I Activities Preparatory to Research
Reviewing patient records to design a research study, or to determine feasibility is considered “preparatory to research” under the Privacy Rule.
To access protected health information (PHI), the use or disclosure must be solely to prepare a research protocol or for similar purposes preparatory to research. Researchers conducting a review may not record information in identifiable form, nor use the information to contact potential subjects, unless the investigator is also the subject’s treating physician. Consult the covered entity regarding any forms necessary to conduct a review preparatory to research.
The IRB may require a waiver or alteration of HIPAA authorization/informed consent when you access patient records to review PHI as necessary for purposes preparatory to research (HIPAA – Personal Identifiers (PI) or Personal Health Information (PHI) or Waiver of Informed Consent). Any use of patient information for recruitment must comply with IRB recruitment policies. For further guidance see HSPP SOPs Section 15.4.2 – Review Preparatory to Research
Limited Data Set: The Privacy Rule also permits a covered entity to grant remote access to PHI to a researcher for activities that qualify as Limited Data Set. HIPAA Definition of Limited Data Set and Rutgers – Limited Data Set/Data Use Agreement.
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