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

PRE-SOLICITATION NOTICE OF INTENT NON-COMPETITIVE

INTRODUCTION

PURSUANT TO FAR Subpart 5.2—Synopses of Proposed Contract Actions, THIS IS A NON-COMPETITIVE PRE-SOLICITATION NOTICE OF INTENT TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION. 

The National Institute on Drug Abuse (NIDA), on behalf of The National Center for Translational Sciences (NCATS), intends to negotiate on a sole source basis with the following vendor for SMART IRB Governance, Administration, and Operations Support (GAOS):

Harvard Catalyst

Harvard Medical School

401 Park Drive

Boston, MA 02215

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541990 - All Other Professional, Scientific and Technical Services, with a Size Standard of $19.5M.

DESCRIPTION OF REQUIREMENT

NCATS established the SMART IRB program in 2016 to harmonize and streamline the IRB review process for multi-site studies. SMART IRB is currently administered by a third party and funded by the NIH Clinical and Translational Science Awards (CTSA) Program. See https://smartirb.org/. SMART IRB is currently used nationwide by over a thousand institutions.

Reliance on and utilization of a sIRB requires that institutions document the reliance on the sIRB. Although the SMART IRB Authorization Agreement eliminates the need to negotiate the terms of the reliance agreement, institutions and IRBs must still document the use of the agreement for specific research. Within the SMART IRB platform, institutions agree to the terms of the SMART IRB agreement by “joining”. The SMART IRB Joinder platform supports the process of joining the SMART IRB agreement, its documentation, and generation of an Institutional Profile documenting key information about the joining institution (and IRBs, where applicable). Institutions that have signed the SMART IRB Agreement through the Joinder platform have access to the SMART IRB Online Reliance System (ORS) to coordinate and document sIRB arrangements with other SMART IRB Participating Institutions.

Purpose and Objectives

In accordance with the requirements defined in the Statement of Work (attached), the contractor shall partner with the National Center for Translational Sciences (NCATS) 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 IRB reliance arrangements under the SMART IRB Agreement are documented on a study-by-study basis. The selected partner will provide support to aid in the facilitation and growth of SMART IRB.

 STATUTORY AUTHORITY

This acquisition is conducted as non-competitive under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements.

SOLE SOURCE JUSTIFICATION:

The determination by the Government to award a contract without providing for full and open completion is based on the following rationale:

A change from the current SMART IRB team to a different team would have several significant detrimental consequences.  The progress made to date on MRA v3.0 would be lost and would likely not be restored, and this would lead to significant loss of potential human subjects research efficiencies for multiple USG agencies.  Human subjects studies that are currently active and that are using SMART IRB for managing reliances would be put in a position of, at a minimum, having to backstop their reliance agreements in the midst of the studies.  This could result in substantial delays and significant unanticipated costs of money, time, and effort.  At worst, this could imperil the success of a subset of studies that are currently underway and that have used the SMART IRB platform for establishing single IRB review and reliances.  This would also completely derail and put at risk other USG entities from joining the agreement, essentially putting several years effort at risk, and losing the opportunity to have a common MRA across multiple agencies. Finally, a new SMART IRB team coming in at this stage would need a minimum of 18-24 months to get up to speed with all SMART operations and to maintain them at their current level.  This would inevitably result in significant loss of current signatories and significant loss of ability to onboard new signatories, undercutting the overall value of the entire platform.

CLOSING STATEMENT

This synopsis is not a request for competitive proposals.  However, all responsible sources may submit a capability statement which shall be considered by the agency. Contractors that believe they possess the ability to provide the required services should submit documentation of their ability to meet the project requirements to the Contract Specialist.  In particular, your capability statement should address the following capabilities:

• Direct experience and knowledge of regulations and guidance relating to reliance agreements.
• Specific knowledge of SMART IRB reliance agreement, its history, and specific terms of reference.
• Access to legal counsel to advise on regulatory issues related to IRB and to update the SMART IRB reliance agreement in conformance with regulations, federal policies, and feedback.
• Established relationships with government agencies (VA, DOE, DOD, NIH, etc.) with the ability to negotiate SMART IRB 3.0.
• Established relationships and points of contact in the community subject to IRB.
• A process for developing recommendations to resolve challenges to single IRB processes.
• An established and vetted system to request public comments on Harmonization Steering Committee recommendations and working groups and for any new amendments or versions of the SMART IRB reliance agreement itself.
• In-depth knowledge and an established management process to ensure the Online Reliance System and Joinder platform are maintained to appropriate standards.
• Distributed and national presence of content experts and Ambassadors who serve as practical and available resources for institutions to join, establish and execute successful SMART IRB reliance.
• An evolving evaluation system that works with single IRB community at large to continuously make improvements, identify best practices, and return results.
• An active harmonization steering committee of academic, industry, and government members that can meet monthly to promote both the alignment of policies and processes and the identification of common practices and workflows.

In addition, the Unique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.”

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.  The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.  

Responses must be submitted via email to Samson Shifaraw, at Samson.shifaraw@nih.gov, and must reference the number PS75N95023R00021. All responses must be received by February 21, 2023 by 3:00 PM EST.