DHA RFI: Human Subjects Protection (HSP) Personnel Management and Support Services

Notice ID: 25-HSP-OHARO

This is a Request for Information (RFI)/Sources Sought for Human Subjects Protection (HSP) Personnel Management and Support Services for the U.S. Army Medical Research and Development Command (USAMRDC), Office of Human and Animal Research Oversight (OHARO).

Scope. The Contractor shall provide all personnel, training, materials, supervision, and non-personal services necessary to provide HSPS support for the OHARO and the OHRO.  The Contractor shall also provide HSPS Subject Matter Expert and program management support for the OHARO and the OHRO operations, including workload management and administrative support, operating procedure development, quality assurance, and process improvement initiatives.  The Contractor shall provide HSPS onsite supervision for personnel that support the OHARO and the OHRO.   The OHARO requires support for the USAMRDC Human Research Protection Program (HRPP), specifically for the USAMRDC OHARO and OHRO extramural and intramural activities.  Research protocols funded, conducted, or supported by the USAMRDC must be reviewed for compliance with DoD, federal, state, host national, and local human subjects’ protection regulations and human research ethical standards. The general scope of the OHARO’s requirements is organized into fourteen (14) support areas as listed below:

Area 1:  Initial Administrative Review

Area 2:  Limited Initial Administrative Review

Area 3:  Post-Approval Oversight

Area 4:  Administrative Support

Area 5:  Human Research and Cadaver UseCompliance Oversight

Area 6:  IRB Research Protocol Pre-review

Area 7:  Human Subjects Protection Policies and Procedures Development Support

Area 8:  Human Subjects Protection Education and Training

Area 9:  Quality Assurance

Area 10:  Performance Improvement

Area 11:  IRB Member Consultant Protocol Review

Area 12:  Cadaver Use Activity Consultation

Area 13:  Management of On-Site Personnel and Reporting

Area 14:  Additional Contract Personnel (SURGE)

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