Final Text
12VAC5-20-10. Definitions.
The following words and terms, when used in this
chapter, shall have the following meanings, unless the context clearly
indicates otherwise:
"Affiliated with the institution" means employed by or contracting with the institution or directly or indirectly involved in the management thereof.
"Commissioner" means the Commissioner of the Department of Health.
"Committee" means human research committee assembled pursuant to 12VAC5-20-70 of this chapter by any institution defined herein.
"Department" means the Department of Health.
"Human research" means any systematic investigation utilizing
human participants who may be exposed to physical or psychological injury as a
consequence of participation and which departs from the application of
established and accepted therapeutic methods appropriate to meet the
participants' needs, including research development, testing, and
evaluation, utilizing human subjects that is designed to develop or contribute
to generalized knowledge. Human research shall not be deemed to include
research exempt from federal research regulation pursuant to 45 CFR 46.101(b).
"Informed consent" means the knowing and voluntary
agreement, without undue inducement or any element of force, fraud, deceit,
duress, or other form of constraint or coercion, of a person who is capable of
exercising free power of choice. For the purposes of human research, the
basic elements of information necessary to such consent shall include:
1. A reasonable and comprehensible explanation to the person
of the proposed procedures or protocols to be followed, their purposes,
including descriptions of any attendant discomforts, and risks and benefits
reasonably to be expected;
2. A disclosure of any appropriate alternative procedures or
therapies that might be advantageous for the individual;
3. An instruction that the person may withdraw his consent
and discontinue participation in the human research at any time without
prejudice to him;
4. An explanation of any costs or compensation which may
accrue to the person and, if applicable, the availability of third party
reimbursement for the proposed procedures or protocols; and
5. An offer to answer any inquiries by any individual
concerning the procedures and protocols.
In addition to the required elements, the information
provided to the individual should also include the following:
1. A statement that the study involves research, and an
explanation that includes identification of any procedures which are
experimental; the expected duration of the individual's participation; and a
statement describing the extent, if any, to which confidentiality of records
identifying the participant will be maintained; and if any data from this study
are published, the individual will not be identified without his written
permission;
2. A statement that there may be other risks not yet
identified;
3. A disclosure of any appropriate alternative procedures or
therapies that might be advantageous for the individual;
4. A statement that participation is voluntary, refusal to
participate will involve no penalty or loss of benefits to which the individual
is otherwise entitled, and the individual may discontinue participation at any
time without penalty or loss of benefits to which he is otherwise entitled;
5. An explanation of whom to contact for answers to
pertinent questions about the research and research participants' rights, and
whom to contact in the event of a research-related injury; and
6. For research involving more than minimal risk, an
explanation as to whether any compensation or medical care is available if
injury occurs and, if so, what is included or where further information may be
obtained.
Information should be provided in a manner that is
understandable to the individual with regard to his educational level and
language of greatest fluency.
"Institution" or "agency" means any facility, program, or organization owned or operated by the Commonwealth, by any political subdivision, or by any person, firm, corporation, association, or other legal entity.
"Legally authorized representative" means, in the
following specified order of priority, (i) the parent or parents having
custody of a prospective participant subject of human research who is
a minor; (ii) the agent appointed under an advance directive as defined in
§ 54.1-2982 of the Code of Virginia, executed by the person who is the
prospective subject of human research, provided the advance directive
authorizes the agent to make decisions regarding the person's participation in
human research; (iii) the legal guardian of a prospective participant
subject of human research; (iv) the spouse of a prospective subject of human
research, except where a suit for divorce has been filed and the divorce decree
is not yet final; (v) an adult child of a prospective subject of human
research; (vi) a parent of a prospective subject of human research when the
individual is an adult; (vii) an adult brother or sister of a prospective
subject of human research; or (viii) any person or judicial or other
body authorized by law or regulation to consent on behalf of a prospective participant
subject of human research to such person's participation in the
particular human research. For the purposes of this chapter, any person authorized
by law or regulation to consent on behalf of a prospective participant subject
to his such subject's participation in the particular human
research shall include an attorney-in-fact appointed under a durable power of
attorney, to the extent the power grants the authority to make such a decision.
