216 Resources
Note: Use this search function to find documents on the website. For everything else, use the search bar in the upper right corner.-
Adverse Event or Safety Information Resource
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Advertising and Recruitment Letter Guidelines Resource
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Application for the use of X-Rays in Human Research Resource
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April 2021 Update on Electronic Consent Signatures Memo Resource
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Ask Andy Form
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Assent #1 - For children 7-12 (simple) Resource
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Assent #2 - For more complex study, more mature children Resource
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Assent #3 - For adolescents 13-17 Resource
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BCH Oakland IRB – UCSF IRB Study Transfer Matrix Resource
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Benioff Children's Hospital Oakland Resource
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Benioff Childrens Hospital Informed Consent Addendum Resource
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Benioff Childrens Hospital Integration Consent Addendum Resource
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Benioff CITI transfer Resource
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Benioff IRB Affiliation Resource
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Benioff Spanish Integration Consent Addendum Resource
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Bulletins Resource
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Changes to Timeline for Post-Approval Reporting Requirements Resource
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Children and Minors in Research Resource
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Summary Table on Subpart D, 45 CFR 46 and 21 CFR 50 Resource
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CITI Human Subjects Protection Training Resource
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Clinical Research Coordinators Council Resource
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Common Rule Resource
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Conflicts of Interest (COI) in Research Resource
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Consent and Assent Form Templates Resource
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Consent Form Guidelines and Suggested Wording Resource
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Consent Guidelines Resource
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Consent Template for Expanded Access Program Resource
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Consenting Non-English Speakers Resource
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Contact Us Resource
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Continuing Review Resource
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COVID-19 Screening Information Sheet Resource
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COVID-19 Testing Assent Form Addendum: Children Aged 7-12 Resource
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COVID-19 Testing Assent/Consent Form Addendum: Adults, Adolescents (13+), and Parents of Minors Resource
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Criteria required for IRB Approval of a Human Research Study Resource
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Data and Safety Monitoring Plans and Boards Resource
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Decision Making Capacity Assessment Tool Resource
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Decision Tool: Does this study qualify as Exempt 1, 2, 3, or 4? Resource
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Decision Tree: Determining Whether Human Subjects are Involved in Research When Obtaining Private Information (data) and/or Biological Specimens Resource
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Definitions Resource
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Does My Research Require IRB Review? Resource
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Duo Two-Factor Authentication Required for MyAccess June 30th | UCSF Institutional Review Board Resource
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Education Opportunities Resource
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Elements of Consent (Common rule, FDA, ICH) Resource
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Emergency Use Post-use Report Form
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Emergency Use Request of an Investigational Drug or Biologic
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Emergency Use Request of an Investigational Drug or Biologic Resource
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English Bill of Rights Resource
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Enrolling Individuals With Cognitive Impairments and Assessing Decisional Capacity Resource
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Enrolling Subjects Who Are Legally Blind, Illiterate, or Cannot Talk or Write Resource
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Exempt Consent Templates and Guidance Resource
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Expedited Categories Resource
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Experimental Participants Bill of Rights Resource
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Federal criteria for waiver or alteration of consent process and/or documentation Resource
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Federalwide Assurance Resource
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Federalwide Assurance (FWA) for the Protection of Human Subjects Resource
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GESCR Consent Guidance | UCSF Institutional Review Board Resource
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Guidance A-Z Resource
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HIPAA Amharic (Ethiopia) Translation Certificate Resource
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HIPAA Arabic Translation Certificate Resource
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HIPAA Armenian (Armenia) Translation Certificate Resource
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HIPAA Bengali (Bangladesh) Translation Certificate Resource
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HIPAA Bosnian (Bosnia) Translation Certificate Resource
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HIPAA Burmese (Myanmar) Translation Certificate Resource
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HIPAA Croatian (Croatia) Translation Certificate Resource
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HIPAA French (Canada) Translation Certificate Resource
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HIPAA Georgian (Georgia) Translation Certificate Resource
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HIPAA German (Germany) Translation Certificate Resource
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HIPAA Greek (Greece) Translation Certificate Resource
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HIPAA Gujurati (India) Translation Certificate Resource
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HIPAA Haitian (Haiti) Translation Certificate Resource
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HIPAA Hebrew (Israel) Translation Certificate Resource
