This Government Contract opportunity from Department Of Health And Human Services was posted on April 29, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.
Regulatory and Legal Advisory Services for IRB Reliance Agreements
Contract Overview
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AI Contract Overview
The contract seeks expert legal counsel to advise on institutional review board reliance agreements, including the preparation, review, and updating of SMART IRB Authorization Agreements, ensuring alignment with current federal human subjects research regulations under 45 C.F.R. Part 46. The advisor must provide authoritative guidance on regulatory compliance, interpret federal requirements, and support the implementation of streamlined multi-site research reliance frameworks. This work is critical to maintaining the integrity of ethical review processes and ensuring that all participating institutions adhere to consistent and legally sound practices across federally funded human subjects research. The contract is classified as a subcontract under NAICS code 541110, issued by the National Institutes of Health through the Department of Health and Human Services. The opportunity was posted on April 29, 2026, with a response deadline of May 8, 2025, indicating a potential error in the timeline, and no specific location is designated for performance, suggesting the work may be conducted remotely. The agency seeks a contractor with demonstrated expertise in federal research regulations and experience in negotiating and managing IRB reliance arrangements to support complex, multi-institutional research initiatives.
General Info
Place of Performance
MD, USASet-Aside
Documents
This scope was carved out of 75N98026Q00287.
The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.
SMART IRB Governance, Administration, and Operations Support (GAOS)
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Timeline
Submission Closed
Organization & Contact Information
Full Description
More opportunities from Department Of Health And Human Services → National Institutes Of Health Nida
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