S. 3224 — Introduced in Senate

II 116th CONGRESS 2d Session S. 3224 IN THE SENATE OF THE UNITED STATES January 21, 2020Mr. Cassidy (for himself and Mr. Tester) introduced the following bill; which was read twice and referred to the Committee on Veterans' Affairs A BILL To require the Secretary of Veterans Affairs to allow for the use of commercial institutional review boards for research, and for other purposes. 1. Short title This Act may be cited as the VA Research Approval Efficiency Act of 2020. 2. Use by Department of Veterans Affairs of commercial institutional review boards in sponsored research trials (a) In general Not later than 90 days after the date of the enactment of this Act, the Secretary of Veterans Affairs shall complete all necessary policy revisions within the directive of the Veterans Health Administration numbered 1200.05 and titled Requirements for the Protection of Human Subjects in Research, to allow sponsored clinical research of the Department of Veterans Affairs to use accredited commercial institutional review boards to review research proposal protocols of the Department. (b) Identification of review boards Not later than 90 days after the completion of the policy revisions under subsection (a), the Secretary shall— (1) identify accredited commercial institutional review boards for use in connection with sponsored clinical research of the Department; and (2) establish a process to modify existing approvals in the event that a commercial institutional review board loses its accreditation during an ongoing clinical trial. (c) Report (1) In general Not later than 90 days after the completion of the policy revisions under subsection (a), and annually thereafter, the Secretary shall submit to the Committee on Veterans’ Affairs of the Senate and the Committee on Veterans’ Affairs of the House of Representatives a report on all approvals of institutional review boards, including central institutional review boards and commercial institutional review boards. (2) Elements The report required by paragraph (1) shall include, at a minimum, the following: (A) The name of each clinical trial with respect to which the use of an institutional review board has been approved. (B) The institutional review board or institutional review boards used in the approval process for each clinical trial. (C) The amount of time between submission and approval. 3. Creation of Office of Research Reviews within the Office of Information and Technology of the Department of Veterans Affairs (a) In general Not later than one year after the date of the enactment of this Act, the Secretary of Veterans Affairs shall establish within the Office of Information and Technology of the Department of Veterans Affairs an Office of Research Reviews (in this section referred to as the Office). (b) Elements The Office shall do the following: (1) Perform centralized security reviews and complete security processes for approved research sponsored outside the Department, with a focus on multi-site clinical trials. (2) Develop and maintain a list of commercially available software preferred for use in sponsored clinical trials of the Department and ensure such list is maintained as part of the official approved software products list of the Department. (3) Develop benchmarks for appropriate timelines for security reviews conducted by the Office. (c) Report (1) In general Not later than one year after the establishment of the Office, the Office shall submit to the Committee on Veterans’ Affairs of the Senate and the Committee on Veterans’ Affairs of the House of Representatives a report on the activity of the Office. (2) Elements The report required by paragraph (1) shall include the following: (A) The number of security reviews completed. (B) The number of personnel assigned for performing the functions described in subsection (b).