Section 50425 - Basic Elements of Informed Consent(a) Except as provided in Sections 50427, 50429(c), in seeking informed consent, the researcher shall ensure that the following information is provided to each subject or representative: (1) An explanation of the research, including its purposes, the duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;(2) A description of any reasonably foreseeable risks or discomforts to the subject;(3) A description of any benefits to the subject or to others which may reasonably be expected from the research;(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;(5) A statement describing how the confidentiality of records which identify the subject will be maintained;(6) For research involving more than minimal risk, an explanation as to whether any compensation will be provided, and a description of any medical treatments that will be provided if a research-related injury occurs;(7) A listing of the name, address and phone number of the persons to contact for answers to questions about the research, research subjects' rights, and possible research-related injury to the subject;(8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled;(9) A statement that the confidentiality of the subjects shall be maintained in any report of the findings of the research project, unless expressly consented to by the client or his or her legally authorized representative.(b) When appropriate, one or more of the following elements of information shall be provided to each subject: (1) A statement of anticipated circumstances under which the subject's participation may be terminated by the researcher without regard to the subject's consent;(2) An explanation of any costs to the subject that may result from participation in the research;(3) A description of the consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject; and(4) A statement indicating that the subject will be advised of any significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation.Cal. Code Regs. Tit. 17, § 50425
1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No. 4).
2. Change without regulatory effect amending subsection (b)(2) filed 1-14-2003 pursuant to section 100, title 1, California Code of Regulations (Register 2003, No. 3). 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).
2. Change without regulatory effect amending subsection (b)(2) filed 1-14-2003 pursuant to section 100, title 1, California Code of Regulations (Register 2003, No. 3).