Guidance

Below are the elements the IRB looks for when reviewing research and other additional requirements as applicable. Federal regulations 45 CFR 46.111 and 21 CFR 56.111 outline the requirements for approval of non-exempt human subjects research. To obtain IRB approval, the IRB must have enough information to determine the criteria in each of the sections below are satisfied.

When applying for initial approval, review each topic to ensure the proposed research meets the requirements for approval. When modifying existing research, ensure that the proposed modifications continue to comply with the requirements.

• Frequently Asked Questions
• Researcher Roles and Responsibilities
  • Research Personnel List
  • Faculty Advisor Responsibilities
  • Student or Medical Resident Researchers
• Conflicts of Interest
• Risks and Benefits of Research
• Subject Selection and Recruitment
• Vulnerable Populations
• Consent Process
  • Surrogate Consent
• Consent Documentation
• Investigational Drugs & Devices
  • Devices
  • Drugs
• Contraception Requirements for Clinical Trials
• Research at Sites Outside of UC Davis
• Monitoring for Safety and Compliance
• Privacy and Confidentiality
• Medical Records
• Student Records and FERPA
• The Common Rule