Oklahoma Administrative Code › Title 340 - Department of Human Services › Chapter 2 - Administrative Components › Subchapter 39 - Innovation Services › Part 3 - OKLAHOMA DEMENT OF HUMAN SERVICES INSTITUTIONAL REVIEW BOARD (DHSIRB) › Section 340:2-39-6 - Definitions

Current through Vol. 41, No. 20, July 1, 2024
The following words and terms, when used in this Part,
					 shall have the following meanings, unless the context clearly indicates
					 otherwise:
"The Belmont Report"
means a statement of
					 basic ethical principles governing research involving human subjects issued by
					 the National Commission for the Protection of Human Subjects in 1978.
"Child"
means an individual, who has not
					 attained the legal age for consent to treatments or procedures involved in the
					 research, under the applicable law of the jurisdiction in which the research is
					 conducted. For research conducted in Oklahoma, where federal regulations and
					 Oklahoma law both apply, an unmarried or unemancipated individual younger than
					 18 years of age meets the definition of "child." For research conducted outside
					 of Oklahoma or in a jurisdiction where Oklahoma law does not apply, individuals
					 who meet the definition of a child are those individuals described under the
					 applicable jurisdiction law where the research is conducted.
"Clinical trial"
means a research study in
					 which one or more human subjects are prospectively assigned to one or more
					 interventions, which may include placebo or other control, to evaluate the
					 effects of the interventions on biomedical or behavioral health-related
					 outcomes, per Section 46.102(b) of Title 45 of the Code of Federal Regulations
					 (
					 45 C.F.R. §
											46.102(b) ).
"Confidentiality"
means the treatment of
					 information an individual discloses in a relationship of trust with the
					 expectation that it is not divulged to others or in ways inconsistent with the
					 understanding of the original disclosure without his or her permission.
"Demonstration project"
means a project,
					 deliberately small in scale and limited in scope , usually with a short project
					 cycle.
"Department of Human Services Institutional Review
					 Board (DHSIRB)"
means a specially constituted review body established or
					 designated by the Oklahoma Department of Human Services (DHS) to protect the
					 welfare of human subjects recruited to participate in research, per 45 C.F.R
					 §§ 46. 102(g), 46. 108, and 46. 109.
"Director"
means the DHS Director, per Chapter
					 1 of this Title.
"Federalwide Assurance (FWA)"
means a formal,
					 written, binding commitment an institution submits to the United States (U.S.)
					 Department of Health and Human Services (DHHS), U.S. Office for Human Research
					 Protections (OHRP), in which it commits to DHHS compliance with the
					 requirements set forth in the regulations for the protection of human subjects,
					 per 45 C.F.R. § 46.
"Generalizable knowledge"
means information
					 where the intended use of the research findings can be applied to populations
					 or situations beyond those being studied. In practice, generalizable knowledge
					 refers to research results that are:
(A) published, including research papers published as a
					 thesis or dissertation;
(B) presented to the public; or
(C) developed for others to build upon. Generalizable
					 knowledge may include theses, dissertations, and some oral histories.
"Human protections administrator (HPA)"
means
					 the person designated by the DHS Innovation Services director, who provides
					 administrative support to the DHSIRB, serves as the OHRP primary institutional
					 contact, and has the administrative responsibility for the program. The HPA:
(A) has comprehensive knowledge of all aspects of the DHS
					 system of protections for human subjects;
(B) is familiar with the institution's commitments under
					 FWA; and
(C) plays a key role in ensuring the institution fulfills
					 its responsibilities under FWA.
"Human subject"
means a living individual
					 about whom an investigator, whether professional or student, conducting
					 research :
(A) obtains information or biospecimens through
					 intervention or interaction with the individual, and uses, studies, or analyzes
					 the information or biospecimens; or
(B) uses, studies, analyzes, or generates identifiable,
					 private information or identifiable biospecimens.
"Identifiable biospecimen"
means a biospecimen
					 for which the identity of the subject is, or may readily be, ascertained by the
					 investigator or associated with the biospecimen.
"Identifiable private information"
means
					 private information for which the identity of the subject is, or may readily
					 be, ascertained by the investigator or associated with the information.
"Individual with impaired decision-making
					 capacity"
means an individual with a compromised ability to make
					 decisions in his or her own best interest, such as individuals:
(A) under the influence of, or dependent on, drugs or
					 alcohol;
(B) suffering from degenerative diseases affecting the
					 brain;
(C) terminally ill patients;
(D) with severely disabling physical handicaps including,
					 but not limited to:
(i) a psychiatric disorder, such as psychosis, neurosis, or
					 personality or behavior disorders;
(ii) dementia; or
(iii) a developmental disorder, such as an intellectual
					 disability affecting cognitive or emotional functions to the extent that
					 capacity for judgment and reasoning is significantly diminished.
