RFQ_75N98026Q00287.pdf

COMPETITIVE COMBINED SYNOPSIS/SOLICITATION

75N98026Q00287

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

(1) 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.

(2) 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.

(3) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2026-01, dated March 13, 2026.

(4) The associated NAICS code is 541990 and the small business size standard is $19.5 mil. This requirement is full and open competition with no set-aside restrictions.

(5) Description: please see Attachment 1, Statement of Work, 5 pages

(6) The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition.

a. Small Business Subcontracting Plan: Offerors (other than small) shall complete HHS Subcontracting Plan.

Pursuant to NIH’s priority of Small Business participation, Offerors shall be required to submit a subcontracting plan in accordance with the terms of the clause entitled "Small Business Subcontracting Plan," at FAR Clause No. 52.219-9 (Sep 2023), Alternate II (Nov 2016), will be applicable to any resultant contract. This clause does not apply to small business concerns.

(7) The provision at FAR clause 52.212-2, Evaluation – Commercial Items, applies to this acquisition.

a. The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered including evaluation of options. Responses shall be evaluated using the technical evaluation criteria set forth in Attachment 2: Technical Evaluation Factors

b. Options:

(i) FAR clause 52.217-8 Option to Extend Services. (Nov 1999).

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 5 days. (End of clause)

(ii) FAR clause 52.217-9 Option to Extend the Term of the Contract (Mar 2000).

The Government may extend the term of this order by written notice to the Contractor any time prior to order expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 5 days before the order expires. The preliminary notice does not commit the Government to an extension. If the Government exercises this option, the extended order shall be considered to include this option clause.

c. A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(8) The Offerors should include a completed copy of the provision at FAR clause 52.212-3 (if not completed electronically in the System for Award Management (SAM) ), Offeror Representations and Certifications—Commercial Items, with its offer.

(9) The FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition. The invoice instructions at FAR 52.212-4(g) are replaced with the NIH IPP Invoice and Payment Provisions attached to this Solicitation. Attachment 3.

(10) The FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders–Commercial Items, applies to this acquisition.

(11) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.

Requests for clarification/Questions shall be submitted no later than November 4, 2026 electronically via email to polina.klimenkova@nih.gov ; email subject line: “Question – RFQ 75N98026Q00287 SMART IRB Governance, Administration, and Operations Support (GAOS)”.

When submitting requests for clarification/question, Offerors must cite the relevant section, paragraph, and page number associated with the question being posed. Requests for clarification/questions should be written in a way that enables clear understanding of the Offerors’ issues or concerns. Statements expressing opinions, sentiments, or conjectures are not considered valid inquiries and will not be provided a response. Further, Offerors are reminded that the Government will not address hypothetical questions aimed at receiving a potential evaluation decision. Responses to requests for clarification/questions will not disclose proprietary information of the Offerors.

(12) Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. The price quote shall include:

unit price, list price, delivery days after contract award, delivery terms, prompt payment discount terms, product description; and any other information or factors that may be considered in the award decision. Such factors may include: past performance; special features required for effective program performance; and etc..

In addition, the vendor Unique Entity Identifier (UEI) 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.

All responses to this solicitation shall be submitted electronically via email to polina.klimenkova@nih.gov.

Email subject line: “RFQ 75N98026Q00287 SMART IRB Governance, Administration, and

Operations Support (GAOS).”

The response must be received on or before November 13, 2026 by 12:00 pm Eastern Time.

mailto:polina.klimenkova@nih.gov http://www.sam.gov/ mailto:polina.klimenkova@nih.gov

Attachment 1-Statement of Work

SMART IRB Governance, Administration, and Operations Support Statement of Work (SOW)

Contents

1. Introduction and Background

2. General Requirements

3. Governance

4. Community Engagement and Growth

5. Harmonization and Alignment

6. Education/Training

7. Software

8. Metrics

9. Deliverables

10. Government Responsibilities

11. Other Considerations

SMART IRB Governance, Administration, and Operations Support Statement of Work (SOW)

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

1. Introduction and Background

1.1. 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.

1.2. Background

The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability by supporting and making medical discoveries. NCATS is the only center at the NIH that focuses exclusively on all aspects of the translation of research with an innovative pipeline of treatment discoveries for all diseases. NCATS brings together a diverse group of scientists, including medicinal chemists, biologists, toxicologists, clinicians, and engineers to translate basic science conducted elsewhere into products and services that help improve people’s health and lives. NCATS’ mission is to improve health through smarter science that results in better treatments faster for all diseases, rare or common.

