Human Subjects Protection

Institutional Review Board (IRB) Guidance

Every institution in the United States that conducts or supports biomedical or behavioral research involving human participants must have, by federal regulation, an IRB that initially approves and periodically reviews the research in order to protect the rights of human participants. An IRB is a committee of physicians, statisticians, researchers, community advocates and others that review research studies to ensure they are ethical and that the rights of study participants are protected.

All studies conducted within M Health Fairview facilities or involving Fairview employees, patients, or data must obtain approval from our local IRB. M Health Fairview’s IRB of record is the University of Minnesota's IRB.

IRB Process at M Health Fairview (for community (non-UMN)) research

Studies being conducted by community providers and staff (non-UMN) must adhere to the guidance below.

  • Each researcher has completed Human Subjects' Protection Training within the past 3 years
  • Each researcher has completed Conflict of Interest Training within the past 3 years
  • Each researcher has completed a Conflict of Interest disclosure within the past year
  • Each researcher has access to the UMN IRB electronic submission and management system, ETHOS.
  • Study is appropriately entered in OnCore, if applicable.
  • The principal investigator has reviewed the Investigator Manual on the UMN IRB website.

Please contact with questions.