Proposed Text
CHAPTER 40
PROTECTION OF PARTICIPANTS IN HUMAN RESEARCH
22VAC30-40-10. 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 covered entity"
means employed by the institution covered entity or a member of a
household containing an employee of the institution covered entity.
"Agent" means any individual performing department designated activities or exercising department delegated authority or responsibility.
"Assent" means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.
"Commissioner" means the Commissioner of the Department of Rehabilitative Services.
"Covered entity" means the Department of Rehabilitative Services, Woodrow Wilson Rehabilitation Center, sheltered workshops, or Independent living centers
"Department" means the Department of Rehabilitative Services.
"Guardian" means an individual who is authorized under applicable state or local law to consent on behalf of a minor to general medical care.
"Human Research Review Committee" or "HRRC" means the committee established in accordance with and for the purposes expressed in this chapter.
"HRRC approval" means the determination of the HRRC that the research has been reviewed and may be conducted within the constraints set forth by the HRRC and by other department, state and federal requirements.
"Human participant or human subject" means a living individual about whom an investigator (whether professional or student) conducting research obtains:
(i) data 1. Data through intervention or
interaction with the individual; or
(ii) identifiable 2. Identifiable private
information.
"Human research" means any systematic
investigation which utilizes 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 participant's needs.
"Human subject research" means a systematic investigation, experiment, study, evaluation, demonstration or survey designed to develop or contribute to general knowledge (basic research) or specific knowledge (applied research) in which a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual; or identifiable private information.
"Identifiable private information" means information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record, Social Security Number). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) to constitute research involving human subjects.
"Independent living center" means a consumer-controlled, community-based, cross disability, nonresidential private nonprofit agency that:
1. Is designed and operated within a local community by individuals with disabilities; and
2. Provides an array of independent living services.
"Informed consent" means a process by which the investigator fully explains the research activities, ensures that the prospective subject has sufficient opportunity to ask questions, and has sufficient time to make a decision whether or not to participate in the research prior to signing the HRRC approved written consent document. Informed consent must be prospectively obtained without coercion, include all of the basic elements of informed consent as specified in 22VAC30-40-100 B, be legally effective, contain no exculpatory language, and as required, include the additional elements of informed consent specified in 22VAC30-40-100 C.
"Institution" means the department, any center of
independent living, sheltered workshop, the Woodrow Wilson Rehabilitation
Center, or any facility or program operated, funded, or licensed by the
department any public or private entity or agency (including federal,
state, and other agencies).
"Interaction" includes means
communication or interpersonal contact between investigator and participant
subject.
"Intervention" includes means both
physical procedures by which data are gathered (for example, venipuncture) and
manipulations of the participant subject or participant's subject's
environment that are performed for research purposes.
"Investigator" means the person, whether professional or student, who conducts the research.
"Legally authorized representative" means, (as
defined in §32.1-162.19 of the Code of Virginia) the parent or parents
having custody of a prospective participant, the legal guardian of a
prospective participant, or any person or judicial or other body authorized by law
or regulation to consent on behalf of a prospective participant to such
person'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 a prospective participant 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 and shall not be authorized to consent
to nontherapeutic medical 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. in the following specified order of
priority:
1. The parent or parents having custody of a prospective subject who is a minor;
2. The agent appointed under an advance directive, as defined in §54.1-2982 of the Code of Virginia, executed by the prospective subject, provided the advance directive authorizes the agent to make decisions regarding the prospective subject's participation in human research;
3. The legal guardian of a prospective subject;
4. The spouse of the prospective subject, except where a suit for divorce has been filed and the divorce decree is not yet final;
5. An adult child of the prospective subject;
6. A parent of the prospective subject when the subject is an adult;
7. An adult brother or sister of the prospective subject; or
8. Any person or judicial or other body authorized by law or regulation to consent on behalf of a prospective subject to such subject'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 a prospective subject to 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
anticipated in the proposed research are not greater, considering
probability and magnitude, of harm or discomfort anticipated in the
research are not greater in and of themselves than those ordinarily
encountered in daily life or during the performance of routine physical or
psychological examinations or tests.
"Minor" means (as defined in §1-13.42 of the Code of Virginia) an individual who is less than 18 years of age.
"Nontherapeutic research" means human subject
research in which there is no reasonable expectation of direct benefit to the
physical or mental condition of the participant subject.
"Parent" means a minor's biological or adoptive parent.
"Permission" means the agreement of parent(s) or legally authorized representative to the participation of their minor or ward in research.
"Private information" includes means
information about the human participant's behavior that occurs when
in a context in which an individual can reasonably expect that no
observation or recording is taking place, and or information
which has been provided for specific purposes by the human participant an
individual and which the participant individual can reasonably
expect will not be made public (for example, a medical record). Private
information must be individually identifiable (i.e., the identity of the human
participant is or may readily be ascertained by the investigator or
associated with the information) in order for obtaining the information to
constitute research involving human participants.
"Research" means a systematic investigation, including
research development, testing, and evaluation, designed to develop or
contribute to general generalizable knowledge (basic research)
or specific knowledge (applied research). 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 investigator" means the person, whether
professional or student, who conducts the research.
