Virginia Administrative Code › Title 22 - SOCIAL SERVICES › Agency 30 - DEPARTMENT FOR AGING AND REHABILITATIVE SERVICES › Chapter 40 - PROTECTIONS OF PARTICIPANTS IN HUMAN RESEARCH › Section 22VAC30-40-10 - Definitions

Current through Register Vol. 40, No. 24, July 15, 2024
The following words and terms when used in this chapter shall
				  have the following meanings unless the context clearly indicates otherwise:
"Affiliated with the covered entity" means employed by the
				  covered entity or a member of a household containing an employee of the covered
				  entity.
"Agent" means an individual performing department-designated
				  activities or exercising department-delegated authority or responsibility.
"Area agency on aging" means the government-sponsored or
				  private nonprofit agency created pursuant to the federal Older Americans Act of
				  1965 (
				  42 USC §
										3001 et seq.), which has submitted a
				  department-approved Area Plan for Aging Services and is designated by contract
				  with the Department for Aging and Rehabilitative Services to develop and
				  administer its Area Plan for Aging Services as approved for a comprehensive and
				  coordinated system of services for older persons.
"Assent" means a child's affirmative agreement to participate
				  in research. Mere failure to object, absent affirmative agreement, shall not be
				  construed as assent.
"Commissioner" means the Commissioner of the Department for
				  Aging and Rehabilitative Services or the commissioner's designee.
"Covered entity" means the Department for Aging and
				  Rehabilitative Services, the Wilson Workforce and Rehabilitation Center, area
				  agencies on aging, sheltered workshops, or independent living centers.
"Department" means the Department for Aging and
				  Rehabilitative Services.
"Guardian" means an individual who is authorized under
				  applicable state or local law to consent on behalf of a minor to general
				  medical care.
"Human Research Review Committee" or "HRRC" means the
				  committee established in accordance with and for the purposes expressed in this
				  chapter.
"HRRC approval" means the determination of the HRRC that the
				  research has been reviewed and may be conducted within the constraints set
				  forth by the HRRC and by other department, state, and federal
				  requirements.
"Human participant" or "human subject" means 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.
"Human subject research" means a systematic investigation,
				  experiment, study, evaluation, demonstration, or survey designed to develop or
				  contribute to general knowledge (basic research) or specific knowledge (applied
				  research) in which a living individual about whom an investigator, whether
				  professional or student, conducting research obtains data through intervention
				  or interaction with the individual or obtains identifiable private information.
"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.
"Independent living center" means a consumer-controlled,
				  community-based, cross disability, nonresidential private nonprofit agency
				  that:
1. Is designed and operated within a local community by
				  individuals with disabilities; and
2. Provides an array of independent living services.
"Informed consent" means a process by which the investigator
				  fully explains the research activities and ensures that the prospective subject
				  has sufficient opportunity to ask questions and has sufficient time to make a
				  decision whether or not to participate in the research prior to signing the
				  HRRC-approved written consent document. Informed consent shall be prospectively
				  obtained without coercion and in accordance with
				  22VAC30-40-100.
"Institution" means any public or private entity or agency,
				  including federal, state, and other agencies.
"Interaction" means communication or interpersonal contact
				  between investigator and subject.
"Intervention" means both physical procedures by which data
				  are gathered (e.g., venipuncture) and manipulations of the subject or the
				  subject's environment that are performed for research purposes.
"Investigator" means the person, whether professional or
				  student, who conducts the research.
"IRB" means an institutional review board.
"Legally authorized representative," as defined in §
									32.1-162.16 of the
				  Code of Virginia, means, in the following specified order of priority:
1. The parent or parents having custody of a prospective
				  subject who is a minor; 2. The agent appointed under an advance directive, as
				  defined in §
									54.1-2982 of the Code
				  of Virginia, executed by the prospective subject, provided the advance
				  directive authorizes the agent to make decisions regarding the prospective
				  subject's participation in human research;
3. The legal guardian of a prospective subject;
4. The spouse of the prospective subject, except where a suit
				  for divorce has been filed and the divorce decree is not yet final;
5. An adult child of the prospective subject;
6. A parent of the prospective subject, when the subject is
				  an adult;
7. An adult sibling of the prospective subject; or
8. Any person or judicial or other body authorized by law or
				  regulation to consent on behalf of a prospective subject to the subject's
				  participation in the particular human research.
For the purposes of this definition, any person authorized by
				  law or regulation to consent on behalf of a prospective subject to the
				  subject's participation in the particular human research shall include an
				  attorney-in-fact appointed under a durable power of attorney, to the extent the
				  power grants the authority to make such a decision. The attorney-in-fact shall
				  not be employed by the person, institution, or agency conducting the human
				  research. No official or employee of the institution or agency conducting or
				  authorizing the research shall be qualified to act as a legally authorized
				  representative.
"Minimal risk" means that 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 the
				  performance of routine physical or psychological examinations or tests.
"Minor," as defined in §
									1-207
				  of the Code of Virginia, means an individual who is younger than 18 years of
				  age.
"Nontherapeutic research" means human subject research in
				  which there is no reasonable expectation of direct benefit to the physical or
				  mental condition of the subject.
"Parent" means a minor's biological or adoptive parent.
"Permission" means the agreement of a parent or parents or a
				  legally authorized representative to the participation of their minor or ward
				  in research.
"Private information" means information about behavior that
				  occurs in a context in which an individual can reasonably expect that no
				  observation or recording is taking place, or information that has been provided
				  for specific purposes by an individual and that the individual can reasonably
				  expect will not be made public (e.g., a medical record).
"Research" means a systematic investigation designed to
				  develop or contribute to generalizable knowledge (basic research) or specific
				  knowledge (applied research). Activities that meet this definition constitute
				  research for purposes of this chapter, whether or not they are supported or
				  funded under a program that is considered research for other purposes. For
				  example, some "demonstration" and "service" programs may include research
				  activities.
"Sheltered workshop" means a program that
(i) provides directly or facilitates the provision of one or
				  more vocational rehabilitation services enumerated in
				  34 CFR
				  361.5(c)(7)(i) to
				  individuals with disabilities to enable them to maximize their opportunities
				  for employment, including career advancement;
(ii) has a vendor relationship with the department;
				  and
(iii) is not operated by a community services board.
"Written" or "in writing" means text or other human
				  communication on a tangible medium (e.g., paper) or in an electronic
				  format.
Statutory Authority: 51.5-131 and 51.5-132 of the Code of
					 Virginia.