The attorney-in-fact shall not be employed by the person, institution or agency
conducting the human research. No official or employee of the institution or
agency conducting or authorizing the research shall be qualified to act as a
legally authorized representative.
"Minimal risk" means that the risks of harm or
discomfort anticipated in the proposed research are not greater, considering
probability and magnitude, than those ordinarily encountered in daily life or
during the performance of routine physical or psychological examinations,
or tests, or treatments.
[ "Minor increase over minimal risk" means there is only slightly more than minimal risk; potential harms are transient and reversible with respect to any harm; and there is an extremely small probability that the subject will experience severe pain, discomfort, stress, or harm. ]
"Nontherapeutic research" means human research in
which there is no reasonable expectation of direct benefit to the physical or
mental condition of the participant subject.
"Protected health information" or "PHI" means individually identifiable health information that is created or received by or on behalf of the institution or agency that is maintained or transmitted in any medium, including electronic media. PHI excludes individually identifiable health information in:
1. Education records covered by the Family Educational Rights and Privacy Act, as amended, 20 USC § 1232g;
2. Records described at 20 USC § 1232g(a)(4)(B)(iv) (educational records not otherwise covered under the Family Educational Rights and Privacy Act in subdivision 1 of this definition); or
3. Employment records held by a covered entity in its role as an employer.
"Subject" or "human subject" means a living person about whom an investigator (whether professional or student) conducting research obtains (i) data through intervention or interaction with the person or (ii) identifiable private information.
12VAC5-20-30. Applicability.
This chapter shall apply to the department, including any
local health department and to any facility operated, funded or licensed by the
department which that conducts or which proposes to
conduct or authorize research which uses using human participants
subjects.
12VAC5-20-40. Policy.
A. No human research may shall be conducted
without informing the participant subject or his legally
authorized representative of the procedures, risks, and discomforts of the
research. The consent of the participant subject or his legally
authorized representative to participate in the research shall be subscribed to
in writing by the participant subject or his legally authorized
representative and supported by the signature of a witness not involved in the
conduct of the research, except as provided for in 12VAC5-20-100 F and H of
this chapter. Special arrangements shall be made for those who need
assistance in understanding the consequences of participating in the research.
B. Each human research activity shall be reviewed and approved
by a committee as set forth in 12VAC5-20-70 of this chapter composed of
representatives of varied backgrounds who shall assure the competent, complete,
and professional review of human research activities.
C. Every person engaged in the conduct of human research or
proposing to conduct human research shall associate himself with an institution
or agency having a research review committee, and the human research which he
conducts or proposes to conduct shall be subject to review and approval by such
committee in the manner set forth in these regulations this chapter.
D. Nontherapeutic research using patients or residents within
an institution as defined herein is forbidden unless it is determined by the
research review committee that such nontherapeutic research will shall
not present greater than minimal risk.
E. The individual person, institution, or agency
conducting the human research shall be required to notify all participants
subjects of human research of the risks caused by the research which
that are discovered after the research has concluded. If consent has
been obtained by the signature of the legally authorized representative, the
legally authorized representative shall also be notified.
F. No official or employee of the institution or agency conducting or authorizing the human research shall be qualified to act as a legally authorized representative for a subject of the particular human research.
12VAC5-20-50. Review process for department.
A. Prior to the initiation of a human research project by any
component of the department, a description of the proposed human research project
shall be submitted to a research review committee established by the department
for review and approval. The description shall include a statement of the
purpose of the proposed project and justification thereof, the criteria for
inclusion of a participant as a subject in the research project,
a description of what will be done to the participants subjects,
and a copy of the informed consent statement.
