How NCCIH Uses the Parent R01 for Human Subjects Research

Investigators are reminded that NCCIH no longer accepts most clinical trial applications through the Parent R01 (NOT-AT-20-001). NIH offers three options for the Parent R01 (see comparison of NOFO types by clinical trial allowability):

• Parent R01 Clinical Trial Not Allowed (PA-25-301): NCCIH will continue to accept applications to this NOFO for observational studies such as survey studies, cohort studies, or case-control studies, as well as secondary analyses of existing data sets or banked samples.
• Parent R01 Clinical Trial Required (PA-25-305): NCCIH will only accept applications that propose human mechanistic trials/studies; no applications will be accepted that include any specific aims that propose to assess efficacy or effectiveness of any intervention (see NOT-AT-20-001).
• Parent R01 Basic Experimental Studies With Humans Required (PA-25-303): NCCIH will accept applications that propose basic science experimental studies involving humans, referred to in NOT-OD-18-212 as “prospective basic science studies involving human participants.” These studies assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application toward processes or products in mind.