TITLE 18. PROFESSIONAL AND OCCUPATIONALLICENSING
VA.R. Doc. No. R20-6307; Filed March 19, 2020, 1:38 p.m.
TITLE 18. PROFESSIONAL AND OCCUPATIONALLICENSING
VA.R. Doc. No. R20-6308; Filed March 19, 2020, 1:39 p.m.
TITLE 18. PROFESSIONAL AND OCCUPATIONALLICENSING
REGISTRAR'S NOTICE: The
Common Interest Community Board is claiming an exemption from Article 2 of the
Administrative Process Act in accordance with § 2.2-4006 A 4 a of the Code of
Virginia, which excludes regulations that are necessary to conform to changes
in Virginia statutory law or the appropriation act where no agency discretion
is involved. The board will receive, consider, and respond to petitions by any
interested person at any time with respect to reconsideration or revision.
Title of Regulation: 18VAC48-50. Common Interest
Community Manager Regulations (amending 18VAC48-50-10, 18VAC48-50-30).
Statutory Authority: § 54.1-2349 of the Code of
Virginia.
Effective Date: June 1, 2020.
Agency Contact: Trisha Henshaw, Executive Director,
Common Interest Community Board, Department of Professional and Occupational
Regulation, 9960 Mayland Drive, Suite 400, Richmond, VA 23233, telephone (804)
367-8510, FAX (866) 490-2723, or email cic@dpor.virginia.gov.
Summary:
The amendments remove the requirement regarding registering
a trade or fictitious name with the clerk of court in the locality where the
business is conducted to conform the regulation to Chapter 594 of the 2017 Acts
of Assembly, which became effective January 1, 2020.
Part I
General
18VAC48-50-10. Definitions.
Section 54.1-2345 of the Code of Virginia provides definitions
of the following terms and phrases as used in this chapter:
"Association"
"Board"
"Common interest community"
"Common interest community manager"
"Declaration"
"Governing board"
"Lot"
"Management services"
The following words, terms, and phrases when used in this
chapter shall have the following meanings unless the context clearly indicates
otherwise:
"Active status" means the status of a certificated
person in the employ of a common interest community manager.
"Address of record" means the mailing address
designated by the regulant to receive notices and correspondence from the
board. Notice mailed to the address of record by certified mail, return receipt
requested, shall be deemed valid notice.
"Applicant" means a common interest community
manager who has submitted an application for licensure or an individual who has
submitted an application for certification.
"Application" means a completed, board-prescribed
form submitted with the appropriate fee and other required documentation.
"Certified principal or supervisory employee"
refers to any individual who has principal responsibility for management
services provided to a common interest community or who has supervisory
responsibility for employees who participate directly in the provision of management
services to a common interest community, and who holds a certificate issued by
the board.
"Contact hour" means 50 minutes of instruction.
"Department" means the Virginia Department of
Professional and Occupational Regulation.
"Direct supervision" means exercising oversight and
direction of, and control over, the work of another.
"Firm" means a sole proprietorship, association,
partnership, corporation, limited liability company, limited liability
partnership, or any other form of business organization recognized under the
laws of the Commonwealth of Virginia and properly registered, as may be
required, with the Virginia State Corporation Commission.
"Principal responsibility" means having the primary
obligation for the direct provision of management services provided to a common
interest community.
"Regulant" means a common interest community
manager as defined in § 54.1-2345 of the Code of Virginia who holds a
license issued by the board or an individual who holds a certificate issued by
the board.
"Reinstatement" means the process and requirements
through which an expired license or certificate can be made valid without the
regulant having to apply as a new applicant.
"Renewal" means the process and requirements for
periodically approving the continuance of a license or certificate.
"Responsible person" means the employee, officer,
manager, owner, or principal of the firm who shall be designated by each firm
to ensure compliance with Chapter 23.3 (§ 54.1-2345 et seq.) of Title 54.1
of the Code of Virginia, and all regulations of the board, and to receive
communications and notices from the board that may affect the firm. In the case
of a sole proprietorship, the sole proprietor shall have the responsibilities
of the responsible person.
"Sole proprietor" means any individual, not a
corporation or other registered business entity, who is trading under his own
name, or under an assumed or fictitious name pursuant to the provisions of §§ 59.1-69
through 59.1-76 Chapter 5 of Title 59.1 (§ 59.1-69 et seq.) of the Code
of Virginia.
"Supervisory responsibility" means providing formal
supervision of the work of at least one other person. The individual who has
supervisory responsibility directs the work of another employee or other
employees, has control over the work performed, exercises examination and
evaluation of the employee's performance, or has the authority to make
decisions personally that affect the management services provided.
18VAC48-50-30. Qualifications for licensure as a common
interest community manager.
A. Firms that provide common interest community management
services shall submit an application on a form prescribed by the board and
shall meet the requirements set forth in § 54.1-2346 of the Code of Virginia,
as well as the additional qualifications of this section.
B. Any firm offering management services as defined in § 54.1-2345
of the Code of Virginia shall hold a license as a common interest community
manager. All names under which the common interest community manager conducts
business shall be disclosed on the application. The name under which the firm
conducts business and holds itself out to the public (i.e., the trade or
fictitious name) shall also be disclosed on the application. Firms shall be
organized as business entities under the laws of the Commonwealth of Virginia
or otherwise authorized to transact business in Virginia. Firms shall register
any trade or fictitious names with the State Corporation Commission or the
clerk of court in the county or jurisdiction where the business is to be
conducted in accordance with §§ 59.1-69 through 59.1-76 Chapter 5
of Title 59.1 (§ 59.1-69 et seq.) of the Code of Virginia before submitting
an application to the board.
