12VAC35-180 Regulations to Assure the Protection of Subjects in Human Research

REGULATIONS

Vol. 26 Iss. 2 - September 28, 2009

TITLE 12. HEALTH

BOARD OF BEHAVIORAL HEALTH AND DEVELOPMENTAL SERVICES

Chapter 180

Fast-Track Regulation

Title of Regulation: 12VAC35-180. Regulations to Assure the Protection of Subjects in Human Research (amending 12VAC35-180-10 through 12VAC35-180-110, 12VAC35-180-130, 12VAC35-180-140, 12VAC35-180-150).

Statutory Authority: §§ 37.2-203 and 37.2-402 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: October 28, 2009.

Effective Date: November 12, 2009.

Agency Contact: Marion Greenfield, Office of Quality Management, Department of Behavioral Health and Developmental Services, 1220 Bank Street, Richmond, VA 23218, telephone [phone], or email [e-mail].

Basis: Section 37.2-402 of the Code of Virginia requires that the board adopt regulations regarding human research. The current version of these regulations became effective in 2004.

Purpose: The purpose of the proposed changes in the human research regulations is to eliminate unnecessary review requirements, reflect the department's name change approved by the 2009 General Assembly, and update the regulatory provisions to provide a more person-centered focus.

Rationale for Using Fast-Track Process: Section 2.2-4012.1 of the Code of Virginia and Executive Order 36 (06) allow state agencies to use a fast-track rulemaking process to expedite regulatory changes that are expected to be noncontroversial. The changes being made in the human research regulations eliminate unnecessary review provisions, reflect the department's name change approved by the 2009 General Assembly, and update the regulatory provisions to provide a more person-centered focus. None of these changes are controversial or establish any additional regulatory burdens.

Substance: The proposed amendments make the regulatory language more person-centered, change the department's name, and eliminate requirements that are no longer needed.

Issues: The primary advantages of the proposed changes to the public are: (i) correcting unnecessary and confusing regulatory language; (ii) adjusting section titles and language to clarify the role of the Review Committees; and (iii) eliminating activities that place unnecessary restrictions on the Review Committee and the organization conducting the research.

The primary advantage to the agency is that the proposed changes will: (i) clarify the role of the state board and commissioner; (ii) more clearly describe the department's responsibilities; and (iii) remove the board's review responsibilities.

Other pertinent matters of interest to the regulated community, government officials, and the public include: (i) changing the name of the department; and (ii) adding a requirement that certain agreements now permitted by the regulation between entities conducting research be in writing.

The Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Behavioral Health and Developmental Services proposes to delete its review responsibilities and more clearly describe those of the department and agency head, to make the regulatory language more person-centered, to change the name of the department, and to eliminate selected provisions of the requirements that are no longer needed.

Result of Analysis. There is insufficient data to accurately compare the magnitude of the benefits versus the costs.

Estimated Economic Impact. The Board of Behavioral Health and Developmental Services proposes to delete its review responsibilities and more clearly describe those of the department and agency head, to make the regulatory language more person-centered, to change the name of the department¹, and to eliminate selected provisions of the requirements that are no longer needed.

The above proposed changes are not expected to create a significant economic impact as they mainly clarify the language, update new agency name, and clarify the responsibilities. Thus, no significant economic effect is expected as a result of these proposed changes.

However, the proposed changes also include adding a provision barring officials and employees of the agency conducting or authorizing research from acting as a legally authorized representative for an individual participating in the research; changing the section title for "certification process" to "affiliation with a research review committee" and deleting several requirements contained within this section; mandating that in the case of several cooperating institutions, a lead institution be established and that the agreement designating such institution must be in writing; mandating that written reports of suspension or termination due to protocol violations be provided by the chair of the research review committee to the head of the institution; deleting several designated categories of certain kinds of human research activities that involve no more than minimal risk; modifying the section concerning informed consent to clarify what is required when consent is secured orally; changing the records retention requirement from three to six years; removing a requirement that institutions or agencies notify the agency head or the board annually of their compliance with federal policy.

