Title of Regulation: 22VAC30-40. Protection of Participants in Human Research (amending 22VAC30-40-100).

Statutory Authority: §§ 51.5-131 and 51.5-132 of the Code of Virginia.

Effective Date: November 21, 2013.

Agency Contact: Vanessa S. Rakestraw, Ph.D., Policy Analyst, Department for Aging and Rehabilitative Services, 8004 Franklin Farms Drive, Richmond, VA 23229, telephone (804) 662-7612, FAX (804) 662-7663, TTY (800) 464-9950, or email vanessa.rakestraw@dars.virginia.gov.

Summary:

The amendments modify the chapter title of the regulation and correct a grammatical error.

CHAPTER 40
PROTECTION PROTECTIONS OF PARTICIPANTS IN HUMAN RESEARCH

22VAC30-40-100. Informed consent.

A. Except as provided elsewhere in this chapter, no investigator may involve a human being as a subject in research covered by this chapter unless the investigator has obtained the legally effective informed consent of the prospective subject or the prospective subject's legally authorized representative in accordance with this chapter. The investigator shall seek such consent only under circumstances that provide the prospective human participant or the prospective human participant's legally authorized representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the prospective human participant or the prospective human participant's legally authorized representative shall be in language understandable to the prospective human participant or the prospective human participant's legally authorized representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the covered entity, or its agents from liability for negligence.

B. In seeking informed consent, the following basic elements shall be provided to each prospective subject or legally authorized representative:

1. A statement that the project involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental;

2. A description of any reasonably foreseeable risks or discomforts to the subject;

3. A description of any benefits to the subject or to others that may reasonably be expected from the research;

4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

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

6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;

7. An explanation of who to contact for answers to pertinent questions about the research and research subject's rights, and who to contact in the event of a research-related injury to the subject; and

8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

C. When the HRRC determines that it is appropriate, one or more of the following additional elements of informed consent shall also be provided to each subject:

1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable;

2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;

3. Any additional costs to the subject that may result from participation in the research;

4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;

5. A statement that significant new findings developed during the course of the research that may relate to the subject's willingness to continue participation will be provided to the subject; and

6. The approximate number of subjects involved in the project.

D. The HRRC may approve a consent procedure that does not include or which alters some or all of the elements of informed consent set forth in this section, or waive the requirement to obtain informed consent provided the HRRC finds and documents that:

1. The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:

a. Public benefit or service programs;

b. Procedures for obtaining benefits or services under those programs;

c. Possible changes in or alternatives to those programs or procedures; or

d. Possible changes in methods or levels of payment for benefits or services under those programs; and

2. The research could not practicably be carried out without the waiver or alteration.

E. The HRRC may approve a consent procedure that does not include or that alters some or all of the elements of informed consent set forth in subsection B of this section, or waive the requirements to obtain informed consent provided the HRRC finds and documents that:

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

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

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

4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

F. The informed consent requirements in this chapter are not intended to preempt any applicable federal, state, or local laws that require additional information to be disclosed in order for informed consent to be legally effective.

G. Nothing in this chapter is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable federal or state law, or local ordinance.

H. Notwithstanding consent by a legally authorized representative, no person shall be forced to participate in any human subjects subject research. Each human subject shall be given a copy of the signed consent form required by this section, except as provided for in subsection J of this section.

I. No legally authorized representative may consent to nontherapeutic research unless the HRRC determines that such nontherapeutic research will present no more than a minor increase over minimal risk to the prospective subject. No nontherapeutic research shall be performed without the consent of the human subject.

J. Documentation of informed consent.

1. Except as provided in subdivision 3 of this subsection, informed consent shall be documented by the use of a written consent form approved by the HRRC and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.

2. Except as provided in subdivision 3 of this subsection, the consent form may be either of the following:

a. A written consent document that embodies the elements of informed consent required in subsection B of 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 subject's legally authorized representative adequate opportunity to read it before it is signed; or

b. A short form written consent document stating that the elements of informed consent required in subsection B of 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 HRRC shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the legally authorized representative, in addition to a copy of the short form.

3. The HRRC may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

a. That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or

b. That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. In cases in which the documentation requirement is waived, the HRRC may require the investigator to provide subjects with a written statement regarding the research.