"Sheltered workshop" means a facility-based
community rehabilitation (i) a program that provides directly or
facilitates the provision of one or more of the following vocational
rehabilitation services enumerated in 34 CFR 361.5(b)(9)(i) to
individuals with disabilities to enable them to maximize their opportunities
for employment, including career advancement; (ii) has a vendor relationship
with the department; and (iii) is not operated by a community services board.
1. Medical, psychiatric, psychological, social, and
vocational services that are provided under one management;
2. Testing, fitting, or training in the use of prosthetic
and orthotic devices;
3. Recreational therapy;
4. Physical and occupational therapy;
5. Speech, language, and hearing therapy;
6. Psychiatric, psychological, and social services,
including positive behavior management;
7. Assessment for determining eligibility and vocational
rehabilitation needs;
8. Rehabilitation technology;
9. Job development, placement, and retention services;
10. Evaluation or control of specific disabilities;
11. Orientation and mobility services for individuals who
are blind;
12. Extended employment;
13. Psycho-social rehabilitation services;
14. Supported employment services and extended services;
15. Services to family members when necessary to the
vocational rehabilitation of the individual;
16. Personal assistance services; or
17. Services similar to the services described in
subdivisions 1 through 16.
"Voluntary informed consent" means the knowing,
written consent of an individual, or the individual's legally authorized
representative, so situated as to be able to exercise free power of choice
without undue inducement or any element of force, fraud, deceit, duress or
other form of constraint or coercion. With regard to the conduct of human
research, the basic elements of information necessary to such consent shall
include in writing:
1. A statement that the study involves research, and a
reasonable and comprehensible explanation to the human participant of the
procedures that the researcher will follow and their purposes, including
identification of any procedures which are experimental; the expected duration
of the human participant'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 description of any attendant discomforts and risks to
the human participant which may reasonably be expected and a statement that
there may be other risks not yet identified;
3. A description of any benefits to the human participant or
to others which may reasonably be expected;
4. A disclosure of any appropriate alternative procedures or
therapies that might be advantageous for the human participant;
5. An offer to answer and answers to any inquiries by any
individual concerning the procedure;
6. A statement that participation is voluntary, refusal to participate
will involve no penalty or loss of benefits to which the human participant is
otherwise entitled, and the human participant may discontinue participation at
any time without penalty or loss of benefits to which he is otherwise entitled;
7. An explanation of who to contact for answers to pertinent
questions about the research and human research participants' rights, and who
to contact in the event of a research related injury;
8. 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 it consists of or where further information may
be obtained; and
9. 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.
Statutory Authority
§§51.5-14 and 51.5-14.01 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 10, eff. March 1, 2000; amended, Virginia Register Volume 21, Issue 16, eff. May 18, 2005.
22VAC30-40-20. [Reserved.]
22VAC30-40-30. Applicability.
This chapter Chapter 22VAC30-40-10 et seq. shall
apply to the Department of Rehabilitative Services, Woodrow Wilson
Rehabilitation Center, any sheltered workshop or and independent
living center, and any facility operated, funded or licensed by the
department which conducts or which proposes to conduct or authorize research
which uses human participants. known as covered entities.
Statutory Authority
§§51.5-5.1 and 51.5-14 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 10, eff. March 1, 2000.
22VAC30-40-40. Policy. General provisions for
conducting human subjects research.
A. No human subjects research may be conducted by a
covered entity without the voluntary informed consent of the participant
subject or his the subject's legally authorized
representative. The required elements of informed consent are provided in
22VAC30-30-40-100. The consent of the participant human subject
or his the human subject's legally authorized representative to
participate in the research must be documented in writing and supported by the
signature of a witness not involved in the conduct of the research, except as
provided for in 22VAC30-40-100 F. 22VAC30-40-100 J. The research
investigator shall ensure that a knowledgeable member of he research team sign
signs and provide provides participants human
subjects of a research study project with a copy of the
written, voluntary informed consent statement document as
defined in 22VAC30-40-10. 22VAC30-40-100 B. The investigator
shall make arrangements for those who need special assistance in understanding
the consequences of participating in the research.
B. Each human subjects research study project
shall be approved by a committee composed of representatives of varied
backgrounds who shall assure the competent, complete, and professional review
of human research activities. The department's HRRC. An
institution may establish its own research review committee, it may work with
other institutions to establish a single committee, or it may use the
department's established committee.
C. Nontherapeutic research using institutionalized
participants is prohibited unless the research review committee HRRC
determines that such nontherapeutic research will not present greater than
minimal risk to the human participant. subjects.
D. The research investigator shall be required to
notify all human participants subjects in research of the
risks caused by the research which are discovered after the research has
concluded.
E. 22 VAC 30-40-160 applies to all research involving minors as subjects, conducted or supported by the covered entity. In addition to other responsibilities assigned to HRRC under 22 VAC 30-40-160, the HRRC shall review research covered by 22 VAC 30-40-160 and approve only research that satisfies the conditions of all applicable sections of this chapter. Exemptions at 22 VAC 30-40-80(1) and 22 VAC 30-40-80(3) through 22 VAC 30-40-80(6) are applicable to 22 VAC 30-40-160. The exemption at 22 VAC 30-40-80(2) regarding educational tests is also applicable to 22 VAC 30-40-160. However, the exemption at 22 VAC 30-40-80(2) for research involving survey or interview procedures or observations of public behavior does not apply to research covered by 22 VAC 30-40-160, except for research involving observation of public behavior when the investigator or investigators do not participate in the activities being observed.
