Title of Regulation: 12VAC5-20. Regulations for the Conduct of Human Research (amending 12VAC5-20-10, 12VAC5-20-30 through 12VAC5-20-130).

Statutory Authority: §§ 32.1-12 and 32.1-12.1 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: March 14, 2014.

Agency Contact: Dev Nair, PhD, Director, Division of Policy and Evaluation, Office of Family Health Services, Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 864-7662, or email dev.nair@vdh.virginia.gov.

Basis: Section 32.1-12.1 of the Code of Virginia states that the State Board of Health shall promulgate regulations pursuant to the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) to effectuate the provisions of Chapter 5.1 (§ 32.1-162.16 et seq.) of Title 32.1 of the Code of Virginia for human research, as defined in § 32.1-162.16 of the Code of Virginia, to be conducted or authorized by the department or any facilities or other entities operated, funded, or licensed by the department.

Purpose: To fulfill the statutory mandate to review regulations and to protect the citizens of the Commonwealth, the Virginia Department of Health conducted a periodic review of 12VAC5-20, Regulations for the Conduct of Human Research, pursuant to Executive Order 14 (2010) and § 2.2-4007.1 of the Code of Virginia. As a result of this review, and in order to help protect the health, safety, and welfare of citizens, the Virginia Department of Health is providing proposed amendments to the regulations. It is necessary to amend these regulations to make corrections to outdated citations, provide consistency in language, and enhance the clarity of the regulations in order to achieve improvements that will be reasonable, prudent, and will not impose an unnecessary burden on users of the Virginia Department of Health's Institutional Review Board, human subject researchers, or the public.

Substance: The proposed amendments to the regulations include:

12VAC5-20-10:

1. Updating the definition of "human research."

2. Adding a definition of "subject" or "human subject."

3. Replacing the term "participants" with "subjects" in various sections.

4. Eliminating the detailed elements of informed consent. This information is duplicated in 12VAC5-20-100.

5. Amending the definition of "legally authorized representative" to be consistent with § 32.1-162.16 of the Code of Virginia.

6. Adding a definition of "protected health information."

12VAC5-20-30 - Replacing the term "human participants" with "human subjects" to be consistent with language used in § 32.1-162.16.

12VAC5-20-40 - Clarifying that no official or employee of the institution or agency conducting or authorizing the research is qualified to act as a legally authorized representative.

12VAC5-20-50 - Changing the committee reporting requirement from January 31 to March 31 of each year.

12VAC5-20-50 and 12VAC5-20-60 - Amending the term "chairman" to "chair."

12VAC5-20-70 - Requiring that the committee have at least five members instead of at least seven members.

12VAC5-20-80:

1. Clarifying that no human research shall be conducted unless a research committee has reviewed and approved the project. The section is also amended to provide details as to the elements of the project that are to be considered in the review.

2. Deleting the requirement that the committee approve a written procedure for when a subject has a complaint regarding the research. The requirement that the committee develop a procedure is retained.

3. Requiring that the committee chair provide a written report to the head of the institution regarding any violation that led to either a suspension or termination of the research.

4. Requiring that the committee ensure compliance with the Health Insurance Portability and Accountability Act (HIPAA) and federal and state regulations regarding disclosure of personal health information.

5. Providing that cooperating institutions conducting research may enter into a joint review, rely on another qualified committee, or come to an agreement that avoids duplication of review effort.

12VAC5-20-90 - Providing additional clarification on when and how an expedited review can be completed and clarifying the authority to suspend or terminate approval for a project.

12VAC5-20-100 - Clarifying the informed consent requirements and when the committee may waive the informed consent requirement.

12VAC5-20-110 - Eliminating the reference to the Alzheimer's Disease and Related Disorders Registry and the reference to § 32.1-116.1:2 of the Code of Virginia.

12VAC5-20-130 - Changing the reporting date from January 31 to March 31 annually.

