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
"Commissioner" means the Commissioner of the
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
Health, Mental Retardation and Substance Abuse Behavioral Health and
"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
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
2. A disclosure of any appropriate alternative procedures or
therapies that might be advantageous for the
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
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
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
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
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.
This chapter shall apply to the Department of
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.
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.
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
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
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
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
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 the a research review
committee has reviewed and approved the proposed human research project giving
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
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
as the board may establish of the department, where
B. Each committee shall review approved projects to ensure conformity with the approved proposal at least annually.
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
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
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
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
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.
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.
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:
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
subject's individual's own behavior, such as sexual behavior,
drug or alcohol use, or illegal conduct.
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,
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 subject's
individual's financial standing, or employability, or reputation;
b. The human research deals with sensitive aspects of
subject's individual's own behavior such as sexual behavior,
drug or alcohol use, or illegal conduct.
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.
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.
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
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 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
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
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
2. The omission, waiver or alteration will not adversely affect
the rights and welfare of the
3. The human research could not practicably be carried out without the omission, waiver or alteration; and
4. Whenever appropriate, the
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
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
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
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
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