The U.S. Air Force Academy Human Research Protection Program (USAFA HRPP) protects the rights and welfare of people who participate in human subjects research (HSR) conducted, supported, or reviewed by USAFA. The HRPP supports ethically sound, scientifically useful research while helping investigators comply with federal, Department of Defense (DoD), Department of the Air Force (DAF), and USAFA requirements.

The HRPP includes the USAFA Institutional Review Board (IRB), which reviews research involving human subjects and supports the Belmont Report principles of respect for persons, beneficence, and justice.

Research Supported by the HRPP

USAFA researchers conduct research in areas such as human physical performance, warfighter effectiveness, human-machine and human weapon systems, organizational effectiveness, education, and training. The HRPP supports these efforts through regulatory oversight, education, consultation, post-approval compliance monitoring, and coordination with operational and academic units.

Before You Begin

Contact the HRPP early if your project may involve people, identifiable private information, identifiable biospecimens, cadets, DoD-affiliated personnel, external collaborators, artificial intelligence-enabled tools or capabilities, surveys, recruitment at USAFA, or USAFA support to a non-DoD institution.

Only designated federal DoD HRPP personnel may make determinations about whether an activity is HSR or exempt HSR. Investigators should not make these determinations for their own projects.

• Do not begin recruitment, consent, data collection, access to identifiable private information or biospecimens, or other HSR activities until the HRPP has issued the required written determination, approval, and institutional permission.
• Submit proposed changes before implementing them, except when a change is necessary to eliminate an immediate hazard to subjects.
• Maintain current training and study records throughout the life of the project and after closure as required.

What Requires HRPP Review?

An activity generally requires HRPP review when it may meet both the regulatory definition of research and the regulatory definition of human subject.

• Research: a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
• Human subject: a living individual about whom an investigator obtains information or biospecimens through intervention or interaction and uses, studies, or analyzes them; or obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Projects may also require HRPP review when USAFA is engaged in HSR by recruiting participants, obtaining informed consent, interacting or intervening with living individuals, or obtaining, using, studying, analyzing, or generating identifiable private information or identifiable biospecimens.

Assurances and IRB Registration

Human subjects research at USAFA is conducted under the following institutional assurances and registrations:

• DoD Assurance: F50046
• Federalwide Assurance: FWA00019017
• Institutional Organization Registration: IORG0006125
• IRB Registration: IRB00007373

The USAFA Institutional Official (IO) is the USAFA approval authority for the HRPP. The DAF Component Office of Human Research Protections (DAF COHRP) is the DAF approval authority for the USAFA HRPP.

Review Pathways

1. Not Human Subjects Research (NHSR) or Not Research determination. The HRPP may determine that an activity does not meet the regulatory definition of research or HSR.
2. Exempt HSR determination. Some HSR may fall into an exemption category under 32 CFR 219.104. Exempt determinations must be made by authorized HRPP personnel or Exempt Determination Officials (EDOs).
3. Exempt HSR with limited IRB review. Some exempt categories require limited IRB review by an IRB member designated by the IRB Chair.
4. Expedited IRB review. Minimal risk, non-exempt HSR that fits an expedited review category may be reviewed by the IRB Chair or an experienced IRB member designated by the Chair.
5. Convened IRB review. HSR that does not qualify for exempt or expedited review is reviewed by the convened IRB when quorum and required membership are present.

Only the convened IRB or IO/AIO may disapprove research. Expedited reviewers and EDOs may require changes, issue determinations within their authority, or refer projects for additional review.

Submitting a Protocol

Principal investigators should submit a complete HRPP Research Protocol Application to usafa.hrpp@afacademy.af.edu. Submission requirements depend on personnel affiliation, research location, whether another IRB has reviewed the activity, and whether USAFA is conducting, supporting, assisting, or reviewing the HSR.

Submissions typically include:

• HRPP Research Protocol Application or determination request;
• Letter of Support or command/institutional documentation, when required;
• current CITI training documentation for all personnel listed, commensurate with role;
• current CVs for all principal investigators, except cadet investigators when not required;
• study instruments, questionnaires, recruitment materials, and survey control documentation when applicable;
• informed consent documents or a request for waiver or alteration of informed consent or documentation of informed consent;
• IAIRs, IIAs, contracts, grants, Cooperative Research and Development Agreements (CRADAs), or other agreements when applicable.

Convened IRB review deadline: Submissions requiring full board review should be initially submitted at least two weeks ahead of the month in which the IRB meets, to work with HRPP staff to ensure the submission is complete. Submissions that are complete and ready for review by the first business day of the month in which the IRB meets may be placed on that month’s agenda. The IRB generally meets on the third Thursday of February, April, June, August, October, and December.

Scientific Merit Review

All HSR conducted at USAFA requires scientific merit review. Scientific merit review helps ensure that proposed HSR has a clear research question, uses methods appropriate to the discipline, can produce scientifically useful data, and minimizes risk through sound research design.