F. Cooperative research projects are those projects covered by 22VAC30-40-10 et seq. which involve a covered entity in conjunction with an institution(s). In the conduct of cooperative research projects, the covered entity and each institution are responsible for safeguarding the rights and welfare of human subjects and for complying with 22VAC30-40-10 et seq. With the approval of the commissioner, a covered entity participating in a cooperative project may enter into a joint review arrangement, rely upon the review of another qualified institutional review board (IRB), or make similar arrangements for avoiding duplication of effort.
G. In the event research is undertaken without the intention of involving human subjects, but it is later proposed to involve human subjects in the research, the research shall first be reviewed and approved by the HRRC, as provided in 22VAC30-40-10 et seq., a certification submitted, by the covered entity, to the commissioner, and final approval given to the proposed change by the commissioner.
H. With respect to any research project or any class of research projects, the commissioner may impose additional conditions prior to or at the time of approval when ,in the judgment of the commissioner, additional conditions are necessary for the protection of human subjects.
I. In reviewing proposed research projects, the HRRC shall consider the requirements of review stated in 22 VAC 30-40-70.
Statutory Authority
§§51.5-5.1 and 51.5-14 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 10, eff. March 1, 2000.
22VAC30-40-50. Certification process.
A. Institutions seeking to conduct or sponsor human
research are required to submit statements to the research review committee
assuring that all human research activities will be reviewed and approved by a research
review committee. Institutions shall report annually No later
than 45 days after the end of each state fiscal year, Woodrow Wilson Rehabilitation Center, sheltered workshops and independent living centers Institutions
shall report annually send a written report to the commissioner
giving assurance that a committee exists and is functioning. These reports
should include a list of committee members, their qualifications for service on
the committee, their institutional affiliation and a copy of the minutes of
committee meetings either all human subjects research conducted during
the fiscal year was reviewed and approved by the department's HRRC prior to
implementation of that research or that no human subjects research was
conducted during that state fiscal year.
B. Prior to the initiation of a human research project,
institutions At the time that the research is approved by the HRRC, the
HRRC chairperson 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 prospective participant human
subjects in the research project, a description of what will be done to the
prospective human participants subjects, and a copy of
the informed consent statement the type of review performed by the HRRC.
C. The commissioner may inspect the records of the research
committee department's HRRC.
D. The chairman of the research committee shall report as
soon as possible to the head of the institution and to the commissioner any
violation of the research protocol which led the committee to either suspend or
terminate the research. The HRRC shall have authority to suspend or
terminate approval of research that is not being conducted in accordance with
the HRRC's requirements or that has been associated with unexpected serious
harm to subjects. Any suspension or termination of approval shall include a
statement of the reasons for the HRRC's action and shall be reported promptly
to the research investigator, the commissioner, the head(s) of other
appropriate covered entities, and in the case of cooperative research, the
institutional officials responsible for human subjects research.
E. Research covered by 22VAC30-40-10 et seq. that has been approved by the HRRC may be subject to further appropriate review and approval or disapproval by officials of the covered entities. However, those officials may not approve the research if it has not been approved by the HRRC.
Statutory Authority
§§51.5-5.1 and 51.5-14 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 10, eff. March 1, 2000.
22VAC30-40-60. Composition of research review committees the
HRRC.
A. Each research committee The HRRC shall have
at least five members, appointed by the head of the institution or
department commissioner, with varying backgrounds to provide promote
complete and adequate review of activities research projects
commonly conducted by the institution covered entities.
The committee HRRC shall be sufficiently qualified through the research
experience, and expertise, and diversity of its members, and
the diversity of the members, including consideration of race, gender,
and cultural background, and sensitivity to such issues as community
attitudes, to promote respect for its advice and counsel in safeguarding
the rights and welfare of participants in human research human
subjects. In addition to possessing the professional competence necessary
to review specific activities research projects, the committee
HRRC must shall be able to ascertain the acceptability of applications
proposed research and proposals in terms of institutional the
department's commitments and regulations, applicable law, standards of
professional conduct and practice, and community attitudes. If a committee
the HRRC regularly reviews research that has an impact on an
institutionalized or other involves a vulnerable category of participants
subjects, including residents of mental health or mental retardation
facilities, such as children, pregnant women, or persons with mental
disabilities, the committee shall have in its membership one or more
individuals who are primarily concerned with the welfare of these participants
and who have appropriate experience to serve in that capacity. consideration
shall be given to the inclusion of one or more individuals who are
knowledgeable about and experienced in working with these subjects. Additional
membership requirements may be imposed on the HRRC by 34 CFR 350.4(c) and
356.3(c) for research sponsored by the National Institute on Disability and
Rehabilitation Research. When minors with disabilities or persons with mental
disabilities are purposefully included as research subjects, the HRRC's
membership must include at least one person who is primarily concerned with the
welfare of these research subjects.
