Can I look through the medical records of my own patients to get an idea if a potential subject pool exists for a research protocol that I am developing?
Yes, if the medical records belong to your patients, you do not have to apply for an exception in order to assess protocol feasibility with your own patient population. If the patients are not yours, you will have to apply for an exception to the authorization before looking through the records. This exception is only to get an idea of the number of potential research subjects that may exist for the purposes of developing a protocol or deciding whether to even consider doing a study. It does not permit activities that lead to identification of potential subjects or their recruitment.
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