Section 50401 - DefinitionsAs used in this subchapter, the following words have the specified meanings.
(a) "Clients Rights Advocate" means the individual or individuals assigned by a regional center or state hospital to be responsible for ensuring that the civil, legal and service rights of persons with developmental disabilities are available and guaranteed to such persons.(b) "Consultant" means a person who gives expert or professional advice and who has competence in special areas or who can provide expertise beyond or in addition to that available to the IRB.(c) "Department" means the State Department of Developmental Services.(d) "Health and Welfare Agency" means the Health and Welfare Agency as defined in Section 12800 of the Government Code.(e) "Human Subject" means a living individual about whom a researcher conducting research obtains (1) date through intervention or interaction with the individual, or (2) confidential information.(f) "Informed Consent" means the knowing consent of an individual or his or her legally authorized representative that is given without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion to participate in an activity. For consent to be "informed," the individual or his or her legally authorized representative must possess accurate and complete information about the procedures which are to be performed, understand the information provided, and give consent voluntarily.(g) "Institutional Review Board (IRB)" means a review board constituted and convened in accordance with the regulations in this subchapter by a state hospital or regional center servicing persons with developmental disabilities for the purpose of reviewing and approving or disapproving research involving human subjects.(h) "Minimal Risk" means that the risk of harm anticipated in the proposed research is not greater, considering probability and magnitude, than that ordinarily encountered in the daily life of the human subject or during the performance of routine physical or psychological examinations or tests.(i) "Regional Center" means a diagnostic, counseling, and service coordination center for persons with developmental disabilities and their families which is established and operated pursuant to Chapter 5 of Division 4.5 of the Welfare and Institutions Code by a private nonprofit community agency/corporation acting as a contracting agency.(j) "Research" means the systematic investigation and acquisition of information for the purpose of developing or contributing to general knowledge, social programs, or scientific advancement and includes the collection of data for possible publication. Studies of the effect of routine treatment services, or the gathering of feedback information about routine treatment services, shall be considered research only if the data are collected with the aim of possible publication.(k) "Researcher" means the principal investigator or project director who has responsibility for conducting the research.(l) "Research Protocol" means a written description of the proposed research activity which is submitted for the appropriate IRB review and consideration and which is written in accordance with these regulations.(m) "Risk" means any potential for harm anticipated in the proposed research which is greater than what might ordinarily be encountered in the daily life of the human subject or during the performance of routine physical or psychological examinations or tests.(n) "State Hospital" means a state hospital serving people with developmental disabilities.(o) "State Institutional Review Board" (State IRB) means a group of individuals constituted and convened in accordance with federal regulations (e.g., Title 45, Code of Federal Regulations, Section 46.101, et seq.) and approved as the State IRB by the U.S. Department of Health and Human Services to review and approve or disapprove research involving human subjects. For purposes of these regulations, the State IRB shall mean the federally approved IRB for the Health and Welfare Agency of the State of California.(p) "Statistical Data" means aggregate information pertaining to individuals which is in such a form that it is not traceable back to the individuals.Cal. Code Regs. Tit. 17, § 50401
1. New subchapter 4 (Articles 1-2, Sections 50401-50429, not consecutive) 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), 4517, 5328(e) and 5329, Welfare and Institutions Code.
1. New subchapter 4 (Articles 1-2, Sections 50401-50429, not consecutive) filed 1-22-87; effective thirtieth day thereafter (Register 87, No. 4).