C. The applicant for a common interest community manager
license shall disclose the firm's mailing address, the firm's physical address,
and the address of the office from which the firm provides management services
to Virginia common interest communities. A post office box is only acceptable
as a mailing address when a physical address is also provided.
D. In accordance with § 54.1-204 of the Code of Virginia,
each applicant for a common interest community manager license shall disclose
the following information about the firm, the responsible person, and any of
the principals of the firm:
1. All felony convictions.
2. All misdemeanor convictions in any jurisdiction that
occurred within three years of the date of application.
3. Any plea of nolo contendere or finding of guilt regardless
of adjudication or deferred adjudication shall be considered a conviction for
the purposes of this section. The record of conviction certified or
authenticated in such form as to be admissible in evidence under the laws of
the jurisdiction where convicted shall be admissible as prima facie evidence of
such guilt.
E. The applicant for a common interest community manager
license shall submit evidence of a blanket fidelity bond or employee dishonesty
insurance policy in accordance with § 54.1-2346 D of the Code of Virginia.
Proof of current bond or insurance policy with the firm as the named bondholder
or insured must be submitted in order to obtain or renew the license. The bond
or insurance policy must be in force no later than the effective date of the
license and shall remain in effect through the date of expiration of the
license.
F. The applicant for a common interest community manager
license shall be in compliance with the standards of conduct and practice set
forth in Part V (18VAC48-50-140 et. seq.) of this chapter at the time of
application, while the application is under review by the board, and at all
times when the license is in effect.
G. The applicant for a common interest community manager
license, the responsible person, and any principals of the firm shall be in
good standing in Virginia and in every jurisdiction and with every board or
administrative body where licensed, certified, or registered and the board, in
its discretion, may deny licensure to any applicant who has been subject to, or
whose principals have been subject to, or any firm in which the principals of
the applicant for a common interest community manager license hold a 10% or
greater interest have been subject to, any form of adverse disciplinary action,
including but not limited to, reprimand, revocation, suspension or
denial, imposition of a monetary penalty, required to complete remedial
education, or any other corrective action, in any jurisdiction or by any board
or administrative body or surrendered a license, certificate, or registration
in connection with any disciplinary action in any jurisdiction prior to
obtaining licensure in Virginia.
H. The applicant for a common interest community manager
license shall provide all relevant information about the firm, the responsible
person, and any of the principals of the firm for the seven years prior to
application on any outstanding judgments, past-due tax assessments, defaults on
bonds, or pending or past bankruptcies, and specifically shall provide
all relevant financial information related to providing management services as
defined in § 54.1-2345 of the Code of Virginia. The applicant for a common
interest community manager license shall further disclose whether or not one or
more of the principals who individually or collectively own more than a 50%
equity interest in the firm are or were equity owners holding, individually or
collectively, a 10% or greater interest in any other entity licensed by any
agency of the Commonwealth of Virginia that was the subject of any adverse
disciplinary action, including revocation of a license, within the seven-year
period immediately preceding the date of application.
I. An applicant for a common interest community manager
license shall hold an active designation as an Accredited Association
Management Company by the Community Associations Institute.
J. Prior to July 1, 2012, in lieu of the provisions of
subsection I of this section, an application for a common interest community
manager license may be approved provided the applicant certifies to the board
that the applicant has:
1. At least one supervisory employee, officer, manager, owner,
or principal of the firm who is involved in all aspects of the management
services offered and provided by the firm and who has satisfied one of the
following criteria:
a. Holds an active designation as a Professional Community
Association Manager by Community Associations Institute;
b. Has successfully completed a comprehensive training program
as described in 18VAC48-50-250 B, as approved by the board, and has at least
three years of experience in providing management services, the quality of
which demonstrates to the board that the individual is competent to have
supervisory responsibility or principal responsibility for management services;
c. Has successfully completed an introductory training program
as described in 18VAC48-50-250 A, as approved by the board, and has at least
five years of experience in providing management services, the quality of which
demonstrates to the board that the individual is competent to have supervisory
responsibility or principal responsibility for management services; or
d. Has not completed a board-approved training program but
who, in the judgment of the board, has obtained the equivalent of such training
program by documented course work that meets the requirements of a
board-approved comprehensive training program as described in Part VI
(18VAC48-50-230 et seq.) of this chapter, and has at least 10 years of
experience in providing management services, the quality of which demonstrates
to the board that the individual is competent to have supervisory
responsibility or principal responsibility for management services.
2. At least 50% of persons in the firm with principal
responsibility for management services to a common interest community in the
Commonwealth of Virginia have satisfied one of the following criteria:
a. Hold an active designation as a Professional Community
Association Manager and certify having provided management services for a
period of 12 months immediately preceding application;
b. Hold an active designation as a Certified Manager of
Community Associations by the National Board of Certification for Community
Association Managers and certify having two years of experience in providing
management services. Of the required two years experience, a minimum of 12
months of experience must have been gained immediately preceding application;
c. Hold an active designation as an Association Management
Specialist and certify having two years of experience in providing management
services. Of the required two years experience, a minimum of 12 months of
experience must have been gained immediately preceding application; or
d. Have completed a comprehensive or introductory training
program, as set forth in 18VAC48-50-250 A or B, and passed a certifying
examination approved by the board and certify having two years experience in
providing management services. Of the required two years experience, a minimum
of 12 months of experience must have been gained immediately preceding
application.