Issues: There are no disadvantages to the public. There are no disadvantages to the agency or the Commonwealth. An advantage to the agency and the Commonwealth is that the amended regulations will provide greater clarification on the requirements for human research and clarification on the protection of research subjects.

Small Business Impact Review Report of Findings: This regulatory action serves as the report of the findings of the regulatory review pursuant to § 2.2-4007.1 of the Code of Virginia.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The State Board of Health (Board) proposes to reduce the number of required members on human research committees from seven to five, and make several other clarifying changes to these regulations. These regulations only apply to research either wholly or in part conducted by the Virginia Department of Health (Department), local health departments in the Commonwealth and to any facility operated, funded or licensed by the Department which conducts or which proposes to conduct or authorize research which uses human participants.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. The regulations state that human research activity shall be reviewed and approved by a committee composed of representatives of varied backgrounds who shall assure the competent, complete, and professional review of human research activities. The current regulations require that the committee shall have at least seven members. The Board proposes to reduce the number of required members to five. Having five committee members is less burdensome and is consistent with federal regulation.¹

The Board proposes several other changes to the language in these regulations. None of the other proposed amendments introduce any new requirements or changes to current requirements that are not either already in federal regulation or Virginia statute. Thus these other proposed changes will have no impact beyond improving clarity.

Businesses and Entities Affected. The proposed amendments affect the Virginia Department of Health, local health departments in the Commonwealth and any facility operated, funded or licensed by the Department which conducts or which proposes to conduct or authorize research which uses human participants.

Localities Particularly Affected. The proposed amendments do not disproportionately affect particular localities.

Projected Impact on Employment. The proposed amendments will not likely affect employment.

Effects on the Use and Value of Private Property. The proposed amendments are unlikely to significantly affect the use and value of private property.

Small Businesses: Costs and Other Effects. The proposed amendments are unlikely to significantly affect costs for small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed amendments are unlikely to significantly affect costs for small businesses.

Real Estate Development Costs. The proposed amendments do not affect real estate development costs.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 14 (10). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, a determination of the public benefit, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

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¹ Relevant federal regulation: 45 CFR 46.107

Agency's Response to Economic Impact Analysis: The Virginia Department of Health concurs with the findings of the economic impact analysis.

Summary:

The proposed amendments (i) revise the definitions of human research, informed consent, and legally authorized representative to be consistent with § 32.1-162.16 of the Code of Virginia and 45 CFR Part 46; (ii) provide additional clarity on committee review procedures; (iii) require that the research review committee ensure compliance with the Health Insurance Portability and Accountability Act and federal and state regulations regarding disclosure of personal health information and change committee membership from seven to five; (iv) clarify the informed consent requirements; and (v) revise the required reporting dates for the research review committee to report yearly activities and the commissioner to report the listing of institutions that are subject to federal regulations regarding human subject research and are exempt from 12VAC5-20.

12VAC5-20-10. Definitions.

The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise:

"Affiliated with the institution" means employed by or contracting with the institution or directly or indirectly involved in the management thereof.

"Commissioner" means the Commissioner of the Department of Health.

"Committee" means human research committee assembled pursuant to 12VAC5-20-70 of this chapter by any institution defined herein.

"Department" means the Department of Health.

"Human research" means any systematic investigation utilizing human participants who may be exposed to physical or psychological injury as a consequence of participation and which departs from the application of established and accepted therapeutic methods appropriate to meet the participants' needs, including research development, testing, and evaluation, utilizing human subjects that is designed to develop or contribute to generalized knowledge. Human research shall not be deemed to include research exempt from federal research regulation pursuant to 45 CFR 46.101(b).

"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 which may accrue to the person and, if applicable, the availability of third party reimbursement for the proposed procedures or protocols; and

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

In addition to the required elements, the information provided to the individual should also include the following:

1. A statement that the study involves research, and an explanation that includes identification of any procedures which are experimental; the expected duration of the individual's participation; and 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;

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

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

4. 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;

5. 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

6. 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 should be provided in a manner that is understandable to the individual with regard to his educational level and language of greatest fluency.