B. No committee shall consist entirely of men or entirely
of women, or entirely of members of one profession. Every
nondiscriminatory effort will be made to ensure that the HRRC does not consist
entirely of men or entirely of women, including the department's consideration
of qualified persons of both sexes, so long as no selection is made to the HRRC
on the basis of gender. The HRRC may not consist entirely of members of one
profession.
C. Each committee The HRRC shall include at
least one of the following:
1. at least One one member whose primary concerns
are in nonscientific areas (e.g., lawyers, ethicists, members of the clergy);
2. at least One one member who is not
otherwise affiliated with the any institution covered
entity and who is not part of the immediate family of a person who is
affiliated with the institution covered entity; and
3. One consumer; and
4. 3. at least One one
member whose primary concerns are in the scientific areas.
D. No member of a committee The HRRC shall not
have a member participate in the committee's HRRC's initial
or continuing review of any project in which the member is directly involved
or for which he has administrative approval authority has a conflicting
interest, except to provide information requested by the committee HRRC.
The committee HRRC has responsibility for determining whether a
member has a conflict of conflicting interest with any study.
The committee HRRC member shall be replaced in the case of a
conflict of conflicting interest resulting in a decrease of the committee
HRRC below five persons members.
E. A committee The HRRC 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 HRRC. These individuals may not vote with the
committee.
F. A quorum of the committee HRRC shall consist
of a majority of its members including at least one member whose primary
concerns are in nonscientific areas. Except when exempt or expedited review procedures
are used, proposed research shall be reviewed at convened meetings at which a
majority of members is present, including at least one member whose primary
concerns are in nonscientific areas. In order for the research to be approved,
it shall receive the approval of a majority of those members present at the
meeting.
G. The committee HRRC and the institution
department shall establish procedures and rules of operation necessary
to fulfill the requirements of these regulations.
Statutory Authority
§§51.5-5.1 and 51.5-14 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 10, eff. March 1, 2000.
22VAC30-40-70. Elements of each committee's HRRC's
review process.
A. No human research shall be conducted or authorized by
the Department of Rehabilitative Services, any independent living center, any
sheltered workshop, or the Woodrow Wilson Rehabilitation Center unless the
committee has reviewed and approved the proposed human research project giving
consideration to: The HRRC shall review and have authority to approve,
require modifications in, or disapprove all research activities covered by
22VAC30-40-10 et seq.
1. The adequacy of the description of the potential benefits
and risks involved and the adequacy of the methodology of the research;
2. The degree of the risk, and, if the research is
nontherapeutic, whether it presents greater than minimal risk;
3. Whether the rights and welfare of the participants are
adequately protected;
4. Whether the risks to the participants are outweighed by
the potential benefits to them;
5. Whether the voluntary informed consent is to be obtained by
methods that adequately and appropriately fulfill the requirements of these
regulations and whether the written consent form is adequate and appropriate in
both content and language for the particular research and for the particular
participants of the research;
6. Whether the research investigators proposing to supervise
or conduct the particular human research are appropriately competent and
qualified;
7. Whether criteria for selection of participants are
equitable, especially in research regarding the future development of mental or
physical illness;
8. Whether the research conforms with such other
requirements as the department may establish; and
9. Whether appropriate studies in nonhuman systems have been
conducted prior to the involvement of human participants.
B. The committee shall review, at least annually, approved
projects to ensure conformity with the approved proposal. The HRRC shall
require that information given to prospective subjects as part of the informed
consent process is in accordance with 22VAC30-40-100. The HRRC may require that
information, in addition to that specifically mentioned in 22VAC30-40-100, be
given to prospective subjects when in the HRRC's judgment the information would
meaningfully add to the protection of the rights and welfare of subjects.
C. Research must be approved by the committee which has
jurisdiction over the participant. When cooperating institutions conduct some
or all of the research involving some or all of the participants, each
cooperating institution is responsible for safeguarding the rights and welfare
of human participants 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 similar arrangements aimed
at avoiding duplication of effort. The committee chairperson may make such
arrangements with the approval of a majority of the members present at a
meeting of the committee. The HRRC shall require documentation of
informed consent or may waive documentation in accordance with 22VAC30-40-100
J.
D. The committee HRRC shall consider research
proposals within 45 days after submission of a complete application to
the committee's HRRC's chairman chairperson. In order for
the research to be approved, it shall receive the approval of a majority of
those members present at a meeting in which a quorum exists. A committee
The HRRC shall notify research investigators and the institution
covered entity in writing of its decision to approve or disapprove the proposed
research activity, or of modifications required to secure committee
HRRC approval.
E. The committee HRRC shall develop a
written complaint description of the procedure procedures
to be followed by a human participant subject who has a complaint
concern(s) about a research project in which he is participating or has
participated.
F. Any participant who has a complaint about a research
project in which he is participating or has participated shall be referred to
the chairperson of the committee HRRC who shall refer it to the committee
HRRC to determine if there has been a violation of the research
protocol as approved by the HRRC.
