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:
(1) The research is conducted in conformance with the approval granted by an institutional review board of a hospital or medical center accredited by the JCAHO or other accrediting body approved by the board; and
(2) 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.
R.C. 119.032 review dates: 06/06/2008 and 06/06/2013
Promulgated Under: 119.03
Statutory Authority: 4731.05
Rule Amplifies: 4731.22
Prior Effective Dates: 12/1/94