UCSD Human Research Protection Program

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UCSD InfoPath

There are a large number of publicly available websites with information relevant to the conduct of research involving human volunteers. A partial list is provided here.

Federal Office of Human Research Protections
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

Online reference materials used by UCSD IRBs in the review of submitted projects:

General Human Subjects Protections References

UCSD HRPP Standard Operating Policies and Procedures
IRB Reviewer Checklists
- IRB Reviewer Worksheet
- Informed Consent Checklist
Text of 45 CFR 46 - Basic DHHS Policy for Protection of Human Research Subjects
OHRP Policy Guidance website
- OHRP Guidance topic list
- OHRP IRB Guidebook
University of California Policy on the Protection of Human Subjects in Research

Biomedical IRB Resources

Text of 21 CFR 50 - FDA Human Subjects regulations
PubMed MEDLINE
Drug information from Rxlist.com
FDA Regulations
- Investigational New Drug regulations
- Investigational Device regulations
  - FDA IRB Guidance on Medical Devices
  - FDA Humanitarian Device Exemption Guidelines
FDA Good Clinical Practice website
Clinical Pharmacology website

Social and Behavioral IRB Resources OHRP Guidebook Section on Behavioral Studies

Other resources

UCSD General Clinical Research Center (GCRC)
Operations: information on IRB policies and procedures developed by UCSD's HRPP that may be useful to other IRB's