RFI EIRB 2-11-2025 MC_wo.docx

Request for Information For the Electronic Institutional Review Board (EIRB) Services

1.0. Purpose:

The Defense Health Agency (DHA) seeks to gather information on existing, emerging, and novel approaches to address workforce wellness using biometric data. The information gathered on availabilities, capabilities, and other pertinent marketplace data will strengthen the DHA’s understanding of the current and future marketplace to enhance its ability to obtain quality services economically and to efficiently and lawfully establish potential vendor sources, listings and requirements. The DHA will not award any contracts under this notice.

1.1. Introduction:

The DHA lacks an ability to quantify the wellbeing of its workforce, identify leading indicators of occupational burnout, and to effectively measure the impact of organizational interventions on staff wellbeing on a continuous basis. The DHA seeks a complete framework and approach to gain insight into the overall function and wellness from the clinic/department level up through the highest levels of leadership in the Agency.

The goal is to inform future acquisition strategies and provide a meaningful mechanism to engage with staff, understand and better architect organizational choices, and align strategic priorities and communications. The DHA is interested in understanding the capabilities of existing and emerging technologies to develop and implement a standardized, data-driven framework for measuring wellbeing, fulfillment, and sentiment / human factors leveraging all data sources relevant to workforce; real-time monitoring of staff wellness across enterprise; and build and delivery of action plans and tools to various workforce populations to address burnout, retention, etc. including both direct and indirect wellness interventions. The information provided by industry will be used to refine requirements, develop future acquisition strategies, and identify potential solutions. The responses to this RFI will contribute to the planning process for a potential future solicitation.

1.2. Background:

The DHA PEO Medical Systems/ CIO(J-6), SDD, will provide programmatic management and technical support for the EIRB, the DoD approved enterprise system for managing the lifecycle research review and oversight processes for DoD Institutional Review Board (IRBs) for Human Subjects biomedical and social/behavioral research, Institutional Animal Care and Use Committee (IACUCs), Institutional Biosafety Committee (IBCs), Radiation Safety, Cooperative Research and Development Agreement (CRADA)/Grants, Scientific Review and Publication Clearance, as well as unique DoD review needs (e.g., FHP&R Program Manager Network, etc.).

EIRB automates these processes, allowing the Government to streamline document submission and review, decrease paper waste, reduce time spent routing work and/or locating misplaced work, and minimize administrative overhead thus allowing staff to focus on complex issues and support to the DoD research innovation community. 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 serves nearly 18,500 users across 200 DoD research sites and compliance boards, and hosts over 700,000 electronic documents in support of more than 30,000 research projects. EIRB is accessible to users via Common Access Card (CAC) as well as Veteran Affairs Personal Identity Verification (PIV) and External Certificate Authority (ECA).

1.3. Description of Need:

This award provides for purchase Cayuse (formerly iMedRIS) integrated Research Information Software (iRIS) enterprise software licenses with the developer supported license agreement and the required platform and software maintenance and sustainment services for the Electronic Institutional Review Board (EIRB) information technology solution. This includes, operations and maintenance support for EIRB and all other system COTS software components (e.g., operating system, database, etc.), continued software maintenance releases, operating system upgrades, software upgrades, database upgrades, Cayuse COTS upgrades, testing, ongoing compliance with DoD Instruction (DoDI) 8500.01, “Cybersecurity, March 2014” and DoDI 8510.01, “Risk Management Framework (RMF) for DoD Information Technology (IT), March 2014” requirements, functional and training support, creation of system and security documentation, and other associated services as directed by the Government.

1.4. Capability Requirements:

The Contractor shall work in collaboration with other Contractors who may be tasked with application development by PEO/MS/J-6. The Contractor shall also provide technical/analytical support for acquisition of hardware and software to support EIRB.

The Contractor shall provide application modifications (code changes, minor functionality development, etc.) for EIRB, databases, and common components identified in this award. The Contractor shall provide support for testing, production pre-insertion testing, transition to production, management and documentation, security maintenance, information assurance and security activities and support Defense Information Assurance Certification and Risk Management Framework (RMF) Accreditation Process of the SDD applications specifically set forth in this order.

