California Code of Regulations › Title 17 - Public Health › Division 2 - Health and Welfare Agency-Department of Developmental Services Regulations › Chapter 1 - General Provisions › Subchapter 4 - Rules for Conducting Research › Article 1 - Definitions › Section 50401 - Definitions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
As 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.
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.