G. The committee shall require periodic reports. The frequency of such reports should reflect the nature and degree of risk of each research project.
H. If the HRRC decides to disapprove a research application, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
I. The HRRC shall conduct continuing review of research covered by this chapter at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.
J. In order to approve research covered by 22VAC30-40-10 et seq., the HRRC shall determine that all of the following requirements are satisfied:
1. Risks to subjects are minimized:
a. by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and
b. whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the HRRC should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The HRRC should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
3. Selection of subjects is equitable. In making this assessment the HRRC should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, pregnant women, persons with mental disabilities, or economically or educationally disadvantaged persons.
4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by 22VAC30-40-100.
5. Informed consent will be appropriately documented, in accordance with, and to the extent required by 22VAC30-40-100.
6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
8. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, pregnant women, persons with mental disabilities, or economically or educationally disadvantaged persons, additional safeguards have been included in the project to protect the rights and welfare of these subjects.
Statutory Authority
§§51.5-14 and 51.5-14.01 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 10, eff. March 1, 2000; amended, Virginia Register Volume 21, Issue 16, eff. May 18, 2005.
22VAC30-40-80. Kinds of research exempt from committee review.
Research activities in which the only involvement of human
participants will be in one or more of the following categories are exempt from
these regulations unless the research is covered by other sections of this
chapter:. The HRRC shall determine whether the proposed research
project satisfies at least one exemption category in this section before the
research can be conducted:
1. Research conducted in established or commonly accepted
educational settings, involving commonly used normal educational
practices, such as:
a. Research on regular and special education instructional strategies; or
b. Research on the effectiveness of or the comparison among instructional techniques, curriculum or classroom management methods.
2. Research involving solely the use and analysis of
the results of standardized psychological, educational, diagnostic, aptitude,
or achievement tests, if information taken from these sources is recorded in
such a manner that participants cannot be reasonably identified, directly or
through identifiers linked to the participants. of educational tests
(cognitive, diagnostic, aptitude, achievement), survey procedures, interview
procedures or observation of public behavior, unless:
a. Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
b. Any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
3. Research involving survey or interview procedures, unless
responses are recorded in such a manner that participants can be identified,
directly or through identifiers linked to the participants, and either: Research
involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures, or observation of public
behavior that is not exempt under 22VAC30-40-80 2, if:
a. The participant'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 the participant's financial
standing, employability, or reputation The human subjects are elected or
appointed public officials or candidates for public office; or
b. The research deals with sensitive aspects of the
participant's own behavior, such as sexual behavior, drug or alcohol use,
illegal conduct, or family planning. Federal statute(s) require(s)
without exception that the confidentiality of the personally identifiable
information will be maintained throughout the research and thereafter.
4. Research involving solely the observation (including
observation by participants) of public behavior, unless observations are
recorded in such a manner that participants can be identified, directly or
through identifiers linked to the participants, and either: Research
involving the collection or study of existing data, documents, records,
pathological specimens, or diagnostic specimens, if these sources are publicly
available or if the information is recorded by the investigator in such a
manner that subjects cannot be identified, directly or through identifiers
linked to the subjects.
a. The observations recorded about the individual, if they
became known outside the research, could reasonably place the human participant
at risk of criminal or civil liability or be damaging to the participant's
financial standing, employability, or reputation; or
b. The research deals with sensitive aspects of the
participant's own behavior, such as illegal conduct, drug use, sexual behavior,
or use of alcohol.
5. 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 participants cannot be identified,
directly or through identifiers linked to the participants. Research and
demonstration projects which are conducted by or subject to the approval of the
commissioner, and which are designed to study, evaluate, or otherwise examine:
a. Public benefit or service programs;
b. Procedures for obtaining benefits or services under those programs;
c. Possible changes in or alternatives to those programs or procedures; or
d. Possible changes in methods or levels of payment for benefits or services under those programs.
6. Taste and food quality evaluation and consumer acceptance studies:
a. If wholesome foods without additives are consumed; or
b. If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Statutory Authority
§§51.5-5.1 and 51.5-14 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 10, eff. March 1, 2000.
22VAC30-40-90. Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
A. The committee may conduct an expedited review of a human
research project which involves no more than minimal risk to the participants
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 research and the changes occur during the
approved project period. The HRRC may use the expedited review procedure
for categories of research that are listed in 63 FR 60364-60367 where either or
both of the following apply:
1. Some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk.
2. Minor changes in previously approved research during the period (of one year or less) for which approval is authorized.
Under an expedited review procedure, the review may be
carried out by the committee HRRC chairperson and one
or by one or more experienced reviewers designated by the chairperson
from among members of the committee HRRC may carry out the
review. In reviewing the research, the reviewers may exercise all of
the authorities of the committee HRRC except that the
reviewers may not disapprove the research. A research activity proposal
may be disapproved only after review in accordance with the nonexpedited
by a convened meeting of the HRRC in which a quorum is present and in
accordance with procedure set forth in 22VAC30-40-70.
B. Each committee which uses When an expedited
review procedure is used, the HRRC shall adopt a method for keeping all
members advised of research proposals which have been approved under the
expedited review procedure.
