General Guidance

The UCSD IRB requires that researchers conducting human subjects research abide by the Health Sciences COVID guidance. For more information see: Novel Coronavirus (COVID-19) Information (ucsd.edu).

This page contains a few different types of documents including: guidances, SOPs, and worksheets/checklists.

Guidance documents are for researchers and their teams to better understand OIA's thinking or expectations on matters for which there isn't an SOP or clear regulatory directive.
SOPs are for outlining how a process is to be completed. Most of the SOPs on this page are for OIA; however, SOPs for research teams are listed in the SOPs section as well.
- NOTE: The SOP section only lists those SOPs promulgated by OIA and should not be regarded as a complete listing of SOPs for researchers as UCSD may have other SOPs that are required.
Worksheets and Checklists are for use by the IRBs and OIA staff. They do not need to be completed or submitted by researchers. They are posted here to allow researchers to better understand the criteria OIA staff and the IRBs use in making certain decisions and determinations.

Your feedback, questions and comments are always welcomed at IRB@ucsd.edu.

Quick Links

Guidances

These documents are for researchers and their teams to better understand OIA's thinking or expectations on matters for which there isn't an SOP or clear regulatory directive.

Early Terminations

- OIA Procedure for Study Terminations

-Participant Study Termination Sample Letter - Safety Plan Needed

-Participant Sample Termination Letter - No Safety Plan Needed

General

- IRB Review Fees (PDF) | Updated JUL 2023

- Sponsor Letter on IRBs & FWA (PDF)

- Known issue with stamped documents in Kuali IRB [Note to File] (PDF)

- UC BRAID’s Guidelines on Multisite Participant Recruitment Using the UC EHR

- NIH Definition of a Clinical Trial (PDF)
- Registration of Clinical Trials in a Public Registry (PDF)

- Is this Human Subject Research? | Box Diagram (PDF)

- Definition of "Enrolled"

IRB Review Process

- Simplified UCSD IRB Review Flowchart
- Detailed UCSD IRB Review Flowchart

Training

- Human Subject Protection Training | CITI (PDF)

HIPAA Research Privacy training is offered by the CITI Program and is now available to UCSD faculty and staff. This training will replace the legacy HIPAA training offered on OIA's old webpage which will be retired by August 2023.

For additional information on available CITI training and instructions for accessing the training modules, please see the Office of Compliance and Privacy’s pulse page: Collaborative Institutional Training Initiative (CITI) Program

Privacy & Confidentiality

- HIPAA Authorization Forms
- Protected Health Information (PHI) in Research (PDF)
- Deidentified Health Information (PDF)
- Certificate of Confidentiality | CoC (PDF)
- HIV Reporting & Research (PDF)
- Research Using Death Records (PDF)

Vulnerable Populations

- Children as Research Subjects (PDF)

- Child Assent (PDF)

- Decisional Capacity (PDF) | Surrogate Consent (PDF)

- Placebo & High Risk Subjects with Psychiatric Illness (PDF)

Reliance

- SDSU Joint Protocol Review February 2024 (PDF)

- IRB Reliance

Informed Consent

- Returning Research Results / Incidental Findings (PDF)

- Guidance: Additional Consent Language for Human Fetal Tissue Collection (Word)

- Guidance: UCSDH Policy on Informed Consent in Human Subjects Research (PDF)

- Guidance: Waivers of Informed Consent (PDF)

- Screening Tests Prior to Enrollment (PDF)

Drugs and Devices

- Chemicals not regulated by the FDA (PDF)

- Medical Devices (PDF)

- Expanded Access | Investigational Device (PDF)

Required Submissions

- Oral History/Journalism Projects (PDF)
- Exempt Amendments (PDF)

- Submitting an Amendment (PDF)
- When to Submit Amendments for Approved Research

- Study Withdrawal or Closure (PDF)

- Guidance and Template for Developing a Corrective and Preventative Action (CAPA) Plan

Research on Specific Medical Conditions

- Postdural Puncture Headaches | PDPH (PDF)

- Diabetes Research | Glycemic Control (PDF)

SOPs

These documents are for outlining how a process is to be completed. Most of the SOPs in this section are for OIA; however, SOPs for research teams are listed in this section as well.

Investigators

013 Legally Authorized Representatives, Children, and Guardians

090 Informed Consent Process for Research

091 Written Documentation of Consent

092 Assent Process for Research

093 Written Documentation of Assent

094 Human Research Internet Recruitment

103 IRB Handbook

Administrative Review

020 Incoming Items Directed to the Office of IRB Administration

021 Pre-Review

023 Emergency Use Review

024 Reportable Events

026 Suspension or Termination of IRB Approval

Non-Committee Review

031 Non-Committee Review Preparation

032 Non-Committee Review Conduct

063 Expiration of IRB Approval

Committee Review

040 IRB Meeting Preparation

041 IRB Meeting Conduct

042 IRB Meeting Attendance Monitoring

043 IRB Meeting Minutes

Review Addenda

051 Consultation to the IRB

052 Post-Review

055 Financial Conflicts of Interest

Reliances and sIRBs

058 UCSD Relying on an External IRB

059 UCSD Serving as the IRB of Record

085 Establishing Reliance Agreements

OIA Operations

001 Definitions

012 Observation of the Consent Process

071 Standard Operating Procedures

Previous SOPPs and SOPs

Previous SOPPs/SOPs which are no longer in effect but may still be needed by researchers to aid in audits by Sponsors or Regulatory Agencies can be found on our Previous SOPPs/SOPs webpage.

Worksheets and Checklists

These documents are generally for use by the IRBs and OIA staff; however, researchers may find them useful for understanding what OIA and the IRBs consider when making decisions and determinations. They do not need to be completed or submitted by researchers.