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Virginia Administrative Code
Title 12. Health
Agency 5. Department of Health
Chapter 20. Regulations for the Conduct of Human Research

12VAC5-20-100. Informed Consent.

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.

B. No human research shall be conducted in the absence of informed consent subscribed to in writing by the person or by the person's authorized representative except as provided for in subsection E of this section. If the person is capable of providing informed consent, written consent shall be provided by the person and witnessed. If the person 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 shall be provided by the person's legally authorized representative and witnessed. If the person 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 person 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 person or, if applicable, the person's legally authorized representative shall be in language understandable to the person or representative.

C. No person shall participate in human research unless the informed consent requirement in this section is met. No informed consent shall include any language through which the person 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. No person 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 person.

D. No legally authorized representative shall consent to nontherapeutic human research unless it is determined by the research review committee that such nontherapeutic research will present no more than a minor increase over minimal risk to the subject and (i) the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations; and (ii) the intervention or procedure is likely to yield generalizable knowledge about the subject's disorder or condition, which is of vital importance for the understanding or amelioration of the subject's disorder or condition. A legally authorized representative may not consent to participation in human research on behalf of a subject 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 subject, whether expressed orally or in writing.

E. 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 this section, 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 subjects;

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

3. The human research could not practicably be performed without the omission, waiver, or alterations; and

4. After participation, the subjects shall be provided with additional pertinent information, whenever appropriate.

F. Consent may take the form of either of the following:

1. A written consent document that embodies the elements of informed consent required by this section. This form may be read to the subject or the subject's legally authorized representative, but, in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed and witnessed; or

2. A short form written consent document stating that the elements of informed consent required by this section have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the committee shall approve a written summary of what is to be said to the subject or the representative. Only the short form written consent is signed by the subject or the representative. However, the witness shall sign both the short form written consent and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary and a copy of the short form written consent shall be given to the subject or the representative.

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

Statutory Authority

§§ 32.1-12 and 32.1-12.1 of the Code of Virginia.

Historical Notes

Derived from VR355-01-400 § 10, eff. July 1, 1993; amended, Volume 26, Issue 13, eff. March 31, 2010; Volume 32, Issue 08, eff. January 14., 2016.

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