Title: VA Research Approval Efficiency Act of 2020
Policy area: Armed Forces and National Security

Summary:
VA Research Approval Efficiency Act of 2020
This bill addresses clinical research procedures within the Department of Veterans Affairs (VA).
Specifically, the bill requires the VA to complete policy revisions within the internal directive titled Requirements for the Protection of Human Subjects in Research to allow sponsored clinical research of the VA to use accredited commercial institutional review boards to review VA research proposal protocols.
The VA must identify accredited commercial institutional review boards for use in connection with sponsored clinical research of the VA and establish a process to modify existing approvals if a board loses its accreditation during an ongoing clinical trial.
The bill also requires the VA to establish an Office of Research Reviews within the VA's Office of Information and Technology. The office shall (1) perform centralized security reviews and complete security processes for approved research sponsored outside the VA, (2) develop and maintain a list of commercially available software preferred for use in sponsored clinical trials of the VA, (3) ensure such software list is maintained as part of the official approved software products list, and (4) develop benchmarks for time lines for security reviews.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 3224 Introduced in Senate (IS)]

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116th CONGRESS
  2d Session
                                S. 3224

 To require the Secretary of Veterans Affairs to allow for the use of 
  commercial institutional review boards for research, and for other 
                               purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            January 21, 2020

Mr. 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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``VA Research Approval Efficiency Act 
of 2020''.

SEC. 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.

SEC. 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).
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