Ohio Administrative Code
Title 3701:1 - Radiation Control
Chapter 3701:1-58 - Medical Use of Radioactive Materials
Section 3701:1-58-04 - Provisions for the protection of human research subjects

Universal Citation: OH Admin Code 3701:1-58-04

Current through all regulations passed and filed through March 18, 2024

(A) A licensee may conduct research involving human research subjects only if it uses the radioactive materials specified on its license for the uses authorized on its license.

(B) If the research is conducted, funded, supported, or regulated by a federal agency that has implemented the federal policy for the protection of human subjects as specified in 45 C.F.R. Part 46(as in effect on the effective date of this rule), the licensee shall, before conducting research:

(1) Obtain review and approval of the research from an "institutional review board," as defined and described in the federal policy; and

(2) Obtain "informed consent," as defined and described in the federal policy, from the human research subject.

(C) If the research will not be conducted, funded, supported, or regulated by a federal agency that has implemented the federal policy, the licensee shall, before conducting research, apply for and receive a specific amendment to its medical use license. The amendment request must include a written commitment that the licensee will, before conducting research:

(1) Obtain review and approval of the research from an "institutional review board," as defined and described in the federal policy, and approved by the office of human research protection; and

(2) Obtain "informed consent," as defined and described in the federal policy, from the human research subject.

(D) Nothing in this rule relieves licensees from complying with the other requirements in this chapter.

Disclaimer: These regulations may not be the most recent version. Ohio may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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