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California Informed Consent Form 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 California Experimental Subject’s Bill of Rights should be signed and dated by the subject or the subject's conservator or guardian, or other representative as specified in the California Health and Safety Code §24173 (a), pdf.
  • Sponsors and PIs should review the Informed Consent Form Check List, pdf provided below and check off each item of their Informed Consent Forms before submitting for Panel review.
  • English and Spanish versions of Califomia Experimental Subject’s Bill of Rights have been provided (in PDF format) under Appendices on this website.
  • For different language versions of the California Experimental Subject's Bill of Rights, please refer to the website at OHRPP, Research Participant Bill of Rights.

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