The parent grant of a training grant to support students and trainees does not describe their specific human subjects research activities. The Principal Investigator on the training grant must submit an application for an IRB determination of Not Human Subjects Research.
The Principal Investigator on the training grant is responsible for informing all trainees that:
- their individual projects involving human subjects or their data or specimens must be submitted separately to the IRB either as a stand-alone submission or as a personnel change amendment to an already-approved study (NOT an amendment to the training grant submission); and
- they may not begin any human subjects related activities (including but not limited to recruitment, enrollment, consenting, data collection, study interventions, data analysis) until full IRB approval for the trainee’s individual projects has been obtained. Conditional approval and deferral do NOT represent full IRB approval.