B. The committee shall report by January March
31 of each year to the commissioner on activities of the committee during the
previous calendar year. Such reports shall include:
1. A description of each human research project reviewed and whether it was approved or disapproved;
2. Any significant deviations from proposals as approved;
3. A list of committee members, their qualifications for service on the committee, and their institutional affiliation; and
4. A copy of the minutes of any committee meetings conducted.
C. The chairman chair of the committee shall
report as soon as possible to the commissioner any violation of the research
protocol which that led the committee to either suspend or
terminate the research.
D. The commissioner may inspect the records of the committee.
E. The commissioner shall report at least annually to the Governor and General Assembly on the human research projects conducted by any component of the department as annually reported to the commissioner by the committee.
12VAC5-20-60. Review process for institutions or agencies funded or licensed by the department.
A. Prior to the initiation of a human research project by any
institution or agency funded or licensed by the department, a description of the
proposed human research project shall be submitted to a research review
committee for review and approval. The description shall include a statement of
the purpose of the proposed project and justification thereof, the criteria for
inclusion of a participant subject in the research project, a
description of what will be done to the participants subjects,
and a copy of the informed consent statement.
B. When more than one such institution or agency is involved in a research project, the cooperating entities may enter into joint review.
C. Such institutions or agencies having a committee shall
report by January March 31 of each year to the commissioner on
activities of the committee during the previous calendar year. Such reports
shall include:
1. A description of each human research project reviewed and whether it was approved or disapproved;
2. Any significant deviations from proposals as approved;
3. A list of committee members, their qualifications for service on the committee, and their institutional affiliation; and
4. A copy of the minutes of any committee meetings conducted.
D. The chairman chair of the committee shall
report as soon as possible to the head of such institution or agency and to the
commissioner any violation of the research protocol which led the committee to either
suspend or terminate the research.
E. The commissioner may inspect the records of the committee.
F. The commissioner shall report at least annually to the Governor and General Assembly on the human research projects conducted by such institutions or agencies as annually reported to the commissioner by the relevant research review committees.
12VAC5-20-70. Composition of research review committee.
A. Each committee shall have at least seven five
members, appointed by the head of the institution, with varying backgrounds to provide
complete and adequate review of activities commonly conducted by the
institution. The committee shall be sufficiently qualified through the
maturity, experience, and diversity of its members, including consideration of
race, gender and cultural background, to promote respect for its advice and
counsel in safeguarding the rights and welfare of participants subjects
in human research. In addition to possessing the professional competence
necessary to review specific activities, the committee shall be able to
ascertain the acceptability of applications and proposals in terms of
institutional commitments and regulations, applicable law, standards of
professional conduct and practice, and community attitudes. If a committee
regularly reviews research that has an impact on patients or residents within
an institution as defined herein or other vulnerable category of participants
subjects, [ the committee shall have in its membership one or
more individuals who are primarily concerned with the welfare of these
participants ] subjects [ and who have
appropriate experience to serve in that capacity such as children,
prisoners, pregnant women, or handicapped or mentally disabled persons,
consideration shall be given to the inclusion of one or more individuals who
are knowledgeable about and experienced in working with these subjects ].
B. No committee shall consist entirely of members of one
profession, and at least one member must shall be an individual
whose primary concerns are in nonscientific areas (e.g., lawyers, ethicists,
members of the clergy).
C. Each committee shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.
D. No member of a committee shall participate in the
committee's initial or continuing review of any project in which the member has
a conflicting interest, except to provide information requested by the
committee. The committee has responsibility for determining whether a member
has a conflicting interest. The committee size shall be maintained at no fewer
than seven five persons by appointment of a substitute
representative for each member with a conflicting interest.
E. A committee may, at its discretion, invite individuals with
competence in special areas to assist in the review of complex issues which
require expertise beyond or in addition to that available on the committee.
These individuals may shall not vote with the committee.
