Section 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 institution" means employed by the institution or a member of a household containing an employee of the institution.

"Board" means the Board of Behavioral Health and Developmental Services.

"Commissioner" means the Commissioner of the Department of Behavioral Health and Developmental Services.

"Community services board" or "CSB" means a public body established pursuant to § 37.2-501 of the Code of Virginia that provides mental health, mental retardation, and substance abuse services to individuals within each city or county that established it. For the purpose of these regulations, community services board also includes a behavioral health authority established pursuant to § 37.2-602 of the Code of Virginia.

"Department" means the Department of Behavioral Health and Developmental Services.

"Health information" means any information, whether oral or recorded in any form or medium, that:

1. Is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and

2. Relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present or future payment for the provision of health care to an individual.

"Human research" means any systematic investigation, including research development, testing, and evaluation, utilizing human subjects, that is designed to develop or contribute to generalized knowledge. Human research shall not be deemed to include research exempt from federal research regulation pursuant to 45 CFR 46.101(b).

"Individual" means a human subject pursuant to 45 CFR 46.102 (f) about whom an investigator (whether professional or student) conducting research obtains (i) data through interaction with the individual; or (ii) protected health information.

"Individually identifiable health information" means information that is a subset of health information, including demographic information collected from an individual, and:

1. Is created or received by a health care provider, health plan, employer, or health care clearinghouse; and

2. Relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual; and

a. That identifies the individual; or

b. With respect to which there is a reasonable basis to believe the information can be used to identify the individual.

"Informed consent" means the knowing and voluntary agreement, without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion, of an individual who is capable of exercising free power of choice. For the purposes of human research, the basic elements of information necessary for such consent shall include:

1. A reasonable and comprehensible explanation to the individual of the proposed procedures or protocols to be followed, and their purposes, including descriptions of any attendant discomforts, risks and benefits reasonably to be expected, how the results of the human research will be disseminated, and how the identity of the individual will be protected;

2. A disclosure of any appropriate alternative procedures or therapies that might be advantageous for the individual together with their side effects, risks, and benefits;

3. A description of any adverse consequences and risks to be expected and an indication whether there may be other significant risks not yet identified;

4. An instruction that the individual may withdraw his consent and discontinue participation in the human research at any time without prejudice to him or fear of reprisal;

5. An explanation of any costs or compensation that may accrue to the individual and, if applicable, the availability of third party reimbursement for the proposed procedures or protocols or any medical care that may be available if an injury occurs; and;

6. An offer to answer and answers to any inquiries by the individual or, if applicable, his legally authorized representative concerning the procedures and protocols and a description of the ways in which concerns may be raised or questions asked;

"Institution" or "agency" means any community services board or any facility or program operated, funded, or licensed by the department.

"Interaction" includes communication or interpersonal contact between investigator and the individual who is the subject of the human research.

"Intervention" includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the individual or individual's environment that are performed for human research purposes.

"Legally authorized representative" means in the following specified order of priority, (i) the parent or parents having custody of an individual who is a prospective subject of human research who is a minor, (ii) the agent appointed under an advance directive as defined in § 54.1-2982 of the Code of Virginia, executed by the individual who is the prospective subject of human research, provided the advance directive authorizes the agent to make decisions regarding the individual's participation in human research, (iii) the legal guardian of an individual who is a prospective subject of human research, (iv) the spouse of individual who is a prospective subject of human research, except where a suit for divorce has been filed and the divorce decree is not yet final, (v) an adult child of the an individual who is a prospective subject of human research, (vi) a parent of the individual who is a prospective subject of human research when the individual is an adult, (vii) an adult brother or sister of the individual who is a prospective subject of human research, or (viii) any person or judicial or other body authorized by law or regulation to consent on behalf of an individual who is a prospective subject of human research to such individual'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 an individual who is a prospective subject of human research to his 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 human research shall be qualified to act as a legally authorized representative.

"Minimal risk" means that the risks of harm anticipated in the proposed human research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations, tests, or treatments.

"Nontherapeutic research" means human research in which there is no reasonable expectation of direct benefit to the physical or mental condition of the individual.

"Protected health information (PHI)" means individually identifiable health information that is created or received by or on behalf of the institution or agency that is maintained or transmitted in any medium, including electronic media. PHI excludes individually identifiable health information in:

1. Education records covered by the Family Educational Rights and Privacy Act, as amended, 20 USC § 1232g;

2. Records described at 20 USC § 1232g(a)(4)(B)(iv) (educational records not otherwise covered under the Family Educational Rights Privacy Act in subdivision 1 of this definition); or

3. Employment records held by a covered entity in its role as an employer.

"Research review committee" or "committee" means a committee of professionals to provide complete and adequate review of human research activities pursuant to § 32.1-162.19 of the Code of Virginia.

Historical Notes

Derived from VR470-06-01:1 § 1, eff. May 15, 1993; amended, Volume 20, Issue 09, eff. February 11, 2004; Volume 26, Issue 02, eff. November 12, 2009.

Statutory Authority

§§ 37.2-203 and 37.2-402 of the Code of Virginia.