South Carolina Code of Regulations
Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL
Subchapter 61-63 - Radioactive Materials (Title A)
Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS
Subpart A - GENERAL INFORMATION
Section 61-63.IV.A.RHA 4.4 - Provisions for the Protection of Human Research Subjects

Current through Register Vol. 48, No. 9, September 27, 2024

4.4.1 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.

4.4.2 If the research is conducted, funded, supported, or regulated by another Federal agency that has implemented the Federal Policy for the Protection of Human Subjects (Federal Policy), the licensee shall, before conducting research--

4.4.2.1 Obtain review and approval of the research from an "Institutional Review Board," as defined and described in the Federal Policy; and

4.4.2.2 Obtain "informed consent," as defined and described in the Federal Policy, from the human research subject.

4.4.3 If the research will not be conducted, funded, supported, or regulated by another Federal agency that has implemented the Federal Policy, the licensee shall, before conducting research, apply for and receive a specific amendment to its South Carolina Radioactive Material medical use license. The amendment request must include a written commitment that the licensee will, before conducting research-

4.4.3.1 Obtain review and approval of the research from an "Institutional Review Board," as defined and described in the Federal Policy; and

4.4.3.2 Obtain "informed consent," as defined and described in the Federal Policy, from the human research subject.

4.4.4 Nothing in this section relieves licensees from complying with the other requirements in this part.

Disclaimer: These regulations may not be the most recent version. South Carolina 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.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.