Section 50403 - Scope of Subchapter(a) These regulations apply to all research conducted by or at state hospitals, regional centers, or by other persons or at places subject to Section 4514 of the Welfare and Institutions Code, whenever the researcher requests access to information or records which are confidential under Section 4514(e) of the Welfare and Institutions Code.(b) Research involving the collection or study or existing data, statistical information, documents, records, or pathological or diagnostic specimens is exempted from these regulations if: (1) such information is publicly available, or if(2) the information provided to the investigator is in such a form that human subjects cannot be identified either directly or through identifiers linked to the human subjects.(c) These regulations do not apply to audits, reviews or studies conducted by federal, state, or local government agencies in the exercise of their management or administrative responsibilities.(d) The IRB may exempt research activities from the requirements of these regulations if the only involvement of human subjects will be in one or more of the following categories: (1) research conducted in established or commonly accepted educational settings, involving normal educational practices, when the data are recorded in such a manner that the subject cannot be identified such as(A) research on regular and special education instructional strategies, or(B) research on the effectiveness of or the comparison among instructional techniques, curricula or classroom management methods;(2) research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), if information taken from these sources or through identifiers linked to the subjects; or(3) research involving survey or interview procedures or the observation of behavior open to public view.Cal. Code Regs. Tit. 17, § 50403
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).