K. Effective July 1, 2012, the applicant for a common
interest community manager license shall attest that all employees of the firm
who have principal responsibility for management services provided to a common
interest community or who have supervisory responsibility for employees who
participate directly in the provision of management services to a common
interest community shall, within two years after employment with the common
interest community manager, hold a certificate as a certified principal or
supervisory employee issued by the board or shall be under the direct
supervision of a certified principal or supervisory employee.
L. Effective July 1, 2012, in lieu of the provisions of
subsection I of this section, an application for a common interest community
manager license may be approved provided the applicant certifies to the board
that the applicant has at least one supervisory employee, officer, manager,
owner, or principal of the firm who is involved in all aspects of the
management services offered and provided by the firm and who has satisfied one
of the following criteria:
1. Holds an active designation as a Professional Community
Association Manager by Community Associations Institute;
2. Has successfully completed a comprehensive training program
as described in 18VAC48-50-250 B, as approved by the board, and has at least
three years of experience in providing management services, the quality of
which demonstrates to the board that the individual is competent to have
supervisory responsibility or principal responsibility for management services;
3. Has successfully completed an introductory training program
as described in 18VAC48-50-250 A, as approved by the board, and has at least
five years of experience in providing management services, the quality of which
demonstrates to the board that the individual is competent to have supervisory
responsibility or principal responsibility for management services; or
4. Has not completed a board-approved training program but who,
in the judgment of the board, has obtained the equivalent of such training
program by documented course work that meets the requirements of a
board-approved comprehensive training program as described in Part VI
(18VAC48-50-230 et seq.) of this chapter, and has at least 10 years of
experience in providing management services, the quality of which demonstrates
to the board that the individual is competent to have supervisory
responsibility or principal responsibility for management services.
M. The firm shall designate a responsible person.
NOTICE: Forms used in
administering the regulation have been filed by the agency. The forms are not
being published; however, online users of this issue of the Virginia Register
of Regulations may click on the name of a form with a hyperlink to access it.
The forms are also available from the agency contact or may be viewed at the
Office of the Registrar of Regulations, 900 East Main Street, 11th Floor,
Richmond, Virginia 23219.
FORMS (18VAC48-50)
Common Interest Community Manager Change of
Personnel Form, A492-0501MGTCHG-v2 (rev. 10/2018)
Common Interest Community Manager License Renewal
Application, A492-0501REN-v4 (rev. 11/2019)
Common Interest Community Manager Training Program
Approval Application, A492-05TRAPRV-v3 (rev. 10/2018)
Experience Verification Form, A492-0501_10EXPv2
(rev. 10/2018)
Common Interest Community Manager License Application,
A492-0501LIC-v4 (rev. 11/2019)
Common
Interest Community Manager License Application, A492-0501LIC-v5 (rev. 4/2020)
Common Interest Community Manager Principal or
Supervisory Employee Certificate Application, A492-0510CERT-v2 (rev. 10/2018)
Principal or Supervisory Employee Certificate Renewal
Form, A492-0510REN-v2 (rev. 10/2018)
Common Interest Community Manager Application
Supplement Comprehensive Training Program Equivalency Form, A492-0501TREQ-v2
(rev. 10/2018)
VA.R. Doc. No. R20-6306; Filed March 19, 2020, 1:36 p.m.
TITLE 18. PROFESSIONAL AND OCCUPATIONALLICENSING
VA.R. Doc. No. R20-6099; Filed March 24, 2020, 8:51 a.m.
TITLE 22. SOCIAL SERVICES
REGISTRAR'S NOTICE: For
changes necessary to conform the regulation to the Code of Federal Regulations,
this action is exempt pursuant to § 2.2-4006 A 4 c of the Code of
Virginia, which excludes regulations that are necessary to meet the
requirements of federal law or regulations, provided such regulations do not
differ materially from those required by federal law or regulation. The
Department for Aging and Rehabilitative Services is also claiming an exemption
from Article 2 of the Administrative Process Act in accordance with
§ 2.2-4006 A 3, which excludes regulations that consist only of changes in
style or form or corrections of technical errors, for other changes. The
department will receive, consider, and respond to petitions by any interested
person at any time with respect to reconsideration or revision.
Title of Regulation: 22VAC30-40. Protections of
Participants in Human Research (amending 22VAC30-40-10, 22VAC30-40-40 through
22VAC30-40-110, 22VAC30-40-130, 22VAC30-40-160).
Statutory Authority: §§ 51.5-131 and 51.5-132 of the
Code of Virginia.
Effective Date: May 14, 2020.
Agency Contact: Charlotte Arbogast, Policy Advisor,
Department for Aging and Rehabilitative Services, 8004 Franklin Farms Drive,
Richmond, VA 23229, telephone (804) 662-7093, FAX (804) 662-7663, TTY (800)
464-9950, or email charlotte.arbogast@dars.virginia.gov.
Summary:
The amendments, which are necessary to comport with federal
regulatory changes, (i) update the list of types of vulnerable human subjects;
(ii) establish new requirements regarding the information that must be given to
prospective research subjects as part of the informed consent process; (iii)
allow the use of broad consent (i.e., seeking prospective consent to
unspecified future research) from a subject for storage, maintenance, and
secondary research use of identifiable private information, as an optional
alternative that an investigator may choose instead of conducting the research
on nonidentified information, having the department's human research review
committee (HRRC) waive the requirement for informed consent, or obtaining
consent for a specific study; (iv) clarify current exempt categories for
research involving minors and establish new exempt categories of research based
on a human subject's risk profile, under some of which exempt research would be
required to undergo HRRC limited review to ensure that there are adequate
privacy safeguards for identifiable private information; (v) create a
requirement for institutions based in the United States that are engaged in
cooperative research to use a single institutional review board for that
portion of the research that takes place within the United States, with certain
exceptions; (vi) remove the requirement to conduct continuing review of ongoing
research for studies that undergo expedited review by the HRRC and for studies
that have completed study interventions and are merely analyzing study data or
involve only observational follow up in conjunction with standard clinical
care; (vii) update the role of the commissioner with regard to terminating or
suspending projects; and (viii) make other minor changes for clarity and
accuracy.