The changes described above may have the potential to create somewhat significant economic impact, but there is no available information from the department to substantiate the extent of their potential impact.

Businesses and Entities Affected. The proposed regulations apply to 40 community service boards, approximately 612 private providers, and 16 state facilities.

Localities Particularly Affected. The proposed regulations apply throughout the Commonwealth.

Projected Impact on Employment. Based on available information, no significant effect on employment is expected.

Effects on the Use and Value of Private Property. Based on available information, no significant effect on the use and value of private property is expected.

Small Businesses: Costs and Other Effects. Most of the 612 private providers are believed to be small businesses. However, based on available information, no significant costs or other economic effects are expected on small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. Based on available information, no significant adverse impact is expected on small businesses.

Real Estate Development Costs. Based on available information, no significant effect on real estate development costs is expected.

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 36 (06). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, 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 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.

__________________________

¹ Until July 1, 2009, this agency was known as the Department of Mental Health, Mental Retardation, and Substance Abuse Services. Chapter 813 of the 2009 Acts of Assembly changed the name.

Agency's Response to the Department of Planning and Budget's Economic Impact Analysis: The agency concurs with the economic impact analysis prepared by the Department of Planning and Budget.

Summary:

The proposed amendments delete the Board of Behavioral Health and Developmental Services' review responsibilities and more clearly describe the responsibilities of the department and agency head, make the regulatory language more person-centered, change the name of the department, and eliminate selected provisions of the requirements that are no longer needed.

12VAC35-180-10. 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 the institution or a member of a household containing an employee of the institution.

"Board" means the State Mental Health, Mental Retardation and Substance Abuse Services Board of Behavioral Health and Developmental Services.

"Commissioner" means the Commissioner of the Department of Mental Health, Mental Retardation and Substance Abuse Behavioral Health and Developmental Services.

"Community services board" or "CSB" means a public body established pursuant to § 37.2-501 of the Code of Virginia that provides mental health, mental retardation, and substance abuse services to individuals within each city or county that established it. For the purpose of these regulations, community services board also includes a behavioral health authority established pursuant to § 37.2-602 of the Code of Virginia.

"Department" means the Department of Mental Health, Mental Retardation and Substance Abuse Behavioral Health and Developmental Services.

"Health information" means any information, whether oral or recorded in any form or medium, that:

1. Is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and

2. Relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present or future payment for the provision of health care to an individual.

"Human research" means any systematic investigation, 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).

"Human subject" or "subject" means a living individual about whom an investigator (whether professional or student) conducting research obtains (i) data through intervention or interaction with the individual, or (ii) protected health information.

"Individual" means a human subject pursuant to 45 CFR 46.102 (f) about whom an investigator (whether professional or student) conducting research obtains (i) data through interaction with the individual; or (ii) protected health information.

"Individually identifiable health information" means information that is a subset of health information, including demographic information collected from an individual, and:

1. Is created or received by a health care provider, health plan, employer, or health care clearinghouse; and

2. Relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual; and

a. That identifies the individual; or

b. With respect to which there is a reasonable basis to believe the information can be used to identify the individual.

"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 an individual who is capable of exercising free power of choice. For the purposes of human research, the basic elements of information necessary for such consent shall include:

1. A reasonable and comprehensible explanation to the person individual of the proposed procedures or protocols to be followed, and their purposes, including descriptions of any attendant discomforts, risks and benefits reasonably to be expected, how the results of the human research will be disseminated, and how the identity of the individual will be protected;

2. A disclosure of any appropriate alternative procedures or therapies that might be advantageous for the person individual together with their side effects, risks, and benefits;

3. A description of any adverse consequences and risks to be expected and an indication whether there may be other significant risks not yet identified;

4. An instruction that the person individual 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 individual 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; and;

6. An offer to answer and answers to any inquiries by the person individual 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;

"Institution" or "agency" means any community services board or any facility or program operated, funded, or licensed by the department.

"Interaction" includes communication or interpersonal contact between investigator and the individual who is the subject of the human research.

