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)
ID: 25-HSP-OHAROType: Sources Sought
Overview

Buyer

DEPT OF DEFENSEDEFENSE HEALTH AGENCY (DHA)ARMY MED RES ACQ ACTIVITYFORT DETRICK, MD, 21702, USA

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) (541715)

PSC

SUPPORT- PROFESSIONAL: OTHER (R499)

Original Source

https://sam.gov/opp/e38a3f127ebc4b6882eae1a91bbbce17/view
Timeline
    Description

    The Department of Defense, through the U.S. Army Medical Research and Development Command (USAMRDC), is issuing a Request for Information (RFI) to identify sources capable of providing Human Subjects Protection (HSP) Personnel Management and Support Services for the Office of Human and Animal Research Oversight (OHARO). The objective of this procurement is to gather industry feedback and interest regarding the necessary support services that comply with federal regulations on human subjects' protection, including protocol reviews, compliance oversight, and training for researchers. This initiative is crucial for ensuring ethical standards and regulatory compliance in medical research, particularly in military contexts, thereby safeguarding the welfare of research participants. Interested parties must submit their capabilities statements by November 20, 2024, and can direct inquiries to Alana M. Sowers at alana.m.sowers.civ@health.mil.

    Point(s) of Contact
    Alana M. Sowers
    alana.m.sowers.civ@health.mil
    Files
    Title
    Posted
    PWS Attachment A - Org Chart - HSP Personnel Management and Support Services - USAMRDC OHARO.pdf
    The document presents the organizational structure of the Office of Human and Animal Research Oversight (OHARO) and its related components, detailing personnel roles and allocations within the federal workforce. It identifies the OHARO’s Director and Office Manager as federal employees, dividing oversight efforts into different teams (Green, Red, White, Blue) with various contractors contributing as Human Subject Protection Scientists across multiple agencies, including USAMRDC, CDMRP, and DARPA. The structure consists of a blend of full-time federal employees (FTE) and contract full-time equivalent staff (CFTE), with a total of 10.325 FTEs and 27.5 CFTEs designated for research review and oversight activities. Each team focuses on distinct aspects of research review related to human and animal subjects, ensuring compliance with regulatory standards. The document highlights the importance of these roles in safeguarding research ethics and participant protections while facilitating scientific inquiry, thus serving as a crucial resource in the context of federal grants and RFPs aimed at advancing human and animal research oversight. This structured approach is vital in aligning with governmental policies and ensuring accountability in research practices.
    RFI - SS Attachment 1 Draft PWS - HSP Personnel Management and Support Services - USAMRDC OHARO.pdf
    The U.S. Army Medical Research and Development Command (USAMRDC) is requesting contractors to provide Human Subjects Protection (HSP) personnel management and support services. The Office of Human and Animal Research Oversight (OHARO) oversees regulatory compliance and welfare of human subjects and animals in research. The contractor will support OHARO and the Office of Human Research Oversight (OHRO) through various tasks including initial and post-approval protocol reviews, administrative support, compliance oversight, and education and training for researchers. The contractor's responsibilities also include managing and supervising on-site personnel, developing compliance policies, and providing quality assurance initiatives. Services must adhere to stringent federal regulations and ethical standards in human research, ensuring the safety of research participants. This initiative showcases the commitment of the USAMRDC to maintain high ethical and regulatory compliance in their medical research activities, vital for maintaining operational effectiveness in military settings.
    RFI - SS for HSP Personnel Management and Support Services - USAMRDC OHARO.pdf
    The U.S. Army Medical Research and Development Command (USAMRDC) is issuing a Request for Information (RFI) for Human Subjects Protection (HSP) Personnel Management and Support Services. This RFI aims to gather industry interest and feedback concerning the upcoming requirement for support to the Office of Human and Animal Research Oversight (OHARO). The selected services must comply with various regulations on human subjects' protection. Respondents are invited to submit a capabilities statement reflecting their past performance and relevant experience related to this requirement. Each submission must include detailed business information and should respond to specific questions regarding the organization’s capabilities and feedback on the draft Performance Work Statement (PWS). The anticipated contract will be a Firm Fixed Price with Cost Reimbursement for 27.5 Full-Time Equivalents (FTEs). Companies interested in bidding must respond by November 20, 2024, and are reminded that this RFI is not a solicitation for contracts. The overarching goal is to identify capable sources to provide necessary personnel and support services while adhering to established regulatory standards.
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