"Institution" or "agency" means any facility, program, or organization owned or operated by the Commonwealth, by any political subdivision, or by any person, firm, corporation, association, or other legal entity.

"Legally authorized representative" means, in the following specified order of priority, (i) the parent or parents having custody of a prospective participant subject of human research who is a minor; (ii) the agent appointed under an advance directive as defined in § 54.1-2982 of the Code of Virginia, executed by the person who is the prospective subject of human research, provided the advance directive authorizes the agent to make decisions regarding the person's participation in human research; (iii) the legal guardian of a prospective participant subject of human research; (iv) the spouse of a prospective subject of human research, except where a suit for divorce has been filed and the divorce decree is not yet final; (v) an adult child of a prospective subject of human research; (vi) a parent of a prospective subject of human research when the individual is an adult; (vii) an adult brother or sister of a prospective subject of human research; or (viii) any person or judicial or other body authorized by law or regulation to consent on behalf of a prospective participant subject of human research to such person's participation in the particular human research. For the purposes of this chapter, any person authorized by law or regulation to consent on behalf of a prospective participant subject to his such subject's participation in the particular human research shall include an attorney-in-fact appointed under a durable power of attorney, to the extent the power grants the authority to make such a decision. The attorney-in-fact shall not be employed by the person, institution or agency conducting the human research. No official or employee of the institution or agency conducting or authorizing the research shall be qualified to act as a legally authorized representative.

"Minimal risk" means that the risks of harm or discomfort anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations, or tests, or treatments.

"Nontherapeutic research" means human research in which there is no reasonable expectation of direct benefit to the physical or mental condition of the participant subject.

"Protected health information" or "PHI" means individually identifiable health information that is created or received by or on behalf of the institution or agency that is maintained or transmitted in any medium, including electronic media. PHI excludes individually identifiable health information in:

1. Education records covered by the Family Educational Rights and Privacy Act, as amended, 20 USC § 1232g;

2. Records described at 20 USC § 1232g(a)(4)(B)(iv) (educational records not otherwise covered under the Family Educational Rights and Privacy Act in subdivision 1 of this definition); or

3. Employment records held by a covered entity in its role as an employer.

"Subject" or "human subject" means a living person about whom an investigator (whether professional or student) conducting research obtains (i) data through intervention or interaction with the person or (ii) identifiable private information.

12VAC5-20-30. Applicability.

This chapter shall apply to the department, including any local health department and to any facility operated, funded or licensed by the department which that conducts or which proposes to conduct or authorize research which uses using human participants subjects.

12VAC5-20-40. Policy.

A. No human research may shall be conducted without informing the participant subject or his legally authorized representative of the procedures, risks, and discomforts of the research. The consent of the participant subject or his legally authorized representative to participate in the research shall be subscribed to in writing by the participant subject or his legally authorized representative and supported by the signature of a witness not involved in the conduct of the research, except as provided for in 12VAC5-20-100 F and H of this chapter. Special arrangements shall be made for those who need assistance in understanding the consequences of participating in the research.

B. Each human research activity shall be reviewed and approved by a committee as set forth in 12VAC5-20-70 of this chapter composed of representatives of varied backgrounds who shall assure the competent, complete, and professional review of human research activities.

C. Every person engaged in the conduct of human research or proposing to conduct human research shall associate himself with an institution or agency having a research review committee, and the human research which he conducts or proposes to conduct shall be subject to review and approval by such committee in the manner set forth in these regulations this chapter.

D. Nontherapeutic research using patients or residents within an institution as defined herein is forbidden unless it is determined by the research review committee that such nontherapeutic research will shall not present greater than minimal risk.

E. The individual person, institution, or agency conducting the human research shall be required to notify all participants subjects of human research of the risks caused by the research which that are discovered after the research has concluded. If consent has been obtained by the signature of the legally authorized representative, the legally authorized representative shall also be notified.

F. No official or employee of the institution or agency conducting or authorizing the human research shall be qualified to act as a legally authorized representative for a subject of the particular human research.