"Intervention" includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject individual or subject's individual's environment that are performed for human research purposes.

"Legally authorized representative" means in the following specified order of priority, (i) the parent or parents having custody of an individual who is a prospective 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 individual who is the prospective subject of human research, provided the advance directive authorizes the agent to make decisions regarding the prospective subject's individual's participation in human research, (iii) the legal guardian of an individual who is a prospective subject of human research, (iv) the spouse of individual who is 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 the an individual who is a prospective subject of human research, (vi) a parent of the individual who is a prospective subject of human research when the subject individual is an adult, (vii) an adult brother or sister of the individual who is 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 an individual who is a prospective subject of human research to such subject's individual's participation in the particular human research. For the purposes of this definition, any person authorized by law or regulation to consent on behalf of an individual who is a prospective subject of human research to his 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 human research shall be qualified to act as a legally authorized representative.

"Minimal risk" means that the risks of harm anticipated in the proposed human 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, 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 human subject individual.

"Protected health information (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 Privacy Act in subdivision 1 of this definition); or

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

"Research" means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to general knowledge. Activities which meet this definition constitute research for purposes of this chapter, whether or not they are supported or funded under a program which is considered research for other purposes. For example, some "demonstration" and "service" programs may include research activities.

"Research review committee" or "committee" means a committee of professionals to provide complete and adequate review of human research activities pursuant to § 32.1-162.19 of the Code of Virginia.

12VAC35-180-30. Applicability.

This chapter shall apply to the Department of Mental Health, Mental Retardation and Substance Abuse Behavioral Health and Developmental Services, any community services board, and any facility operated, funded or licensed by the department which conducts or which proposes to conduct or authorize human research in which uses individuals participate as human subjects.

12VAC35-180-40. Policy.

A. No human research may be conducted without obtaining the informed consent of the subject individual or his legally authorized representative. The This informed consent of the subject or his legally authorized representative to participate in the research must shall be documented in writing and supported by the signature of a witness. Arrangements Adequate and appropriate arrangements shall be made for those who need special assistance in understanding the consequences of participating in the human research.

B. 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 an individual participating in the particular human research.

C. Each human research activity shall be approved by a research review committee composed of representatives of varied backgrounds who shall assure the competent, complete, and professional review of human research activities.

C. D. Institutions or agencies, as defined by this chapter, may participate in human research activity when such activity has been considered and approved by a university institutional review board (IRB) that complies with the relevant requirements of § 32.1-162.19 of the Code of Virginia.

D. E. Nontherapeutic human research using subjects individuals receiving care services in a residential or hospital setting is prohibited unless it is determined by the research review committee that such nontherapeutic human research will present no more than a minor increase over minimal risk to the human subject individual.

E. F. The individual person, institution, or agency conducting the human research shall be required to notify all individuals who are subjects of the human research of the risks caused by the human research which that are discovered after the human research has concluded.

12VAC35-180-50. Certification process Affiliation with a research review committee.

A. Institutions or agencies seeking to conduct or sponsor human research are required to submit statements to the department assuring that all human research activities will be reviewed and approved by an internal or external research review committee. Institutions shall report annually to the commissioner giving assurance that a committee exists and is functioning. These reports shall include a list of committee members, their qualifications for service on the committee, their institutional or agency affiliation and a copy of the minutes of committee meetings.

B. Prior to the initiation of a human research project, institutions shall also send to the commissioner a description of the research project to be undertaken, which shall include a statement of the criteria for inclusion of a subject in the research project, a description of what will be done to the subjects, and a copy of the informed consent statement.

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

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

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

12VAC35-180-60. Composition of research review committees.

A. Each research review committee shall have at least five members, appointed by the head of the institution or agency, with varying backgrounds to ensure the competent, complete and professional review of human research activities commonly conducted by the institution or agency. 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 individuals who are the subjects in of human research. In addition to possessing the professional competence necessary to review specific human research activities, the committee must 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 human research that has an impact on an individuals who are institutionalized or other are otherwise vulnerable category of subjects, including residents of individuals who reside in mental health or mental retardation facilities or state training centers, the committee shall have in its membership one or more individuals persons who are primarily concerned with the welfare of these subjects individuals 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 a person 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 or agency and who is not part of the immediate family of a person who is affiliated with the institution or agency.

