What do I check in Item 4 if I do not have definite plans to conduct human subjects research?
If you are not sure whether human subjects will be involved, or if the eventual research design is dependent on preliminary studies described in your application, check “Yes” in Item 4. In the Human Subjects section of your application, provide a description of possible planned human subjects research. After you have enough information to more completely describe the human subjects research, submit both a protocol and a revised Human Subjects section (as per the PHS 398 Instructions) to your Program Official for approval. This situation is specifically covered in sections 46.118 and 46.119 of the HHS regulations.
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?
- What do I check in Item 4 if I do not have definite plans to conduct human subjects research?
