PROTECT eIRB Software Subscription, Maintenance, and Technical Support

Active

Contract Opportunity

1.0 DESCRIPTION

The Department of Health and Human Services (HHS), on behalf of the National Institutes of Health (NIH), Office of Human Subjects Research Protections (OHSRP), Intramural Research Program, intends to procure on a sole source basis, continued subscription, maintenance, and technical support for the existing PROTECT eIRB environment.

Huron Consulting Group Inc.

550 West Van Buren Street

Chicago, IL 60607

This acquisition will be processed under FAR Part 12 – Acquisition of Commercial Products and Commercial Services and will be made pursuant to the authority at 41 U.S.C. 1901, utilizing simplified procedures in accordance with FAR 12.201-1. Competition is being restricted in accordance with FAR 12.102(a), based on the Contracting Officer's determination that only one source is available to meet the Government's requirements.

The following is the requirement for the solicitation number 7571TE26Q00388

NIH requires continued subscription, maintenance, and technical support for the existing PROTECT eIRB environment supporting the NIH Intramural Research Program. The requirement includes:

• Software subscription and support for Huron IRB for up to 3,000 active protocols

• Huron Radiation Safety Committee

• Huron Safety for Scientific Review Committee

• Huron Portal for Ancillaries

• Huron REST API support for integration between Huron IRB and internal NIH systems

• Remotely delivered product-level technical support

• 24-hour Tier 1 support for critical system-outage issues

• Client Services Manager support • Software and portal updates and upgrades

• Resolution of software bugs

• Enhanced response and remediation of identified software security vulnerabilities within NIH-required timeframes

The period of performance is September 30, 2026 through September 29, 2027.

2.0 UNIQUE QUALIFICATIONS OF THE CONTRACTOR

Huron Consulting Services is the developer and proprietary source of the PROTECT software currently deployed at NIH. PROTECT is proprietary Huron software already deployed and operational within NIH, supporting submission, review, approval, and oversight of human subjects research along with interactions with multiple NIH regulatory and ancillary review functions.

The existing NIH environment consists of the Huron Research Suite IRB, integrated Huron safety and ancillary modules, and a custom Huron REST API developed to interface with internal NIH IT systems, enabling protocol information required for Clinical Center operations to be transmitted from PROTECT to internal NIH systems. As the developer of the system, Huron possesses the product-specific expertise and access necessary to provide the proprietary software subscription, product updates and upgrades, maintenance, and product-level technical support required under this acquisition.

PROTECT is a mission-critical system. Replacement of PROTECT with another eIRB platform would constitute a separate system-replacement and implementation effort rather than an alternative means of obtaining the subscription, maintenance, upgrades, and support required under this acquisition, and would introduce additional cost, schedule, and operational impacts related to data migration, system configuration, validation, user retraining, and parallel operations. Based on market research, Huron Consulting Services LLC is the only source identified with the combination of proprietary product ownership, development knowledge, and demonstrated experience necessary to perform these requirements without substantial duplication of effort or unacceptable performance risk.

3.0 RESPONSE INSTRUCTIONS

This notice is not a request for competitive quotations. However, all responsible sources may submit a capability statement, which will be considered by the agency. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow the Government to determine if the party can perform the requirement.

All responses must be sent via email to Contracting Officer, Anita Edwards, at Anita.edwards@hhs.gov by no later than 4:00 pm EST on Thursday, September 24, 2026.

A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, Contractors must be registered and have valid certification through SAM.gov.

Reference solicitation number: 7571TE26Q00388 on all correspondence.

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