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), 108, and 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. • 1
"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. §§ 50.20and 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.
INSTRUCTIONS TO STAFF 340:2-39-6
1.While deceased individuals cannot be human subjects according to the United States Department of Health and Human Services, the deceased may be human subjects according to the Federal Drug Administration.The Health Insurance Portability and Accountability Act of 1996 (HIPAA) or other state or local laws may still apply to activities involving deceased individuals. Applicants are encouraged to consult the entity from which they received or accessed the information for further guidance.