California Informed Consent Guidelines

The Panel's requirements mirror the federal requirements defined in Title 45 CFR Part 46, combined with those contained in California's "Protection of Human Subjects in Medical Experimentation Act”, and "California Health and Safety Code §24172, pdf and §24173, pdf".

The Panel has no authority to regulate any of the above laws. If you have any questions regarding California Informed Consent Form and Experimental Subject’s Bill of Rights, please refer to California Health & Safety Code Chapter 1.3 Human Experimentation, §24172, pdf and §24173, pdf provided under Appendices on this website.

The California Research Subjects’ Bill of Rights should be present at the onset of the consenting process before every California subject participating in the research signs the informed consent form. The research participating subjects do not have to sign the California Research Subjects’ Bill of Rights, if the sponsors or PIs request for the subjects to sign the form for keeping the record for their own benefit, then the subjects may sign the bill.

Sponsors and PIs should review the Consent Form Check List, pdf provided below and check off each item of their Informed Consent Forms before submitting for Panel review.

• Consent Form Check List, pdf

Experimental Subject’s Bill of Rights and Spanish version also have been provided (in PDF format) under Appendices on this website.