JA IRBNet VAIRRS 2.0 Redacted.pdf

VAIRRS 2.0 Control Number: VA-24-00059617

IRBNet’s solution meets the Government’s functional requirements for a committee-based, electronic research administration solution to support regulatory committee review, research oversight activities, financial conflict of interest submission and tracking, and research compliance officer audit submission and review. IRBNet has the flexibility to operate as a committee-based solution with unlimited routing opportunities.

IRBNet offers a committee-based solution where locally developed forms can be attached. Those forms do not dictate routing. Routing is done through administrative users on a case-by-case basis. Metrics based forms can be developed centrally and do not affect routing. Standardized forms can be created within the IRBNet solution, but they are not tied to predetermined routing. This flexibility is a required feature of the Government’s requirements. As a committee-based solution, IRBNet start up time relies solely on the complexity of the number of committees at each VHA medical center conducting research. Workspaces and decisions on committee outcomes are standardized centrally ensuring consistent metrics across VHA.

IRBNet is the sole commercial product that meets VA’s requirements for a FedRAMP compliant electronic research administration SaaS solution- inclusive of functionality to support the RCO audit function, with an existing VA Authority to Operate (ATO). If another vendor is selected, additional costs, time, and risk would be incurred. The RCO reporting module is a key component of the VHA research review and oversight process. The ORD is responsible for auditing compliance with VHA Directive 1058.01.

To complete its review, the ORD requires access to all study documents and committee records associated with the review of the study. The ORD is also responsible for submitting yearly reports of the results of all reviews conducted during the reporting year. The enterprise IRBNet solution includes an interoperable RCO reporting module to capture RCO audit results, report audit results to the oversight committee, and provide yearly audit reporting data. The additional costs and time are estimated at $15,000,000.00 and 2 years, to include decommission of the existing solution across 108 sites, procuring a new enterprise license, configuration, and obtaining an ATO. The $15,000,000.00 is based on the migration of 108 sites, with costs including the deployment of 2 employees per site and the acquisition of the new solution. These estimated are based on previous acquisition history deploying the IRBNet solution across VHA. Any new product would also require an additional procurement to support RCO audits. Furthermore, another product would require a steep learning curve for over 10,000 end users.

6. Efforts to Obtain Competition: Market research was conducted, details of which are in the market research section of this document. This effort did not yield any additional sources that can meet the Government’s requirements. There is no competition anticipated for this acquisition. In accordance with FAR 5.301 and 16.505(b)(2)(ii)(D), the award notice for this action will be synopsized on the Contract Opportunities Page of SAM.gov and the justification will be made publicly available within 14 days of award.

7. Actions to Increase Competition: The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed.

8. Market Research: The VHA ORD Research Officers conducted market research through review of industry trade publications and internet research for other similar software. This market research is an ongoing process which started in 2023 and has been continuously conducted as recently as March 2024. The other similar software reviewed included Cayuse (formerly iMEDRIS), Tech Software’s OneAegis (formerly IRBManager), Key Solutions, and Huron Research Suite. Based on reviews of these products, the Government’s technical experts determined that none of these products can meet the Government’s functional and security requirements.

All reviewed products are form-based products with programmed routing and do not include the required enterprise RCO module. Form-based solutions require concurrence from user groups to create the forms and designate the routing workflow for each form. With 108 independently functioning VHA research sites, a form-based solution is not feasible as it would require standardizing the routing workflow of more than 400 forms.

Market research identified no other products containing an RCO reporting module.

Market research completed indicates that other companies’ similar products lack the committee-based solution feature; as such, they do not meet, or cannot be modified to meet, the agency’s needs. Based on all of these market research efforts, the Government’s technical experts have determined that only IRBNet can meet all of VA’s needs.

Additional market research was conducted in March 2024 by utilizing the NASA SEWP V GWAC Provider Look-up Tool to determine whether IRBNet products are available from NASA SEWP V GWAC resellers. The Provider Lookup Tool yielded only one contract holder, which is Minburn, a Service-Disabled Veteran-Owned Small Businesses (SDVOSB) offering the required IRBNet brand name product.

Furthermore, the NASA SEWP V GWAC has a dynamic catalog where line items can be added based on customer requests; therefore, as long as the required item or service is within scope of the NASA SEWP V GWAC, items and services can be added to the catalog daily. This requirement has been found to be within scope of the NASA SEWP V GWAC.

9. Other Facts: None.

13. Office of General Counsel (OGC) Review

I have reviewed this document and find it legally sufficient, based on the representations set forth in the documents and, if any, attachments. The Head of the Contracting Activity's approval is an independently supported decision not wholly reliant on the legal sufficiency determination.

Date

Approval

In my role as Head of the Contracting Activity, based on the foregoing justification, I hereby approve the acquisition of IRBNet Software SaaS solution on an other than fair opportunity basis pursuant to the authority cited in Section 4 above, subject to availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.

Date

9/12/2024

9/13/2024