Cal. Code Regs. tit. 17 § 50413

Current through Register 2024 Notice Reg. No. 25, June 21, 2024

Section 50413 - Responsibilities of the Researcher

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.

(c) Sign and date the research protocol.

(d) Submit a copy of his or her vita, including address and telephone number, and any prior experience in research involving confidential information.

(e) Include a copy of the application if the researcher is applying for federal, state or other funds for the research.

(f) Submit the written protocol to IRBs appropriate for the particular group of human subjects involved.

(g) Send an informational copy of the research protocol after it is approved by the IRB(s) and Executive Director(s) to the Director of the Department at his office in Sacramento.

(h) Submit to the IRB a supplement to the original protocol approved by the IRB if the supplement proposes to change the involvement of human subjects in the research in a way that is materially different from that which was initially approved by the IRB.

(i) The researcher shall be responsible for securing the approval of the Food and Drug Administration (FDA) and for notifying the IRB of that approval whenever an investigational new drug or device exemption is required pursuant to law.

Cal. Code Regs. Tit. 17, § 50413

1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No. 4).
2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).
3. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).
4. Change without regulatory effect amending subsections (b)(6), (b)(10) and (e) filed 1-14-2003 pursuant to section 100, title 1, California Code of Regulations (Register 2003, No. 3).

Note: Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections 4514(e), 4791(i) and 5328(e), Welfare and Institutions Code. Reference: Sections 4514(e), 4791 and 5328(e), Welfare and Institutions Code.