Under the authority granted in FAR 6.302-1, the United States (US) Environmental Protection Agency (EPA), Office of Research and Development (ORD), Center for Public Health and Environmental Assessment (CPHEA), Public Health and Integrated Toxicology Division (PHITD) intends to seek a quotation on a SOLE SOURCE BASIS from the University of North Carolina at Chapel Hill Office of Human Research Ethics (UNC-OHRE). This notice satisfies the requirement at FAR 5.101(a)(1) for publicizing the proposed contract action. This requirement is to procure the services of an Institutional Review Board (IRB) to review human subjects research. The services required are essential for research experiments involving human subjects conducted by the CPHEA of the EPA ORD. Federal regulations, including 40 CFR Part 26, 45 CFR Part 46 (The Common Rule), and EPA Order 1000.17A dated 06/15/2016, require written approval from an IRB under a Federal Wide Assurance prior to conducting any human subjects research. The activities performed must be in compliance with 40 CFR Part 26. Human research projects covered by this contract include but are not limited to: Measurement of human health effects endpoints associated with controlled chamber exposures to environmental pollutants such as ozone, carbon monoxide, volatile organic compounds, sulfur dioxide, particulate matter, nitrogen oxides, and noise, whether alone or in combinations which may include drugs or other substances; Measurement of human health effects endpoints associated with naturally occurring environmental exposures; In vitro exposures of human cells or fluids to known or suspected toxicant agents; Physiological and neurobehavioral assessment of populations potentially exposed to toxicant agents; Pharmacokinetics (PK) and dosimetry studies that characterize the fate and clearance of environmental agents; and Development of biomarkers that are indicators of either exposure or health effects resulting from either experimental or naturally occurring exposures. For this opportunity, the contractor will need to perform the following: 1. Serve as the designated IRB of record for EPA's Federal Wide Assurance from the U.S. Department of Human Services Office for Human Research Protections (OHRP) for the conduct of human research. The IRB must be appropriately registered with the OHRP and should be fully accredited with the Association for the Accreditation of Human Research Protection Programs. The IRB must also execute an IRB Authorization Agreement with the EPA. 2. Provide review and continuing oversight of EPA's human subject research following all the requirements established in 40 CFR Part 26. The services shall include initial review of research protocols and related materials, review of amendments, continuing review of on-going research studies, and appropriate follow-up regarding problems or following a report of an adverse event (AE). Expedited reviews may be used for protocols involving no more than minimal risk to subjects. Written determinations (such as letters of approval, disapproval, and requests for additional information) shall be provided to the study's Principal Investigator (PI) after each review. 3. Coordinate with and establish IRB authorization agreements with other IRBs as appropriate when collaborations involve researchers from other organizations. 4. Provide information and guidance to EPA Investigators, researchers, and administrative staff as needed regarding IRB requirements, policies, and procedures as outlined in the IRB s Standard Operating Procedures (SOP) manual. This information may be provided in writing (letters and email), telephone, or face-to-face meetings. 5. Provide training for Investigators and research staff related to ethics and other topics relevant to conducting human research. Such training shall be available via the Internet, for example, online training modules via the Collaborative Institutional Training Initiative (CITI) sponsored by the IRB. In addition, the contractor shall make available to EPA staff up to four seminars/training opportunities per year. The seminars shall address topics specific to the area of human subject s research, and the EPA shall be notified of on-campus training events when applicable. These may include venues such as Research Ethics Grand Rounds, study coordinator training events, visiting lectures, or EPA-specific seminars. Handouts and/or other supporting materials for seminars shall be provided as needed. Topics, formats, and schedules must be approved by the EPA Contracting Officer Representative. 6. Have the authority to inspect, monitor, and audit all research subject to this agreement. Part of CPHEA s mission is to conduct research to characterize the effects of environmental pollutants and toxicants on human health. The preponderance of CPHEA s research conducted using human subjects is carried out by, or in collaboration with, researchers in the PHITD located on the medical school campus of the University of North Carolina at Chapel Hill, North Carolina (UNC-CH). The PHITD was strategically located at UNC-CH by Congressional action that culminated in a twenty-plus year agreement to lease the facility housing PHITD from UNC-CH. The lease includes provisions requiring collaboration between EPA and UNC-CH on projects of common interest. Currently, this collaboration is being supported in part by EPA Cooperative Assistance Agreement CR83578501. The UNC-CH Office of Human Research Ethics currently has five IRBs, each with members who have specialized areas of technical expertise that align with CPHEA s diverse human research program. Consequently, the UNC-OHRE offers CPHEA access to multiple IRBs with study-specific expertise under one Federal Wide Assurance. These IRBs have provided expert review and oversight to PHITD for over two decades and as such are familiar with the large number and complexity of CPHEA's often unique research studies. The ethical treatment and medical safety of CPHEA's research volunteers are critically dependent upon the creditable review, approval, and ongoing monitoring that can only be provided by a nationally and internationally recognized yet local IRB. The Director of the UNC-OHRE is a nationally recognized, published expert on IRBs. The UNC-OHRE and its IRBs are located on the same campus as the leased PHITD facility and are sensitive to community attitudes of the area. As a result of PHITD's unique relationship with UNC-CH with regard to both collaborations with UNC-CH staff and location, the majority of the human research protocols conducted by CPHEA must be reviewed and monitored by a UNC-CH IRB to comply with UNC-CH policy that requires research involving UNC-CH staff or facilities be approved by a UNC-CH IRB. Since the majority of human research protocols must be reviewed and monitored by a UNC-CH IRB to ensure compliance with UNC policy for on-campus research involving UNC staff, the introduction of another IRB would disrupt critical time-sensitive, on-going research resulting in unacceptable delays. Furthermore, CPHEA's research with the highest degree of risk (studies exposing volunteers to controlled concentrations of environmental pollutants, as well as medical/clinical procedures performed in conjunction with the exposures) is conducted in the EPA leased facilities on the UNC-CH campus. THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITVE PROPOSALS. However, interested parties may identify their interest and capability by timely submission of a written response as provided below. Documentation must be received by close of business on July 15, 2020 in order to be considered by the EPA. A determination by the Government not to compete this proposed contract based on assessment of 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. Interested parties should e-mail a written response to Matthew J. Growney at growney.matthew@epa.gov to receive consideration for this contract telephonic responses will not be honored.
