POLICIES, REGULATIONS, AND STANDARD OPERATING PROCEDURES

STATE REGULATIONS

• California Health and Safety Code Section 24170-24179.5 (PDF) (Effective 4/03/2006)
• UCOP Policies on Research (including human subjects)

UNIVERSITY OF CALIFORNIA, OFFICE OF THE PRESIDENT POLICIES

• UC Contracts and Grants Manual, Chapter 18, Sections 100 through 999 available at: http://www.ucop.edu/raohome/cgmanual/chap18.html#18

UC DAVIS POLICIES

• Policy and procedure manual, Section 240 “Research Involving Human Subjects”, available at: http://manuals.ucdavis.edu/PPM/contents.htm#240

UC DAVIS STANDARD OPERATING PROCEDURES

Is My Proposed Activity “Human Subjects Research” and Does it Require IRB Review and Approval?

• What is Research Involving Human Subjects? (PDF)
• Activities Subject to IRB Review (PDF)
• Emergency Use - Life-Threatening Situation (PDF)
• Communicating with the IRB (PDF)

What Educational Training Am I and My Research Personnel Required to Undergo?

• Education and Training (PDF)
• Investigator Qualifications (PDF)

What Type of Application Form Do I Use for IRB Review?

• Exempt Review (PDF)
• Expedited Review (PDF)
• Full Committee Review (PDF)

How Do I Complete the “Description of Study” Section Needed for IRB Review?

• Risks / Benefit Analysis (PDF)
• Recruitment of Subjects (PDF)
• Informed Consent (PDF)   
• Vulnerable Populations (PDF)  
• Non-English Speaking Subjects (PDF)
• Surrogate Consent (PDF)
• Waiver or Alteration of Informed Consent (PDF)
• Privacy and Confidentiality (PDF)
• Data and Safety Monitoring Plans (PDF)
• Investigational Drugs and Biologics (PDF)
• Investigational Devices (PDF)
• Investigator Qualifications (PDF)
• Investigator Conflict of Interest (PDF)
• Resources for the Conduct of Research (PDF)
• Multiple Research Sites (PDF)
• Humanitarian Use Devices (PDF)
• Planned Emergency Research (PDF)

What is “Informed Consent” and How Do I Develop it?

• Informed Consent (PDF)   
• Non-English Speaking Subjects (PDF)
• Community Outreach (PDF)
• Surrogate Consent (PDF)
• Documentation of Informed Consent (PDF)
• Waiver or Alteration of Informed Consent (PDF)
• Humanitarian Use Devices (PDF)
• Planned Emergency Research (PDF)

Are There Other Internal or External Reviews That I Need to Obtain in Addition to the IRB?

• Other Internal and External Reviews (PDF)
• Resources for the Conduct of Research (PDF)

What is the Submission Process, Are There Deadlines, and How Long Will it Take to Hear from the IRB?

• Investigator Responsibilities (PDF)
• Submission of New Applications (PDF)
• Criteria for Approval (PDF)
• IRB Determinations (PDF)
• Communicating with the IRB (PDF)

What Are My Responsibilities After I have Obtained IRB Approval?

• Investigator Responsibilities (PDF)
• Dispensing of Investigational Drugs and Biologics (PDF) 
• Adverse Experiences "Revised" (PDF)
• Modifications/Amendments (PDF)
• Deviation from an Approved Study (PDF)

What is the Process for Renewing My Study and is There A Deadline?

• Continuing Review (PDF)
• Criteria for Approval (PDF)
• IRB Determinations (PDF)
• Communicating with the IRB (PDF)

What Happens if There Is A Violation of the Regulations and/or Requirements of the IRB?

• Deviation from an Approved Study (PDF)
• Adverse Experiences (PDF)
• Quality Improvement Program (PDF)
• Investigating Non-Compliance (PDF)
• Suspension or Termination of IRB Approval (PDF)

Who is the IRB, Where Does the Authority Come From, and What is the Responsibility of the IRB Administration?

• Human Research Protection Program (PDF)
• Federalwide Assurance (PDF)
• IRB Authority (PDF)
• Institutional Review Boards (PDF)
• Representation on the IRB (PDF)
• IRB Appointments (PDF)
• Expertise on the IRB (PDF)
• Resources to the IRB (PDF) 
• Creation of Policies (PDF)
• IRB Records (PDF)
• IRB Meeting Minutes (PDF)
• IRB Committee Member Conflict of Interest (PDF)
• Communicating with the IRB (PDF)
• Delegation Policy (PDF)