Research Advisory

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,"California Health and Safety Code, Section 24170. Consent requirements more specific to California and Research Advisory Panel applications include:

1) Requirement for presentation of the Experimental Subject’s Bill of Rights (see link below) to subjects prior to presentation of the consent document.

2) Language requirement: California law requires that the consent form and the Experimental Subject’s Bill of Rights must be written in a language in which the subject is fluent. Further, the consent form must include a clear statement that this prerequisite is available to subjects.

3) If supplemental DNA testing is to be included in the research study, it should be stated in the consent, with disclosure specifics conforming with local IRB requirements.

4) The “confidentiality section” of the consent must disclose to potential research subjects that their study participation records may be inspected by the Research Advisory Panel of California (RAPC).

5) The consent form should include a statement that the subject will be given a copy of the consent form as well as a copy of the Experimental Subject’s Bill of Rights.

More specific, line by line consent content guidelines can be found in the Panel’s “Consent Form Check List”; provided as a PDF attachment below. A sample Bill of Rights document is also provided.

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