D. No member of a committee shall participate in the committee's initial or continuing review of any project in which the member is directly involved or for which he has administrative approval authority, except to provide information requested by the committee. The committee has responsibility shall be responsible for determining whether a member has a conflicting interest. The committee member shall be replaced in the case of conflicting interests resulting in a decrease of the committee below five persons.

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 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 or agency shall establish procedures and rules of operation necessary to fulfill the requirements of this chapter.

12VAC35-180-70. Elements of each committee's review process.

A. No human research shall be conducted or authorized by such an institution or agency unless the 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 individuals who are the subjects of the human research are adequately protected;

4. Whether the risks to the individuals who are the subjects of human research are outweighed by the potential benefits to them;

5. Whether the risks to subjects individuals are minimized by using procedures that are consistent with sound human research design and that do not unnecessarily expose subjects individuals to risk and, whenever appropriate, by using procedures already being performed on the subjects individuals for diagnostic or treatment purposes;

6. When some or all of the subjects individuals 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, whether additional safeguards have been included in the study to protect the rights and welfare of these subjects individuals;

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 individuals who are 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 individuals to participate as human research subjects are equitable; and

10. Whether the human research conforms with such other requirements as the board may establish of the department, where applicable.

B. Each committee shall review approved projects to ensure conformity with the approved proposal at least annually.

C. Research must be approved by the committee that has jurisdiction over the subject. When cooperating institutions conduct some or all of the human research involving some or all of the subjects individuals, each cooperating institution is responsible for safeguarding the rights and welfare of human subjects the individuals and for complying with this chapter, except that in complying with this chapter institutions may enter into joint review, rely upon the review of another qualified committee, or make come to similar arrangements agreements aimed at avoiding duplication of effort. These agreements must be in writing and designate a lead institution, which shall be the institution responsible for reporting and dealing with possible misconduct in human research. Such arrangements agreements may be made by the committee chairperson chair with the approval of a majority of the members present at a meeting of the committee. If a given institution or agency does not have a research review committee, this arrangement shall be approved by the chief executive officer of the institution, or his designee.

D. The committee shall consider human research proposals within 45 days after submission to the committee's chairman chair. In order for the human research to be approved, it shall receive the approval of a majority of those members present, including one nonscientific person, 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 human research activity, or of modifications required to secure committee approval.

E. The committee shall develop a written description of the procedure to be followed by a subject an individual who has a complaint about a human research project in which he is participating or has participated.

F. Any subject individual who has a complaint about a human research project in which he is participating or has participated shall be referred to the chairperson of the committee who shall refer it to the committee to determine if there has been a violation of the protocol.

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

G. H. The committee shall require periodic written reports to ensure that the project is being carried out in conformity with the proposal. The frequency of such reports should reflect the nature and degree of risk of each human research project.

H. I. The committee shall ensure compliance with the Health Insurance Portability and Accountability Act of 1996 (Public Law 104-19 104-191) and the federal and state regulations promulgated thereunder 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).

12VAC35-180-80. Kinds of human research exempt from committee review.

Research Human research activities in which the only involvement of human individuals as subjects will be in is limited to one or more of the following categories are exempt from this chapter unless the human research is covered by other sections of this chapter:

1. Research Human research conducted in established or commonly accepted educational settings, involving commonly used educational practices, such as:

a. Research on regular and special education instructional strategies; or

b. Research on the effectiveness of or the comparison among instructional techniques, curriculum or classroom management methods.

2. Research Human research involving solely the use and analysis of the results of educational tests, whether cognitive, diagnostic, aptitude, or achievement, if the data from such tests are recorded in such a manner so that subjects individuals cannot be identified, directly or through identifiers linked to the subjects individuals.

