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Policy 208Santa Ana Police Department Custody Manual Copyright Lexipol, LLC 2023/07/14, All Rights Reserved. Published with permission by Santa Ana Police DepartmentResearch Involving Incarcerated Persons - 1Research Involving Incarcerated Persons 208.1 PURPOSE AND SCOPE The purpose of this policy is to establish safeguards and guidelines to protect incarcerated persons from being used as research subjects in medical and other research experiments based only on their status as incarcerated persons and without proper approval, review, or informed consent. 208.2 POLICY The Santa Ana Police Department will conduct and support research that improves operations, enhances professional knowledge, decreases recidivism, and advances the department's mission in accordance with existing laws and with appropriate protection of all incarcerated persons. However, the use of incarcerated persons for medical, pharmaceutical, or cosmetic experiments is prohibited. 208.3 AUTHORIZATION REQUIREMENTS Prior to initiating any approved research, all persons conducting research in this facility must agree to abide by all department policies relating to the security and confidentiality of incarcerated person files. Based upon the intended use of the research, guidelines will be established regarding what information shall be accessible to the researcher or the research organization. Any requests for an exception shall include a response to the following questions as part of the proposed research project: •Who is conducting the research? •What is the purpose of the research? •What is the methodology? •Do the researchers or persons advocating research involving the use of incarcerated persons have an understanding of their ethical responsibilities, including considerations for the establishment of an Institutional Review Board (IRB), as described in 45 CFR 46.301 et seq.? •Any other information as deemed appropriate by the Jail Administrator or Chief of Police. Inquiries regarding proposed research projects from local, state, and federal executive and legislative bodies/agencies will be brought to the attention of the Chief of Police immediately by the employee who receives the request. At the direction of the Chief of Police, an appropriate and timely response will be made to each legitimate inquiry. Research or studies involving more than the information identified as public information may require signed release/waiver forms from the involved incarcerated persons. The Chief of Police should consult and seek guidance from the legal counsel serving the Department or other legal expert in these matters. Santa Ana Police Department Custody Manual Research Involving Incarcerated Persons Copyright Lexipol, LLC 2023/07/14, All Rights Reserved. Published with permission by Santa Ana Police DepartmentResearch Involving Incarcerated Persons - 2Incarcerated persons are not precluded from individual treatment based on the need for a specific medical procedure that is not generally available. An incarcerated person's treatment with a new medical procedure by the incarcerated person's own physician shall be undertaken only after the incarcerated person has received a full explanation of the positive and negative features of the treatment, and only with the incarcerated person's informed consent. 208.4 LEGAL CONSIDERATIONS Any research conducted or supported by the United States Department of Health and Human Services (DHHS) will be required to comply with the provisions of 45 CFR 46.301 et seq. 208.4.1 BIOMEDICAL RESEARCH Research relating to or involving biological, medical, or physical science shall not be conducted on any incarcerated person. This does not include the accumulation of statistical data in the assessment of the effectiveness of nonexperimental public health programs or treatment programs in which incarcerated persons routinely participate (Penal Code § 3502). Records-based biomedical research using existing information, without prospective interaction with incarcerated persons, may be conducted consistent with Penal Code § 3500 et seq. and federal law. 208.5 INCARCERATED PERSONS IN COMMUNITY-BASED RESEARCH When incarcerated persons who are participants in a community-based research protocol are admitted to the facility, the following shall occur: (a)The intake nurse shall collect all relevant data, including name and contact information of the treating physician, and all available detail about the treatment regimen and the condition being treated. (b)The responsible physician shall be contacted prior to the initiation of treatment. (c)Consultation with community researchers shall be made by the responsible physician to determine the intent of the study and any necessary parameters to measure as the treatment period progresses. (d)Necessary information shall be obtained so that withdrawal from the research protocol is done without harming the health of the incarcerated person. 208.6 HUMAN RESEARCH STUDIES This department does not endorse enrolling incarcerated persons in human research studies. Requests to enroll incarcerated persons in human research studies will not ordinarily be approved. However, any request to enroll an incarcerated person into such a study must be reviewed by the Chief of Police, the Responsible Physician, and legal counsel, and authorization provided prior to enrollment. Any authorized enrollments shall comply with all state and federal guidelines.