45 C.F.R. Part 46, Protection of Human Subjects, also known as the Common Rule, requires review by an IRB of any research involving human subjects that is conducted, supported, or regulated by any Federal department or agency. Historically, institutions establish their own IRBs, which for multi-site research could result in multiple IRBs reviewing the same research. However, multi-site research is required by NIH to designate a single IRB (sIRB). See NOT-OD-16-094 and subsequent notices. In addition, the Common Rule requires single IRB review of multi-site research for research supported or conducted by any of the Common Rule signatory agencies.

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.

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html https://smartirb.org/

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.

The contractor shall support NCATS in making SMART IRB Joinder and ORS processes and workflows more user friendly and responding to documented needs communicated by the existing user community, which will lead to increased use of SMART IRB Framework and allow for more efficient implementation of sIRB and therefore facilitate collaborative research nationwide. These needs will be relayed to NCATS for consideration; any suggested website and systems development will be handled outside of this contract.

For information technology (IT) related areas, the NCATS Information Technology Resources Branch (ITRB) is responsible for the operating system(s), databases, applications, system architecture, server and the security infrastructure provided and/or hosted by NCATS, while the contractor will be expected to be knowledgeable about and support these tasks and/or responsibilities in collaboration with ITRB as specified in the SOW.

1.3. Period of Performance

The anticipated period of performance is as follows:

Base Period: Jan 1, 2027– Dec 31, 2027 (12 months).

Option Period 1: Jan 1, 2028 – Dec 31, 2028 (12 months).

Option Period 2: Jan 1, 2029 – Dec 31, 2029 (12 months).

Option Period 3: Jan 1, 2030 – Dec 31, 2030 (12 months).

Option Period 4: Jan 1, 2031 – June 30, 2031 (6 months).

2. General Requirements

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the specific requirements below:

3. Governance

3.1. Development and maintenance of a governance model to oversee SMART IRB operations, process improvements, workflow, and metrics, including a key group of diverse stakeholders.

3.2. Coordination with the SMART IRB Regulatory body to align with and progress the SMART IRB mission.

3.3. Coordination of governance and process control of proposed changes, amendments, and versioning of the SMART IRB authorization agreement(s).

3.4. Versioning, transitioning, and maintenance of SMART IRB authorization agreement(s) by which Reliance and Joinder operate.

3.5. Process and workflow recommendations related to governance and use of SMART IRB based on user/community feedback.

3.6. Coordination of responses to legal, governance, or operational questions from current or potential user community.

3.7. Responsibility for coordination of governance committees, bodies, and administration.

4. Community Engagement and Growth

4.1. Promotion/dissemination of SMART IRB to grow the community of institutions and users.

4.2. Messaging and documentation pertaining to SMART IRB.

4.3. Promotion/dissemination of SMART IRB to direct more institutions to utilize reliance as their preferred system for IRB review with emphasis on multisite studies.

4.4. Provision of expert consultation services for institutions that have joined or wish to join the

SMART IRB platform.

4.5. Development and maintenance of periodic communications to inform, update, and maintain network of users.

5. Harmonization and Alignment

5.1. Identification of areas of discordance in processes and procedures of sIRB review.

5.2. Development and maintenance of resources, tools, and materials to simplify and align sIRB institutional processes.

5.3. Promote/disseminate the implementation of SMART IRB developed guidance on sIRB processes.

6. Education/Training

6.1. Identification of areas of needed education and training in sIRB utilization and review processes.

6.2. Development and maintenance of educational materials in the form of educational modules.

6.3. Development and maintenance of written documentation on utilization of SMART IRB, processes and procedures.

6.4. Facilitation of training opportunities in the form of live webinars, on demand training videos, and in-person workshops for institutions that have joined or wish to join the SMART IRB network.

6.5. Community support of the SMART IRB network.

6.6. Maintenance of current educational materials on the SMART IRB website and removal of outdated or irrelevant materials on the website.

7. Software

7.1. Software development and infrastructure operations of the SMART IRB Ecosystem is provided by a separate partner. The selected partner for the work outlined in this document will provide the following.

7.2. Development of mechanisms to elicit and review feedback periodically from the SMART IRB community regarding potential software development needs.

7.3. Facilitation of the support of the functional aspects of the Joinder system related to the user administration, joinder processes, and prioritization of potential feature updates to the development team.