F. A quorum of the committee shall consist of a majority of its members including at least one member whose primary concerns are in nonscientific areas.
G. The committee and the institution shall establish procedures and rules of operation necessary to fulfill the requirements of this chapter.
12VAC5-20-80. Elements of committee review process.
A. No human research shall be conducted or authorized by a person, institution, or agency unless a research review committee has reviewed and approved the proposed human research project giving consideration to:
1. The adequacy of the description of the potential benefits and risks involved and the adequacy of the methodology of the human research;
2. The degree of the risk and, if the human research is nontherapeutic, whether it presents greater than minimal risk;
3. Whether the rights and welfare of the human subjects involved are adequately protected;
4. Whether the risks to the human subjects are outweighed by the potential benefits to them;
5. Whether the risks to subjects are minimized (i) by using procedures that are consistent with sound human research design and that do not unnecessarily expose subjects to risk and (ii) whenever appropriate, by using currently accepted procedures for diagnostic or treatment purposes;
6. Whether additional safeguards have been included in the
study to protect the rights and welfare of the subjects when some or all of the
subjects are likely to be incapable of providing informed consent or are
otherwise vulnerable to coercion or undue [ influence
inducement ], such as children, prisoners, pregnant women, mentally
disabled persons, or economically or educationally disadvantaged persons;
7. Whether the informed consent is to be obtained by methods that are adequate and appropriate and whether the written consent form is adequate and appropriate in both content and language for the particular human research and for the particular subjects of the human research;
8. Whether the persons proposing to supervise or conduct the particular human research are appropriately competent and qualified;
9. Whether criteria for selection of subjects are equitable; and
10. Whether the human research conforms with other requirements of the department, where applicable.
A. B. The committee shall consider a
research proposals proposal within 45 days after its
submission to the committee. In order for the research proposal to be
approved, it shall receive the approval of a majority of those the
committee members present at a meeting in for which a quorum
exists. A committee shall notify investigators and the institution in writing
of its decision to approve or disapprove the proposed research activity,
proposal or of modifications required to secure committee approval.
B. C. During the committee review of research projects
proposals, no personal identifiers of present or potential subjects
shall be stated.
C. D. The committee shall approve or
develop a written description of the procedure to be followed when a subject
has a complaint about a research project in which he is participating or has
participated.
D. E. Any subject who has a complaint about a
research project in which he is participating or has participated shall be
referred to the committee to determine if there has been a violation of the
protocol.
F. The committee shall have the authority to suspend or terminate approval of research that is not being conducted in accordance with the committee requirements or that has been associated with unexpected serious harm to the subjects. Any suspension or termination of approval shall include a statement of the reasons for the committee's action and shall be reported promptly to the investigator, appropriate institutional officials, the department or agency head, and the commissioner.
G. The chair of the committee shall provide a written report to the head of the institution of any violation of the human research protocol that led the committee to suspend or terminate the human research.
E. H. The committee shall require reports from
approved research projects at least annually to ensure conformity with the
approved proposal. The frequency of such reports shall be consistent with the
nature and degree of risk of each research project. The committee shall also
require a report from the research project at the conclusion of the research
project.
I. The committee shall ensure compliance with the Health Insurance Portability and Accountability Act of 1996 (42 USC § 1320d et seq.), if applicable, and federal and state regulations regarding the use and disclosure of PHI created for human research. In particular, authorization shall be obtained for the use and disclosure of PHI created for the purpose of human research, except as otherwise permitted by 45 CFR 164.512(i).
J. When cooperating institutions conduct some or all of the human research involving some or all of the subjects of the human research, each cooperating institution shall be responsible for safeguarding the rights and welfare of the subjects and for complying with this chapter, provided however, in complying with this chapter, institutions may enter into joint review, rely upon the review of another qualified committee, or come to similar agreements aimed at avoiding duplication of effort. Any such agreement shall be in writing and designate a lead institution, which shall be the institution responsible for reporting and handling any possible misconduct in the human research. Such agreements shall be entered into by the committee chair with the approval of a majority of the committee members. If an institution or agency does not have a research review committee, such agreements shall be approved and entered into by the chief executive officer of the institution or his designee.
