check with HRPO if there are any questions on whether reporting to HRPO is required.

Training

Air Force policy is to accept from any engaged DoD institution any HRPP training certificate documenting compliance with standards set forth by Assistant Secretary of Defense for Research and Engineering; duplicate local HRPP training shall not be required.

Compensation

Air Force will not accept voluntary services without compensation when such services may provide a basis for a future claim against the government. An individual may enter into an independent contractor relationship with the Air Force and participate for compensation, as authorized by applicable directives (e.g., 45 Comptroller General 649).

For Air Force conducted research involving human subjects, one of the following statements need to be included in each informed consent document:

  • If compensation is not provided, state there are no plans to provide compensation for participation in the research.

  • If compensation is provided, state there are no plans to provide other compensation beyond that described in the informed consent document.

Additional Protections for Confidentiality

All proposals to use authority under Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA) or a Certificate of Confidentiality must be coordinated with AFMSA/SGE-C prior to implementation

Air Force Emergency Use of a Drug, Device or Biological Product

Emergency use means the use of an investigational drug, device, or biological product with a patient in a life-threatening situation in which no standard acceptable treatment is available and there is not sufficient time to obtain IRB approval.

AFI40-02 provides the following regarding emergency use:

  • Emergency use of an investigational drug, device, or biological product under life-threatening circumstance for treatment purposes is not research.

  • The treating physician initiating emergency use procedures is responsible for compliance with applicable FDA regulations, to include reporting the emergency use to the IRB within five days after the use.

  • In a timely manner after completion of their review of the emergency use, the Air Force IRB shall forward documentation demonstrating regulatory compliance of the emergency use to AFMSA/SGE-C, with patient identifiers redacted. AFMSA/SGE-C will review the use and concur, nonconcur, or concur with comments.

This guidance document supersedes those previously drafted.

Version Date: 9-21-2022

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