La. Admin. Code tit. 48 § I-2507

Current through Register Vol. 50, No. 11, November 20, 2024
Section I-2507 - Statement of Principles
A. The DHH believes that research involving human subjects must be based upon the principles of respect for persons, beneficence, and justice.
1. Respect for persons involves a recognition of personal dignity and autonomy of individuals, and special protection of those persons with diminished autonomy.
2. Beneficence entails an obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm.
3. Justice requires that benefits and burdens of research be distributed fairly.
B. DHH also recognizes that many consumers of its services may be cognitively impaired and therefore deserve special consideration as potential research subjects. The predominant ethical concern in research involving persons with psychiatric, cognitive, developmental, or chemical dependency disorders is that their conditions may compromise their capacity to understand the information presented and their ability to make a reasoned decision about participation. Consequently, approval of proposals to use these individuals as research subjects will be conditioned upon the researcher demonstrating that:
1. such individuals comprise the only appropriate subject population;
2. the research question focuses on an issue unique to these subjects;
3. the research involves no more than minimal risk, except when the purpose of the research is therapeutic for these individual subjects and the risk is commensurate with the degree of expected benefit.

La. Admin. Code tit. 48, § I-2507

Promulgated by the Department of Health and Hospitals, Office of the Secretary, LR 24:450 (March 1998).
AUTHORITY NOTE: Promulgated in accordance with 56 FR 28002.