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 covered entity" means employed
by the covered entity or a member of a household containing an employee of the
covered entity.
"Agent" means any an 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, shall not be construed as assent.
"Commissioner" means the Commissioner of the
Department for Aging and Rehabilitative Services or the commissioner's
designee.
"Covered entity" means the Department for Aging and
Rehabilitative Services, the Wilson Workforce and Rehabilitation Center,
sheltered workshops, or independent living centers.
"Department" means the Department for Aging and
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,
whether professional or student) student, conducting research
obtains:
1. Data through intervention or interaction with the
individual; or
2. Identifiable private information.
"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, whether professional or student)
student, conducting research obtains data through intervention or
interaction with the individual or obtains 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 that
has been provided for specific purposes by an individual and that the
individual can reasonably expect will not be made public (e.g., a medical
record or 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 private information for
which the identity of the subject is or may readily be ascertained by the
investigator or associated with the information.
"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 and 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 shall 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 and in accordance with 22VAC30-40-100.
"Institution" means any public or private entity or
agency (including, including federal, state, and other agencies)
agencies.
"Interaction" means communication or interpersonal
contact between investigator and subject.
"Intervention" means both physical procedures by
which data are gathered (e.g., venipuncture) and manipulations of the subject
or subject's environment that are performed for research purposes.
"Investigator" means the person, whether
professional or student, who conducts the research.
"IRB" means an institutional review board.
"Legally authorized representative," as defined in
§ 32.1-162.16 of the Code of Virginia, means, 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 sibling 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 the
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 the
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 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," as defined in § 1-207 of the Code of
Virginia, means an individual who is less younger 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 subject.
"Parent" means a minor's biological or adoptive
parent.
"Permission" means the agreement of parent(s)
a parent or parents or a legally authorized representative to the
participation of their minor or ward in research.
"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, or information that has been
provided for specific purposes by an individual and that the individual can
reasonably expect will not be made public (e.g., 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
designed to develop or contribute to generalizable knowledge (basic research)
or specific knowledge (applied research). Activities that meet this definition
constitute research for purposes of this chapter, whether or not they are supported
or funded under a program that is considered research for other purposes. For
example, some "demonstration" and "service" programs may
include research activities.
"Sheltered workshop" means a program that (i)
provides directly or facilitates the provision of one or more vocational
rehabilitation services enumerated in 34 CFR 361.5(b)(9)(i) 361.5(c)(7)(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.
"Written" or "in writing" means text
or other human communication on a tangible medium (e.g., paper) or in an
electronic format.
22VAC30-40-40. General provisions for conducting human subjects
research.
A. No human subjects research may shall be
conducted by a covered entity without the informed consent of the subject or
the subject's legally authorized representative. The required elements of
informed consent are provided in 22VAC30-40-100. The consent of the human
subject or the human subject's legally authorized representative to participate
in the research must shall 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 J L. The investigator
shall ensure that a knowledgeable member of the research team signs and
provides human subjects of a research project with a copy of the written,
informed consent document as defined in 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 project shall be approved by
the department's HRRC as provided by this chapter.
C. Nontherapeutic research is shall be
prohibited unless the HRRC determines that such nontherapeutic research will
not present greater than minimal risk to human subjects.
D. The investigator shall be required to notify all human
subjects of the risks caused by the research that are discovered after the
research has concluded.
E. 22VAC30-40-160 applies shall apply to all
research involving minors as subjects conducted or supported by the covered
entity. In addition to other responsibilities assigned to the HRRC under
22VAC30-40-160, the HRRC shall review research covered by 22VAC30-40-160 and
approve only research that satisfies the conditions of all applicable sections
of this chapter. Exemptions in subdivisions 1 and 3 through 6 of
22VAC30-40-80 are applicable to 22VAC30-40-160. The exemption in subdivision 2
of 22VAC30-40-80 regarding educational tests is also applicable to
22VAC30-40-160. However, the exemption in subdivision 2 of 22VAC30-40-80 for
research involving survey or interview procedures or observations of public
behavior does not apply to research covered by 22VAC30-40-160, except for
research involving observation of public behavior when the investigator or
investigators do not participate in the activities being observed. Notwithstanding
this subsection, some projects involving minors may qualify as exempt research
as outlined in 22VAC30-40-80 and as approved by the HRRC. Such qualifications
are described in the following table:
|
Exempt Category
|
Potential Qualification
|
|
Category 1
|
May qualify as exempt
|
|
Category 2 and the project involves observation of public
behavior when the investigators do not participate in the activities being
observed
|
May qualify as exempt
|
|
Category 2 and the project involves:
(i) Surveys or interviews;
(ii) The investigator's participation in the activities
being observed; or
(iii) Educational testing, sensitive information, and
identifiers collected with responses
|
Cannot qualify as exempt
|
|
Category 3
|
Cannot qualify as exempt
|
|
Category 4
|
May qualify as exempt
|
|
Category 5
|
May qualify as exempt
|
|
Category 6
|
May qualify as exempt
|
|
Category 7
|
May qualify as exempt
|
|
Category 8
|
May qualify as exempt
|
F. Cooperative research projects are shall be
those projects covered by this chapter that involve a covered entity in
conjunction with an institution(s) institution. In the conduct of
cooperative research projects, the covered entity and each institution are
shall be responsible for safeguarding the rights and welfare of human
subjects and for complying with this chapter. 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) 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 shall be reviewed and
approved by the HRRC, as provided in this chapter, a certification submitted by
the covered entity to the commissioner, and final approval given to of
the proposed change shall be given 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 22VAC30-40-70.
