Outside Resources

International Resources

• International Compilation of Human Research Standards (HSS)
  

Guidance And Educational Materials

• National Institute on Alcohol Abuse and Alcoholism (NIAAA) Guidance
• American Psychological Association - Research Ethics & Regulation, Human Participants
• PRIM&R
• NIH Protecting Human Research Participants Tutorial
• OHRP Procedures For Working With Children
• OHRP Procedures For Working With Prisoners
• Model Tribal Research Code

Ethical Guidelines

• Nuremberg Code
• The Belmont Report
• Declaration of Helsinki - World Medical Association (WMA)
• The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
• International Ethical Guidelines for Biomedical Research Involving Human Subjects - Council for International Organizations of Medical Sciences (CIOMS)
• Tri-Council Policy Statement/ - Canada
• Ethical Considerations in Research With Socially Identifiable Population – American Academy of Pediatrics

Federal Regulations and Guidance

• 45 Code of Federal Regulations Part 46 U.S. Department of Health and Human Services regulations for the protection from research risks and of human research subjects
• 21 Code of Federal Regulations 50 and 56 U.S. Food and Drug Administration, DSHS regulations
• U.S. Dept. of Education Subpart D (34 CFR 97)
• Family Educational Rights and Privacy Act (FERPA) Guidance
• Protection of Pupil Rights Amendment
• OHRP Policy Guidance on Research Involving Coded Private Information or Biological Specimens
• Guidelines for Conduct of Research Involving Human Subjects at NIH
• OHRP IRB Guidebook
• OHRP Guidance on Reviewing and Reporting Unanticipated Problems
• United States Office of Management and Budget 

Federal Oversight Agencies

• Office for Human Research Protections (OHRP)
• DHHS Office of Research Integrity (ORI)
• Food & Drug Administration (FDA) Information Sheet Guidances

Health Insurance Portability and Accountability Act (HIPAA)

• OHRP Office for Civil Rights - HIPAA
• NIH Research & the HIPAA Privacy Rule
• Impact of the HIPAA Privacy Rule on NIH Processes Involving the Review, Funding, and Progress Monitoring of Grants, Cooperative Agreements and Research Contracts
• More HIPAA information

Training

• NIH Human Participation Protection