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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).  

Welcome to the new home for IRB guidance! Our previous site housed the Standard Operating Policies & Procedures, Frequently Asked Questions, Facts Sheets and more—across multiple pages.  Here, we have tried to bring all guidance together and grouped them into logical topical areas.

This process of reviewing and revising our written guidance is continuous as regulations, policies, and procedures change.  However, in 2018 with the anticipation of a new electronic IRB system anticipated in 2020, we began a deep and careful review of all guidance documents.

This website is only a first step.  Over the coming weeks and months, many documents on this page will be updated or replaced.  In order to manage situations where existing guidance has not been updated, HRPP leadership may allow alternate courses of action consistent with regulatory requirements, the advice of legal counsel or properly promulgated University policies.

We will sunset and remove guidance when practical. In addition, in the coming months, we will be developing a Researcher Manual which supplements information on ResearchCompass. Changes and revisions in IRB guidance will be announced on our website and via our new newsletter.

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

1 | Administration

Related Guidance & Information
1.1  Responsibility & Authority (PDF)
1.2  HRPP Program Organization (PDF)
1.3  Review & Updating of SOPPs (PDF)
1.4  Documentation & Record Retention (PDF)
1.5  UCSD Institutional Policies (PDF)

2 | Organization

Related Guidance & Information
2.1  Composition of IRBs (PDF) - IRBs & FWA (PDF) 
2.2  Member Appointment, Compensation & Responsibilities (PDF)
2.3  Orientation & Training (PDF)

- 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

3 | Review Procedures

Related Guidance & Information
3.1  Initial Screening (PDF)
3.2  Convened IRB Review (PDF)
3.3  Criteria for Approval (PDF) - Duration of IRB Approval (PDF)
- Chemicals not regulated by the FDA (PDF)
3.4  Informed Consent (PDF)
3.5  Emergency Use & Informed Consent (PDF) - Expanded Access | Investigational Device (PDF)
3.6  Privacy & Confidentiality of Research Records (PDF) - 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)
3.7  Protected Populations (PDF)
3.8  Financial Disclosure & Conflict of Interest (PDF)
3.9  Exemption from IRB Review (PDF) - IRB Exemption (PDF)
- EBP | QA | QI Projects (PDF)
- Oral History/Journalism Projects (PDF)
- Exempt Amendments (PDF) 
3.10  Expedited Review (PDF) - Approval-in-Principle | AIP (PDF)
3.11  Continuing Review (PDF) - Study Withdrawal or Closure (PDF)
3.12  Protocol Amendments (PDF) - Submitting an Amendment (PDF)
3.13  Adverse Events & Unanticipated Problems PDF)
3.14  Protocol & Regulatory Violations (PDF)
3.15  Radiation Exposure & Radioisotopes (PDF)
3.16  Banking of Specimens (PDF) - Research on Existing Data/Specimens | Secondary Use (PDF)
3.17  Advertisements, Recruiting Materials & Procedures Preparatory to Research (PDF)
3.18  Subject Complaints | Concerns | Questions (PDF)
3.19  Collaboration with other UCSD Committees (PDF)
3.20  Specimen & Data Confidentiality (PDF)
3.21  Oversight by Non-UCSD "Centralized" IRBs (PDF) - Non-UCSD Centralized IRBs (PDF)
- RCR-sIRB-Matrix (PDF)

4 | Functions & Operations

Related Guidance & Information
4.1  IRB Meeting (PDF)
4.2  Categories of Action (PDF)

5 | Protocol Audits & Scientific Misconduct

Related Guidance & Information
5.1  Protocol Audits (PDF)
5.2  Communications, Sanctions, Appeals & Disciplinary Actions (PDF) - Reporting Certain Determinations (PDF)

6 | eIRB Services

Related Guidance & Information
6.1  eIRB Submissions & Review (PDF) - Known issue with stamped documents in Kuali IRB [Note to File] (PDF)

7 | Multi-Site Studies

Related Guidance & Information
7.1  Multi-Site Studies (PDF) UC BRAID’s Guidelines on Multisite Participant Recruitment Using the UC EHR

8 | Appendix

Related Guidance & Information
8.1  Abbreviations (PDF)
8.2  Definitions (PDF)
- Is this Human Subject Research? | Flowchart (PDF) | Box Diagram (PDF)