22VAC30-40-50. Certification process.
A. No later than 45 days after the end of each state fiscal
year, the Wilson Workforce and Rehabilitation Center, sheltered workshops, and
independent living centers shall send a written report to the commissioner
giving assurance that 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. At the time that the research is approved by the HRRC, the
HRRC chairperson shall send to the commissioner a description of the research
project to be undertaken, which shall include a statement of the criteria for
inclusion of prospective human subjects in the research project, a description
of what will be done to prospective human subjects, and the type of review
performed by the HRRC.
C. The commissioner may inspect the records of the
department's HRRC.
D. 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) heads of
other appropriate covered entities, and in the case of cooperative research,
the institutional officials responsible for human subjects research.
E. Research covered by this chapter 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
shall not approve the research if it the research has not
been approved by the HRRC.
22VAC30-40-60. Composition of the HRRC.
A. The HRRC shall have at least five members, appointed by
the commissioner, with varying backgrounds to promote complete and adequate
review of research projects commonly conducted by covered entities. The HRRC
shall be sufficiently qualified through the experience and expertise 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 human subjects. In addition to possessing
the professional competence necessary to review specific research projects, the
HRRC shall be able to ascertain the acceptability of proposed research in terms
of the department's commitments and regulations, applicable law, standards of
professional conduct and practice, and community attitudes. If the HRRC
regularly reviews research that involves a vulnerable category of subjects,
such as children, pregnant women, or persons with mental disabilities prisoners,
individuals with impaired decision-making capacity, or economically or
educationally disadvantaged persons, 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 intellectual or developmental disabilities are purposefully
included as research subjects, the HRRC's membership must shall
include at least one person who is primarily concerned with the welfare of
these research subjects.
B. Every nondiscriminatory effort will shall 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 shall not consist entirely of members of one profession.
C. The HRRC shall include:
1. At least one member whose primary concerns are in
nonscientific areas;
2. At least one member who is not otherwise affiliated with any
a covered entity and who is not part of the immediate family of a person
who is affiliated with the a covered entity; and
3. At least one member whose primary concerns are in the
scientific areas.
D. The HRRC shall not have a member participate in the HRRC's
initial or continuing review of any project in which the member has a conflicting
interest, except to provide information requested by the HRRC. The HRRC has
responsibility for determining whether a member has a conflicting interest. The
HRRC member shall be replaced in the case of conflicting interest resulting in
a decrease of the HRRC below to fewer than five members.
E. The HRRC may, at its discretion, may invite
individuals with competence in special areas to assist in the review of complex
issues which that require expertise beyond or in addition to that
available on the HRRC. These individuals may not vote.
F. A quorum of the 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 HRRC and the department shall establish procedures and
rules of operation necessary to fulfill the requirements of these
regulations this chapter.
22VAC30-40-70. Elements of the HRRC's review process.
A. The HRRC shall review and have authority to approve,
require modifications in, or disapprove all research activities covered by this
chapter.
B. 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. The HRRC shall require documentation of informed consent
or may waive documentation in accordance with 22VAC30-40-100 J L.
D. The HRRC shall consider research proposals within 45 days
after submission of a complete application to the HRRC's 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.
The HRRC shall notify investigators and the covered entity in writing of its
decision to approve or disapprove the research, or of modifications required to
secure HRRC approval.
E. The HRRC shall develop written complaint procedures to be
followed by a human subject who has a concern(s) concern 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 HRRC, who shall refer it the complaint
to the HRRC to determine if there has been a violation of the research protocol
as approved by the HRRC.
G. The committee HRRC shall require periodic
reports. The, the frequency of such reports which
should reflect the nature and degree of risk of each research project.
H. If the HRRC decides to disapprove a research application, it
the HRRC 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 often than once per year, and shall have authority to observe or
have a third party observe the consent process and the research. Unless the
HRRC determines otherwise, continuing review of research shall not be required
in the following circumstances:
1. Research eligible for expedited review in accordance
with 22VAC30-40-90;
2. Research reviewed by the HRRC in accordance with the limited
IRB review described in 22VAC30-40-80 B 3, 22VAC30-40-80 C 1 c, and
22VAC30-40-80 G and H; or
3. Research that has progressed to the point that it
involves only one or both of the following, which are part of the HRRC-approved
study:
a. Data analysis, including analysis of identifiable
private information; or
b. Accessing follow-up clinical data from procedures that
subjects would undergo as part of clinical care.
J. In order to approve research covered by this chapter, the
HRRC shall determine that all of the following requirements are satisfied:
1. Risks to subjects are minimized:
a. By using procedures that are consistent with sound research
design and that 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 as distinguished from risks and benefits of
therapies subjects would receive even if not participating in the research)
research. The HRRC should not consider possible long-range effects of
applying knowledge gained in the research (for example (e.g., 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.
The HRRC 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 prisoners, individuals with impaired
decision-making capacity, or economically or educationally disadvantaged
persons.
