Notice of Intent to Sole Source-Electronic Institutional Review Board (EIRB)

This is a notice of intent to sole source a procurement under FAR 6.302-1(a)(2)(iii)(A), Substantial duplication of cost to the Government that is not expected to be recovered through competition." This requirement is to renew the current Cayuse integrated Research Information Software (iRIS) enterprise software licenses subscriptions with the developer-supported license agreement and to provide the required platform and software maintenance and support services for the Electronic Institutional Review Board (EIRB) program. The applicable NAICS Code is 541519, Electronics and Communications Services.

EIRB is the DoD-approved enterprise system for managing the lifecycle research review and oversight processes for DoD Institutional Review Boards (IRBs). EIRB automates the following processes:

• Human Subjects biomedical and social/behavioral research;
• Institutional Animal Care and Use Committee (IACUCs);
• Institutional Biosafety Committee (IBCs), Radiation Safety, Cooperative Research;
• Development Agreement (CRADA)/Grants, Scientific Review, and Publication Clearance;
• Unique DoD review needs (e.g., FHP&R Program Manager Network, etc.).

EIRB gathers data to support enterprise level strategic decisions regarding regulatory system performance, resource utilization, and research portfolio management across the DoD. The system facilitates collaboration and data sharing amongst Researchers and Administrators via a secured web environment. EIRB allows the Government to streamline document submission/review, decrease paper waste, reduce time spent routing work and/or locating misplaced work and minimize administrative overhead.

Renewal of the current Cayuse iRIS enterprise software licenses and related support is essential to the Government's requirements for support of EIRB. Aderas Inc., is the current incumbent and is a privately held small business and has an exclusive partnership with the EIRB Commercial-Off-The-Shelf (COTS) vendor Cayuse for EIRB support. Aderas Inc., is the only Cayuse consulting partner and authorized Tier III support for the iRIS COTS software for which EIRB is built upon at this time.

Market research, including a Sources Sought (HT0011-25-RFI-0224), examined various COTS solutions at the time of the expiring contract and determined that none of them meet, or can reasonably be modified to meet, the Government requirements. Additionally, standing up a new solution at this time presents additional and unacceptable schedule risks due to delays encountered with onboarding personnel, background screening, and access.

DHA intends to award this requirement to Aderas, Inc. under the authority 10 U.S.C. 3204(a)(1) or 41 U.S.C 3304(a)(1).

This notice of intent is NOT a request for competitive quotes; however, all responsible sources may submit a capability statement or quotation which shall be considered by the agency. Capability statements or quotes, if received timely, will be considered; however, a determination by the Government not to compete the requirement based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.

Responses shall be emailed to Kevin Hodge, kevin.d.hodge8.civ@health.mil; Marc Cypert marco.a.cypert.civ@health.mil; and author.e.sandlain.ctr@health.mil no later than 9 June 2025, 12:00 p.m. Central Time, and shall include the control number HT0011-25-R-0038 in the subject line. Late responses will not be considered.