Regulatory and Guidance Links

The IRB's foundation and primary charge are supported in the Code of Federal Regulations. While interpretive differences between these governing regulations may exist, it should be noted that regulations offering the most stringent guidelines for the protection of human subjects are followed. Furthermore, these regulations are to be upheld by the Mayo Clinic Investigator and members of the research team without regard to with whom the research is conducted or the source of support for the research.

Office for Human Research Protections (OHRP)

• 45 CFR 46 DHHS Protection of Human Subjects
• OHRP Determination Letters
• OHRP Glossary of Terms
• IRB Guidebook
• OHRP Terms of Assurance

Guidance (OHRP):

• 407 Review Process
• AIDS Research
• Assurance FAQs
• Biological Specimens (see also Coded Private Information)
• Certificate of Confidentiality
• Children - Special Protections to Consider
• Children Involved as Subjects in Research
• Children FAQs
• Clinical Trials Website
• Coded Private Information
• Common Rule FAQs
• Consent Form Checklist
• Continuing Review
• Expedited Review
• Guidance on the use of Expedited Review
• Fetal tissue transplantation
• Frequently Asked Questions
• Human Subjects Basic Protections
• Human Subjects Decision Charts
• Incident Reporting to OHRP
• Investigator Responsibilities
• In Vitro Medical Devices
• IRB Guidance on Written Procedures
• IRB Knowledge of Local Research Context
• Prisoner Research
• Prisoner Research FAQs
• Tips on Informed Consent
• Unanticipated Problems Involving Risk to Subjects or Others

U.S. Food and Drug Administration (FDA)

• 21 CFR 50 FDA Protection of Human Subjects
• 21 CFR 54 FDA Financial Disclosure by Clinical Investigators
• 21 CFR 56 FDA Institutional Review Boards
• 21 CFR 312 Investigational New Drug Application
• 21 CFR 812 Investigational Device Exemptions
• Center for Drug Evaluation and Research (CDER)
• FDA Center for Biologics Evaluation and Research (CBER)
• FDA Information Sheets for Investigators and IRBs
• FDA - GCP in FDA Regulated Clinical Trials

Additional Resource Links

• National Cancer Institute
• National Cancer Institute - Simplification of Informed Consent Documents
• Office of Research Integrity