Federal Regulations

Federal Regulations for IRB

Code of Federal Regulations, Title 45 Part 46 (45 CFR 46)
The federal legislation for Protection of Human Subjects, which guides all Institutional Review Boards.

Ethical Principles and Guidelines for the Protection of Human Subjects Research - the Belmont Report attempts to summarize the basic ethical principles identified by the1976 National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (the "Commission") in the course of its deliberations.

OHRP provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research.

OHRP's Human Subject Regulations Decision Charts
OHRP provides these graphic aids as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR 46.

OHRP's IRB Guidebook
The IRB Guidebook was last updated in 1993. Developments over the intervening years have made portions of the Guidebook information obsolete, while portions of the information remain valid. There is no errata document to indicate which information has been superseded. OHRP cautions users to verify the current validity of any Guidebook information before relying on the information in a program of human subjects protection.


Robert Halliday

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(315) 792-3006
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