C. Research activities involving no more than minimal risk
and in which the only involvement of human participants will be in one or more
of the categories referred to in 34 CFR 97.110. The commissioner may
restrict, suspend, terminate, or choose not to authorize the HRRC's use of the
expedited review procedure.
Statutory Authority
§§51.5-5.1 and 51.5-14 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 10, eff. March 1, 2000.
22VAC30-40-100. Informed consent.
A. No human research may be conducted in the department,
any independent living center, any sheltered workshop, or the Woodrow Wilson
Rehabilitation Center or approved by the research committee in the absence of
voluntary informed, written consent. If the participant is competent at the
time the consent is required, then the consent must be subscribed to in writing
by the participant and witnessed. If the participant is not competent at the
time the consent is required, then the consent shall be subscribed to in
writing by the participant's legally authorized representative and witnessed
except as provided for in subsection F of this section. If the participant is a
minor otherwise capable of rendering voluntary informed consent, the consent
must be subscribed to in writing by both the minor and his legally authorized
representative and witnessed. Except as provided elsewhere in
22VAC30-40-10 et seq., no investigator may involve a human being as a subject
in research covered by this chapter unless the investigator has obtained the
legally effective informed consent of the prospective subject or the
prospective subject's legally authorized representative in accordance with this
chapter. A research The investigator shall seek such consent
only under circumstances that provide the prospective human participant
or the representative prospective human participant's legally
authorized 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 prospective human
participant or the prospective human participant's legally authorized
representative shall be in language understandable to the prospective human
participant or the prospective human participant's legally authorized
representative. No informed consent, whether oral or written, may include
any exculpatory language through which the subject or the legally authorized
representative is made to waive or appear to waive any of the subject's legal
rights, or releases or appears to release the investigator, the sponsor, the
covered entity, or its agents from liability for negligence.
B. No individual shall participate in research unless this
requirement is met for each individual. The giving of consent by a legally
authorized representative shall be subject to the provisions of subsection C of
this section. No voluntary informed consent shall include any language through
which the participant waives or appears to waive any of his legal rights,
including any release of any individual, institution or agency or any agents
thereof from liability for negligence. Notwithstanding consent by a legally
authorized representative, no person shall be forced to participate in any
human research. Each human participant shall be given a copy of the signed
consent form required by 22VAC30-40-40 A, except as provided for in
22VAC30-40-100 F. In seeking informed consent, the following basic
elements shall be provided to each prospective subject or legally authorized
representative:
1. A statement that the project involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
2. A description of any reasonably foreseeable risks or discomforts to the subject;
3. A description of any benefits to the subject or to others which may reasonably be expected from the research;
4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
7. An explanation of whom to contact for answers to pertinent questions about the research and research subject's rights, and whom to contact in the event of a research-related injury to the subject; and
8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
C. No legally authorized representative may consent to
nontherapeutic research unless the committee determines that such
nontherapeutic research will present no more than a minor increase over minimal
risk to the participant. No nontherapeutic research shall be performed without
the consent of the human participant. When the HRRC determines that it
is appropriate, one or more of the following additional elements of informed
consent shall also be provided to each subject:
1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
3. Any additional costs to the subject that may result from participation in the research;
4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
5. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
6. The approximate number of subjects involved in the project.
D. The committee may approve a consent procedure which does
not include or which alters some or all of the elements of informed consent set
forth in 22VAC30-40-10. The committee may waive the requirements to obtain some
or all informed consent provided the committee finds and documents that: The
HRRC may approve a consent procedure which does not include, or which alters,
some or all of the elements of informed consent set forth above, or waive the
requirement to obtain informed consent provided the HRRC finds and documents
that:
1. The research involves no more than minimal risk to the
human participants;
2. The waiver or alteration will not adversely affect the rights
and welfare of the human participants;
3. The research could not practicably be carried out without
the waiver or alteration; and
4. Whenever appropriate, the human participants will be
provided with additional pertinent information after participation.
1. The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:
a. Public benefit or service programs;
b. Procedures for obtaining benefits or services under those programs;
c. Possible changes in or alternatives to those programs or procedures; or
d. Possible changes in methods or levels of payment for benefits or services under those programs; and
2. The research could not practicably be carried out without the waiver or alteration.
E. Except as provided in subsection F of this section, the
consent form may be either of the following: The HRRC may approve a
consent procedure which does not include, or which alters, some or all of the
elements of informed consent set forth in subsection B of this section, or
waive the requirements to obtain informed consent provided the HRRC finds and
documents that:
1. A written consent document that embodies the elements of
informed consent required by 22VAC30-40-10. This form may be read to the
participant or the participant's legally authorized representative, but in any
event, the investigator shall give either the participant or the 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 22VAC30-40-10 have been presented
orally to the participant or the participant'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 participant or the representative. Only the short form itself is
to be signed by the participant 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 human participant or the representative, in
addition to a copy of the short form.