4. Informed consent will be is 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 is 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.
K. For purposes of conducting the limited review required
by 22VAC30-40-80-G, the HRRC need not make the determinations at subdivisions J
1 through J 7 of this section and shall make the following determinations:
1. Broad consent for storage, maintenance, and secondary
research use of identifiable private information is obtained in accordance with
the requirements of 22VAC30-40-100 A and D;
2. Broad consent is appropriately documented or waiver of
documentation is appropriate, in accordance with 22VAC30-40-100 L; and
3. If there is a change made for research purposes in the
way the identifiable private information is stored or maintained, there are
adequate provisions to protect the privacy of subjects and to maintain the
confidentiality of data.
8. L. 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 prisoners, individuals with
impaired decision-making capacity, or economically or educationally
disadvantaged persons, there are additional safeguards have been
included in the project place to protect the rights and
welfare of these the human subjects.
22VAC30-40-80. Kinds of research exempt from committee review.
Research activities in which the only involvement of
human participants will shall be in limited to one
or more of the following categories are shall be exempt from these
regulations this chapter unless the research is covered by other
sections of this chapter. The HRRC shall determine whether the proposed
research project satisfies at least one of the following exemption category
categories in this section before the research can may be
conducted pursuant to the exemption provided under this section:
1. Category 1. Research conducted in established or
commonly accepted educational settings, involving normal educational practices that
are not likely to impact adversely student opportunity to learn required educational
content or the assessment of educators who provide instruction, 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. Category 2. Research involving the use of
educational tests (cognitive, diagnostic, aptitude, or achievement),
survey procedures, interview procedures, or observation of public
behavior (including visual or auditory recording), 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, educational
advancement, or reputation; or
c. The information obtained is recorded in such a manner
that human subjects can be identified, directly or through identifiers linked
to the subjects and the HRRC conducts a limited review to make the
determination required by 22VAC30-40-70 J 7.
3. 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
subdivision 2 of 22VAC30-40-80 if:
a. The human subjects are elected or appointed public
officials or candidates for public office; or
b. Federal statute(s) require(s) without exception that the
confidentiality of the personally identifiable information will be maintained
throughout the research and thereafter.
3. Category 3. Research involving benign behavioral
interventions.
a. Research involving benign behavioral interventions in
conjunction with the collection of information from an adult subject through
verbal or written responses, including data entry, or audiovisual recording if
the subject prospectively agrees to the intervention and information collection
and at least one of the following criteria is met:
(1) The information obtained is recorded by the
investigator in such a manner that the identity of the human subjects cannot
readily be ascertained, directly or through identifiers linked to the subjects;
(2) Any disclosure of the human subjects' responses outside
the research would not reasonably place the subjects at risk of criminal or
civil liability or be damaging to the subjects' financial standing,
employability, educational advancement, or reputation; or
(3) The information obtained is recorded by the
investigator in such a manner that the identity of the human subjects can
readily be ascertained, directly or through identifiers linked to the subjects,
and the HRRC conducts a limited review to make the determination required by
22VAC30-40-70 J 7.
b. For the purpose of this subsection, benign behavioral
interventions are brief in duration, harmless, painless, not physically
invasive, and not likely to have a significant adverse lasting impact on the
subjects, and the investigator has no reason to think the subjects will find
the interventions offensive or embarrassing. Provided all of these criteria are
met, examples of benign behavioral interventions include having the subjects
play an online game, having them solve puzzles under various noise conditions,
or having them decide how to allocate a nominal amount of received cash between
themselves and someone else.
c. If the research involves deceiving the subjects
regarding the nature or purposes of the research, this exemption is not
applicable unless a subject authorizes the deception through a prospective
agreement to participate in research in circumstances in which a subject is
informed that he will be unaware of or misled regarding the nature or purposes
of the research.
4. Category 4. Secondary research for which consent is not
required: Secondary research using identifiable private information, if at
least one of the following criteria is met:
Research involving a. The research involves the
collection or study of existing data, documents, records, pathological
specimens, or diagnostic specimens, if these sources are publicly available or
if the;
b. The information is recorded by the investigator in such
a manner that subjects (i) cannot be identified, directly or through
identifiers linked to the subjects; (ii) the investigator does not contact
the subjects; and (iii) the investigator will not reidentify the subject;
c. The research involves only information collection and
analysis involving the investigator's use of identifiable health information
when that use is regulated under 45 CFR Part 160, General Administrative
Requirements, and Part 164, Security and Privacy, Subparts A and E, for the
purposes of "health care operations'' or "research'' as those terms
are defined at 45 CFR 164.501 or for "public health activities and
purposes'' as described under 45 CFR 164.512(b); or
d. The research is conducted by, or on behalf of, the
department using department-generated or department-collected information
obtained for nonresearch activities if the research generates identifiable
private information that is or will be maintained on information technology
that is subject to and in compliance with § 208(b) of the E-Government Act of
2002, 44 USC § 3501 note; if all of the identifiable private information
collected, used, or generated as part of the activity will be maintained in
systems of records subject to the Privacy Act of 1974, 5 USC § 552a; and
if applicable, the information used in the research was collected subject to
the Paperwork Reduction Act of 1995, 44 USC § 3501 et seq.
5. Category 5. Research and demonstration projects that
are conducted by or subject to the approval of the commissioner, and
that 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. Category 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.
7. Category 7. Storage or maintenance for secondary
research for which broad consent is required. Storage or maintenance of
identifiable private information for potential secondary research use if the
HRRC conducts a limited review and makes the determinations required by
22VAC30-40-70 J 8.
