Federal Regulations

• Office for Human Research Protections (OHRP)
  • 45 CFR 46: Protection of Human Subjects
• U.S. Food and Drug Administration (FDA)
  • 21 CFR 50: Protection of Human Subjects
  • 21 CFR 56: Institutional Review Boards

Guidance

      Federal Guidance

• National Institutes of Health (NIH)
  • Guidelines on Women and Minorities
  • Inclusion of Women and Minorities as Participants in Research Involving Human Subjects – Policy Implementation Page
  • Inclusion of Children Policy Implementation
  • Research Involving Individuals with Questionable Capacity to Consent: Points to Consider
• U.S. Department of Health and Human Services (HHS) ~ Office for Civil Rights (OCR)
  • HIPAA – National Standards to Protect the Privacy of Personal Health Information
• Federal Advisory Committee on Human Subjects Research
  • Secretary's Advisory Committee on Human Research Protections (SACHRP)
• Office for Human Research Protections (OHRP)
  • IRB Guidebook
  • Human Subject Regulations Decision Charts

      Guidance Adopted by the UM Institutional Review Board (IRB)

• ClinicalTrials.gov Guidance
• Oral History Guidance
• Guidance on Public Use Data Files
• Qualtrics and Anonymous Survey Guidance
• Anonymous Qualtrics Surveys and Incentives
• Qualtrics and Survey Accessibility Guidance
• Guidance for Protocols using DEXA Equipment
• Guidance for Cash/Gift Card Incentives
• Determination of Intensity of Exercise (Background)     
• Determination of Minimal Risk for Child Research
• UM FERPA Guidance 
• Determination of Quality Assurance and Quality Improvement Research (QA/QI)
• Use of Snowball Recruiting 
• Public Use Data Files
• Use of Human Tissue and Human Cell Lines
• Certificates of Confidentiality
• Using Incentives for Research Subjects
• Adverse Events/Unanticipated Problems

UM IRB

• Policy Directory

Ethical Principles and Guidelines for Human Subjects Research

• Nuremberg Code (1949)
• Declaration of Helsinki (1964)
• Belmont Report (1997)