Institutional Review Board Services

The Environmental Protection Agency (EPA), National Health and Environmental Effects Research Laboratory (NHEERL) intends to negotiate on a sole source basis with the University of North Carolina - Chapel Hill (UNC-CH), Office of Human Research Ethics, Chapel Hill, NC 27599, for providing Institutional Review Board (IRB) Services for Human Research. The services required are essential for research experiments involving human subjects. The contractor shall serve as the designated IRB of record; provide review and oversight of EPA's human subject research; coordinate with and establish IRB authorization agreements; provide consultation to EPA staff; and provide training for EPA staff related to ethics and other topics relevant to conducting human research. The period of performance is anticipated to be 12months from date of award with four 12-month optional periods of performance. EPA believes that UNC-CH Office of Human Research Ethics is the only source capable of providing the specific review services. UNC-CH has five IRBs, each with members who have specialized areas of technical expertise that align with NHEERL?s diverse human research program. These IRBs have provided expert review and oversight to the Environmental Public Health Division (EPHD) for over two decades and as such are familiar with the large number and complexity of NHEERL?s often unique research studies. Other unique qualifications of UNC-CH supporting EPA's beliefs are a preponderance of the human subjects research is conducted in collaboration with UNC-CH; the EPA EPHD is located on the campus of UNC-CH; and the research must be reviewed by UNC's IRB to comply with UNC policy. 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. The circumstance permitting "Other than Full and Open Competition" is FAR 6.302-1, "Only one responsible source and no other supplies or services will satisfy agency requirements". All interested parties who believe they can provide the required services shall fully explain their capabilities and qualifications in writing within 15 days from the date of this announcement. The North American Industry Classification System (NAICS) Code 541690, which has a small business size standard of $7.0 million, is applicable. The intent of this synopsis is to determine if any source(s) exist, and therefore, no solicitation (RFQ) is available. Consequently, any response(s) failing to provide the aforementioned data but instead choosing to merely submit a routine letter requesting a copy of the RFQ will not be ho nored. Submit response via US Mail to the U.S. EPA, Attn: Marsha B. Johnson (E105-02), RTP Procurement Operations Division, Research Triangle Park, NC 27711. No telephonic or faxed requests will be honored.