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Mandatory Training Requirements

The Office of the Assistant Secretary of Defense has established minimum education requirements for DoD personnel involved in human subjects research, to include an annual training with required educational topics (Minimum Education Requirements Memo, 16 August 2012). To ensure your compliance with these requirements, the Air Force Surgeon General’s Office (AF-SG) provides human subjects protection training through the Collaborative Institutional Training Initiative (CITI).

Investigators and Research Support Personnel involved in human subjects research must complete the appropriate training. Below are the various groups available when you affiliate with the Surgeon General’s office on CITI for training. Please discuss your role in the research project with the Principle Investigator, then read each description and choose the appropriate training based on your research activities. If you have multiple roles, you must have multiple certificates (e.g. IRB member and investigator).

Group 1: Senior AF Leadership, Institutional Officials, Advisors to the Institutional Official
- Senior DoD Component Leadership: Examples include, but are not limited to, the Senior DoD Component Designated Official identified in the Component’s HRPP Management Plan, the person(s) responsible for approving and accepting assurances, the DoD Coordinating Committee for Human Research Protection Programs (CCHRPP) member, and other personnel above the organizational level of the DoD Component HRPP Headquarters Oversight office.

- Institutional Officials (IO): The senior person authorized to establish and responsible to maintain the HRPP for the DoD institution. If the institution has a Federal assurance, this is the individual in the institution who signs the Federal assurance and is responsible for the institution’s compliance with the terms of the assurance.

- Advisors to the Institutional Official: Personnel (e.g., attorneys, ethicists) outside of the IRB and IRB Office who provide an interpretation of part 219 of title 32, Code of Federal Regulations (32 CFR 219), DoDI 3216.02, and other HRPP policies to the institutional official.

Group 2: AF Headquarters Oversight Personnel.
- DoD Component HQ Oversight Personnel: Personnel responsible to the Senior DoD Component Leadership for implementing the Component HRPP Management Plan and providing day-to-day guidance and oversight to the Component’s institutions.

Group 3: IRB Members and Support Staff, Regulatory Oversight of Extramural Human Subjects Research
- Institutional Review Board Members: All members of the IRB (e.g., Chairs, co-Chairs, primary members, alternate members, prisoner representative, community members, etc.). Consultants (i.e., non-voting members) to the IRB are not required to have the same level of education as the voting members. Consultants should be educated on the ethics, policies, or other topics for which they are being asked to consult.
- Institutional Review Board Support Staff: The personnel supporting the IRB members (e.g., staff who are advising the investigators, conducting preliminary review of protocols before submission to the board, and providing training to HRPP personnel).
- Regulatory Oversight of Extramural Human Subject Research: Personnel involved in ensuring the research involving human subjects that is supported by DoD but conducted by non-DoD institutions is compliant with DoD Component policies. For extramural contracts, this role is known as the Human Research Protection Official.

Group 4: Investigators - Investigators: Personnel who are responsible for creating the research protocol and/or conducting the research. There can be more than one investigator on a protocol.

Group 5: Research Support Personnel, Research Monitors, Ombudsmen, Subject Advocates, DSMB Members
- Research Support Personnel: Personnel who are participating in a limited and/or defined part of the research protocol under the direct supervision or guidance of an investigator.
- Research Monitors, Ombudsman, Subject Advocates, Data Safety Monitoring Boards (DSMBs): Personnel who are not part of the research team and who have been appointed by the IRB or are identified in the IRB-approved protocol to act on behalf of the IRB (e.g., Research Monitor or Ombudsman) or on behalf of the research subject (e.g., Subject Advocate). Personnel in this category should be educated on the ethical and regulatory topics at a depth appropriate for which they are being tasked.

Group 6: Research Coordinators, Clinical Coordinators, Study Coordinators, Research Administrators
- Research Coordinators, Clinical Coordinators, Study Coordinators, and Research Administrators: Personnel, such as the Research Coordinators, Clinical Coordinators, Study Coordinators, and Research Administrators, responsible for conducting the research under the auspices of the investigator(s) or personnel involved in the preparation and administration of research protocols.

Associated Instructions:
• Researcher Instructions - You have NEVER taken human subjects training through the Collaborative Institutional Training Initiative (CITI)
• Researcher Instructions – You have taken human subjects training through the Collaborative Institutional Training Initiative (CITI), but were not affiliated with the U.S. Air Force Surgeon General’s Office
• Researcher Instructions – You have taken human subjects training through the Collaborative Institutional Training Initiative (CITI) affiliated with the U.S. Air Force Surgeon General’s Office in the past 365 days
• Researcher Instructions – You have taken human subjects training through the Collaborative Institutional Training Initiative (CITI) affiliated with the U.S. Air Force Surgeon General’s Office more than one year ago

Contact Us

HQ USAFA/A9N
2304 Cadet Drive,
Suite 3800
USAF ACADEMY, CO 80840-5002

Email Address:
usafa.irb@usafa.edu

Telephone Number, HRPP Administrator
Commercial: 719-333-6593 DSN: 333-6593

Telephone Number, Exemption Determination Official (EDO) for Educationally Exempt Research
Commercial: 719-333-3277 DSN: 333-3277