1. The research involves no more than minimal risk to the subject;
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
3. The research could not practicably be carried out without the waiver or alteration; and
4. Whenever appropriate, the subject will be provided with additional pertinent information after participation.
F. The committee may waive the requirement for the research
investigator to obtain a signed consent form for some or all participants if it
finds that the only record linking the participant and the research would be
the consent document and the principal risk would be potential harm resulting
from a breach of confidentiality and there is no greater than a minimal risk of
physical or mental harm to the human participant. Each participant will be
asked whether the participant wants documentation linking the participant with
the research, and the participant's wishes will govern. In cases where the
documentation requirement is waived, the committee may require the investigator
to provide participants with a written statement regarding the research. The
informed consent requirements in this chapter are not intended to preempt any
applicable federal, state, or local laws which require additional information
to be disclosed in order for informed consent to be legally effective.
G. Nothing in this chapter is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable federal or state law, or local ordinance.
H. Notwithstanding consent by a legally authorized representative, no person shall be forced to participate in any human subjects research. Each human subject shall be given a copy of the signed consent form required by this section, except as provided for in subsection J of this section.
I. No legally authorized representative may consent to nontherapeutic research unless the HRRC determines that such nontherapeutic research will present no more than a minor increase over minimal risk to the prospective subject. No nontherapeutic research shall be performed without the consent of the human subject.
J. Documentation of informed consent.
1. Except as provided in 22VAC30-40-100 J 3, informed consent shall be documented by the use of a written consent form approved by the HRRC and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.
2. Except as provided in 22VAC30-40-100 J 3, the consent form may be either of the following:
a. A written consent document that embodies the elements of informed consent required in 22VAC30-40-100 B. 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 subject's legally authorized representative adequate opportunity to read it before it is signed; or
b. A short form written consent document stating that the elements of informed consent required in 22VAC30-40-100 B 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 HRRC shall approve a written summary of what is to be said to the subject or the 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 legally authorized representative, in addition to a copy of the short form.
3. The HRRC may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:
a. That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
b. That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. In cases in which the documentation requirement is waived, the HRRC may require the investigator to provide subjects with a written statement regarding the research.
Statutory Authority
§§51.5-5.1 and 51.5-14 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 10, eff. March 1, 2000.
22VAC30-40-110. Committee HRRC records.
A. An institution, or when appropriate a committee, The
HRRC shall prepare and maintain adequate documentation of committee HRRC
activities, including the following:
1. Copies of all research proposals applications
reviewed, scientific evaluations, if any, that accompany the proposals applications,
approved sample consent documents, progress reports submitted by
investigators, and reports of injuries to participants subjects;
2. Minutes of committee HRRC meetings which shall
be in sufficient detail to show attendance at the meetings; actions taken by
the committee HRRC; the vote on these actions 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
controverted issues and their resolution;
3. Records of continuing review activities;
4. Copies of all correspondence between the committee HRRC
and the research investigators;
5. A list of all committee HRRC members identified
by name; earned degrees; representative capacity; indications of experience
such as board certifications, licenses, etc., sufficient to describe each
member's chief anticipated contributions to HRRC deliberations; and any
employment or other relationship between each member and the covered entity;
for example: full-time employee, part-time employee, member of governing panel
or board, or paid or unpaid consultant;
6. Written procedures for the committee; Statements
of significant new findings provided to participants; and
7. Statements of significant new findings provided to
participants. Written procedures for the HRRC which shall include:
a. Conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the department;
b. Determining which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous HRRC review;
c. Ensuring prompt reporting to the HRRC of proposed changes in a research activity, and for ensuring that such changes in approved research, during the period for which HRRC approval has already been given, may not be initiated without HRRC review and approval except when necessary to eliminate apparent immediate hazards to the subject; and
d. Ensuring prompt reporting to the HRRC and the commissioner of (1) any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the HRRC; and (2) any suspension or termination of HRRC approval.
B. The records required by this chapter shall be retained for at least three years, and records relating to research which 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 or federal agency at reasonable times and in a reasonable manner.
C. The HRRC shall ensure that an overview of approved human subject research projects and the results of such projects are made public on the department's website unless otherwise exempt from disclosure under the Virginia Freedom of Information Act (§ 2.2-3700 et seq.).
Statutory Authority
§§51.5-5.1 and 51.5-14 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 10, eff. March 1, 2000.
22VAC30-40-120. Mandatory reporting.
Each research review committee The HRRC shall
submit to the Governor, the General Assembly, and the commissioner or his
designee at least annually a report on the human subject research
projects reviewed and approved by the committee HRRC, including
any significant deviations from the proposals as approved.
Statutory Authority
§§51.5-5.1 and 51.5-14 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 10, eff. March 1, 2000.
22VAC30-40-130. Role of the department and the
commissioner.
A. The commissioner shall establish and maintain
records of institutional federal assurances, annual reports, and
summary descriptions of research projects.
B. The commissioner shall review communications from committees
the HRRC 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 participants
subjects.
C. The commissioner shall arrange for the printing and
dissemination of copies of these regulations.
Statutory Authority
§§51.5-14 and 51.5-14.01 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 10, eff. March 1, 2000; amended, Virginia Register Volume 21, Issue 16, eff. May 18, 2005.
22VAC30-40-140. Applicability of state policies.
Nothing in this chapter shall be construed as limiting in any
way the rights of participants human subjects in research under
regulations promulgated in response to §§32.1-162.19 and 37.1-84.1 §32.1-162.16
et seq. of the Code of Virginia.
