The UCSD Human Research Protections Program provides brief summaries on topics of special interest.

UC San Diego, HRPP Topic Summary List

Summary papers for topics of special interest

• Advertisement/Recruitment Materials Guidelines (updated 6/26/2017)
• Amendments: Submitting an Amendment/Modification to a Research Plan (updated 11/9/2016)
• Child Assent
• Children as Research Subjects
• Closure/Withdrawal of Study (updated 3/27/2012)
• CSUSM/UCSD Agreement for IRB Review (released 10/30/2013)
• Death Records use in Research
• Decisional Capacity Assessment
• Diabetes Research: Glycemic Control Guidelines for Type 2 Diabetes studies
• DNA and Informed Consent Issues (updated 1/19/2019)
• DoD/DON-funded Research (released 11/12/2010)
• Duration of IRB Approval
• EBP/QA/QI Projects (updated 7/17/2015)
• Exempt from IRB Review (updated 3/1/2018)
• Expanded Access - Investigational Device (released 5/9/2018)
• HIPAA Privacy Rule Information
• HIV Reporting and Research (a letter from the California Dept. of Health Services, Office of AIDS, November 2003)
• Human Stem Cell Study Information
• HRPP Human Subjects Training Requirement (updated 4/17/2018)
• Investigator-Initiated Clinical Trials/IND Applications (updated 5/7/2018)
• IRB:
• Recommendations on treatment of Postdural Puncture Headaches
• Review fees for commercially-sponsored projects (updated 12/21/2016)
• Medical Devices (released 3/5/2009; updated 4/2/2009)
• NIH Definition of a Clinical Trial (released 2/6/2018)
• NIH Policy for Issuing Certificates of Confidentiality (released 4/21/2018)
• Oral History/Journalism Projects (released 10/1/2013)
• Placebo-controlled Studies in High Risk Psychiatric Populations
• Postapproval Reporting Timeframes (released 5/10/2013)
• Registration of Clinical Trials in a Public Registry for Publication
• Reporting Unanticipated Problems Involving Risk to Participants or Others (UPRs), Non-UPRs, and Off-site Reports to the IRB (updated 2/28/2020)
• Research Involving the Use of Existing Data/Specimens (updated 11/28/2012)
• Returning Research and/or Incidental Findings (released 2/6/2018)
• Screening Tests Prior to Study Enrollment
• SDSU/UCSD Agreement for:
• Joint Review of Faculty Protocols (updated 12/20/2012)
• JDP/Master's Degree-IRB Review (updated 12/20/2012)
• Sponsor Letter about UCSD IRBs
• Surrogate Consent Use
• UC IRB Reliance Registry/UC MOU (released 6/24/2013)
• Use of Chemicals and other substances that are not regulated by the FDA