Certification Preparatory to Research
Review of data and/or biospecimens preparatory to research are not regulated under the Common Rule if any data obtained is not used for future research. However, if you or any member of the study team will be accessing Protected Health Information (PHI) to assess the feasibility of a research project (for example, determining whether there are enough potential subjects in order to pursue the research project), the activities must comply with HIPAA Privacy Rule.
HIPAA Privacy Rule permits access to PHI as part of Activities Preparatory to Research if the researcher provides appropriate representations (or assurances) to the covered entity. These representations are recorded in the eResearch Regulatory Management (eRRM) system.
Questions?
Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)
2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800
A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.
Edited By: larkspur@umich.edu
Last Updated: August 31, 2020 2:45 PM