7.4. Facilitation of the support of the functional aspects of ORS related to user administration, reliance processes, and prioritization of potential feature updates to the development team.

7.5. Facilitation of the support of the functional aspects of the SMARTIRB.org website related to the content moderation, user educational materials for the SMART IRB platform, notifications, and prioritization of potential feature updates to the development team.

7.6. Maintenance of the SMART IRB Helpdesk in collaboration with the software partner.

8. Metrics

8.1. Gathering of metrics from across SMART IRB ecosystem related to growth, institution additions and removals, user base growth and access and/or use trends, and utilization of the reliance system to facilitate the IRB process.

8.2. Gathering of metrics on how many institutions are using the SMART IRB AA to document reliance in the conduct of studies.

8.3. Provision, on a quarterly basis, of the number of institutions using the SMART IRB AA, the number of studies for which AA is being used, and size of studies, as appropriate.

8.4. Gathering of any other quantitative and qualitative metrics pertinent to facilitate and grow the SMART IRB community of users.

8.5. Provide analysis of the metrics on a quarterly basis to provide supporting information for future investments in the SMART IRB platform.

9. Deliverables

9.1. Monthly Status Reports (MRSs) will be submitted to the Federal task lead no later than the 5th of each month.

9.2. Work with development and infrastructure operations partner to produce quarterly metrics reports.

9.3. End of Contract Closeout report to be provided after expiration of the period of performance.

10. Government Responsibilities

10.1. The Government is responsible for the governance of the infrastructure and policy for

SMART IRB.

10.2. The Government is responsible for the operating system(s), databases, applications, system architecture, server and the security infrastructure supporting SMART IRB.

10.3. The Government is responsible for website development and support.

11. Other Considerations

11.1. Place of performance shall be at the contractor’s facility.

11.2. The cost of travel is reimbursable provided that it is approved in advance by the Contracting

Officer’s Representative and is in accordance with FAR 31.205-46 Travel Costs. The contractor shall attend and participate in up to four conferences per year, including the following:

• PRIM&R

• NCATS CTSA Annual Meeting

11.3. Rights in data shall be governed by FAR 52.227-14 Rights in Data-General.

SMART IRB Evaluation Criteria

TECHNICAL EVALUATION CRITERIA

Criterion 1: Management Approach and Technical Capabilities (40 points)

1. Understanding of the work, including creativity and thoroughness shown in understanding the objectives of the SOW and specific tasks, and planned execution of the project.

2. Evidence of specific methods and techniques for completing each discrete task, to include such items as quality assurance, and customer-service.

3. Ability to address anticipated potential problem areas, and creativity and feasibility of solutions to problems and future integration of new processes and technology enhancements.

4. Quality and effectiveness of the allocation of personnel and resources.

Criterion 2: Personnel Qualifications (30 points)

1. The currency, quality and depth of experience of individual personnel in working on similar projects. Similar projects must convey similarity in topic, dollar value, workload, duration, and complexity.

2. Quality and depth of education and experience on other projects which may not be similar enough to include in response to 1. (immediately above) but may be relevant.

3. The currency, quality and depth of how the Project Manager will supervise and coordinate the workforce.

Criterion 3: Organizational Experience (30 points)

1. Evidence that the organization has current capabilities; and for assuring performance of this requirement. Evidence of supporting subcontractors, consultants and business partners will be considered.

2. Appropriate mix and balance of education and training of team members.

SCORE SUMMARY

Criterion 1 Score

Criterion 2 Score

Criterion 3 Score

Total Score

Technically Acceptable

(Yes/No)

Further Consideration

(Yes/No)

40 30 30 100 Yes Yes

Attachment 02

Attachment 03

Updated April 2026

Invoice and Payment Provisions

The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: Revolutionary FAR Overhaul (RFO) 52.232-25 Prompt Payment (Jan 2017).

Highlights of this clause and NIH implementation requirements follow:

I. Invoice Requirements

A. An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed. A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12 below, in addition to the requirements of RFO 32.9. If the invoice does not comply with these requirements, the Contractor will be notified of the defect within 7 days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats, or oils) with a statement of the reasons why it is not a proper invoice. (See exceptions under II., below). Untimely notification will be considered in the computation of any interest penalty owed the Contractor.

1. Vendor/Contractor: Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact).

2. Remit-to address (Name and complete mailing address to send payment).

3. Remittance name must match exactly with name on original order/contract. If the

Remittance name differs from the Legal Business Name, then both names must appear on the invoice.

