Guidance

Certification Preparatory to Research

May 8, 2015 11:45 am
  • Process Flowchart

    Note: You may not begin any study-related activities until after you receive a Determination Letter.

  • Applicability

    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. This means the project will need to be reviewed by the Privacy Board.

  • Required representations (assurances)

    1. The use or disclosure is requested solely to review PHI as necessary to prepare a research protocol or for similar purposes preparatory to research (eResearch application question 25-3.1), 
    2. The PHI will not be removed from the covered entity in the course of review, (eResearch 25-3.2) and
    3. The PHI for which use or access is requested is necessary for the research (eResearch 1.8).
  • Process for application

    To request “Certification for pre-review of clinical data” from Privacy Board, complete a new application in eResearch Regulatory Management (eRRM). Fill out system-required sections, including:

    • Question 1.8 (project summary): explain the purpose of the project, and why this requires access to PHI.
    • Section 01-1: “Activities Not Regulated…”;
    • Section 04-1: “Pre-review of Clinical Data Sets”;
    • Section 25-3: provide required assurances. 

    Once completed and submitted, the application will be reviewed by IRBMED Staff for clarity and completeness, then assigned to the Privacy Board for determination.

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: sophiach@umich.edu
Last Updated: May 25, 2018 12:00 PM