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HIPAA Hindi (India) Translation Certificate Resource
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HIPAA Hmong Translation Certificate Resource
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HIPAA Ilocano Translation Certificate Resource
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HIPAA Indonesian (Indonesia) Translation Certificate Resource
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HIPAA Italian (Italy) Translation Certificate Resource
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HIPAA Japanese (Japan) Translation Certificate Resource
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HIPAA Khmer (Cambodia) Translation Certificate Resource
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HIPAA Korean (South Korea) Translation Certificate Resource
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HIPAA Lao (Laos) Translation Certificate Resource
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HIPAA Malayalam (India) Translation Certificate Resource
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HIPAA Mongolian (Mongolia) Translation Certificate Resource
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HIPAA Nepali (Nepal) Translation Certificate Resource
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HIPAA Persian (Iran) Translation Certificate Resource
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HIPAA Persian-Dari (Afghanistan) Translation Certificate Resource
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HIPAA Polish (Poland) Translation Certificate Resource
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HIPAA Portuguese (Brazil) Translation Certificate Resource
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HIPAA Punjabi Translation Certificate Resource
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HIPAA Requirements and Forms for Research Resource
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HIPAA Romanian (Romania) Translation Certificate Resource
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HIPAA Russian (Russia) Translation Certificate Resource
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HIPAA Simplified Chinese (China) Translation Certificate Resource
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HIPAA Spanish (Latin America) Translation Certificate Resource
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HIPAA Spanish (Mexico) Translation Certificate Resource
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HIPAA Spanish (Spain) Translation Certificate Resource
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HIPAA Spanish (United States) Translation Certificate Resource
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HIPAA Tagalog (Philippines) Translation Certificate Resource
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HIPAA Telugu (India) Translation Certificate Resource
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HIPAA Thai (Thailand) Translation Certificate Resource
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HIPAA Tibetan Translation Certificate Resource
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HIPAA Traditional Chinese (Hong Kong) Translation Certificate Resource
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HIPAA Traditional Chinese (Taiwan) Translation Certificate Resource
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HIPAA Turkey (Turkey) Translation Certificate Resource
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HIPAA Ukrainian (Ukraine) Translation Certificate Resource
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HIPAA Urdu (Pakistan) Translation Certificate Resource
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HIPAA Vietnamese (United States) Translation Certificate Resource
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HIPAA Vietnamese (Vietnam) Translation Certificate Resource
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How to Consent, Assess Comprehension, and Document Informed Consent for Clinical Research Resource
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Human Gene Transfer/Recombinant DNA Research Resource
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Human Research Protection Program (HRPP) Resource
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Humanitarian Use Device Resource
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Initial Submission Checklist Resource
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Instructions for filling out a Research Protocl Safety Survey (RPSS aka the 10-0398 form) Resource
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Investigational Devices Resource
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Investigational New Drugs and Biologics Resource
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IORG0000135 Resource
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IRB Approval Packets Resource
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IRB COVID-19 FAQs & Resources Resource
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IRB Limited Meeting Schedule: Impact on Studies Expiring in November, December, January | UCSF Institutional Review Board Resource
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IRB Member Handbook Resource
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IRB Review Resource
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IRB Review Fees Resource
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IRB Rosters & Meeting Dates Resource
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iRIS Departmental or Research Administrator Permission Request Form Resource
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iRIS Online Application System: Info and FAQs Resource
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Letter for Sponsors Resource
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Levels of Review Resource
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Logging into iRIS for the First Time Resource
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Medical Record Review Resource
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Minimum Submission Standards Implemented Resource
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Modification Resource
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Monitoring Resource
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New Greater-than-minimal-risk Studies Require a Scientific Protocol Starting 5/1/15 Resource
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New Study | UCSF Institutional Review Board Resource
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NIH Genomic Data Sharing (GDS) Policy and the Genome-Wide Association Studies (GWAS) Resource
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NIH Single IRB Mandate Resource
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Not Human Subjects Research Resource
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Obtaining and Documenting Informed Consent Resource
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Obtaining and Documenting Informed Consent Resource
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Participating in Research Resource
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Post Approval Reporting Requirements Summary Sheet Resource
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Pregnant Women Summary Table Resource
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Principal Investigator Status Request Resource