8. Category 8. Secondary research for which broad consent
is required: Research involving the use of identifiable private information, if
it meets the following criteria:
a. Broad consent for the storage, maintenance, and
secondary research use of the identifiable private information is obtained in
accordance with 22VAC30-40-100 A and D;
b. Documentation of informed consent or waiver of
documentation of consent is obtained in accordance with 22VAC30-40-100 L;
c. The HRRC conducts a limited review and makes the
determination required by 22VAC30-40-70 J 7 and makes the determination
that the research to be conducted is within the scope of the broad consent
referenced in subdivision 1 of this subsection; and
d. The investigator does not include returning individual
research results to subjects as part of the study plan. The investigator shall
not be prevented from abiding by any legal requirements to return individual research
results.
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 HRRC may use the expedited review procedure for
categories of research that are listed in 63 FR 60364-60367 where either or
both one or more of the following apply:
1. Some or all of the research appearing on the list and found
by the reviewer(s) reviewer to involve no more than minimal risk.
2. Minor changes in previously approved research during the
period (of of one year or less) less for which
approval is authorized; or
3. Research for which limited review is a condition of
exemption under 22VAC30-40-80 B 3, 22VAC30-40-80 C 1 c, and 22VAC30-40-80 G and
H.
Under an expedited review procedure, the review may be
carried out by the HRRC chairperson or by one or more experienced reviewers
designated by the chairperson from among members of the HRRC. In reviewing the
research, reviewers may exercise all of the authorities of the HRRC except that
reviewers may not disapprove the research. A research proposal may be
disapproved only after review 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. 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. The commissioner may restrict, suspend, terminate, or
choose not to authorize the HRRC's use of the expedited review procedure.
22VAC30-40-100. Informed consent.
A. Except as provided elsewhere in this chapter, 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 human subject or the prospective human
subject's legally authorized representative in accordance with this chapter.
The investigator shall seek such consent only under circumstances that provide
the prospective human participant subject or the prospective
human participant's subject'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 subject or the
prospective human participant's subject's legally authorized
representative shall be in language understandable to the prospective human participant
subject or the prospective human participant's subject's
legally authorized representative. The prospective human subject or the
prospective human subject's legally authorized representative shall be provided
with the information that a reasonable person would want to have in order to
make an informed decision about whether to participate, and an opportunity to
discuss that information. No informed consent, whether oral or written, may
include any exculpatory language through which the human subject or the human
subject's legally authorized representative is made to waive or appear to
waive any of the human 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. In seeking informed consent, the following basic elements
shall be provided to each prospective human subject or prospective
human subject's 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 human
subject's participation, a description of the procedures to be followed, and
identification of any procedures that are experimental;
2. A description of any reasonably foreseeable risks or
discomforts to the human subject;
3. A description of any benefits to the human subject
or to others that may reasonably be expected from the research;
4. A disclosure of appropriate alternative procedures or
courses of treatment, if any, that might may be advantageous to
the human subject;
5. A statement describing the extent, if any, to which
confidentiality of records identifying the human 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 who to contact for answers to pertinent
questions about the research and research the human subject's
rights, and who 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 human
subject is otherwise entitled, and the human subject may discontinue
participation at any time without penalty or loss of benefits to which the
subject is otherwise entitled; and
9. One of the following statements about research that
involves the collection of identifiable private information:
a. A statement that identifiers may be removed from the
identifiable private information and that, after such removal, the information
could be used for future research studies or distributed to another
investigator for future research studies without additional informed consent
from the human subject or the human subject's legally authorized
representative, if this may be a possibility; or
b. A statement that the human subject's information
collected as part of the research, even if identifiers are removed, shall not
be used or distributed for future research studies.
C. When the HRRC determines that it is appropriate, one or
more of the following additional elements of informed consent shall also
shall 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) that 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 that 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;
and
7. A statement regarding whether clinically relevant
research results, including individual research results, shall be disclosed to
subjects, and if so, under what conditions.
D. Broad consent for the storage, maintenance, and
secondary research use of identifiable private information (collected for
either research studies other than the proposed research or nonresearch
purposes) is permitted as an alternative to the informed consent requirements
in subsections B and C of this section. If the subject or the subject's legally
authorized representative is asked to provide broad consent, the following
shall be provided to each subject or the subject's legally authorized
representative:
1. The information required in subdivisions B 2, B 3, B 5,
and B 8 of this section;
2. A general description of the types of research that may
be conducted with the identifiable private information. This description shall
include sufficient information such that a reasonable person would expect that
the broad consent would permit the types of research conducted;
3. A description of the identifiable private information
that may be used in research, whether sharing of identifiable private
information may occur, and the types of institutions or researchers that may
conduct research with the identifiable private information;
4. A description of the period of time that the
identifiable private information may be stored and maintained, which period of
time could be indefinite, and a description of the period of time that the
identifiable private information may be used for research purposes, which
period of time could be indefinite;
5. Unless the subject or legally authorized representative
will be provided details about specific research studies, a statement that they
will not be informed of the details of any specific research studies that may
be conducted using the subject's identifiable private information, including
the purposes of the research, and that they may have chosen not to consent to
some of those specific research studies;
6. Unless it is known that clinically relevant research
results, including individual research results, will be disclosed to the
subject in all circumstances, a statement that such results may not be
disclosed to the subject; and
7. An explanation of whom to contact for answers to
questions about the subject's rights and about storage and use of the subject's
identifiable private information, and whom to contact in the event of a
research-related harm.
