• a
• b
• c
• d
• e
• f
• h
• i
• k
• m
• n
• o
• p
• r
• s
• t
• u
• v

A

• About HRPP
• Adolescent Assent Samples
• Adult Consent Samples
• Advertisement/Recruitment Materials Guidelines
• Amendment
  • Request Cover Letter
  • Submission Factsheet
• Application instructions
  • Approval-in-Principle
  • EBP/QA/QI
  • Non-UCSD "Centralized" IRB
• Approval-In-Principle Form - New Application
• Assent Samples
• Audio Recording Release Samples

B

• Biomedical Research
  • Continuing Review Facepages
  • Forms
    • Continuing Review
    • New Application/Re-submission
    • Study Closure/Withdrawal
    • Unanticipated Problem Involving Risk to Subject or Others/Adverse Event Addendum
    • Request Key Personnel Changes Only
    • Secondary Use Research
  • IRB Meeting dates

C

• Certificate of Confidentiality
• Checklists
  • For Biomedical Research Studies (includes checklist for both Research Plan and consent)
  • For Emergency Use of a Test Article
  • For Initial Review Submission
    • Biomedical Research Studies
    • Social and Behavioral Sciences Research Studies
  • For Social and Behavioral Sciences Research Studies (includes checklist for both Research Plan and consent)
  • To Determine Whether Proposed Activities are Human Research
    • Flowchart
    • Box Diagram
• Child Assent Samples
• Children as Research Subjects
• Clinical
• Pharmacology website
• Trials Directory
• Closure/Withdrawal of Study
• Compassionate Use — Device (see page 3)
• Contact Us
• Consent Samples
• Continuing Review
  • Biomedical
  • SBS
• Coronavirus (COVID-19) IRB Guidance
• CSUSM/UCSD Agreement for IRB Review

D

• Dates - IRB Meeting
• Death Records use in Research
• Decisional Capacity Assessment
• Diabetes Research: Glycemic Control Guidelines for Type 2 Diabetes studies
• DNA and Informed Consent Issues
• DoD/DON-funded Research
• Drug information from Rxlist.com
• Duration of IRB Approval

E

• EBP/QA/QI Projects Forms
• e-IRB Services
• Emergency Use
  • Investigational Device (see bottom of page 4)
  • Investigational Drug (see page 4)
• Enrolled Definition
• Exempt
  • Forms
• Expanded Access
  • Investigational Device
  • Investigational Drug

F

• Fact Sheets
• FAQs
• FDA
  • Good Clinical Practice website
  • Regulations
  • Investigational Device regulations
    • FDA IRB Guidance on Medical Devices — FAQs
    • FDA IRB Guidance on Medical Devices — SR and NSR
    • FDA Humanitarian Device Exemption Guidelines
  • Investigational New Drug regulations
• Forms
  • Biomedical Research
    • New Submission
    • Study Closure/Withdrawal
    • Unanticipated Problem Involving Risk to Subject or Others/Adverse Event Addendum
  • Social and Behavioral Sciences (SBS) Research
    • New Submission
    • Study Closure/Withdrawal
    • Unanticipated Problem Involving Risk to Subject or Others
  • RCHSD-only
  • Exempt Status
  • Approval-in-Principle
  • Non-UCSD "Centralized" IRBs — Fact Sheet with links to forms
  • EBP/QA/QI Projects
• FWA statement letter

H

• UCSD research HIPAA authorization forms
  • UCSD research HIPAA authorization forms can be found on the Research Compliance Program (RCP) intranet site at https://pulse.ucsd.edu/departments/research-compliance/study/Pages/Forms.aspx . The HIPAA authorization form is available in the following languages with copies of the translation certificates, as provided by UCOP: English, Cambodian, Farsi, Mandarin, Russian, Spanish, and Vietnamese. For additional information, please contact RCP at rcp@ucsd.edu.
• HIPAA Privacy Rule Information
• HIV Reporting and Research (a letter from the California Dept. of Health Services, Office of AIDS, November 2003)
• Home
• How To
• HRPP Human Subjects Training Requirement
• Human Stem Cell Study Information