12VAC5-20-50. Review process for department.

A. Prior to the initiation of a human research project by any component of the department, a description of the proposed human research project shall be submitted to a research review committee established by the department for review and approval. The description shall include a statement of the purpose of the proposed project and justification thereof, the criteria for inclusion of a participant as a subject in the research project, a description of what will be done to the participants subjects, and a copy of the informed consent statement.

B. The committee shall report by January March 31 of each year to the commissioner on activities of the committee during the previous calendar year. Such reports shall include:

1. A description of each human research project reviewed and whether it was approved or disapproved;

2. Any significant deviations from proposals as approved;

3. A list of committee members, their qualifications for service on the committee, and their institutional affiliation; and

4. A copy of the minutes of any committee meetings conducted.

C. The chairman chair of the committee shall report as soon as possible to the commissioner any violation of the research protocol which that led the committee to either suspend or terminate the research.

D. The commissioner may inspect the records of the committee.

E. The commissioner shall report at least annually to the Governor and General Assembly on the human research projects conducted by any component of the department as annually reported to the commissioner by the committee.

12VAC5-20-60. Review process for institutions or agencies funded or licensed by the department.

A. Prior to the initiation of a human research project by any institution or agency funded or licensed by the department, a description of the proposed human research project shall be submitted to a research review committee for review and approval. The description shall include a statement of the purpose of the proposed project and justification thereof, the criteria for inclusion of a participant subject in the research project, a description of what will be done to the participants subjects, and a copy of the informed consent statement.

B. When more than one such institution or agency is involved in a research project, the cooperating entities may enter into joint review.

C. Such institutions or agencies having a committee shall report by January March 31 of each year to the commissioner on activities of the committee during the previous calendar year. Such reports shall include:

1. A description of each human research project reviewed and whether it was approved or disapproved;

2. Any significant deviations from proposals as approved;

3. A list of committee members, their qualifications for service on the committee, and their institutional affiliation; and

4. A copy of the minutes of any committee meetings conducted.

D. The chairman chair of the committee shall report as soon as possible to the head of such institution or agency and to the commissioner any violation of the research protocol which led the committee to either suspend or terminate the research.

E. The commissioner may inspect the records of the committee.

F. The commissioner shall report at least annually to the Governor and General Assembly on the human research projects conducted by such institutions or agencies as annually reported to the commissioner by the relevant research review committees.

12VAC5-20-70. Composition of research review committee.

A. Each committee shall have at least seven five members, appointed by the head of the institution, with varying backgrounds to provide complete and adequate review of activities commonly conducted by the institution. The committee shall be sufficiently qualified through the maturity, experience, and diversity of its members, including consideration of race, gender and cultural background, to promote respect for its advice and counsel in safeguarding the rights and welfare of participants subjects in human research. In addition to possessing the professional competence necessary to review specific activities, the committee shall be able to ascertain the acceptability of applications and proposals in terms of institutional commitments and regulations, applicable law, standards of professional conduct and practice, and community attitudes. If a committee regularly reviews research that has an impact on patients or residents within an institution as defined herein or other vulnerable category of participants subjects, the committee shall have in its membership one or more individuals who are primarily concerned with the welfare of these participants subjects and who have appropriate experience to serve in that capacity.

B. No committee shall consist entirely of members of one profession, and at least one member must shall be an individual whose primary concerns are in nonscientific areas (e.g., lawyers, ethicists, members of the clergy).

C. Each committee shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.

D. No member of a committee shall participate in the committee's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the committee. The committee has responsibility for determining whether a member has a conflicting interest. The committee size shall be maintained at no fewer than seven five persons by appointment of a substitute representative for each member with a conflicting interest.

E. A committee may, at its discretion, invite individuals with competence in special areas to assist in the review of complex issues which require expertise beyond or in addition to that available on the committee. These individuals may shall not vote with the committee.

F. A quorum of the committee shall consist of a majority of its members including at least one member whose primary concerns are in nonscientific areas.

