Title of Regulation: 12VAC5-20. Regulations for the Conduct of Human Research (amending 12VAC5-20-80, 12VAC5-20-100, 12VAC5-20-120).

Statutory Authority: § 32.1-12.1 of the Code of Virginia.

Effective Date: March 31, 2010.

Agency Contact: Kathy Wibberly, PhD, Director, Division of Primary Care and Rural Health, Department of Health, 109 Governor Street, 10th Floor, Richmond, VA 23219, telephone (804) 864-7426, or email kathy.wibberly@vdh.virginia.gov.

Summary:

The amendments conform the regulation to Chapter 754 of the 2002 Acts of Assembly, which (i) changes the definition of human research to include research development, testing, and evaluation and make the overall definition consistent with federal regulations; (ii) broadens the list of legally authorized representatives who can provide informed consent on behalf of a subject should a subject be deemed incapable of making an informed decision concerning participation in human research, including, in priority order, parent or parents of a minor, agents appointed under an advance directive that specifically authorizes research, legal guardians, spouses, children, parents of an adult subject, and adult siblings; (iii) prohibits a legally authorized representative to consent to (a) participation on behalf of a prospective subject if he knows that it is contrary to the religious beliefs or basic values of the prospective subject, and (b) research involving nontherapeutic sterilization, abortion, psychosurgery, or admission to a facility or hospital for the mentally ill or mentally retarded; and (iv) changes the terminology of "competent" and "not competent" to "capable" and "incapable" of making an informed decision and provides consistency between the standards of the human research review committee and other applicable sections of state law.

In addition, the amendments conform the regulation to Chapter 413 of the 2007 Acts of Assembly, which requires each human research review committee of a state institution or agency to ensure that an overview of approved human research projects and the results of such projects are made public on the institution's or agency's website unless otherwise exempt from disclosure under the Virginia Freedom of Information Act.

12VAC5-20-80. Elements of committee review process.

A. No human research shall be conducted or authorized by the institution or agency unless a research review committee has reviewed and approved the proposed human research project giving consideration to:

1. The necessity and utility of the research;

2. The adequacy of the description of the potential benefits and risks involved and the adequacy of the methodology of the research;

3. The degree of the risk, and, if the research is nontherapeutic, whether it presents greater than minimal risk;

4. Whether the rights and welfare of the participants are adequately protected;

5. Whether the risks to the participants are outweighed by the potential benefits of the research to them;

6. Whether the voluntary informed consent is to be obtained by methods that are adequate and appropriate to the individual's educational level and language of greatest fluency;

7. Whether the written consent form is adequate and appropriate in both content and wording for the particular research and for the particular participants of the research relative to their educational level and language of greatest fluency and whether the consent document reasonably reflects full explanation and adequate understanding;

8. Whether the persons proposing to supervise or conduct the particular human research are appropriately competent and qualified; and

9. Whether criteria for selection of participants are equitable, especially in research regarding the future development of mental or physical illness.

B. A. The committee shall consider research proposals within 45 days after submission to the committee. In order for the research to be approved, it shall receive the approval of a majority of those members present at a meeting in which a quorum exists. A committee shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure committee approval.

C. B. During the committee review of research projects, no personal identifiers of present or potential participants should subjects shall be stated.

D. C. The committee shall approve or develop a written description of the procedure to be followed when a participant subject has a complaint about a research project in which he is participating or has participated.

E. D. Any participant subject who has a complaint about a research project in which he is participating or has participated shall be referred to the committee to determine if there has been a violation of the protocol.

F. E. The committee shall require reports from approved research projects at least annually to ensure conformity with the approved proposal. The frequency of such reports shall be consistent with the nature and degree of risk of each research project. The committee shall also require a report from the research project at the conclusion of the project.

12VAC5-20-100. Informed consent.

A. To conduct human research, informed consent of the participant or his legally authorized representative must be obtained, subscribed to in writing by the participant or his legally authorized representative and supported by the signature of a witness not involved in the conduct of research, except as provided for in subsections F and H of this section. If the participant is a minor otherwise capable of rendering informed consent, consent shall be subscribed to in writing by both the minor and his legally authorized representative.

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 such consent shall include:

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;

2. A disclosure of any appropriate alternative procedures or therapies that might be advantageous for the individual;

3. An instruction that the person may withdraw his consent and discontinue participation in the human research at any time without prejudice to him;

4. 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;

5. An offer to answer any inquiries by any individual concerning the procedures and protocols;

6. A statement that the study involves research, and an explanation that includes identification of any procedures that are experimental; the expected duration of the individual'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 individual will not be identified without his written permission;

7. A statement that there may be other risks not yet identified;

8. A disclosure of any appropriate alternative procedures or therapies that might be advantageous for the individual;

9. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the individual is otherwise entitled, and the individual 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 individual with regard to his educational level and language of greatest fluency.

B. A legally authorized representative may not consent to nontherapeutic research unless it is determined by the committee that such research will present no more than a minor increase over minimal risk to the participant.

C. An investigator shall seek such consent only under circumstances that provide the prospective participant or the representative sufficient opportunity to consider whether or not to participate and that assures absence of coercion or undue influence. The information that is given to the participant or the representative shall be in language understandable to the participant or the representative with regard to his educational level and language of greatest fluency.

D. No informed consent form shall include any language through which the prospective participant waives or appears to waive any of his legal rights, including any release of any individual, institution or agency or any agents thereof from liability for negligence.

E. Notwithstanding consent by a legally authorized representative, no person who is otherwise capable of rendering informed consent shall be forced to participate in any human research. In the case of persons suffering from organic brain diseases 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 a legally authorized representative has given informed consent shall not constitute the use of force.

F. The committee may approve a consent procedure which omits or alters some or all of the elements of informed consent set forth in 12VAC5-20-10, or waives the requirement to obtain informed consent provided the committee finds and documents that:

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

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

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

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

G. Except as provided in subsection H of this section, the consent form may be B. Consent may take the form of either of the following:

1. A written consent document that embodies the elements of informed consent required by 12VAC5-20-10 this section. This form may be read to the participant subject or the participant's subject's legally authorized representative, but, in any event, the investigator shall give either the participant 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 12VAC5-20-10 has this section have been presented orally to the participant subject or the participant's 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 participant subject or the representative. Only the short form itself is to be signed by the participant 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 and a copy of the short form shall be given to the participant subject or the representative.

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

12VAC5-20-120. Committee records.

A. Documentation of committee activities shall be prepared and maintained and shall include the following:

1. Copies of all research proposals reviewed, scientific evaluations that may accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to participants;

2. Minutes of committee meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the committee; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controversial issues and their resolution;

3. Records of continuing review activities;

4. Copies of all correspondence between the committee and the investigators;

5. A list of committee members;

6. Written procedures for the committee; and

7. Statements of significant new findings provided to participants.

B. The records required by this chapter shall be retained for at least three years, and records relating to research which is conducted shall be retained for at least three years after completion of the research. All records shall be accessible for inspection and copying by authorized employees or agents of the department at reasonable times and in a reasonable manner.

C. An overview of approved human research projects and the results of such projects will be made public on the department's website unless otherwise exempt from disclosure under the Virginia Freedom of Information Act (§ 2.2-3700 et seq. of the Code of Virginia).