I

• Information about Certificates of Confidentiality
• Information about Insurance Code 10145.4 which calls for insurers to pay for standard of care costs incurred during participation in a cancer clinical trial
• Initial Review Submission Checklist for
  • Biomedical Research Studies
  • Social and Behavioral Sciences Research Studies
  • 3-year Approval Checklist
  • Rapid Cycle Review
• Investigational
  • Device regulations
  • New Drug regulations
• Investigator-Initiated Clinical Trials/IND Applications
• IRB
  • Meeting dates
  • Recommendations on treatment of Postdural Puncture Headaches
  • Review fees for commercially-sponsored projects
  • Training Requirements

K

• Key Personnel Changes Only

M

• Medical Devices

N

• News
• NIH Definition of a Clinical Trial
• NIH Policy for Issuing Certificates of Confidentiality
• Non-UCSD "Centralized" IRBs Forms — Fact Sheet with links to forms

O

• Oral History/Journalism Projects
• ORHP
  • Home page
  • Policy Guidance website
  • Guidance topic list
  • Guidebook Section on Behavioral Studies (archived information)
  • Information Related to Notice of Proposed Rulemaking (NPRM) for Revisions to the Common Rule

P

• Parent Permissions Samples
• Placebo-controlled Studies in High Risk Psychiatric Populations
• Postapproval Reporting Timeframes
• Project Reviewer Checklists
  • Biomedical Research Studies (includes checklist for both Research Plan and consent)
  • Social and Behavioral Sciences Research Studies (includes checklist for both Research Plan and consent)
  • Emergency Use of a Test Article
• Pregnant Partner
• Public Notices
• PubMed MEDLINE

R

• RCHSD-only Research Forms
• References
• Registration of Clinical Trials in a Public Registry for Publication
• Reporting Unanticipated Problems Involving Risk to Participants or Others (UPRs), Non-UPRs, an Off-site Reports to the IRB
• Request Key Personnel Changes Only
• Research
• Directory
• Involving the Use of Existing Data/Specimens
• Research Plan instructions
  • Biomedical
  • Exempt Forms
  • RCHSD-only Forms
  • Social and Behavioral Sciences
• Revised Common Rule
• Overview
• Consent Process
• Sample Informed Consents/Permissions/Assents

S

• School of Medicine Home page
• Screening Tests Prior to Study Enrollment
• SCRO
• SDSU/UCSD Agreements
  • Joint Review of Faculty Protocols
  • JDP/Master's Degree-IRB Review
• Secondary Use Research
• Short Form Consent
• Social and Behavioral Sciences Research Forms
  • New Application/Re-submission
  • Continuing Review
  • Continuing Review Facepages
  • Study Closure/Withdrawal
  • Unanticipated Problem Involving Risk to Subject or Others
  • IRB Meeting dates
• SOPPs
• Sponsor Letter about UCSD IRBs
• Supplements to the Research Plan
  • Research involving an IND exemption — required for research requesting an IND exemption for the use of a drug, bioavailability or bioequivalence studies, studies involving radioactive or cold isotopes, or foods including dietary supplements and conventional/medical foods (released 1/28/2014)
  • Research involving pregnant women, neonates, and/or human placenta or fetal material — required for research that involves pregnant women, neonates, and/or human placenta, the dead fetus, or fetal material obtained after delivery (updated 1/11/2013)
  • Research involving prisoners — required for research that involves prisoners (updated 10/2/2014)
  • Research funded through the DoD — required for research supported by or in collaboration with the Department of Defense (updated 11/8/2010)
• Surrogate Consent Use

T

• Text of
  • 21 CFR 50 - FDA Human Subjects regulations
  • 45 CFR 46 - Basic DHHS Policy for Protection of Human Research Subjects
• Training

U

• UC IRB Reliance Registry/UC MOU
• UCSD
  • Clinical and Translational Research Institute
  • Fact Sheets on Human Subjects Research topics
  • Home Page
  • HRPP Standard Operating Policies and Procedures
• University of California Policy on the Protection of Human Subjects in Research
• Use of Chemicals and other substances that are not regulated by the FDA

V

• Video Recording Release Sample