The protection of the rights and welfare of research subjects is an accepted service responsibility. Air University holds a DoD Assurance number: F50436.
The Air University's Human Research Protection Program (HRPP) is responsible for the ethical and regulatory requirements related to the protection of human participants in research. The HRPP Point of Contact (POC), Dr. Christine M. Ross, email@example.com oversees and facilitates all research protocols involving human subjects research. Air University's HRPP POC serves as a member of Air University's IRB of Record, Air Force Research Laboratory (AFRL), and conducts applicability reviews to make Not Research, Not Human Subjects Research, and Exempt determinations. The HRPP POC provides compliance oversight, independently and in conjunction with the IRB, for research activities involving the use of human subjects. The HRPP POC serves as an advisor and informational resource for institutional policy and regulatory requirements; provides educational opportunities, training, and investigator consultations; and serves as the IRB's facilitator. The HRPP POC conducts required reporting to federal regulatory agencies, external organizations, and institutional administration.
As part of the determination, Air University's HRPP and IRB may recommend approval, require modifications in, withhold approval, or suspend research involving human subjects. No human subject research in any form (including recruitment, consent, or data collection) can take place without proper review and approval by Air University's IRB of Record, Air Force Research Laboratory (AFRL).
For the HRPP review, the following definitions are used:
Under 45 CFR 46, "Research" means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Additionally, under 45 CFR 46, "Human Subject" means a living individual about whom an investigator conducting research obtains:
(i) data through intervention or interaction with the individual, or
(ii) identifiable private information.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.
The research protocol will be reviewed to determine if the protocol meets the research definition. If the protocol is deemed research, then the protocol is reviewed to determine if it meets the definition of human subjects research.
If the protocol does not meet the definition of research or HSR, there is no further action required.
If the protocol meets the research definition and involves human subjects, the principal investigator must submit a full protocol packet outlined in B. AU Conducted
AU Conducted Protocol Packets must include, but not limited to the following items:
Please contact AU's HRPP Point of Contact (POC), Dr. Christine M. Ross, firstname.lastname@example.org
AU Supported Research must undergo a HRPO review. The AFRMA has appointed AU's HRPP POC as AU's HRPO. An HRPO review begins with reviewing the approving IRB (not AU's IRB of Record) packet, IRB determination, contract, agreements, CITI training, and Commander Approval. The HRPO will work with the Principle Investigator to determine additional requirements to complete the review.
AU's HRPP must review research External to AU. Other DoD and other external researchers must provide the approving IRB (not AU's IRB of Record) packet, IRB determination, contract, agreements, CITI training, and Commander Approval.
Please note: Additional requirements may be required, such as a survey control number or public affairs review. Refer to Brief Steps to Obtaining Approval for Research Involving Human Subjects at Air University.