• For exempt HSR, scientific merit review may be documented through a department research director, comparable delegated authority, or qualified peer expert.
• For non-exempt HSR, completion of a detailed scientific merit review form is required.
• Scientific reviewers must not have a conflict of interest with the research they review.
• For HSR involving AI-enabled tools or capabilities, scientific merit review must consider DoD responsible artificial intelligence principles.

Human Subjects Research Training

USAFA personnel who conduct, support, review, or oversee HSR must complete human subjects protection training commensurate with their roles and responsibilities before carrying out HRPP or HSR responsibilities. USAFA uses CITI training through the U.S. Air Force Surgeon General’s Office account, including modules addressing DoD and DAF requirements.

• Investigators must complete the investigator training group and include current training documentation with submissions unless already on file.
• Research support personnel must complete training appropriate to their role.
• Training is renewed at least every three years, with continuing education in intervening years as required.
• USAFA may accept current CITI training from other DoD affiliations. USAFA does not accept civilian-institution CITI training that does not address DoD requirements.

Research Involving Cadets or DoD-Affiliated Personnel

Cadets, cadet candidates, Service members, civilian employees, and other DoD-affiliated personnel require special attention in recruitment, consent, privacy, confidentiality, compensation, and command influence. Cadets are students, military trainees, and DoD-affiliated personnel; research procedures must address these overlapping roles.

• Participation in HSR must be voluntary. Military and civilian supervisors, officers, faculty, and others in the chain of command may not use their positions to coerce, influence, or prevent participation.
• Supervisors and chain-of-command personnel generally may not be present during recruitment or informed consent procedures for DoD-affiliated personnel.
• Research involving risks to fitness for duty, accession, clearance, credentials, privileged access, or other duty-related consequences must disclose those risks when applicable.
• Recruitment during Basic Cadet Training is not allowed unless approved by the Superintendent.
• Compensation to DoD-affiliated personnel for research participation while on duty is prohibited except as allowed by applicable law and policy.

Informed Consent

Informed consent is a process, not only a form. It requires disclosing information needed for an informed decision, promoting understanding, and preserving voluntariness. Consent materials must use language appropriate for the participant population and must explain that participation is voluntary and that no sanctions will occur for declining participation.

For Service members and cadets, informed consent documents should address limits to confidentiality when applicable, including mandatory reporting obligations, harm to self or others, certain substance-related disclosures, sexual assault or abuse reporting requirements, and cadet honor code reporting obligations.

External Collaborators and USAFA-Supported Research

USAFA generally permits USAFA-conducted and/or USAFA-supported research. HSR conducted by non-DoD personnel with permission to recruit DoD personnel as subjects is DoD-assisted research, a subset of supported research. Exceptions require IO approval.

External investigators and institutions should coordinate with the HRPP early to determine whether USAFA is engaged, whether USAFA support or material assistance is involved, whether an IAIR or IIA is needed, and whether HRPO review, CLAR, or institutional approval is required before the research begins.

Human Research Protection Official (HRPO) Review

HRPO review is required for USAFA-supported HSR conducted by non-DoD institutions, including support provided through funding, facilities, equipment, personnel, access to or information about USAFA-affiliated personnel for recruitment, data, or specimens. HRPO review may also be required when USAFA collaborates with non-DoD investigators and a non-DoD IRB serves as the IRB of record.

The HRPO reviews the non-DoD IRB approval package and related documents to ensure applicable DoD and DAF requirements have been addressed before USAFA support or material assistance begins. HRPO review may be coordinated through DAF COHRP or a local HRPO.

Component-Level Administrative Review (CLAR)

DAF COHRP conducts CLAR before research begins when required by DoDI 3216.02_DAFI40-402. Examples include certain non-exempt HSR conducted in a foreign country, non-exempt HSR requiring waiver of informed consent under 10 U.S.C. 980, fetal research, classified HSR, large-scale genomic data collected from DoD-affiliated personnel, or other research requiring COHRP approval.

Privacy, Confidentiality, Records, and Post-Approval Monitoring

• Investigators must protect privacy and confidentiality as described in the approved protocol and consent materials.
• Investigators must maintain required HSR records, including determinations, approved protocols, consent documents, review correspondence, amendments, approvals, and progress or closure documentation.
• Approved and permitted HSR is subject to post-approval compliance monitoring (PACM), risk assessment, audit, and reporting procedures.
• Investigators must promptly report possible noncompliance, deviations, unanticipated problems involving risks to subjects or others (UPIRTSOs), and other reportable events according to HRPP requirements.

Education, Consultation, and Resources

The Human Protections Director and HRPP staff provide consultation, training, local guidance, and educational tools for cadets, faculty, staff, departments, and research centers. HRPP staff are available to help investigators determine review requirements, prepare submissions, understand DoD-specific protections, and navigate the HSR lifecycle.

USAFA personnel may access internal forms, templates, consultation scheduling, policy updates, and Nova Notes through the Research Protections SharePoint site. External collaborators should contact the HRPP at usafa.hrpp@afacademy.af.edu for current submission instructions and required templates.

Contact

USAFA Human Research Protection Program
Email: usafa.hrpp@afacademy.af.edu
Internal resources: Academic Wing Research Protections SharePoint site

Frequently Asked Questions