Louisiana Administrative Code › Title 48 - PUBLIC HEALTH-GENERAL › Part I - General Administration › Subpart 1 - General › Chapter 25 - Departmental Research › Section I-2505 - Definitions

Current through Register Vol. 50, No. 6, June 20, 2024
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.
AUTHORITY NOTE:
					 Promulgated in accordance with 56 FR
					 28002.