OHSP has recently updated the policies listed below. None of the revisions included in these policies impact currently approved/ongoing research.
- NEW! Policy 105 HRPP Emergency Preparedness – This policy establishes an HRPP emergency preparedness process to ensure the protection of human subjects in the event of an emergency or disaster situation.
- Policy 502 Types of RSRB Submissions – In addition to editorial/administrative revisions, the updated policy provides clarification regarding Just-in-Time submissions (Section 5.1.2) and administrative closures following lapse in IRB approval (Section 8.8).
- Policy 504 IRB Reliance and Collaborative Research – Section 10 was added to provide clarification on reliance-related requirements for research that is conducted or supported by the Department of Defense
- Policy 609 Research Supported by the Department of Defense (DoD) – Extensive revisions were made to this policy based on updated DoD regulations. In summary, these revisions include: clarifying Investigator responsibilities and requirements (Sections 5.2, 5.3, 5.9, 6.4); defining requirements for the appointment of an ombudsperson (Section 5.8); further defining/clarifying requirements for RSRB (Sections 6.1, 6.6) and DoD Office for Human Research Protections (Section 6.2); and adding considerations for research involving vulnerable populations (Section 7). The corresponding Checklist for RSRB Review of Research Supported by DoD has also been updated to reflect these requirements.
- Policy 701 Informed Consent – The revisions made to this policy are largely editorial/administrative in nature and are intended to provide clarification on consent-related requirements and further alignment with federal regulations and current practice. Specific additions include: a) definition of e-consent and legally authorized representatives (Section 3); b) disclosure requirements related to the use of e-mail and text messaging (Section 6.6.5); c) expectations pertaining to the e-consent process (Section 7.1.2); and d) alternative consent processes for screening and recruiting purposes (Section 9).