Resource Information and Regulation Websites
The Declaration of Helsinki (official 2013 version; all previous versions should not be used or cited except for historical purposes)
Office of Human Research Protections (OHRP) including:
- Compliance Oversight
- Special Issues
- Regulations and Policy Guidance
- Educational Resources
OHRP "Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events"
OHRP "Special Protections for Children as Research Subjects"
OHRP New Set of Frequently Asked Questions and Answers (FAQs) on informed consent
OHRP Types of Determinations of Noncompliance
OHRP offers educational videos on various topics like unanticipated problems and adverse events. OHRP plans to release additional educational videos in the future on a variety of topics.
HIPAA (Health Insurance Portability and Accountability Act of 1996)
Office of Research Integrity (ORI)
National Institutes of Health (NIH)
Alaska Federation of Natives, Guidelines for Research
NSF Principles for the Conduct of Research in the Arctic
International Compilation of Human Research Standards (compilation for 101 countries)
JERHRE (Journal of Empirical Research on Human Research Ethics) "Jerry Notes" is an educational resource designed to introduce key concepts and develop evidence-based ethical problem-solving skills for students, investigators, and human research administrators.
45 CFR 46 - U.S. Department of Health and Human Services (DHHS)
10 CFR 745 - U.S. Department of Energy (DOE)
21 CFR 50 - Food and Drug Administration (FDA)
34 CFR 97 - U.S. Department of Education