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 2 - Rules for the Conduct of Research › Section 50413 - Responsibilities of the Researcher

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Before any research involving human subjects is initiated
						at a state hospital, the research shall:
(a) Identify each state hospital in which the
					 human subjects are residents or with which the human subjects are
					 affiliated.
(b) Prepare a written
					 research protocol containing:
(1) A statement
					 indicating whether the researcher considers the research to be exempt from
					 these regulations as outlined in Section
					 50403(d) and the
					 reasons for this determination. Even if the researcher considers the research
					 to be exempt pursuant to Section
					 50403(d), the
					 requirements of Section
					 50413 shall be met by the
					 researcher.
(2) A summary of the
					 nature, purpose and design of the research including:
(A) the specific questions to be
					 addressed;
(B) the research methods
					 such as sampling, data collection, and data analysis to be employed to answer
					 these questions; and
(C) a review
					 of pertinent, contemporary literature.
(3) A full description of the type of human
					 subjects proposed to be involved in the research, including their
					 characteristics, the total number anticipated, how they will be selected and
					 the rationale for the use of this population.
(4) A full description of how the subjects
					 will be used in the activity. If human remains or material that used to be part
					 of a human body are to be used, details as to their origin, nature and
					 disposition should be given.
(5) A
					 full description and assessment of potential benefits, if any, to the
					 individual human subjects, the group or class of which the subjects are
					 members, society in general , and to science as a result of the
					 activity.
(6) A description and
					 assessment of potential risks, if any, to the individual human subjects, the
					 group or class of which the subjects are members, and to society in general as
					 a result of the activity, whether such risks by physical, psychological, social
					 or legal. The protocol shall assess the likelihood, severity and duration of
					 such risks. If the research methods create potential risks, the protocol shall
					 describe other less risky methods, if any, which were considered and explain
					 why they will not be used.
(A) Human subjects
					 shall be considered at risk in research if they are involved without having
					 given their informed consent.
(B)
					 Human subjects shall not be considered at risk if they are involved in a
					 research activity which makes use of:
1.
					 observations of behavior open to public view,
2. materials available to the public,
					 or
3. statistical
					 data.
(7) A
					 description of the means to be taken to minimize such risks, including the
					 means by which the subject's personal privacy is to be protected and the
					 confidentiality of the information obtained from or about the subject is to be
					 maintained. The protocol shall assess the likely effectiveness of such
					 precautionary measures.
(8) A
					 description of the procedures to be used in obtaining and documenting the prior
					 informed consent of the subject. Copies of the material to be used in obtaining
					 informed consent shall be attached to the protocol.
(9) A waiver of the requirement for written
					 informed consent, if sought. The justification for the waiver shall be
					 specified.
(10) The questionnaires
					 or interview schedules, if any are to be used in the project. If they are not
					 available at the time of submission, an informative description of their
					 content and of the manner of administration shall be included in the protocol,
					 along with an assurance that, when completed, they will be filed with the
					 IRB.
(11) A description of any
					 special or unusual circumstances regarding the research activity which the
					 researcher believes could be relevant or material to the IRB's
					 decision.
(12) A statement which
					 indicates acceptance of responsibility for ensuring that the research activity
					 will be conducted by the researcher, and his or her associated research and
					 staff assistants, in accordance with the procedures outlines in the research
					 protocol and these regulations.