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64. Additional DoD Requirements for Recruitment and Informed Consent

Recruitment

  • Officers are not permitted to influence the decision of their subordinates.
  • Officers and senior non-commissioned officers may not be present at the time of recruitment.
  • Officers and senior non-commissioned officers must be given a separate opportunity to participate (when applicable).

When research involves service members and recruitment will take place in a group setting, an independent ombudsman must be present when risk is greater than minimal. Under similar conditions when research risk is no greater than minimal, the IRB may require that an ombudsman be appointed. In the latter case, The IRB will base its decision to require an ombudsman on the sample population, and recruitment and consent processes.

Informed Consent

  • For individuals with impaired consent capacity when consent is to be obtained from participants' legal representative
    • the intent of the research must be to benefit the individual participant, and
    • an IRB must make the determination that the intent of the research is to benefit the individual experimental subject.
  • Waivers of the consent process are prohibited for classified research.
  • Waivers of the consent process are prohibited for emergency research unless a waiver is obtained from the Secretary of Defense.
  • Waivers of the consent process are prohibited if the research participant meets the definition of "experimental subject" unless a waiver is obtained from the Assistant Secretary of Defense for Research and Engineering and the research
    • is necessary to advance the development of a medical product for the Military Services,
    • may directly benefit the individual experimental subject, and
    • is conducted in compliance with all other applicable laws and regulations.
  • Research-related injury language in consent documents must follow the requirements of the DoD component. University and affiliate PIs conducting DoD research are advised to contact the DoD component for details about component-specific language.
    • Stricter requirements for disclosure of research-related injury language may apply: See item 10.b. in the Department of Defense directive 3216.02 dated November 11, 2011, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research available online at http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf.

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