D. E. The HRRC may approve a consent procedure
that does not include or which that alters some or all of the
elements of informed consent set forth in subsection B of this section,
or waive waives the requirement to obtain informed consent provided
the HRRC finds and documents that:
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. F. The HRRC may approve a consent procedure
that does not include or that 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. 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. If the research involves using identifiable private
information, the research could not practicably be carried out without using
such information in an identifiable format; and
5. Whenever appropriate, the subjects will be provided
with additional pertinent information after participation.
F. G. The HRRC may approve a research proposal in
which an investigator will obtain information for the purpose of screening,
recruiting, or determining the eligibility of prospective subjects without the
informed consent of the prospective subject or the subject's legally authorized
representative if either of the following conditions are met:
1. The investigator will obtain information through oral or
written communication with the prospective subject or the prospective subject's
legally authorized representative; or
2. The investigator will obtain identifiable private
information by accessing records.
H. The informed consent requirements in this chapter are
shall not intended to preempt any applicable federal, state, or
local laws that require additional information to be disclosed in order for
informed consent to be legally effective.
G. I. Nothing in this chapter is intended to
shall 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. J. Notwithstanding consent by a legally
authorized representative, no person shall be forced to participate in any
human subject research. Each human subject shall be given a copy of the
signed consent form required by this section, except Except as
provided for in subsection J L of this section, human subjects
shall be given a copy of the signed consent form required by this section.
I. K. 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. L. Documentation of informed consent.
1. Except as provided in subdivision 3 of this subsection,
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 subdivision 3 of this subsection, the
consent form may be either of the following:
a. A written consent document that embodies the elements of
informed consent required in subsection B of 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 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 subsection B of 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 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; or
c. If the subjects or subjects' legally authorized
representatives are members of a distinct cultural group or community in which
signing forms is not the norm, that the research presents no more than minimal
risk of harm to subjects and provided there is an appropriate alternative
mechanism for documenting that informed consent was obtained.
4. 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.
22VAC30-40-110. HRRC records.
A. The HRRC shall prepare and maintain adequate documentation
of HRRC activities, including the following:
1. Copies of all research applications reviewed, scientific
evaluations, if any, that accompany the applications, approved consent
documents, progress reports submitted by investigators, and reports of injuries
to subjects;
2. Minutes of HRRC meetings which shall be in sufficient detail
to show attendance at the meetings; actions taken by the 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 HRRC and the
investigators;
5. A list of all 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. Statements of significant new findings provided to
participants; and
7. Written procedures for the HRRC that 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 (i) 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 (ii) any suspension or termination of HRRC
approval.
8. The rationale for an expedited reviewer's determination
under 22VAC30-40-90 A 1 that research appearing on the expedited review list
described in 63 FR 30364-60367 is more than minimal risk.
9. As applicable, documentation specifying the
responsibilities that the covered entity and another qualified IRB other than
the HRRC, each shall undertake to ensure compliance with the requirements of
this chapter when (i) nonexempt research involving human subjects or (ii)
exempt research with a limited review is overseen by another qualified IRB
other than the HRRC. Such documentation may include:
a. A written agreement between the covered entity and the
qualified IRB that is not the HRRC;
b. Implementation of an institution-wide policy directive
providing the allocation of responsibilities between the covered entity and the
qualified IRB that is not the HRRC; or
c. A research protocol.
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 may be maintained in printed or electronic form and 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. of the Code of
Virginia).
D. The HRRC shall have access to meeting space and
sufficient staff to support the HRRC's review and recordkeeping duties.
22VAC30-40-130. Role of the commissioner.
A. The commissioner shall maintain records of federal
assurances, annual reports, and summary descriptions of research projects.
B. The commissioner shall review communications from the HRRC
reporting violations of research protocols which that led to
suspension or termination of the research to ensure that appropriate steps have
been taken for the protection of the rights of human subjects.
C. The commissioner shall arrange for printing and
dissemination of copies of these regulations this chapter.
D. The commissioner may require that support for a project
be terminated or suspended in the manner prescribed in applicable program
requirements when the commissioner finds a covered entity has materially failed
to comply with the terms of this chapter.
E. In making decisions about supporting or approving
applications or proposals covered by this chapter, the commissioner may take
into account, in addition to all other eligibility requirements and program
criteria, factors such as whether the applicant has been subject to a termination
or suspension under subsection D of this section and whether the applicant or
the person who would direct or has directed the scientific and technical
aspects of an activity has, in the judgment of the commissioner, materially
failed to discharge responsibility for the protection of the rights and welfare
of human subjects (whether or not the research was subject to federal
regulation).
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 that 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' subject's disorder or
condition that is of vital importance for the understanding or amelioration of
the subjects' subject's 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 that 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
subsection 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: (e.g., science, medicine, education, ethics, or law)
and following opportunity for public review and comment, has determined either
that:
a. The research in fact satisfies the conditions pursuant to
subsection 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 may 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)
parent or parents or guardian(s) guardian. 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 subsection A or B
of this 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
shall 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 is able to 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 subdivision 2 of this subsection, 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 shall
be documented in accordance with and to the extent required by 22VAC30-40-100 J
L.
5. If the HRRC determines that assent is required, it shall
also determine whether and how assent must shall 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 subdivision 1 of this
subsection, 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 shall 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, except in
the role as advocate or member of the HRRC) HRRC, with the
research, the investigator or investigators, or the guardian
organization.
VA.R. Doc. No. R20-5670; Filed March 24, 2020, 7:54 a.m.