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Virginia Regulatory Town Hall

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Action:
Amend Regulations Following Periodic Review
Stage: Fast-Track

CHAPTER 180
REGULATIONS TO ASSURE ENSURE THE PROTECTION OF SUBJECTS IN HUMAN RESEARCH

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 Board of Behavioral Health and Developmental Services.

"Commissioner" means the Commissioner of the Department of Behavioral Health and Developmental Services.

"Community services board" or "CSB" means a the public body established pursuant to § 37.2-501 of the Code of Virginia that provides mental health, mental retardation developmental, 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 Behavioral Health and Developmental Services.

"Health information" means "health information" pursuant to 45 CFR 160.103, or 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).

"Individual" means a human subject pursuant to 45 CFR 46.102 (f) 45 CFR 46.102 (e)(1)  about whom an investigator (whether professional or student) conducting research obtains (i) data through interaction with the individual; or (ii) protected health identifiable private information pursuant to 45 CFR 46.102 (e)(5).

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

"Interaction" includes communication or interpersonal contact between the 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 individual or 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 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 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 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 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 review committee," or "committee," "human research review committee," or "institutional review board" means a committee of professionals to that provide provides 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 Behavioral Health and Developmental Services, any community services board, and any facility operated, funded or licensed by the department which that conducts or which that proposes to conduct or authorize human research in which individuals participate as human subjects.

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 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 individuals who are institutionalized or are otherwise vulnerable, including individuals who reside in mental health state facilities or state training centers, the committee shall have in its membership one or more persons who are primarily concerned with the welfare of these 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 shall be 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 shall be responsible for determining whether a member has a conflicting interest. The committee member shall be replaced in if the case of conflicting interests interest resulting results 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 an 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 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 individuals are minimized by using procedures that are consistent with sound human research design and that do not unnecessarily expose individuals to risk and, whenever appropriate, by using procedures already being performed on individuals for diagnostic or treatment purposes;

6. When some or all of the 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 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 of the department, where applicable.

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

C. When cooperating institutions conduct some or all of the human research involving some or all of the individuals, each cooperating institution is responsible for safeguarding the rights and welfare of 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 come to similar 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 agreements may be made by the committee 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.C. The committee shall consider human research proposals within 45 days after submission to the committee's 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 project, or of modifications required to secure committee approval.

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

F.E. Any 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.

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 any individuals. 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 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.

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, but shall be at least annually.

I. Prior to participation by individuals in any human research project, the institution or agency shall inform and provide a copy of the research review committee approval to the local human rights committee established pursuant to 12VAC35-115-10 et seq. Once the research has been initiated, the institution or agency shall update the local human rights committee periodically on the status of the individual's participation.

J. The committee shall ensure compliance with the Health Insurance Portability and Accountability Act of 1996 (Public Law 104-191) 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).

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

Human research activities in which the involvement of individuals as subjects 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. 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.c. 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 individuals cannot be identified, directly or through identifiers linked to the individuals.

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

a. The 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 individual's financial standing, employability, or reputation; or

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

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

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

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

5.4. 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 individuals cannot be identified, directly or through identifiers linked to the individuals.

6.5. 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. A research review committee may conduct an expedited review of a human research project 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 chair and two or more experienced reviewers designated by the 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 project may be disapproved only after review in accordance with the nonexpedited procedure review elements§ set forth in 12VAC35-180-70.

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

12VAC35-180-100. Informed consent.

A. No human research shall be conducted in the absence of informed consent subscribed to in writing by the individual or by the individual's legally authorized representative except as provided for in subsection F of this section. If the individual is capable of providing informed consent, written consent must be provided by the individual and witnessed. If the 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, written consent must be provided by the individual's legally authorized representative and witnessed. If the individual 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 individual 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 individual or, if applicable the individual's legally authorized representative shall be in language understandable to the 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 individual in human research, the individual shall not be enrolled in the human research that is the subject of the consent.

B. For the purposes of human research, the basic elements of information necessary for such consent shall include:

1. A statement that the study involves research, and a reasonable and comprehensible explanation to the individual of the proposed procedures or protocols to be followed and their purposes including: descriptions of any reasonably foreseeable discomforts, risks and benefits reasonably to be expected; and how the results of the human research will be disseminated;

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

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

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

5. A statement that participation is voluntary and instruction that the individual may refuse to participate or withdraw his consent and discontinue participation in the human research at any time without prejudice to him, fear of reprisal, penalty, or loss of any benefit to which he is otherwise entitled;

6. An explanation of any costs or compensation that may accrue to the 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

7. A statement of whom to contact for answers to any inquiries by the individual or, if applicable, his legally authorized representative concerning the research and a description of the ways in which concerns may be raised or questions asked, and notification of whom to contact in the event of any research-related injury to the individual.

C. No individual shall participate in human research unless this requirement is met. No informed consent shall include any language through which the individual waives or appears to waive any of his legal rights, including any release of any person, institution, or agency or any agents thereof from liability for negligence. Notwithstanding the informed consent by alegally a legally authorized representative, no 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 individual. In the case of 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 individual shall be given a copy of the signed consent form required by 12VAC35-180-40 A except as provided for in subsection F H of this section.

C.D. Prior to participation by an individual in any human research project, the institution or agency shall meet the requirements of 12VAC35-115-130.

E. 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 individual. A legally authorized representative may not consent to participation in human research on behalf of 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 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 § 37.2-100 of the Code of Virginia. No nontherapeutic human research shall be performed without the consent of the individual or, if applicable, his legally authorized representative.

D.F. 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 12VAC35-180-10, 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 individuals;

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

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

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

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

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

B. The records required by this chapter shall be retained for at least three years, and records relating to human research which that is conducted shall be retained for 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).

12VAC35-180-120. Mandatory reporting.

Each research review committee shall submit to the governor, the General Assembly, and the commissioner or his designee at least annually a report on the human research projects reviewed and approved by the committee, including any significant deviations from the proposals as approved, in accordance with § 37.2-402 of the Code of Virginia and this chapter.

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

The commissioner shall assure ensure that the department's human rights program, through procedures described in 12VAC35-115 12VAC35-115-130 Research, protects the rights of individuals who are admitted to a state hospital, training center facility, or other facility operated, funded, or licensed by the department to refuse to participate as a subject of human research and assure ensure 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 under regulations promulgated by the State Board of Behavioral Health and Developmental Services pursuant to § 37.2-400 of the Code of Virginia of individuals participating in human research under regulations promulgated by the State Board of Behavioral Health and Developmental Services pursuant to § 37.2-400 of the Code of Virginia.

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

Human research at institutions or agencies which that are subject to policies and regulations for the protection of individuals promulgated by any agency of the federal government shall be exempt from this chapter.