HRPP Manual Section 8-8-A

Exemption Category (97)

Exemption Category (97)
Research involving the study of previously collected identifiable data. The data may include documents or records (but not identifiable biospecimens), unless disclosure of the data outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.  This exemption allows the information to be recorded by the investigator in such a manner that subjects can be identified, directly or through identifiers linked to the subjects.

Exclusions
To qualify for exemption category (97), the research study must not include any of the following:

  • Federal funding or federal training grants
  • FDA regulated
  • Sponsor or other contractual restrictions
  • Clinical interventions (including clinical behavioral interventions)
  • Prisoners as subjects, unless the research is aimed at involving a broader subject population that only incidentally includes prisoners
  • Receipt of an NIH issued certificate of confidentiality to protect identifiable research data
  • Be a study for which MSU serves as the IRB of record

If any of the above criteria become applicable to a study determined exempt under this flexibility initiative, the IRB office must be promptly notified prior to implementation of the criteria and the study must be reviewed and approved in accordance with the appropriate review level (e.g. expedited, committee review).

Requirements
The requirements in HRPP Manual 8-1 “Exemptions” apply to activities that meet the criteria for exemption category (97).  Research studies that meet the above criteria for exempt category (97) will be evaluated and determined exempt by IRB staff and/or the IRB chair when appropriate. See the following HRP Manual section for review procedures: HRPP Manual 8-1 “Exemptions.”

Process
The investigator must submit a new study submission or continuing review submission to the IRB office. Review procedures as defined in the HRP Manual will be followed for submissions under consideration for exempt category (97). See HRPP Manual 8-1 “Exemptions.”

IRB staff will review the submission and determine if the research meets the criteria for exempt category (97). If the study does not include any of the exclusions and the research study meets the criteria for the flexibility initiative, the exempt determination will be documented and processed in accordance with HRPP Manual 8-1 “Exemptions.”

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 12-11-2015. Revision 1 approved by Assistant VP Regulatory Affairs on 7-21-2016. Revision 2 approved by Assistant VP Regulatory Affairs on 6-27-2018. Revision 3 approved by Senior VP for Research and Innovation on 1-18-2019.

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