SMART IRB Governance, Administration, and Operations Support (GAOS)

Open Solicitation Posted

Solicitation number
75N98026Q00287
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Maryland, United States

Notice details come from SAM.gov. Updated .

About this opportunity

NIH's National Center for Translational Sciences (NCATS) seeks a partner for governance, administration, and operations support of the SMART IRB program through a combined synopsis/solicitation, with responses due November 13, 2026 at 12:00 pm Eastern. The notice lists the National Institute on Drug Abuse as the agency of record. The procurement is full and open with no set-aside used. It is a commercial services acquisition conducted under FAR Subpart 13.5 and FAR Part 12, and the notice states it is expected to exceed the simplified acquisition threshold.

Place of performance is Maryland. The contractor will facilitate user administration, process and workflow improvements, content development and moderation, requirements gathering, and dissemination across three systems: the SMARTIRB.org website, Joinder (institutional enrollment and Authorization Agreement signing), and the Online Reliance System (study-by-study IRB reliance documentation). Additional responsibilities include developing governance models with diverse stakeholders, harmonizing institutional sIRB processes, delivering education and training through webinars and workshops, operating a helpdesk, and reporting quarterly metrics on platform usage and institutional participation.

The base period runs January 1, 2027 through December 31, 2027, with four option periods extending through June 30, 2031. Evaluation totals 100 points: Management Approach and Technical Capabilities (40 points), Personnel Qualifications (30 points), and Organizational Experience (30 points). The NAICS code is 541990, with a small business size standard of $19.5 million, and the PSC is R499. Non-small business offerors must submit an HHS Small Business Subcontracting Plan. Responses must include pricing, Unique Entity Identifier (UEI), business size certification, and active SAM.gov registration, submitted by email to polina.klimenkova@nih.gov.

Notice text

Title:  SMART IRB Governance, Administration, and Operations Support (GAOS)

This is a combined synopsis/solicitation for commercial items/services prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) FAR Subpart 13.5—Simplified Procedures for Certain Commercial Items; and FAR Part 12— Acquisition of Commercial Items; and is expected to exceed the simplified acquisition threshold.

Introduction and Background Objectives

The National Center for Translational Sciences (NCATS) requires a partner to facilitate user administration, process/workflow improvements, content development/moderation, requirements gathering, and dissemination of the SMART IRB (Streamlined, Multisite, Accelerated Resources for Trials Institutional Review Board) portfolio of services. SMART IRB relies on three systems: (1) the SMARTIRB.org website which is used for content distribution, notification, and educational purposes, (2) Joinder, through which institutions enter institutional information and sign the SMART IRB Authorization Agreement (AA), and (3) the Online Reliance System (ORS), through which Institutional Review Board (IRB) reliance arrangements under the SMART IRB Agreement are documented on a study-by-study basis. The selected partner will provide support in accordance with this SOW to aid in the facilitation and growth of SMART IRB.

Please see the attached RFQ 75N98026Q00287 for more details

Files

File Type Posted
RFQ_75N98026Q00287.pdf PDF

Notice history

Notice Type Posted
This notice Latest solicitation Solicitation
SMART IRB Governance, Administration, and Operations Support (GAOS) Original Pre-Solicitation

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