Current through Register Vol. 51, No. 6, December 1, 2024
RELATES TO: 45 C.F.R. 46.101-46.409, 164.512(i)
NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires
the secretary to promulgate administrative regulations necessary to implement
programs mandated by federal law, or to qualify for receipt of federal funds
and necessary to cooperate with other state and federal agencies for the proper
administration of the cabinet and its agencies. 45 C.F.R. 46.101(a) requires
the cabinet to have an Institutional Review Board for the Protection of Human
Subjects to protect the rights and welfare of human subjects involved in
research. This administrative regulation establishes specific requirements for
protecting human subjects involved in research and incorporates by reference
applicable publications that establish additional requirements.
Section 1. Definitions.
(1) "Board" or "IRB" means the cabinet's
Institutional Review Board required by Section 2 of this administrative
regulation.
(2) "Cabinet" is
defined by KRS 194A.005(1).
(3)
"Principal investigator" means the investigator involved in the research
project who has responsibility for making decisions regarding the research
study.
(4) "Research" is defined by
45 C.F.R. 46.102(d).
Section
2. Institutional Review Board.
(1) An IRB for the Protection of Human
Subjects shall be created within the cabinet.
(2) The board shall:
(a) Consist of not less than five (5) nor
more than eleven (11) members appointed by the secretary;
(b) Include members from various professional
and academic fields including consideration of race, gender, and cultural
backgrounds in accordance with 45 C.F.R. 46.107(a);
(c) Include, in accordance with 45 C.F.R. 46.107(c), at least one (1) member each with primary concerns in the following
areas:
(d) Include, in accordance with 45 C.F.R. 46.107(d), at least one (1) member who shall not:
1. Otherwise be affiliated with the cabinet;
and
2. Be part of the immediate
family of a person who is affiliated with the cabinet;
(e) Include at least one (1) member
designated by the secretary to act as a chair; and
(f) Meet as needed to review a
project.
(3) The
secretary shall appoint an IRB administrator, within a cabinet department or
office, who shall:
(a) Serve as liaison
between the board and the U.S. Department of Health and Human
Services;
(b) Maintain records in
accordance with 45 C.F.R. 46.115;
(c) Conduct a preliminary review of a
submitted project;
(d) Determine if
a project requires board review in accordance with:
2.
45 C.F.R. 46.102(d); and
3. Section 3(1) of this administrative
regulation;
(e) Refer to
the board a project to which this administrative regulation applies;
and
(f) Make recommendations to the
board on the disposition of an applicable project.
(4) The commissioner or executive director of
the department or office in which the IRB Administrator is appointed shall:
(a) Provide administrative support to the
board; and
(b) Assign necessary
staff.
Section
3. Project Submission.
(1) A
research project involving a human subject shall be submitted by the principal
investigator to the board chair or board staff for review if it:
(a) Is conducted, supported financially,
endorsed, or approved by the cabinet;
(b) Uses staff or facilities provided by the
cabinet;
(c) Involves a present or
former client or beneficiary of the cabinet as a subject because of that
relationship with the cabinet;
(d)
Involves a present or former employee of the cabinet as a subject because of
that relationship with the cabinet; or
(e) Involves a cabinet record relating to a
present or former client, beneficiary, or employee of the cabinet.
(2) Project submission shall
include the following, if applicable:
(a) A
completed "Request for Research Activity Approval, Institutional Review Board
for the Protection of Human Subjects (IRB), Kentucky Cabinet for Health and
Family Services";
(b) A narrative
description of the project's purpose and proposed research
procedures;
(c) The research
instrument to be used;
(d) A
narrative description of how subject confidentiality shall be maintained;
and
(e) The research subject
consent documents to be used.
(3) Unless first approved by the board,
modification in the research protocol or design of an approved research project
that may increase the level of risk to a subject shall not be implemented.
(a) If an alteration becomes necessary, the
principal investigator shall obtain prior approval of the board.
(b) Failure to obtain prior approval of the
board may result in suspension or termination of all research activity,
depending on whether the failure to obtain prior approval was willful and the
severity of the potential increase of the level of risk to a subject.
Section 4. Board
Approval.
(1) The board shall review a
research project submitted as specified in Section 3(1) of this administrative
regulation and not specifically exempted from board review by 45 C.F.R. 46.101(b).
(2) Board approval of a
project shall represent a judgment that human subjects are adequately
protected, and shall not represent a:
(a)
Judgment concerning its ultimate research value; or
(b) Policy decision regarding the value of
the research to the cabinet.
(3) Except to provide information requested
by the IRB, a member of the board shall not participate in the IRB's initial or
continuing review of any project in which the member has a conflicting
interest.
(4) A principal
investigator may request a reconsideration of an adverse decision by the board
by submitting a written request for reconsideration to the chair of the
IRB.
(5) The request shall be made
within thirty (30) days of the principal investigator's receipt of notification
of the adverse decision.
(6) A
reconsideration shall be made in the same manner as the initial
review.
(7)
(a) The IRB may invite individuals with
competence in special areas to assist in the review of issues that require
expertise beyond or in addition to that available on the IRB.
(b) These individuals shall not vote with the
IRB.
Section
5. Board Responsibilities. The board shall:
(1) In coordination with IRB staff, call a
meeting as needed to conduct board business; and
(2) Review and determine disposition of an
applicable research project consistent with 45 C.F.R. 46.101 to 46.409.
Section 6.
Responsibilities of Principal Investigators.
(1) If a change is made in research design or
protocol that affects the level of risk to a subject, confidentiality
procedures, or consent procedures, the principal investigator shall submit the
change, before implementation, to the board for approval.
(2) The principal investigator shall report
to the board:
(a) An unanticipated problem
involving a risk to a subject or another individual, as a result of research
activity, within ten (10) working days; and
(b)
1. A
research subject death within seven (7) days of the principal investigator's
knowledge of a death; and
2.
Whether the death appears likely to be related to participation in the research
project.
(3)
The principal investigator shall submit to the board:
(a) A copy of final research findings and
conclusions; and
(b) An annual
report and request for reapproval for a research study that extends beyond one
(1) year.
Section
7. Confidentiality.
(1) Research
information that identifies an individual subject shall be regarded as
confidential in accordance with KRS 194A.060(1), 45 C.F.R. 46.111(a)(7), and 45 C.F.R. 164.512(i) and shall not be disclosed to a person outside the research
project staff or published without the subject's prior written
authorization.
(2) Raw or summary
data may be released if the data does not identify a subject.
Section 8. References. The
decision of the board concerning the protection of a human subject shall be in
accordance with:
(1) The "Belmont Report
Ethical Principles and Guidelines for the Protection of Human Subjects of
Research, National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research, edition April 18, 1979";
(2)
45 C.F.R. 46.101 through 45 C.F.R. 46.409; and
(3)
45 C.F.R. 164.512(i).
Section 9.
Incorporation by Reference.
(1) The following
material is incorporated by reference:
(a) The
"Belmont Report: Ethical Principles and Guidelines for the Protection of Human
Subjects of Research, National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research, edition April 18, 1979"; and
(b) "Request for Research Activity Approval,
Institutional Review Board for the Protection of Human Subjects (IRB), Kentucky
Cabinet for Health and Family Services, edition 1/07".
(2) This material may be inspected, copied,
or obtained, subject to applicable copyright law, at the Cabinet for Health and
Family Services, IRB Administrator, 275 East Main Street, Frankfort, Kentucky
40621, Monday through Friday, 8 a.m. through 4:30 p.m.
STATUTORY AUTHORITY: KRS 194A.050(1), 194A.060(1), 45 C.F.R. 46.101(a)