4. Invoice date.

5. Unique invoice #s for all invoices per vendor regardless of site.

6. NBS document number formats must be included for awards created in the NBS:

Contract Number; Purchase Order Number; Task or Delivery Order Number and Source Award Number (e.g., Indefinite Delivery Contract number; General Services Administration number); or, BPA Call Number and BPA Parent Award Number.

7. Unique Entity Identifier (UEI) which is in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number.

8. Federal Taxpayer Identification Number (TIN). In those rare cases where a Contractor does not have a UEI number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice. The VIN is the number that appears after the contractor’s name on the face page of the award document.

9. Identify that payment is to be made using a three-way match.

10. Description of supplies/services that match the description on the award, by line billed.*

11. Freight or delivery charge must be billed as shown on the award. If it is included in the item price do not bill it separately. If identified in the award as a separate line item, it must be billed separately.

12. Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that match the line items specified in the award.*

NOTE: If your invoice must differ from the line items on the award, please contact the Contracting Officer before submitting the invoice. A modification to the order or contract may be needed before the invoice can be submitted and paid.

Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order. If authorized, shipping costs must be itemized. Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt.

B. The Contractor must submit invoices to the Department of Treasury’s Invoice Processing

Platform (IPP) at https://www.ipp.gov with a copy to the approving official for approval, as directed below, No Later Than (NLT) 30 days after delivery or acceptance of goods whichever is later. For ongoing services, invoices for the previous billing period (month, quarter, etc.)

must be submitted NLT 30 days following the period for which the services were delivered.

The contractor’s failure to submit timely invoice(s) to the Government, as set forth in the preceding paragraph, waives the contractor’s rights to receive payment pursuant to this contract. In the event of the contractor’s failure to submit timely invoice(s), the Government is not obligated to make such payment, and the Contracting Officer shall have the authority to unilaterally deobligate the funds in accordance with the requirements at 31 U.S.C. 1552(a) and downwardly adjust the total amount of the award by the amount of the deobligation. The contractor shall be given an opportunity to request the excusal of a late invoice from the Contracting Officer. If excused, the Contracting Officer will respond in writing to confirm that the contractor’s right to receive payment has not been waived.

The Contractor must submit a copy of the electronic invoice to the following Approving Official (Contracting Officer if applicable) and Contracting Officer’s Representative:

Contracting Officer’s Representative Name- TBD

II. Invoice Payment A. Except as indicated in paragraph B., below, the due date for making invoice payments by the designated payment office shall be the later of the following two events:

1. The 30th day after the designated billing office receives a proper invoice from the contractor.

2. The 30th day after Government acceptance of supplies delivered or services performed.

B. The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, must be in accordance with the Prompt Payment Act, as amended.

III. Interest Penalties

A. An interest penalty will be paid automatically, if payment is not made by the due date https://www.ipp.gov/ and the conditions listed below are met, if applicable.

1. A proper invoice was received by the designated billing office.

2. A receiving report or other Government documentation authorizing payment was processed and there was no disagreement over quantity, quality, or Contractor compliance with a term or condition.

3. In the case of a final invoice for any balance of funds due the Contractor for supplies delivered or services performed, the amount was not subject to further settlement actions between the Government and the Contractor.

B. Determination of interest and penalties due will be made in accordance with the provisions of the Prompt Payment Act, as amended, the Contract Disputes Act, and regulations issued by the Office of Management and Budget.

IV. RFO 52.232-40 PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, (Mar 2023)

(a)

(1) In accordance with 31 U.S.C. 3903 and 10 U.S.C. 3801 , within 15 days after receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

(2) The Contractor agrees to make such payments to its small business subcontractors without any further consideration from or fees charged to the subcontractor.

(b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial products or commercial services.

(End of clause)

V. HHSAR 352.232-71 Electronic Submission of Payment Requests (February 2, 2022)

(a) Definitions. As used in this clause—

Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), ‘‘Content of Invoices’’ and the applicable Payment clause included in this contract.

https://www.govinfo.gov/content/pkg/USCODE-2022-title31/pdf/USCODE-2022-title31-subtitleIII-chap39-sec3903.pdf https://www.govinfo.gov/content/pkg/USCODE-2022-title10/pdf/USCODE-2022-title10-subtitleA-partV-subpartD-chap277-sec3801.pdf

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer’s written authorization with each payment request.

(End of clause) http://www.ipp.gov/