12VAC5-20-90. Expedited review of human research projects.
A. The committee is authorized to conduct an expedited review
of a human research project which that involves no more than
minimal risk to the subjects if: and involves only research
procedures listed in one or more categories established by the Secretary of
Health and Human Services and published in the Federal Register pursuant to 45
CFR 46.110.
B. The committee also is authorized to conduct an expedited review of a human research project that involves no more than minimal risk to the subjects if:
1. Another institution's or agency's human research review committee has reviewed and approved the project; or
2. The review involves only minor changes in previously approved research and the changes occur during the approved project period.
C. An expedited review may be carried out by the chair of the committee or by one or more experienced reviewers designated by the chair from among the committee members. In reviewing the research project, the reviewers may exercise all of the authorities of the committee except that the reviewers may not disapprove the research project. A research project may be disapproved only after review by the full committee in accordance to the procedures set forth in 12VAC5-20-80.
B. D. Each committee which that
uses an expedited review procedure shall adopt a method for keeping all members
advised of research proposals which projects that have been
approved under the procedure.
12VAC5-20-100. Informed consent.
A. "Informed consent" means the knowing and voluntary agreement, without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion, of a person who is capable of exercising free power of choice. For the purposes of human research, the basic elements of information necessary to determine the existence of such consent shall include the following:
1. A reasonable and comprehensible explanation to the person of the proposed procedures or protocols to be followed, their purposes, including descriptions of any attendant discomforts, and risks and benefits reasonably to be expected, how the results of the human research are disseminated, and how the identity of the person is protected;
2. A disclosure of any appropriate alternative procedures or
therapies that might be advantageous for the individual person,
together with their side effects, risks, and benefits;
3. A description of any adverse consequences and risks to be expected and an indication of whether there may be other significant risks not yet identified;
3. 4. An instruction that the person may withdraw
his consent and discontinue participation in the human research at any time
without prejudice to him or fear of reprisal;
4. 5. An explanation of any costs or compensation
that may accrue to the person and, if applicable, the availability of third
party reimbursement for the proposed procedures or protocols or any medical
care that may be available if an injury occurs;
5. 6. An offer to answer any inquiries by any
individual the person or, if applicable, his legally authorized
representative concerning the procedures and protocols and a description
of the ways in which concerns may be raised or questions asked;
6. 7. A statement that the study involves
research, and an explanation that includes identification of any procedures
that are experimental; the expected duration of the individual's person's
participation; a statement describing the extent, if any, to which
confidentiality of records identifying the participant will be maintained; and
if any data from this study are published, the individual person
will not be identified without his written permission;
7. [ 8. A statement that there may be
other risks not yet identified; ]
[ 8. 9. ] A disclosure of any
appropriate alternative procedures or therapies that might be advantageous for
the individual person;
[ 9. 10. ] A statement that
participation is voluntary, refusal to participate will involve no penalty or
loss of benefits to which the individual person is otherwise
entitled, and the individual person may discontinue participation
at any time without penalty or loss of benefits to which he is otherwise
entitled;
[ 10. 11. ] An explanation of whom to
contact for answers to pertinent questions about the research and research
participants' rights, and whom to contact in the event of a research-related
injury; and
[ 11. 12. ] For research involving more
than minimal risk, an explanation as to whether any compensation or medical
care is available if injury occurs and, if so, what is included or where
further information may be obtained.
Information shall be provided in a manner that is
understandable to the individual person with regard to his
educational level and language of greatest fluency.
