La. Admin. Code tit. 22 § I-767

Current through Register Vol. 50, No. 11, November 20, 2024

Section I-767 - Research

A. Purpose. To establish the deputy secretary's policy regarding medical and social science research of secure care facilities and to address the direct participation of youth in such research.

B. Applicability. Deputy assistant secretaries and all facility directors.

C. Policy. It is the deputy secretary's policy that secure care facilities are encouraged to support, engage in, and use medical and social science research activities relevant to program services and operations. Requests and proposals for such research will be reviewed and approved in accordance with the procedures outlined herein. Proposed medical and social science studies which involve more than minimal risk to youth must be reviewed under and comply with federal regulations and shall be reviewed and approved by an authorized Institutional Review Board (IRB). The sole purpose for overseeing human subject research is to ensure that it meets applicable federal guidelines, complies with Youth Services (YS) policies, and protects the individual.

D. Definitions

Certification - the official notification by the facility to YS Central Office that a research project or activity involving human subjects has been reviewed and approved by an Institutional Review Board in accordance with an approved assurance.

Human Subject - a living individual about whom an investigator (whether a professional or student) conducting research obtains data through intervention or interaction with the individual or identifiable private information.

Institution - any public or private entity or agency.

Institutional Review Board (IRB) - a board, consisting of at least five members with various backgrounds, established to provide complete review of research activities commonly conducted by the institution as described above.

Minimal Risk - the probability and magnitude of harm or discomfort anticipated in the research are not greater than that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Research - a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

E. Procedures

1. Studies of the possible causes, effects, and processes of secure care and studies of these facility structures and/or youth in secure care facilities may only be conducted upon the approval of the deputy secretary.

2. The director shall review the research proposal and meet with the researcher(s) to discuss the contents of the proposal and plans for the results. During the discussion the director shall cover appropriate issues listed below under criteria and negotiate the level of review and dissemination of the results with the researcher(s) prior to initial approval.

3. The director shall initially approve a research proposal based on the following criteria before forwarding it to the deputy secretary for final approval:

a. the conduct of research in the facility complies with professional and scientific ethics and with applicable state and federal guidelines for the use and dissemination of research findings;

b. the research presents no more than minimal risk to youth;

c. the research consists of no more than interviews and/or written questionnaires and surveys, analysis of census and demographic data, or procedures that do not manipulate bodily conditions;

d. facility staff may assist research personnel in carrying out research and evaluation;

e. any direct youth participation or involvement is voluntary and requires consent from the youth's parents or legal guardians if the youth is under the age of 17; if there is no direct contact with youth and the research proposal only consists of retrieving data which has been previously collected during the normal course of business, no parental/guardian consent is needed;

f. the names of all participants are confidential;

g. prior to publication and/or presentation, a written report of the results of all medical and social science research must be shared with YS;

h. the research activities will not interfere with the normal operations of the facility;

i. qualified persons conduct the research;

j. the research will be conducted at no cost to YS, unless conducted at its request;

k. research findings will not be shared without express written consent of the deputy secretary;

l. no studies or research may be conducted for profit; and

m. the deputy secretary must approve the distribution list of the research findings and reports.

4. Any proposed research studies that involve more than minimal risk to youth must be reviewed under and comply with applicable federal regulations. The director shall ensure that the researcher(s) verifies that the proposal has been reviewed and approved by an authorized IRB prior to forwarding it to the deputy secretary for final approval.

5. The deputy secretary will review the research proposal prior to final approval to ensure that it meets the overall goals, objectives, and mission of YS.

6. From the point that the deputy secretary has approved a research project, the director shall monitor its progress to ensure compliance with the provisions of this policy.

La. Admin. Code tit. 22, § I-767

Promulgated by the Department of Public Safety and Corrections, Youth Services, Office of Youth Development, LR 32:1249 (July 2006).

AUTHORITY NOTE: Promulgated in accordance with R.S. 15:574.12(D)(2), 45 CFR § 46.101 et seq.