4731-11-07 Research utilizing controlled substances.

The provisions of this chapter of the Administrative Code shall not apply to or in any way prohibit research conducted under the auspices of an accredited medical school, or research which meets both of the following conditions:

(A) The U.S. food and drug administration has approved an investigational new drug ("IND") application for the research or has notified the researchers that the proposed study is exempt from the "IND" regulations; and

(B) The research is conducted in conformance with the approval granted by either of the following:

(1) An institutional review board of a hospital or medical center accredited by the "Joint Commission," "Healthcare Facilities Accreditation Program" or other accrediting body approved by the board; or

(2) An institutional review board accredited by the association for the accreditation of human research protection programs.

Replaces: 4731-11-07

Effective: 9/30/2015
Five Year Review (FYR) Dates: 09/30/2020
Promulgated Under: 119.03
Statutory Authority: 4731.05
Rule Amplifies: 4731.22
Prior Effective Dates: 12/1/94