La. Admin. Code tit. 48 § I-2505
Cognitively Impaired-having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders), an organic impairment (e.g., dementia) or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgement and reasoning is significantly diminished. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps may also be compromised in their ability to make decisions in their best interests.
Competence-technically, a legal term used to denote capacity to act on one's own behalf; the ability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. (See also: Incompetence, Incapacity .) Competence may fluctuate as a function of the natural course of a mental illness, response to treatment, effects of medication, general physical health, and other factors. Therefore, mental status should be re-evaluated periodically. As a designation of legal status, competence or incompetence pertains to an adjudication in court proceedings that a person's abilities are so diminished that his or her decisions or actions should have no legal effect. Such adjudications are often determined by inability to manage business or monetary affairs and do not necessarily reflect a person's ability to function in other situations.
DHH-Department of Health and Hospitals (Louisiana).
DHHS-U.S. Department of Health and Human Services. This federal agency promulgated 45 CFR, Part 46, Protection of Human Subjects, revised June 18, 1991, effective August 19, 1991. DHH's research policies are based upon 45 CFR, Part 46.
Human Subject-a living individual about whom an investigator (whether professional or student) conducting research obtains:
1. data through intervention or interaction with the individual; or
2. identifiable private information.
Identifiable Private Information-private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., a medical record). Private information must be individually identifiable (i.e., the identification of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
Incapacity-a person's mental status and means inability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. Often used as a synonym for incompetence.
Incompetence-technically, a legal term meaning inability to manage one's affairs. Often used as a synonym for incapacity.
IRB Approval-the determination of the IRB that the research has been reviewed and may be conducted within the constraints set forth by the IRB and by other state and federal requirements.
Institutional Review Board (IRB)-the DHH committee with responsibility for reviewing and recommending approval/disapproval of all research proposals.
Interaction-includes communication or interpersonal contact between investigator and subject.
Intervention-includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or his/her environment that are performed for research purposes.
Investigator-the person conducting research.
Minimal Risk-the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during performance of routine physical or psychological examinations or tests.
Programmatic Offices-the major programmatic offices in DHH are: Bureau of Health Services Financing (BHSF), Office of Alcohol and Drug Abuse (OADA), Office for Citizens with Developmental Disabilities (OCDD), Office of Mental Health (OMH), and Office of Public Health (OPH).
Research-systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
La. Admin. Code tit. 48, § I-2505