Anonymous asked 7 years ago
Recent submission went in and under Special Review tab, we selected Human Subjects, pending approval. Next under the questionnaire we marked N/A for consent needed for human subjects since the samples were already collected from previous studies. We are wondering if KC automatically selects the Human Subjects in the application to NIH as exempt or if there was somewhere that was selected in the proposal development in KC that we are unaware we did?
mcoolahan answered 7 years ago
KC does not automatically generate an exempt status when you answer N/A to the informed consent question. This question relates to clinical trial applications. Exempt status is determined by entering Human Subjects on the Special Review Tab and choosing a status of exempt and entering an exemption number.