Principal Investigator (PI)

The PI is the subject matter expert who is responsible for

• Developing a scientifically sound and ethically appropriate research proposal
• Ensuring a clear, concise, and complete protocol
• Implementing the research as described in the approved protocol

Exemption Determination Official (EDO)

The EDO is the institution level HRPP expert who is responsible for

• Reviewing all activities for their institution(s) that appear to involve humans in research and determine if those activities
  - Meet the regulatory definition of human subjects and research
  - Are exempt from the human subjects research regulations
  - Require IRB review
• Providing researchers with documentation of exemption when appropriate
• Serving as liaison between researchers and HRPP reviewers and oversight

Institutional Review Board (IRB)

The IRB is a group of individuals, constituted as required by regulation and DoD Directive, with the authority and responsibility to

• Review all nonexempt human subjects research to ensure it is compliant with applicable statutes, regulations, directives and policies, including ethical human use practices.
• Recommend approval, modification, or disapproval of research protocols

Other Offices as Needed

Depending on the nature of the activity, it may require additional reviews for compliance with other statutes, regulations or policies. Most of these other offices are not under the purview of the HRPP; however, we attempt to coordinate review activities among our offices because there is frequently overlap in responsibilities. For example, using identifiable private information about individuals triggers reviews for compliance with the human subjects regulations as well as with the Privacy Act. Likewise, if the protocol involves the use of recombinant DNA, then it would need to be reviewed by both an Institutional Biosafety Committee (IBC) and an IRB. The timing of these reviews varies depending upon protocol specific characteristics, so sometimes these reviews will occur before EDO or IRB review and sometimes after.

Facility Commander / Institution Director

Research protocols that have been recommended for approval by an IRB must also be approved by the commander or director. For intramural research, this approval generally occurs after IRB review; for extramural research, this approval generally occurs prior to IRB review. The commander or director is responsible for

• Ensuring there are sufficient resources available to complete the protocol as designed
• Ensuring the protocol is consistent with institutional goals and objectives
• Ensuring researchers and others fulfill their responsibilities
• Ensuring appropriate response to issues as needed

2^nd Level Review at Component HQ

The Component Designated Official (CDO) for the OUSD(P&R) is the Deputy Under Secretary of Defense (Force Health Protection & Readiness). The CDO and staff are responsible for

• Promoting policies and procedures for ensuring efficient and effective protocol reviews
• Conducting second level reviews as needed
• Responding to compliance issues
• Conducting quality assurance reviews of component activities