G. The committee and the institution shall establish procedures and rules of operation necessary to fulfill the requirements of this chapter.

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

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

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

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

3. Whether the rights and welfare of the human subjects involved are adequately protected;

4. Whether the risks to the human subjects are outweighed by the potential benefits to them;

5. Whether the risks to subjects are minimized (i) by using procedures that are consistent with sound human research design and that do not unnecessarily expose subjects to risk and (ii) whenever appropriate, by using currently accepted procedures for diagnostic or treatment purposes;

6. Whether additional safeguards have been included in the study to protect the rights and welfare of the subjects when some or all of the subjects are likely to be incapable of providing informed consent or are otherwise vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons;

7. Whether the informed consent is to be obtained by methods that are adequate and appropriate and whether the written consent form is adequate and appropriate in both content and language for the particular human research and for the particular subjects of the human research;

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

9. Whether criteria for selection of subjects are equitable; and

10. Whether the human research conforms with other requirements of the department, where applicable.

A. B. The committee shall consider a research proposals proposal within 45 days after its submission to the committee. In order for the research proposal to be approved, it shall receive the approval of a majority of those the committee members present at a meeting in for 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, proposal or of modifications required to secure committee approval.

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

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

D. E. Any 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. The committee shall have the authority to suspend or terminate approval of research that is not being conducted in accordance with the committee requirements or that has been associated with unexpected serious harm to the subjects. Any suspension or termination of approval shall include a statement of the reasons for the committee's action and shall be reported promptly to the investigator, appropriate institutional officials, the department or agency head, and the commissioner.

G. The chair of the committee shall provide a written report to the head of the institution of any violation of the human research protocol that led the committee to suspend or terminate the human research.

E. H. 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 research project.

I. The committee shall ensure compliance with the Health Insurance Portability and Accountability Act of 1996 (42 USC § 1320d et seq.), if applicable, and federal and state regulations regarding the use and disclosure of PHI created for human research. In particular, authorization shall be obtained for the use and disclosure of PHI created for the purpose of human research, except as otherwise permitted by 45 CFR 164.512(i).

J. When cooperating institutions conduct some or all of the human research involving some or all of the subjects of the human research, each cooperating institution shall be responsible for safeguarding the rights and welfare of the subjects and for complying with this chapter, provided however, in complying with this chapter, institutions may enter into joint review, rely upon the review of another qualified committee, or come to similar agreements aimed at avoiding duplication of effort. Any such agreement shall be in writing and designate a lead institution, which shall be the institution responsible for reporting and handling any possible misconduct in the human research. Such agreements shall be entered into by the committee chair with the approval of a majority of the committee members. If an institution or agency does not have a research review committee, such agreements shall be approved and entered into by the chief executive officer of the institution or his designee.

12VAC5-20-90. Expedited review of human research projects.

A. The committee is authorized to conduct an expedited review of a human research project which that involves no more than minimal risk to the subjects if: and involves only research procedures listed in one or more categories established by the Secretary of Health and Human Services and published in the Federal Register pursuant to 45 CFR 46.110.

B. The committee also is authorized to conduct an expedited review of a human research project that involves no more than minimal risk to the subjects if:

1. Another institution's or agency's human research review committee has reviewed and approved the project; or

2. The review involves only minor changes in previously approved research and the changes occur during the approved project period.

C. An expedited review may be carried out by the chair of the committee or by one or more experienced reviewers designated by the chair from among the committee members. In reviewing the research project, the reviewers may exercise all of the authorities of the committee except that the reviewers may not disapprove the research project. A research project may be disapproved only after review by the full committee in accordance to the procedures set forth in 12VAC5-20-80.

B. D. Each committee which that uses an expedited review procedure shall adopt a method for keeping all members advised of research proposals which projects that have been approved under the procedure.

