711 HPW - Institutional Review Board Our Vision: To be a leading enabler and trusted vital partner in all AFRL research endeavors involving human subjects and biologics designed to advance war-fighting capabilities in air, space, and cyberspace. Our Mission: To facilitate excellence in human-performance and technological research through ensuring biological safety for all, the protection of the rights and welfare of human subjects and use of their data, timely and fair application of research regulations, promotion of ethical and scientifically valid research methodologies, competent consultation, continuous education of research community, and unwavering attention to research quality assurance. IR maintains two programs: a Human Research Protection Program (HRPP) and a Biosafety Program. IR HUMAN RESEARCH PROTECTION PROGRAM There are two types of submissions under HRPP: Intramural (Investigators affiliated with AFRL conducting activities with participants, their data, biospecimens from living individuals, or things under FDA oversight) and Extramural (Investigators receiving “support” from AFRL to conduct activities with participants, their data, biospecimens from living individuals, or things under FDA oversight). Intramural research: Investigators should visit the Institutional Review Board Information Center (CAC required) to download the latest submission templates and review information on processes for protocol submission and training requirements necessary to engage in human subjects research. They should also review applicable regulations and guidance documents, including the AFRLI 40-402 Protection of Human Subjects in Research. All conducted human subject research activity must receive a determination or approval from the AFRL IRB prior to initiation. Questions and submissions can be directed to: AFRL.IR.PROTOCOLMANAGEMENT@us.af.mil Extramural research: defined as a non-DoD institution receiving “support” from AFRL. “Support” means you are receiving funding, equipment, use of DoD facilities, or use of DoD-affiliated personnel to conduct an activity that involves humans, their data, or biospecimens from living individuals. If this is the case, you are required to receive an AFRL Human Research Protection Official (HRPO) review prior to the start of your activity. The AFRL HRPO review is a regulatory review to ensure DoD regulation is followed, not a second IRB review. Generally, the non-DoD institution will obtain their own IRB review and then submit that documentation along with the contract/proposal information for HRPO review. Questions and submissions can be directed to: AFRL.IR.HRPO@us.af.mil EXTRAMURAL DOCUMENTS: 1. INSTRUCTIONS – Extramural Submission Instructions 2. CHECKLIST – Extramural Initial Submission Checklist 3. INFO SHEET – DoD Supported Human Subjects Research IR BIOSAFETY PROGRAM The 711 HPW Biosafety program advises 711 HPW and collaborators on matters involving biosafety, coordinates the transfer of biosafety information to personnel and standing committees that overlap with biosafety issues, makes biohazard policy consistent with federal, state, and local laws, regulations and guidelines, and provides expedient and proactive consultation and review for investigators, laboratory, staff, and the research community at large. The IR Biological Safety Program implements DoDM 6055.18 and establishes the Institutional Biosafety Committee to ensure personnel safety and Institutional compliance for research and laboratory activities involving the use of infectious agents and toxins, recombinant/or synthetic nucleic acids, and Human source materials. CONTACT THE 711 HPW/IR OFFICE: Intramural submissions: AFRL.IR.PROTOCOLMANAGEMENT@us.af.mil Extramural submissions: AFRL.IR.HRPO@us.af.mil Biosafety submissions: 711HPW.ir.biosafety@us.af.mil REGULATION REFERENCES: This is a list of the common human subject regulations. 10 USC 980 – Limitations On Use Of Humans as Experimental Subjects 21 CFR 50 – Protection of Human Subjects 21 CFR 56 – Protection of Human Subjects 32 CFR 219 – Protection of Human Subjects AFRLI 40-402 – Using Human Subjects in Research DoD 5400.11-R – Department of Defense Privacy Program DoD 6025.18-R – DoD Health Information Privacy Regulation DoD 3216.02 – Protection of Human Subjects and Adherence to Ethical Standards in DoD-conducted and DoD-supported Research DoDI3216.02_DAFI 40-402 – Protection of Human Subjects and Adherence to Ethical Standards in DAF-conducted and DAF-supported Research This is a list of the common biosafety regulations. DoDM 6055.18 - Standards for Microbiological and Biomedical Laboratories 711 HPW Operating Instructions 90-800 - 711 HPW Biosafety Program (CAC required located on IR SharePoint) NIH Guidelines - Research Involving Recombinant DNA and synthetic Nucleic Acids USG Policy - Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC)