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Virginia Administrative Code
Title 12. Health
Agency 35. Department of Behavioral Health And Developmental Services
Chapter 180. Regulations to Ensure the Protection of Subjects in Human Research

12VAC35-180-100. Informed consent.

A. No human research shall be conducted in the absence of informed consent subscribed to in writing by the individual or by the individual's legally authorized representative except as provided for in subsection F of this section. If the individual is capable of providing informed consent, written consent must be provided by the individual and witnessed. If the individual is incapable of making an informed decision, as defined in § 54.1-2982 of the Code of Virginia, at the time consent is required, written consent must be provided by the individual's legally authorized representative and witnessed. If the individual is a minor otherwise capable of rendering informed consent, the consent shall be provided by both the minor and his legally authorized representative. An investigator shall seek such consent only under circumstances that provide the individual who is the prospective subject or the representative sufficient opportunity to consider whether to participate and that minimize the possibility of coercion or undue influence. The information that is given to the individual or, if applicable, the individual's legally authorized representative shall be in language understandable to the individual or the representative.

If two or more persons who qualify as legally authorized representatives have equal decision-making priority under this chapter inform the principal investigator or attending physician that they disagree as to participation of the individual in human research, the individual shall not be enrolled in the human research that is the subject of the consent.

B. For the purposes of human research, the basic elements of information necessary for such consent shall include:

1. A statement that the study involves research and a reasonable and comprehensible explanation to the individual of the proposed procedures or protocols to be followed and the purposes, including descriptions of any reasonably foreseeable discomforts, risks, and benefits and how the results of the human research will be disseminated;

2. A statement describing the extent, if any, to which confidentiality of records identifying the individual will be maintained;

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

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

5. A statement that participation is voluntary and instruction that the individual may refuse to participate or withdraw his consent and discontinue participation in the human research at any time without prejudice to him, fear of reprisal, penalty, or loss of any benefit to which he is otherwise entitled;

6. An explanation of 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

7. A statement of whom to contact for answers to inquiries by the individual or, if applicable, the individual's legally authorized representative concerning the research and a description of the ways in which concerns may be raised or questions asked and notification of whom to contact in the event of any research-related injury to the individual.

C. No individual shall participate in human research unless this requirement is met. No informed consent shall include any language through which the individual waives or appears to waive any of his legal rights, including any release of any person, institution, or agency or any agents thereof from liability for negligence. Notwithstanding the informed consent by a legally authorized representative, no individual shall be forced to participate in any human research if the investigator conducting the human research knows that participation in the human research is protested by the individual. In the case of individuals suffering from organic brain disease causing progressive deterioration of cognition for which there is no known cure or medically accepted treatment, the implementation of experimental courses of therapeutic treatment to which the legally authorized representative has given informed consent shall not constitute the use of force. Each individual shall be given a copy of the signed consent form required by 12VAC35-180-40 A except as provided for in subsection H of this section.

D. Prior to participation by an individual in any human research project, the institution or agency shall meet the requirements of 12VAC35-115-130.

E. No legally authorized representative may consent to nontherapeutic human research unless it is determined by the research review committee that such nontherapeutic human research will present no more than a minor increase over minimal risk to the individual. A legally authorized representative may not consent to participation in human research on behalf of an individual if the legally authorized representative knows, or upon reasonable inquiry ought to know, that any aspect of the human research protocol is contrary to the religious beliefs or basic values of the individual, whether expressed orally or in writing. A legally authorized representative may not consent to participation in human research involving nontherapeutic sterilization, abortion, psychosurgery, or admission for human research purposes to a facility or hospital as defined in § 37.2-100 of the Code of Virginia. No nontherapeutic human research shall be performed without the consent of the individual or, if applicable, the individual's legally authorized representative.

F. The research review committee may approve a consent procedure that does not include or that alters some or all of the elements of informed consent set forth in 12VAC35-180-10, or that waives the requirements to obtain informed consent provided the committee finds and documents that:

1. The human research involves no more than minimal risk to the individuals;

2. The omission, waiver, or alteration will not adversely affect the rights and welfare of the individuals;

3. The human research could not practicably be carried out without the omission, waiver, or alteration; and

4. Whenever appropriate, the individuals shall be provided with additional pertinent information after participation.

G. A written consent document that embodies the elements of informed consent as defined in 12VAC35-180-10 may be read to the individual or, if applicable, the individual's legally authorized representative, but in any event, the investigator shall give either the individual or the legally authorized representative adequate opportunity to read it before it is signed.

H. The committee may waive the requirement in subsection A of this section for the investigator to obtain a written informed consent form for some or all individuals if it finds that the only record linking the individual and the human research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each individual shall be asked whether the individual wants documentation linking the individual with the human research, and the individual's wishes shall govern. In cases where the documentation requirement is waived, the committee may require the investigator to provide individuals with a written statement explaining the human research.

Statutory Authority

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

Historical Notes

Derived from VR470-06-01:1 § 10, eff. May 15, 1993; amended, Virginia Register Volume 20, Issue 9, eff. February 11, 2004; Volume 26, Issue 2, eff. November 12, 2009; Volume 36, Issue 11, eff. March 15, 2020.

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