§63-2-805. Approval – Termination date – Reporting – Rules.

63 OK Stat § 63-2-805 (2019) (N/A)
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A. The State Commissioner of Health shall have the authority to approve physicians conducting clinical trials performed pursuant to the provisions of this act. In the event of a substantial violation of this act, the Commissioner shall provide written notice to the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control and the Governor. The Governor, upon receipt of a notice from the Commissioner, shall have the authority to terminate the operations of a clinical trial found to be in violation of any provision of this act.

B. The clinical trials and related research authorized by this act shall adhere to the highest standards of academic research including, but not limited to, peer review of research conducted pursuant to this act.

C. Clinical trials and related research authorized by this act shall conclude no later than December 31, 2017. Nothing in this act shall be construed as to permit the continuation of clinical trials after December 31, 2017, without approval by a concurrent resolution approved by the Legislature expressing approval of such continuation.

D. The State Commissioner of Health shall submit a report to the Chair and Vice Chair of the Senate Health and Human Services Committee, the Chair and Vice Chair of the House Alcohol, Tobacco and Dangerous Drugs Committee, and the Chair and Vice Chair of the House Public Health Committee on or before December 31, 2017. Such report shall include a summary of findings from clinical trials authorized by this act. The Commissioner shall, upon request by the Chair and Vice Chair of the Committees specified in this subsection, make available any data, excluding individual health records, relating to clinical trials authorized by this act.

E. The Oklahoma State Bureau of Narcotics and Dangerous Drugs Control, the State Board of Health, and the Oklahoma State Regents for Higher Education shall promulgate rules to implement the provisions of this act.

Added by Laws 2015, c. 203, § 7, emerg. eff. April 30, 2015.