The Northwestern University IRB reviews research proposals to ensure risks have been minimized and the potential for benefit has been maximized before human subjects participate in the research. The IRB also ensures, when required, that human subjects only volunteer to participate in research after providing legally effective informed consent. Ongoing oversight ensures that the conduct of the research maintains those subject protections at NU, NMH, RIC, the Jesse Brown VAMC, and at other sites when negotiated through separate Assurances.

Finally, the NU IRBs are responsible for the research use and disclosure of protected health information (PHI) at NU. The IRBs review and approve authorization agreements, applications for the use or disclosure of limited or de-identified data sets, and applications for waiver of the authorization requirements.

Statement of GCP Compliance

The Northwestern University IRB is compliant with Good Clinical Practice Guidelines insofar as those guidelines are consistent with the U.S. Food and Drug Administration regulations (21 CFR Parts 50 and 56) and the Department of Health and Human Services regulations (45 CFR 46) pertaining to the protection of human subjects in research.. Official documentation from Don Workman, OPRS Executive Director, is available to document this compliance:

Statement of GCP Compliance.