Resource Information and Regulation Websites

Resources

The Belmont Report

The Declaration of Helsinki (official 2008 version; all previous versions should not be used or cited except for historical purposes)

The Nurenberg Code

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 has revised its 2005 document "Significant Findings and Concerns of Noncompliance" adding determinations that have been made since 2005, and provides additional regulatory citations.  Here is the revised document titled OHRP Compliance Oversight Activities: 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)

Summary of HIPAA Privacy Rule

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

Chapter VI (IRB), UAA Faculty Handbook

2011 International Compilation of Human Research Protections (compilation for 101 countries)

NIH Just-in-Time Procedures

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.

Federal Regulations

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