Researchers who need to access protected health information (PHI) to assess study feasibility, to design a study, or formulate a hypothesis must first obtain approval to do so. A preparatory to research form such as this example is usually submitted to the IRB and a HIPAA Privacy Officer. PHI accessed for these types of pre-research activities may not be used to recruit subjects on conduct actual research. Click here to download.
Pace WD, Staton EW, Holcomb S. Practice-based research network studies in the age of HIPAA. Annals of Family Medicine. 2005;3(Suppl 1):S38-S45. http://www.annfammed.org/cgi/data/3/suppl_1/s38/DC1/3
