Resources

Office of Human Research Protections (OHRP)

The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and social-behavioral research. 

History of Human Subjects Protections

The history behind human subjects protections began in 1947 with the Nuremberg Code, developed for the Nuremberg Military Tribunal as standards by which to judge the human experimentation conducted by the Nazis. The Code captures many of what are now taken to be the basic principles governing the ethical conduct of research involving human subjects. For more about the history of human subjects protection system, please visit the following links: OHRP 45 CFR part 46 FAQs or search the Office of Human Research Protections.

Federal Policy for the Protection of Human Subjects (“Common Rule”)

• 45 CFR 46 - Pre 2018 Requirements - Use this for all research submitted, reviewed, and/or approved prior to January 21, 2019. 
• 45 CFR 46 - 2018 Requirements - Use this for all research submitted, reviewed, and/or approved January 21, 2019 after . 

Belmont Report

• Belmont Report

OHRP Resources/Guidance Materials:

• Informed Consent Checklist
• Tips on Informed Consent
• Health Information Privacy:  HIPAA Privacy Ru le
• Vulnerable Populations
• Guidance on Engagement of Institutions in Human Subjects Research
• Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues

Understanding the HIPAA Privacy Rule:

• Protecting Personal Health Information in Research 

Responsible Conduct Of research Training:

• Importance of Formal Instruction in the Responsible Conduct of Research for Federally Funded Research