B--Intent to Sole Source Notice for Ethical Review of Human Subjects Research being conducted at the Brimingham VA Medical Center.

This Notice of Intent to Sole Source is not a request for competitive proposals. No solicitations documents are available. Under Statutory Authority 41 U.S.C. 253(g), the Birmingham VA Medical Center, Network Contracting Office 7, intends to procure services for Ethical Oversight of Human Subjects Research under a firm fixed contract with University of Alabama at Birmingham., 1720 2nd Avenue South, Birmingham, AL 35294 on an other than full and open completion basis. Funding does not exceed $1 Million. The contract is expected to be awarded under FAR 6.302-1. A justification and Approval for Limited Sources Justification will be prepared. The Contract will consist of and will provide oversight and review of the Birmingham VA Medical Center use of humans and/or data for the VA human Research Protection Program (HRPP). The Birmingham VA Medical Center Research and Development Program administers VA Research Grants which have been approved for the use of humans and/or their data for research. The VA Human Research Protection Program (HRPP) must follow VA policy on the use of human subjects and their data found in Handbook 1200.5, Protection of Human Use in Research, which incorporates compliance with federal guidelines such as the Common Rule CFR 45, 46, and 55 and OHRP (Office of Human Research Protections) under PHS Policy. All VA research that includes human subjects and/or their data must have oversight by an ethical committee called the IRB (Institutional Review Board). This station is currently phasing out our own on site IRB for the oversight and ethical review of human subjects research and must contract this service from another accredited facility in order to support approved and potential research grants. The contractor must abide by the following procedures: To conduct initial reviews of research studies submitted to ensure that all safeguards and requirements for ethical research and protection of vulnerable subjects are met prior to approval. To conduct continuing reviews of research studies and to determine which projects require continuing review more often than annually To conduct review of proposed informed consent forms/process involving human subjects and review proposed exemptions to informed consent To conduct review of modifications and amendments to previously approved research; to ensure that changes in approved research are not initiated without IRB review and approval; and to determine whether projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review To conduct reviews by the expedited process, when appropriate To conduct review of study closures To conduct review of and ensure that unanticipated problems involving risks to subjects, protocol deviations, and adverse effects, whether research related or not, are promptly reported to the IRB To conduct review of allegations and findings of noncompliance To conduct review of participant recruitment and outreach materials To conduct review of safety issues, compliance audits, and quality improvement activities To determine if an investigational device is of significant risk or can be categorized as a non-significant risk device The following services are also required: The UAB IRB will review 20-30 documents, at a minimum, monthly by full board review or chair review. Period of Performance is for 1 Year and 4 Option periods This procurement is being conducted in accordance with FAR 6.302-1, only one responsible source and no other supplies or services will satisfy the agency requirements. Contract is firm fixed price and the NAICS Code is 541715. Interested parties may identify their interest and capability to respond to the requirement. THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. A determination not to compete this 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. All responsible sources may submit an offer; however, only services meeting the Department of Veterans Affairs requirements will be considered for award. The Department of Veterans Affairs will NOT be responsible for any costs incurred by interested parties in responding to this notice of intent. Only written responses will be considered and must be received no later than 05 July 2018. All responses from responsible sources will be fully considered. As a result of analyzing responses to this notice of intent, the Government shall determine that a solicitation will be issued. Any prospective contractor must be registered in the System for Award Management (SAM) in order to be eligible for award. Information concerning SAM registered requirements may be viewed via the Internet at SAM.GOV or by calling the SAM Registration Center at +1 (555) 000-0000. Interested parties are encouraged to furnish information. All documents submitted will not be returned. All interested parties shall submit clear and convincing documentation demonstrating their capabilities to satisfy the requirements listed above to Contract Specialist by email at contact@example.gov. The capability documentation should include general information and technical background describing in detail the prospective contractor s capabilities and experience that will demonstrate the ability to support these requirements.