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 › Section 12VAC35-180-100 - Informed consent

Current through Register Vol. 40, No. 24, July 15, 2024
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.