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 individual 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;

3. 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;

4. 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;

5. 6. An offer to answer any inquiries by any individual 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;

6. 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 individual's 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 individual person will not be identified without his written permission;

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

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

9. 10. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the individual person is otherwise entitled, and the individual person may discontinue participation at any time without penalty or loss of benefits to which he is otherwise entitled;

10. 11. 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. 12. 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 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 therof 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. 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.

B. 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 itself written consent is to be 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.

12VAC5-20-110. Categories of human research exempt from regulation.

Research activities in which the only involvement of human participants will be subjects is in one or more of the following categories are exempt from this chapter:

1. The surveillance and investigation by the department into all preventable diseases and epidemics in the Commonwealth and into the means for the prevention of such diseases and epidemics conducted pursuant to § 32.1-39 of the Code of Virginia.

2. Research designed to study on a large scale anonymous vital records and registry data collected pursuant to the Code of Virginia, Chapter 7 (§ 32.1-249 et seq.) of Title 32.1 (Vital Records), § 32.1-64.1 (Virginia Hearing Impairment Identification and Monitoring System), § 32.1-69.1 (Viginia (Virginia Congenital Anomalies Reporting and Education System), § 32.1-70 (Statewide Cancer Registry), § 32.1-71.l (Statewide Alzheimer's Disease and Related Disorders Registry), § 32.1-46.01 (Virginia Immunization Information System), and §§ § 32.116.1 and 32.116.1:2 (Emergency Medical Services Patient Care Information System).

3. Research or student learning outcomes assessment conducted in educational settings such as research involving:

a. Regular or special education instructional strategies; or

b. The effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods; or

c. The use of educational tests, whether cognitive, diagnostic, aptitude, or achievement, if the data from such tests are recorded in a manner so that participants subjects cannot be identified, directly or through identifiers linked to the participants subjects.

4. Research involving survey or interview procedures unless responses are recorded in such a manner that the participants subjects can be identified, directly or through identifiers linked to the participants subjects, and either:

a. The participant's subject's responses, if they became known outside the research, could reasonably place the participant at risk of criminal or civil liability or be damaging to his financial standing, employability, or reputation; or

b. The research deals with sensitive aspects of the participant's subject's own behavior such as sexual behavior, drug or alcohol use, or illegal conduct.

5. Research involving survey or interview procedures, when the respondents are elected or appointed public officials or candidates for public office.

6. Research involving solely the observation of public behavior, including observation by participants, unless observations are recorded in such a manner that the participants subjects can be identified, directly or through identifiers linked to the participants subjects, and either:

a. The observations recorded about the individual subject, if they became known outside the research, could reasonably place the participant subject at risk of criminal or civil liability or be damaging to his financial standing, employability, or reputation; or

b. The research deals with sensitive aspects of the participant's subject's own behavior, such as sexual behavior, drug or alcohol use, or illegal conduct.

7. Research involving the collection or study of existing data, documents, records, or pathological specimens, if these sources are publicly available or if the information is recorded by the investigator in a manner so that participants subjects cannot be identified, directly or through identifiers linked to the participants subjects.

12VAC5-20-120. Committee records.

A. Documentation of committee activities shall be prepared and maintained by each such committee 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 subjects;

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 each action, 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 subjects.

B. The records required by this chapter shall be retained for at least three years, and records relating to research which that 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 Each research review committee of a state institution or agency shall ensure that an overview of approved human research projects and the results of such projects will be are made public on the department's such institution's or agency's website unless otherwise exempt from disclosure under the Virginia Freedom of Information Act (§ 2.2-3700 et seq. of the Code of Virginia).

12VAC5-20-130. Applicability of federal policies.

Human research at institutions which are that is subject to policies and regulations for the protection of human participants subjects promulgated by any agency of the federal government shall be exempt from this chapter. Such institutions Institutions where research is performed that is subject to federal policies and regulation shall notify the commissioner annually, by January March 31, of their compliance with the policies and regulations of federal agencies. The commissioner shall identify institutions exempt from this chapter as reported in accordance with this section in the annual report to the Governor and the General Assembly provided in accordance with 12VAC5-20-60 F.