"Informed consent"
means a person's voluntary
					 agreement, based upon adequate knowledge and understanding of relevant
					 information, to participate in research or to undergo a diagnostic,
					 therapeutic, or preventive procedure. In giving informed consent, subjects may
					 not waive or appear to waive any of their legal rights, or release or appear to
					 release the investigator, the sponsor, the institution, or agents thereof from
					 liability for negligence, per
					 45 C.F.R. §
											46.116 and 21 C.F.R. §§ 50.20 and
					 50.25.
"Innovation Services (IS)"
means the DHS
					 office that provides technical assistance in the design, development,
					 implementation, and evaluation of projects, programs, and grants conducted or
					 supported by DHS. IS conducts data-driven research and statistical analysis of
					 programs and services, and disseminates information and results.
"Institution"
means DHS unless the context
					 clearly indicates otherwise.
"Interaction"
means communication or
					 interpersonal contact between investigator and subject.
"Intervention"
means physical procedures by
					 which information or biospecimens are gathered, such as venipuncture because it
					 is a physical procedure to gather a biospecimen, as well as manipulations of
					 the subject or his or her environment that are performed for research purposes.
"Investigator"
means a scientist or scholar,
					 who may be a professional or a student, with primary responsibility for the
					 design and conduct of research.
"Legally-authorized representative"
means an
					 individual, judicial entity, or other body authorized under applicable law to
					 consent on behalf of a prospective subject to his or her participation in the
					 procedure(s) involved in the research. When there is no applicable law
					 addressing this issue, legally-authorized representative means an individual
					 recognized by DHS policy as acceptable to provide consent in the non-research
					 context on behalf of the prospective subject to his or her participation in the
					 procedure(s) involved in the research.
"Minimal risk"
means the probability and
					 magnitude of harm or discomfort anticipated in the proposed research are not
					 greater, in and of themselves, than those ordinarily encountered in daily life
					 or during the performance of routine physical or psychological examinations or
					 tests, per
					 45 C.F.R. §
											46.102(j). For example, the
					 risk of drawing a small amount of blood from a healthy individual for research
					 purposes is no greater than the risk of doing so as part of routine physical
					 examination.
"Office of Human Research Protection (OHRP)"
means a federal agency that provides leadership in the protection of the
					 rights, welfare, and well-being of subjects involved in research conducted or
					 supported by DHHS. OHRP ensures this by:
(A) providing clarification and guidance;
(B) developing educational programs and materials;
(C) maintaining regulatory oversight; and
(D) providing advice on ethical and regulatory issues in
					 biomedical and social-behavioral research.
"Principal investigator (PI)"
means the
					 research investigator who is ultimately responsible for ensuring compliance
					 with applicable federal, state, and local laws, rules, and regulations, and the
					 conduct of the research.
"Privacy"
means having control over the
					 extent, timing, and circumstances of sharing one's self physically,
					 behaviorally, or intellectually with others.
"Private information"
means information, such
					 as medical records, about behavior that occurs in a context in which an
					 individual can reasonably expect that no observation or recording is taking
					 place. Information is provided for specific purposes, and he or she can
					 reasonably expect the information is not made public.
"Research"
means a systematic investigation,
					 including research development, testing, and evaluation, designed to develop or
					 contribute to generalizable knowledge, per
					 45 C.F.R. §
											46.102(l).
"Research subject"
means a DHS employee,
					 client, and/or patient:
(A) who is voluntarily participating as a human subject in
					 a research project;
(B) who is voluntarily participating in a survey or
					 interview conducted as part of a research or program evaluation project; and/or
(C) whose protected information is disclosed to, and used
					 by, an investigator during a research or program evaluation project. The words
					 "subject" and "participant" are used interchangeably.
"Risk"
means the probability of harm or injury
					 whether physical, psychological, social, or economic occurring as a result of
					 participation in research. Both the probability and magnitude of possible harm
					 may vary from minimal to significant.
"Systematic investigation"
means an activity
					 that involves a prospective plan incorporating data collection, either
					 quantitative or qualitative, and data analysis to answer a question, such as
					 systematic investigations that include surveys and questionnaires, interviews
					 and focus groups, analyses of existing data or biological specimens,
					 epidemiological studies, evaluations of social or educational programs,
					 cognitive and perceptual experiments, and medical chart review studies.