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

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

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

4. Research Human research involving solely the observation (including observation by subjects) individuals who are the subjects of human research) of public behavior, unless observations are recorded in such a manner that subjects individuals can be identified, directly or through identifiers linked to the subjects individuals, and either:

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

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

5. Research Human research involving solely the collection or study of existing data, documents, records, or pathological or diagnostic specimens, if these sources are publicly available or if the information taken from these sources is recorded in such a manner that subjects individuals cannot be identified, directly or through identifiers linked to the subjects individuals.

6. Research Human research involving solely a combination of any of the activities described in this section.

12VAC35-180-90. Expedited review procedures for certain kinds of human research involving no more than minimal risk.

A. The A research review committee may conduct an expedited review of a human research project which that involves no more than minimal risk to the individuals who are the subjects of the human research if (i) another institution's or agency's human research review committee has reviewed and approved the project, or (ii) the review involves only minor changes in previously approved human research and the changes occur during the approved project period. Under an expedited review procedure, the review may be carried out by the committee chairperson chair and one two or more experienced reviewers designated by the chairperson chair from among members of the committee. In reviewing the human research, the reviewers may exercise all of the authority of the committee except that the reviewers may not disapprove the human research. A human research activity may be disapproved only after review in accordance with the nonexpedited procedure set forth in 12VAC35-180-70.

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

C. Research activities involving no more than minimal risk and in which the only involvement of human subjects will be in one or more of the following categories (carried out through standard methods) may be reviewed by the research review committee through the expedited review procedure.

1. Collection of hair and nail clippings, in a nondisfiguring manner; nonpermanent teeth at a time of natural loss or if patient care indicates a need for extraction; and permanent teeth if patient care indicates a need for extraction.

2. Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.

3. Recording of data from subjects 18 years of age or older using noninvasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject's privacy. It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example, x-rays, microwaves).

4. Collection of blood samples by venipuncture or less invasive procedures, in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week, from subjects 18 years of age or older and who are in good health and not pregnant.

5. Collection of both supra-gingival and subgingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques.

6. Voice recordings made for research purposes such as investigations of speech defects.

7. Moderate exercise by healthy volunteers.

8. The study of existing data, documents, records, pathological specimens, or diagnostic specimens.

9. Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the research will not involve stress to subjects.

10. Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.

12VAC35-180-100. Informed consent.

A. No human research may shall be conducted in this Commonwealth in the absence of informed consent subscribed to in writing by the subject individual or by the subject's legally individual's authorized representative except as provided for in subsection F of this section. If the subject individual is capable of providing informed consent, then it shall be subscribed to in writing written consent must be provided by the subject individual and witnessed. If the subject individual is incapable of making an informed decision, as defined in § 54.1-2982 of the Code of Virginia, at the time consent is required, then it shall be subscribed to in writing written consent must be provided by the person's legally individual's legally authorized representative and witnessed. If the subject individual is a minor otherwise capable of rendering informed consent, the consent shall be subscribed to provided by both the minor and his legally authorized representative. An investigator shall seek such consent only under circumstances that provide the individual who is the prospective subject or the 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 subject individual or, if applicable the individual's legally authorized representative shall be in language understandable to the subject individual or the representative.

If two or more persons who qualify as legally authorized representatives have equal decision-making priority under this chapter inform the principal investigator or attending physician that they disagree as to participation of the prospective subject individual in human research, the subject individual shall not be enrolled in the human research that is the subject of the consent.

B. No individual shall participate in human research unless this requirement is met for each individual. The giving of informed consent by a legally an authorized representative shall be subject to the provisions of subsection C of this section. No informed consent shall include any language through which the subject individual waives or appears to waive any of his legal rights, including any release of any individual person, institution, or agency or any agents thereof from liability for negligence. Notwithstanding the informed consent by a legally authorized representative, no person individual 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 prospective subject individual. In the case of persons individuals suffering from organic brain disease 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 the legally authorized representative has given informed consent shall not constitute the use of force. Each subject individual shall be given a copy of the signed consent form required by 12VAC35-180-40 A except as provided for in subsection F of this section.

