Which projects/studies must be reviewed by the IRB?
The University of Minnesota has assured the federal regulatory agencies that the institution will review and approve all research involving human subjects before it is initiated.
- Federal Definition of Research
- a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. - from 45 CFR 46.102
Research requiring IRB review prior to initiation, irrespective of funding:
- involving human subjects
(Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
1. data through intervention or interaction with the individual, or 2. identifiable private information. - from 45 CFR 46.102)
- using records gathered on human subjects
- involving human tissue
This includes research which falls into any of the following categories:
- The research is conducted by University faculty, staff, students or Fairview Employees
- The procedures are performed on the premises of the University or Fairview Health Services;
- The procedures are performed with or involve the use of facilities or equipment belonging to the University
- The research involves University patients, students, staff or faculty
- The research involves Fairview Health Services patients and/or patient data
- The research project satisfies a requirement imposed by the University as the condition for the award of a degree or for completion of a course of study in the University
- A Dean or Department Head certifies that the research project satisfies an obligation of the faculty appointment at the University, as consistent with departmental research goals and objectives, including "clinical or adjunct" appointments
New University Policy on Donated Human Bodies:
The University has implemented a new
policy; "Procuring, Using, and Disposing of Donated Human
Bodies Used for Research and Teaching." The Anatomy Bequest
Program, with the assistance of the Senior Vice President for Health
Sciences and the Vice President for Research, developed this policy
to ensure that donated human bodies and body parts are obtained
and disposed of ethically and in compliance with federal and state
regulations.
For more specific examples of what must be reviewed by the IRB, see 2. What Is Subject to Review? in the Protecting Human Subjects Guide
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