The Contractor shall sustain all the Production (Prod), Production Test, Demonstration and Training, Development (Dev) and Development Test (Dev/test) Environments; to include operating system patches, database patches, IAVA patches, patching, backup & recovery of code. All patches are to be tested and test results shall be submitted. The Contractor shall perform all required security scans, mitigations, and associated documentation for Information Assurance Activities.

Specific business rules are embedded in the commercial product suite of the Cayuse (formerly iMedRIS) products now known as EIRB. Due to the proprietary nature of the Cayuse suite of products, the Contractor should have knowledge of the EIRB application and data load interface.

The EIRB maintenance support shall include but be not limited to:

· Tier III help desk and triage support,

· Systems analysis,

· Database and code administration,

· Database upgrade and maintenance,

· Application/code installation,

· Application upgrade and maintenance,

· System administration,

· Change control and testing,

· Documentation,

· Security maintenance and all security activities

· Trouble-shooting and problem resolution support including root cause analysis,

· Configuration management

1.5. Questions to Industry:

1. Describe your company’s overall capability. Ensure the responses includes the answer to the following questions:

a. What is your company’s ability with digital capability application based, (i.e. mobile), web based, or both?

b. What is your company’s ability with manage lifecycle research review, oversight processes, and data load interface?

c. What is your company’s ability with applying the DoD Risk Management Framework (RMF) processes and maintaining cybersecurity?

d. What is your company’s ability with embedded in the commercial product suite of the Cayuse products known as EIRB? What is your company’s ability with EIRB application and data load interface do you have?

e. What is your company’s ability to support end-users in terms of help desk support/operations and training?

f. What is your company’s ability with applications hosted at Defense Information System Agency (DISA)?

g. What is your company’s ability with managing DoD tasks of this nature?

1.6. Instructions for Submission of Response:

Responses shall be in PDF format with a page limit of no more than 10 single-sided pages (8 1/2” X 11, no less than 10-point Font when printed). A Cover Page is allowed and will not count against page limit.

Vendors interested in responding to this RFI need to provide a capability overview of their platform and address the following:

a. Name of Company and Point of Contact with Contact Information

b. DUNS & CAGE Numbers

c. Current business size status

d. Provide applicable NAICS codes for the supplies/services to the Government and indicate if a small business or other socio-economic category for each NAICS code listed.

e. Current contracts or vehicles used by Government to purchase or license product. [i.e. GSA PSS, GSA OASIS, NASA SEWP, etc.] (This information is for market research only and does not preclude your company from responding to this notice.)

Responses to this RFI are due by (24 February 2025; 12:00 PM CST). All responses and any questions under this RFI must be submitted via email to Kevin D. Hodge and email address Kevin.d.hodge8.civ@health.mil, and Author E. Sandlain and email address author.e.sandlain.ctr@health.mil. Please use the following title in your email subject line HT0011-24-RFI-0224 Electronic Institutional Review Board (EIRB) Services.

Proprietary information, if any, should be minimized and MUST BE CLEARLY MARKED. To aid the Government, please segregate proprietary information. Please be advised that all submissions become Government property and will not be returned. RFI submissions submitted after the due date will not be assessed.

Each of the responses will be maintained by the DHA as a source of market research information.

Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions. Questions submitted regarding this RFI will not be accepted or acknowledged nor will there be a response.

No Solicitation or Marketing Materials shall be submitted. Any response submitted for this RFI constitutes consent for that submission to be reviewed by military personnel, Government civilians, and associated support contractors who are regulated. No information will be disclosed outside DHA. Submissions to this RFI is deemed to be DHA property which shall not be returned to sender.

Legal Disclaimer:

THIS IS A REQUEST FOR INFORMATION (RFI) ONLY. This RFI is issued solely for information and planning purposes. It does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. This request for information does not commit the Government to contract for any supply or service. Further, the DHA is not at this time seeking proposals and will not accept unsolicited proposals. Respondents are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested party’s expense. Not responding to this RFI does not preclude participation in any future RFP, if any is issued. It is the responsibility of the vendor who is interested in any potential future solicitation(s) to monitor all sites for additional information pertaining to this requirement.

The Government reserves the right to use results of the communications with industry for any purpose consistent with, and not otherwise prohibited by FAR Part 10. Any organization responding to this notice should ensure that its response provides the organization’s capability to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, in no case shall responses to this notice be considered either a response to a solicitation or a submission of an unsolicited proposal, as defined by FAR 2.101.