Section 50429 - Documentation of Informed Consent(a) Except as provided in Section 50427, informed consent shall be documented by the use of a written consent form that: (1) embodies the elements of informed consent required by Section 50425;(2) is approved by the appropriate IRB or IRBs; and(3) is signed by the subject or the subject's legally authorized representative.(b) Research investigators shall ensure that each person signing the written consent form is given a copy of that form.(c) Research investigators may use a consent form which is either: (1) a written consent document that embodies the elements of informed consent required by Section 50425. This form may be read by or read to the subject or the subject's legally authorized representative, but, in any event, the researcher shall give either the subject or the representative adequate opportunity to read and understand the form before signing it; or,(2) a "short form" written consent document stating that the elements of informed consent required by Section 50425 have been presented orally to the subject or the subject's legally authorized representative. When the "short form" is used, the researcher shall insure that: (A) a witness is present at the oral presentation,(B) the short form is signed by the subject or the representative,(C) the witness signs both the short form and a copy of the written summary of the oral presentation,(D) the person obtaining consent signs a copy of the summary,(E) a copy of both the short form and summary is given to the subject or the representative, and(F) the written summary of what is to be said to the subject or the representative receives the prior approval of the IRB.(d) In cases where the documentation requirement is waived, the IRB may require the researcher to provide subjects with a written statement regarding the research.Cal. Code Regs. Tit. 17, § 50429
1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No. 4). Note: Authority cited: Sections 4514(e) and 5328(e), Welfare and Institutions Code. Reference: Sections 4514(e) and 5328(e), Welfare and Institutions Code.
1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No. 4).