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Prisoner Regulations Resource
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Program Description Resource
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Protocol Enrollment Exception Addendum – Additional Risk Information Resource
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Protocol Enrollment Exception Request Resource
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Protocol Violation or Incident Resource
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Public Health Surveillance vs. Research Resource
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Quality Improvement (QI) and Quality Assurance (QA) Resource
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Quick Guide: Activities Requiring IRB Review Resource
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Quick Guide: Consenting Non-English Speaking Subjects Resource
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Quick Guide: How to Complete the Personnel Changes Form Resource
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Quick Guide: How to Complete the Protocol Enrollment Exception Request Form Resource
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Radiation Exposure Form for Skin Dose Calculation and Reporting Resource
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Recruitment Methods Resource
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Recruitment, Consent and HIPAA Resource
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Relying on Other IRBs and Current Reliances Resource
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Reporting Resource
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Reporting Research Concerns and Complaints Resource
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Request for R&D Commmitee Approval Resource
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Research at the SF VA Healthcare System Resource
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Research in Emergency Settings Resource
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Research in PTCA Template UD PCM Letter of Support Resource
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Research in PTCA Template UD PCM Letter of Support Followup Resource
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Research Protocol Safety Survey (RPSS) Cover Sheet Resource
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Research Protocol Safety Survey (VA) Resource
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Research Requiring GESCR Review Resource
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Research Tools and Checklists | UCSF Institutional Review Board Resource
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Research Using Human Biological Specimens Resource
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Responding to and Reporting Research-Related Concerns and Complaints Resource
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Responding to Stipulations in iRIS Resource
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Responsibilities of PIs and CRCs Resource
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Reviewer Checklist Resource
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Reviewer Guide Resource
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Sample Informed Consent Form Addendum Resource
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Sample Recruitment Phone Script Resource
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San Francisco Department of Public Health Policy Title: HIPAA Compliance Resource
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Scientific Review Approval Resource
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Self-Certification Form: Determining Whether Human Subjects Are Involved in Research When Obtaining Coded Private Information (Data) and/or Biological Specimens Resource
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SFVAHCS HIPAA Authorization Form Resource
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SFVAHCS Investigation Drug Record Information Resource
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SFVAHCS Research Office guidance on remote consent, data collection, and video communications Resource
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SFVAHCS Revocation of Authorization for Release of PHI — Open the file in Adobe Reader. Resource
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Significant vs. Non-significant Risk Devices Resource
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Single IRB Consultation Form Resource
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Social and Behavioral Research Resource
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Special Consent Requirements for Vulnerable Populations Resource
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Stem Cell Resource
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Stem Cell Research Regulatory Q&A and Resources Resource
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Study Closeout Report Resource
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Study Expiration Dates and Extended Approval Criteria Resource
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Submissions Resource
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Submitting COVID-19 Research to the IRB (New Studies & Modifications) Resource
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Surrogate Consent Resource
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Telephone Script (Eligibility Screening Only) Resource
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Telephone Script (Main Study Procedures) Resource
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Template: Letter to Colleagues Resource
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The New Common Rule Resource
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Training Resource
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Treatment and Compensation for Injury Resource
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UCSF Affiliated Institutions Resource
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UCSF Benioff Children’s Hospital Oakland Integration with UCSF IRB Resource
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UCSF Cancellation of Permission to Use Personal Health Information for Research Resource
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UCSF HIPAA Authorization Research Form Resource
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UCSF research projects using SFVAHCS resources Resource
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Updated Electronic Consent Guidance & Memo for Sponsors Resource
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Using Stem Cell Lines Resource
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Using Stem Cell Lines Resource
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Va Consent Form Resource
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Verbal, Electronic or Implied Consent (Waiver of Signed Consent) Resource
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VHA Research Protocol Privacy Review Checklist Resource
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Waiving Informed Consent Resource
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When UCSF Can Serve as IRB of Record Resource
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Where is my Study? Resource
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Working With Other Institutions Resource