IRB Regulations, Policies & Procedures

Researchers engaged in activities involving human participants must be aware of the regulations that outline protections for human research participants.

Federal Regulations

DHHS Regulations for the Protection of Human Subjects: 45 CFR 46 - Describes the basic mandates regarding protection of human research participants; also called "The Common Rule"

Additional Protections for Pregnant Women, Human Fetuses & Neonates
Additional Protections for Prisoners as Research Subjects
Additional Protections for Children as Research Subjects

FERPA (Family Educational Rights and Privacy Act): 34 CFR 99 - Protects the privacy of student education records; can apply to research if project utilizes data from a student's "educational record"

HIPAA (Health Information Portability and Accountability Act): 45 CFR 160, 162, 164 - Protects the privacy of a person's "personal health information" can apply to research if project utilizes health related data obtained from a HIPAA-covered entity.

National and International Policies

Belmont Report - Originally published in 1978 by a special commission charged with exploring the mistreatment of humans during research; identifies the three fundamental ethical principle for human subjects research (respect for participants, beneficence, and justice)

Helsinki Declaration - Adopted by the World Medical Association (WMA) in 1964 and most recently updated in 2008; outlines the ethical principles recommended for medical research involving human participants.

National Institutes of Health (NIH) Policy on the Inclusion of Children in Research

NIH Policy on the Inclusion of Women and Minorities as Participants in Research Involving Human Subjects

University of West Florida Policies, Procedures, and Guidelines


Compliance with Federalwide Assurance (FWA)

Requests from External Researchers, UWF Policy AC-10.00 - 8/10

Conflict of Interest, UWF Policy AC-11.02 - 5/13

Reporting Adverse Events and Unanticipated Problems‌ (PDF)

Mandatory Training for Investigators

UWF Guidelines on Ethnography and IRBs: UWF follows the guidelines expressed in the American Anthropological Association's (AAA) "Statement on Ethnography and IRBs."

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