B. No human research shall be conducted in the absence of informed consent subscribed to in writing by the person or by the person's authorized representative except as provided for in subsection E of this section. If the person is capable of providing informed consent, written consent shall be provided by the person and witnessed. If the person is incapable of making an informed decision as defined in § 54.1-2982 of the Code of Virginia, at the time consent is required, written consent shall be provided by the person's legally authorized representative and witnessed. If the person is a minor otherwise capable of rendering informed consent, the consent shall be provided by both the minor and his legally authorized representative. An investigator shall seek such consent only under circumstances that provide the person who is the prospective subject or the representative sufficient opportunity to consider whether to participate and that minimize the possibility of coercion or undue influence. The information that is given to the person or, if applicable, the person's legally authorized representative shall be in language understandable to the person or representative.
C. No person shall participate in human research unless the informed consent requirement in this section is met. No informed consent shall include any language through which the person waives or appears to waive any of his legal rights, including any release of any person, institution, or agency or any agents therof from liability for negligence. No person shall be forced to participate in any human research if the investigator conducting the human research knows that participation in the human research is protested by the person.
D. No legally authorized representative shall consent to nontherapeutic human research unless it is determined by the research review committee that such nontherapeutic research will present no more than a minor increase over minimal risk to the subject [ and (i) the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations; and (ii) the intervention or procedure is likely to yield generalizable knowledge about the subject's disorder or condition, which is of vital importance for the understanding or amelioration of the subject's disorder or condition ]. A legally authorized representative may not consent to participation in human research on behalf of a subject if the legally authorized representative knows, or upon reasonable inquiry ought to know, that any aspect of the human research protocol is contrary to the religious beliefs or basic values of the subject, whether expressed orally or in writing.
E. The research review committee may approve a consent procedure that does not include or that alters some or all of the elements of informed consent set forth in this section, or that waives the requirements to obtain informed consent provided the committee finds and documents that:
1. The human research involves no more than minimal risk to the subjects;
2. The omission, waiver, or alteration will not adversely affect the rights and welfare of the subjects;
3. The human research could not practicably be performed without the omission, waiver, or alterations; and
4. After participation, the subjects shall be provided with additional pertinent information, whenever appropriate.
B. F. Consent may take the form of either of the
following:
1. A written consent document that embodies the elements of informed consent required by this section. This form may be read to the subject or the subject's legally authorized representative, but, in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed and witnessed; or
2. A short form written consent document stating that the
elements of informed consent required by this section have been presented
orally to the subject or the subject's legally authorized representative. When
this method is used, there shall be a witness to the oral presentation. Also,
the committee shall approve a written summary of what is to be said to the
subject or the representative. Only the short form itself written
consent is to be signed by the subject or the representative.
However, the witness shall sign both the short form written consent and
a copy of the summary, and the person actually obtaining consent shall sign a
copy of the summary. A copy of the summary and a copy of the short form written
consent shall be given to the subject or the representative.
G. The research review committee may waive the requirement in subsection B of this section for the investigator to obtain a written informed consent form for some or all subjects if it finds that the only record linking the subject and the human research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject shall be asked whether the subject wants documentation linking the subject with the human research, and the subject's wishes shall govern. In cases where the documentation requirement is waived, the committee may require the investigator to provide subjects with a written statement explaining the human research.
12VAC5-20-110. Categories of human research exempt from regulation.
Research activities in which the only involvement of human participants
will be subjects is in one or more of the following categories are
exempt from this chapter:
1. The surveillance and investigation by the department into all preventable diseases and epidemics in the Commonwealth and into the means for the prevention of such diseases and epidemics conducted pursuant to § 32.1-39 of the Code of Virginia.
2. Research designed to study on a large scale anonymous vital
records and registry data collected pursuant to the Code of Virginia, Chapter 7
(§ 32.1-249 et seq.) of Title 32.1 (Vital Records), § 32.1-64.1 (Virginia
Hearing Impairment Identification and Monitoring System), § 32.1-69.1 (Viginia
(Virginia Congenital Anomalies Reporting and Education System), §
32.1-70 (Statewide Cancer Registry), § 32.1-71.l (Statewide Alzheimer's
Disease and Related Disorders Registry), § 32.1-46.01 (Virginia
Immunization Information System), and §§ § 32.116.1 and
32.116.1:2 (Emergency Medical Services Patient Care Information System).
