University of Minnesota
Institutional Review Board
http://www.research.umn.edu/irb
612-626-5654

 

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IRB Forms

Download Research Exempt from Committee Review Application Form

Category 4: Existing Data: Records review, Pathological Specimens

These and other files can be found and downloaded on our Forms page.

 

Additional Appendices (only required for specific research activities)

  • Appendix A: Sponsored Projects
  • Appendix H: Use of Personal Health Information (HIPAA)
  • Appendix J: Student as Principal Investigator Worksheet
  • Appendix K: International Research
  • Appendix P: Research Methods Class Protocol (for courses teaching research methods)
  • Additional Personnel

Reminders for Exemption Category 4 Research:

  1. Records considered private based on federal and state statute, including medical records and education records, require written release by the study subject or by the custodian of the record.
  2. Review of private records involving access to and/or recording of identifiable information is not exempt from IRB review and requires written subject consent.
  3. Existing public records do not require prior consent to review the record.
  4. Exempt Category 4 is not intended to exempt research which gathers protected health information (PHI) within a covered entity.
  5. Pathological or diagnostic specimens which are considered waste and are destined to be destroyed can be used and are considered exempt from IRB review if there are no patient identifiers linked to the specimen and if the data will not be used in the diagnosis or treatment of a patient. (If either of these conditions apply, subject consent is required and IRB review is required.) Specimens retrieved as extra during a clinical procedure require IRB review and require written consent from the subject.
  6. Inclusion of fetal tissue in this category of exempt research is prohibited by regulation.

Reminders for Exemption Category 4 Application Form:

  1. For approval in this category you must plan to use:
    1. an existing data set without access to identifiers
    2. records review to which you have legitimate access to records when the chart is older than January 1, 1997, or where the patient has signed a consent form which is in the file after January 1, 1997
    3. collected waste tissue after it has been released to pathology
  2. When completing the abstract briefly explain the original study, or the origin of the waste tissue, and briefly explain what you intend to do with the data or waste tissue.
  3. Explain that you will not get any identifiers linked to the data or if you will, that you have permissible access to the data, and how you have permissible access, and that you will not be recording identifiers.
  4. Complete all required HIPAA documentation and initial and date form(s).
  5. Consent forms are not required.
  6. Instruments from the original study are not required for submissions.
  7. The original study must have IRB approval.
More Information

Submitting forms

Exempt applications may be submitted electronically to irb@umn.edu Submissions must come from the principal investigator’s University of Minnesota email address.

If the Principal Investigator is a student, the faculty advisor must be copied on the email.

If you have questions please contact us at irb@umn.edu or (612) 626-5654.

 

Reminder: Keep a copy for your records