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Research Integrity Office

Federal Regulations & Guidelines


Department of Health and Human Services (DHHS)

  • OHRP - Office for Human Research Protections, DHHS, home page
  • 45 CFR 46 - DHHS Regulations for the Protection of Human Subjects
  • 45 CFR Parts 160, 162 and 164 - Health Insurance Reform: Security Standards; Final Rule
  • Exempt Guidelines - Categories of Research That May Be Reviewed by the IRB through an Exempt Review Procedure
  • Expedited Guidelines - Categories of Research That May Be Reviewed by the IRB through an Expedited Review Procedure

Food and Drug Administration (FDA)


Good Clinical Practice (GCP)


Ethical Codes

  • Belmont Report - Ethical Principles and Guidelines for the Protection of Human Subjects of Research
  • Declaration of Helsinki - Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects
  • Nuremberg Code - Directives for Human Experimentation
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