Statutory Authority
§§51.5-14 and 51.5-14.01 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 10, eff. March 1, 2000; amended, Virginia Register Volume 21, Issue 16, eff. May 18, 2005.
22VAC30-40-150. Applicability of federal policies.
Human research at institutions The conduct of human
subjects research which 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 requirements of
this chapter. Such institutions When the HRRC reviews or approves
federally funded or sponsored human research proposals, the HRRC shall
notify the commissioner at least annually of their its
compliance with the federal policies and regulations of
federal agencies for the protection of human research subjects.
Statutory Authority
§§51.5-14 and 51.5-14.01 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 10, eff. March 1, 2000.
Amended, Virginia Register Volume 21, Issue 16, eff. May 18, 2005.
22VAC30-40-160. Additional protection for minors involved as subjects in research.
A. Research not involving greater than minimal risk. The covered entity may conduct or fund research in which the HRRC finds that no greater than minimal risk to minors is presented, only if the HRRC finds that adequate provisions are made for soliciting the assent of the minors and the permission of their parents or guardians, pursuant to subsection E of this section.
B. Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. The covered entity may conduct or fund research in which the HRRC finds that more than minimal risk to minors is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject's well-being, only if the HRRC finds that:
1. The risk is justified by the anticipated benefit to the subjects;
2. The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and
3. Adequate provisions are made for soliciting the assent of the minors and permission of their parents or guardians, pursuant to subsection E of this section.
C. Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition. The covered entity may conduct or fund research in which the HRRC finds that more than minimal risk to minors is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject, only if the HRRC finds that:
1. The risk represents a minor increase over minimal risk;
2. 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;
3.The intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition that is of vital importance for the understanding or amelioration of the subjects' disorder or condition; and
4. Adequate provisions are made for soliciting assent of the minors and permission of their parents or guardians, pursuant to subsection E of this section.
D. Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of minors. The covered entity may conduct or fund research that the HRRC does not believe meets the requirements pursuant to subsections A, B, or C of this section only if:
1. The HRRC finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of minors; and
2. The Secretary of the United States Department of Education, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, has determined either that:
a. The research in fact satisfies the conditions pursuant to subsections A, B, or C of this section, as applicable; or
b. (i) The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of minors; (ii) The research will be conducted in accordance with sound ethical principles; and (iii) Adequate provisions are made for soliciting the assent of minors and the permission of their parents or guardians, pursuant to subsection E of this section.
E. Requirements for permission by parents or guardians and for assent by minors.
1. In addition to the determinations required under other applicable subsections of this section, the HRRC shall determine that adequate provisions are made for soliciting the assent of the minors, if in the judgment of the HRRC the minors are capable of providing assent. In determining whether minors are capable of assenting, the HRRC shall take into account the ages, maturity, and psychological state of the minors involved. This judgment may be made for all minors to be involved in research under a particular protocol, or for each minor, as the HRRC deems appropriate. If the HRRC determines that the capability of some or all of the minors is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the minors and is available only in the context of the research, the assent of the minors is not a necessary condition for proceeding with the research. Even if the HRRC determines that the subjects are capable of assenting, the HRRC may still waive the assent requirement under circumstances in which consent may be waived in accord with 22VAC30-40-100.
2. In addition to the determinations required under other applicable subsections of this section, the HRRC shall determine, in accordance with and to the extent that consent is required by 22VAC30-40-100, that adequate provisions are made for soliciting the permission of each minor's parent(s) or guardian(s). If parental permission is to be obtained, the HRRC may find that the permission of one parent is sufficient for research to be conducted pursuant to subsections A or B of the section. If research is covered pursuant to subsections C and D of this section and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or if only one parent has legal responsibility for the care and custody of the minor. Only the legal custodial parent can give informed consent
3. In addition to the provisions for waiver contained in 22VAC30-40-100, if the HRRC determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused minors), it may waive the consent requirements in 22VAC30-40-100 and subsection E 2 of this section, provided an appropriate mechanism for protecting the minors who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with Federal, State, or local law. The choice of an appropriate mechanism depends upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.
4. Permission by parents or guardians must be documented in accordance with and to the extent required by 22VAC30-40-100 J.
5. If the HRRC determines that assent is required, it shall also determine whether and how assent must be documented.
F. Wards.
1. Minors who are wards of the State or any other agency, institution, or entity may be included in research approved under subsection C or D of this section only if that research is:
a. Related to their status as wards; or
b. Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of minors involved as subjects are not wards.
2. If research is approved under 22VAC30-40-160 F 1, the HRRC shall require appointment of an advocate for each minor who is a ward, in addition to any other individual acting on behalf of the minor as guardian or in loco parentis. One individual may serve as advocate for more than one minor. The advocate must be an individual who has the background and experience to act in, and agrees to act in, the best interest of the minor for the duration of the minor's participation in the research and who is not associated in any way (except in the role as advocate or member of the HRRC) with the research, the investigator or investigators, or the guardian organization.
Statutory Authority
§ of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume , Issue , eff. Month dd, yyyy.