Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 20 - REGULATIONS FOR THE CONDUCT OF HUMAN RESEARCH › Section 12VAC5-20-100 - Informed consent

Current through Register Vol. 40, No. 24, July 15, 2024
A. "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 a person who is capable of exercising free power of choice. For
				the purposes of human research, the basic elements of information necessary to
				determine the existence of such consent shall include the following:
1. A reasonable and comprehensible
				explanation to the person of the proposed procedures or protocols to be
				followed, their purposes, including descriptions of any attendant discomforts,
				and risks and benefits reasonably to be expected, how the results of the human
				research are disseminated, and how the identity of the person is
				protected;
2. A disclosure of any
				appropriate alternative procedures or therapies that might be advantageous for
				the person, together with their side effects, risks, and benefits;
3. A description of any adverse consequences
				and risks to be expected and an indication of whether there may be other
				significant risks not yet identified;
4. An instruction that the person 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 person 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;
6. An offer to answer any inquiries by the
				person 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;
7. A
				statement that the study involves research, and an explanation that includes
				identification of any procedures that are experimental; the expected duration
				of the person's participation; a statement describing the extent, if any, to
				which confidentiality of records identifying the participant will be
				maintained; and if any data from this study are published, the person will not
				be identified without his written permission;
8. A disclosure of any appropriate
				alternative procedures or therapies that might be advantageous for the
				person;
9. A statement that
				participation is voluntary, refusal to participate will involve no penalty or
				loss of benefits to which the person is otherwise entitled, and the person may
				discontinue participation at any time without penalty or loss of benefits to
				which he is otherwise entitled;
10.
				An explanation of whom to contact for answers to pertinent questions about the
				research and research participants' rights, and whom to contact in the event of
				a research-related injury; and
11.
				For research involving more than minimal risk, an explanation as to whether any
				compensation or medical care is available if injury occurs and, if so, what is
				included or where further information may be obtained.
Information shall be provided in a manner that is
				  understandable to the person with regard to his educational level and language
				  of greatest fluency.