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National Legislative Efforts Aimed at Reducing Regulatory Burden

The Office of Research Integrity has been paying close attention to national legislative efforts aimed at reducing research regulatory burden. Recently, legislation has been approved that includes the 21st Century Cures Act, the American Innovation and Competitiveness Act, and changes to the National Defense Authorization Act. Many of these new legislative activities focus on creating a research policy board, requiring agencies to harmonize regulations, and reducing institutional administrative burden that will allow us to focus our resources on enhancing customer service. Our national partner, the Council on Governmental Relations (COGR) summarized these initiatives in a clear and concise manner.

Another significant policy change of late is the federal policy for the protection of human subjects that we will be working to implement by the January 19, 2018 deadline. The significance of the change to the federal policy is that there is intent to provide institutions and Institutional Review Boards (IRB) more flexibility that will result in a reduction in researcher burden.  UT has already begun to implement one of the proposed changes: a new regulation which calls upon institutions to use a “Single IRB” when investigators are collaborating from different institutions. We facilitate the use of a “Single IRB” through inter-institutional agreements where both institutions agree that one institution will take the lead on review and approval of proposed research, while the other defers their review. The outcome (once the agreement is in place) is that a researcher would only be required to gain IRB approval from one institution involved in the collaboration. Researchers collaborating with individuals external to UT should contact the IRB office to see if their proposed activity qualifies for a single IRB review.

The ORI will continue to monitor these and other legislative efforts. If you have any questions or concerns, please contact any member of the ORI staff.

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