C. No legally authorized representative may consent to nontherapeutic human research unless it is determined by the research review committee that such nontherapeutic human research will present no more than a minor increase over minimal risk to the subject individual. A legally authorized representative may not consent to participation in human research on behalf of a prospective subject an individual 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 prospective subject individual, whether expressed orally or in writing. A legally authorized representative may not consent to participation in human research involving nontherapeutic sterilization, abortion, psychosurgery, or admission for human research purposes to a facility or hospital as defined in § 37.1-1 § 37.2-100 of the Code of Virginia. No nontherapeutic human research shall be performed without the consent of the subject individual or, if applicable, his legally authorized representative.

D. The research review committee may approve a consent procedure which that does not include, or which that alters some or all of the elements of informed consent set forth in 12VAC35-180-10, or waive 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 individuals;

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

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

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

E. Except as provided in subsection F of this section, the consent form may be either of the following:

1. E. A written consent document that embodies the elements of informed consent required by 12VAC35-180-10. This form may be read to the subject individual or, if applicable, the subject's individual's legally authorized representative, but in any event, the investigator shall give either the subject individual or the legally authorized representative adequate opportunity to read it before it is signed; or.

2. A short form written consent document stating that the elements of informed consent required by 12VAC35-180-10 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 legally authorized 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 representative, in addition to a copy of the short form.

F. The committee may waive the requirement in subsection E of this section for the investigator to obtain a written informed consent form for some or all subjects individuals if it finds that the only record linking the subject individual 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 individual shall be asked whether the subject individual wants documentation linking the subject individual with the human research, and the subject's individual's wishes shall govern. In cases where the documentation requirement is waived, the committee may require the investigator to provide subjects individuals with a written statement explaining the human research.

12VAC35-180-110. Committee records.

A. An institution or agency, or when appropriate a committee shall prepare and maintain adequate documentation of committee activities, including the following:

1. Copies of all human research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to individuals who are subjects of the human research.

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 human research; and a written summary of the discussion of controverted issues about which opposition has been voiced 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.

7. Statements of significant new findings provided to subjects individuals.

B. The records required by this chapter shall be retained for at least three years, and records relating to human research which is conducted shall be retained for at least three six years after completion of the human 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. An overview of approved human research projects and the results of such projects shall be made public on the website of the institution or agency conducting the human research unless otherwise exempt from disclosure under the Virginia Freedom of Information Act, (§ 2.2-3700 et seq. of the Code of Virginia).

12VAC35-180-130. Role of the department, and commissioner, and the board.

A. The commissioner shall establish and maintain records of institutional assurances, annual reports, and summary descriptions of research projects to be reviewed by the board.

B. The commissioner shall review communications from committees reporting violations of research protocols which led to suspension or termination of the research to ensure that appropriate steps have been taken for the protection of the rights of human research subjects. The board shall be kept informed.

C. The commissioner shall arrange for the printing and dissemination of copies of this chapter.

The commissioner shall assure that the department's human rights program, through procedures described in 12VAC35-115, protects the rights of individuals who are admitted to a state hospital, training center, or other facility operated, funded, or licensed by the department to refuse to participate as a subject of human research and assure that written and informed consent is received from individuals or their legally authorized representative prior to their participation as a subject of human research.

12VAC35-180-140. Applicability of state policies.

Nothing in this chapter shall be construed as limiting in any way the rights of subjects individuals in human research under regulations promulgated by the board State Board of Behavioral Health and Developmental Services pursuant to § 37.1-84.1 § 37.2-400 of the Code of Virginia.

12VAC35-180-150. Applicability of federal policies.

Human research at institutions or agencies which are subject to policies and regulations for the protection of human subjects individuals promulgated by any agency of the federal government shall be exempt from this chapter. Such institutions or agencies shall notify the commissioner and the board annually of their compliance with the policies and regulations of federal agencies.

VA.R. Doc. No. R10-1787; Filed September 8, 2009, 2:37 p.m.