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Institute for Research & Scholarship

Federal Guidance

  • Categories of Research That Are Exempt From the Requirements of 45 CFR 46, 45 CFR 46 August 19, 1991
  • Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure - November 9, 1998
  • Human Subject Regulations Decision Charts
  • Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs - OPRR Reports August 13, 1993
  • Privacy Protection for Research Subjects
  • International Conference on Harmonization (ICH) Efficacy Guidelines
  • Good Clinical Practice (ICH): Consolidated Guidance (PDF)

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