3. Research or student learning outcomes assessment conducted in educational settings such as research involving:
a. Regular or special education instructional strategies;
[ or ]
b. The effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods; or
c. The use of educational tests, whether cognitive,
diagnostic, aptitude, or achievement, if the data from such tests are recorded
in a manner so that participants subjects cannot be identified,
directly or through identifiers linked to the participants subjects.
4. Research involving survey or interview procedures unless
responses are recorded in such a manner that the participants subjects
can be identified, directly or through identifiers linked to the participants
subjects, and either:
a. The participant's subject's responses, if
they became known outside the research, could reasonably place the participant
at risk of criminal or civil liability or be damaging to his financial
standing, employability, or reputation; or
b. The research deals with sensitive aspects of the participant's
subject's own behavior such as sexual behavior, drug or alcohol use, or
illegal conduct.
5. Research involving survey or interview procedures, when the respondents are elected or appointed public officials or candidates for public office.
6. Research involving solely the observation of public
behavior, including observation by participants, unless observations are
recorded in such a manner that the participants subjects can be
identified, directly or through identifiers linked to the participants subjects,
and either:
a. The observations recorded about the individual subject,
if they became known outside the research, could reasonably place the participant
subject at risk of criminal or civil liability or be damaging to his
financial standing, employability, or reputation; or
b. The research deals with sensitive aspects of the participant's
subject's own behavior, such as sexual behavior, drug or alcohol use, or
illegal conduct.
7. Research involving the collection or study of existing data,
documents, records, or pathological specimens, if these sources are publicly
available or if the information is recorded by the investigator in a manner so
that participants subjects cannot be identified, directly or
through identifiers linked to the participants subjects.
12VAC5-20-120. Committee records.
A. Documentation of committee activities shall be prepared and maintained by each such committee and shall include the following:
1. Copies of all research proposals reviewed, scientific
evaluations that may accompany the proposals, approved sample consent
documents, progress reports submitted by investigators, and reports of injuries
to participants subjects;
2. Minutes of committee meetings which shall be in
sufficient detail to show attendance at the meetings; actions taken by the
committee; the vote on these actions each action, including the
number of members voting for, against, and abstaining; the basis for requiring
changes in or disapproving research; and a written summary of the discussion of
controversial issues and their resolution;
3. Records of continuing review activities;
4. Copies of all correspondence between the committee and the investigators;
5. A list of committee members;
6. Written procedures for the committee; and
7. Statements of significant new findings provided to participants
subjects.
B. The records required by this chapter shall be retained for
at least three years, and records relating to research which that
is conducted shall be retained for at least three years after completion of the
research. All records shall be accessible for inspection and copying by
authorized employees or agents of the department at reasonable times and in a
reasonable manner.
C. An Each research review committee of a state
institution or agency shall ensure that an overview of approved human
research projects and the results of such projects will be are
made public on the department's such institution's or agency's
website unless otherwise exempt from disclosure under the Virginia Freedom of
Information Act (§ 2.2-3700 et seq. of the Code of Virginia).
12VAC5-20-130. Applicability of federal policies.
Human research at institutions which are that is
subject to policies and regulations for the protection of human participants
subjects promulgated by any agency of the federal government shall be exempt
from this chapter. Such institutions Institutions where research is
performed that is subject to federal policies and regulation shall notify
the commissioner annually, by January March 31, of
their compliance with the policies and regulations of federal agencies. The
commissioner shall identify institutions exempt from this chapter as reported
in accordance with this section in the annual report to the Governor and the
General Assembly provided in accordance with 12VAC5-20-60 F.