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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

- 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)

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)

Required Submissions

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