Are requests to conduct human research treated as requests for a license amendment?
A licensee that intends to conduct research on human subjects must meet the requirements in 35.6(b) or receive a license amendment before conducting the research. As long as the conditions in 35.6(b) are met, it is not necessary for a medical licensee to apply for and receive an amendment to its NRC license prior to conducting research involving human subjects. A license amendment request is required if the licensee wishes to use a radionuclide or type of use that is not currently authorized on its license.
Related Questions
- Do all researchers working with human subjects have to take a responsible conduct in research compliance training?
- What Are the Basic Ethical Principles That Should Underlie the Conduct of Research Involving Human Subjects?
- Are the notification requirements under 10 CFR 35.14 treated as requests for amendment of the license?
