Title of Regulation: 22VAC30-40. Protections of Participants in Human Research (amending 22VAC30-40-10, 22VAC30-40-30, 22VAC30-40-50).

Statutory Authority: §§ 51.5-131 and 51.5-132 of the Code of Virginia.

Effective Date: July 15, 2015.

Agency Contact: Vanessa S. Rakestraw, Ph.D., CRC, Policy Analyst, Department for Aging and Rehabilitative Services, 8004 Franklin Farms Drive, Richmond, VA 23229, telephone (804) 662-7612, FAX (804) 662-7663, TTY (800) 464-9950, or email vanessa.rakestraw@dars.virginia.gov.

Summary:

The amendments change the name of the Woodrow Wilson Rehabilitation Center to Wilson Workforce and Rehabilitation Center pursuant to Chapter 542 of the 2015 Acts of Assembly.

22VAC30-40-10. Definitions.

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 any individual performing department-designated activities or exercising department-delegated authority or responsibility.

"Assent" means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

"Commissioner" means the Commissioner of the Department for Aging and Rehabilitative Services.

"Covered entity" means the Department for Aging and Rehabilitative Services, Woodrow the Wilson Workforce and Rehabilitation Center, 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 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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, a medical record, or social security number). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) to constitute research involving human subjects.

"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 must be prospectively obtained without coercion, include all of the basic elements of informed consent as specified in 22VAC30-40-100 B, be legally effective, contain no exculpatory language, and as required, include the additional elements of informed consent specified in 22VAC30-40-100 C.

"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 (for example, venipuncture) and manipulations of the subject or subject's environment that are performed for research purposes.

"Investigator" means the person, whether professional or student, who conducts the research.

"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 brother or sister 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 such 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 such 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 less 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 parent(s) 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 (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the human participant 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 participants.

"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(b)(9)(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.

22VAC30-40-30. Applicability.

This chapter shall apply to the Department for Aging and Rehabilitative Services, Woodrow the Wilson Workforce and Rehabilitation Center, sheltered workshops, and independent living centers, known as covered entities.

22VAC30-40-50. Certification process.

A. No later than 45 days after the end of each state fiscal year, Woodrow the Wilson Workforce and Rehabilitation Center, sheltered workshops, and independent living centers shall send a written report to the commissioner giving assurance that either all human subjects research conducted during the fiscal year was reviewed and approved by the department's HRRC prior to implementation of that research or that no human subjects research was conducted during that state fiscal year.

B. At the time that the research is approved by the HRRC, the HRRC chairperson shall send to the commissioner a description of the research project to be undertaken, which shall include a statement of the criteria for inclusion of prospective human subjects in the research project, a description of what will be done to prospective human subjects, and the type of review performed by the HRRC.

C. The commissioner may inspect the records of the department's HRRC.

D. The HRRC shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the HRRC's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the HRRC's action and shall be reported promptly to the research investigator, the commissioner, the head(s) of other appropriate covered entities, and in the case of cooperative research, the institutional officials responsible for human subjects research.

E. Research covered by this chapter that has been approved by the HRRC may be subject to further appropriate review and approval or disapproval by officials of the covered entities. However, those officials may not approve the research if it has not been approved by the HRRC.