Guidance A-Z

A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z

• Biological Specimens/Tissue
• Blind Subjects​

• Children and Minors
• Certificate of Confidentiality from NIH
• CLIA Compliance and Lab Test Results
• Clinical Research Services (CRS) Application and Guidelines
• ClinicalTrials.gov (CT.gov) 
• Committee on Enterprise Information and Analytics (EIA)
• Cognitively Impaired Subjects and Assessing Decisional Capacity
• Compassionate Use Protocols
• Conflict of Interest
• Consent Guidelines
• Costs to Subjects - Consent Form Language
• CTSI Consultation Services

• Data and Safety Monitoring Plans and Boards (DSMP, DSMB)
• Data Death Files
• Data Use Agreement – Work with UCSF Innovation, Technology & Alliances (ITA) to determine if a Data Use Agreement is necessary.
• Data Resources (UCSF)
• Definitions
• Department of Defense Research
• Devices – Investigational Devices (IDE) and Significant Risk vs. Non-Significant Risk
• Drugs – Investigational New Drugs and Biologics (IND)

• Electronic Data Security
• Emergency Setting Research
• Emergency Use of Experimental Drugs and Devices
• Exempt and Exempt Reliances

• Federal Regulations, State Statutes and Guidance
• Federal Wide Assurance (FWA)
• Fetuses or Fetal Tissue

• Genomic Data Sharing (GDS) Policy and the Genome-Wide Association Studies (GWAS) — NIH

• HIPAA
• Healthcare Compliance and Privacy Office (UCSF)
• Human Gene Transfer/Recombinant DNA Research

• Illiterate Subjects or Those Physically Unable to Write or Talk
• International Research
• In Vitro Fertilization (IVF) Research
• iRIS FAQs, Accounts and Quick Guides

• Mandatory Companion Studies
• Medical Record Review
• Monitoring

• Neonates
• NIH Single IRB Mandate
• Non-English Speaking Subjects

• Patient Care Manager: Letter of Support
• Paying Subjects, Guidelines and Payment Procedures
• Personnel Change (Instructions on filling out the Personnel Change form can be found here. MyAccess login required)
• Phlebotomy Related Safety Alert and Advisory for Clinical Investigators and Other Research Personnel from Risk Management and Insurance Services
• Photography and Video Tip Sheet (MyAccess Login Required) and UCSF Photography & Media Consent Forms
• Placebos or Inactive Interventions in Place of Potentially Effective Therapy
• PI Eligibility
• Pregnant Women
• Prisoners
• Privacy Office (UCSF)
• Public Health Surveillance 
• Publication FAQs

• Reconsent
• Record Storage, Retention and Disposition
• Recruitment Methods and Advertising Guidelines
• Reliances
  • Relying on Other IRBs
  • UCSF as IRB of Record
  • UC Reliance Registry

• Skin Biopsies in Children
• Social and Behavioral Research

• Treatment and Compensation for Injury

• Veterans and Research at the SFVAMC