Texas Register
.
The proposed new rules would establish uniform guidelines for the review,
approval, conduct, and oversight of research in TDMHMR facilities. The rules
describe TDMHMR's general principles for research in its facilities; describe
four options under which a facility may choose an institutional review board
(IRB) as its designated IRB; describe the functions and operations of a designated
IRB, including the responsibilities and requirements for reviewing, approving,
and monitoring research; and describe the requirements for procedures for
obtaining informed consent from prospective human subjects. The proposed new
rules would also adopt by reference Title 45, Code of Federal Regulations
(CFR), Part 46 (Protection of Human Subjects), Subparts A, B, and D, to ensure
the protection of human subjects involved in research; "The Belmont Report:
Ethical Principles and Guidelines for the Protection of Human Subjects of
Research, Report of the National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research" (April 18, 1979), to ensure ethical
principles are maintained when research involving human subjects is conducted;
and 42 CFR Part 50, Subpart A, (Responsibility of PHS Awardee and Applicant
Institutions for Dealing With and Reporting Possible Misconduct in Science),
to ensure all research undertaken at TDMHMR facilities is conducted with a
fundamental commitment to high ethical standards regarding the conduct of
scientific research.
The key difference between the proposed new rules and the rules proposed
for repeal is that the new rules incorporate requirements related to privacy
of health information by adopting by reference the Federal Standards for Privacy
of Individually Identifiable Health Information, 45 CFR Part 160 and Part
164, Subparts A and E, which are promulgated by the U.S. Department of Health
and Human Services pursuant to the Health Insurance Portability and Accountability
Act of 1996 (HIPAA). Additionally, the proposed new rules do not adopt by
reference 45 CFR Part 46, Subpart C (Additional DHHS Protections Pertaining
to Biomedical and Behavioral Research Involving Prisoners as Subjects), yet
they contain all the subpart's requirements that are applicable to a TDMHMR
facility.
Cindy Brown, Chief Financial Officer, has determined that for each year
of the first five years the proposed new rules are in effect, there will not
be foreseeable implications relating to costs or revenues of state or local
government.
Marcia Toprac, Ph.D., Director, Research and Academic Collaboration, has
determined that, for each year of the first five years the proposed new rules
are in effect, the public benefit expected is the promulgation of rules that
provide for the protection and confidentiality of human subjects involved
in research at TDMHMR facilities. It is not anticipated that there will be
any additional economic cost to persons required to comply with the new rules
because the rules do not impose any more requirements on such persons than
those contained in the rules proposed for repeal or those required by existing
federal and state laws, rules, and regulations.
It is not anticipated that the new rules will affect a local economy.
It is not anticipated that the proposed new rules will have an adverse
effect on small businesses or micro-businesses because the rules do not place
requirements on small or micro-businesses.
Written comments on the proposed new rules may be sent to Linda Logan,
Director, Policy Development, Texas Department of Mental Health and Mental
Retardation, P.O. Box 12668, Austin, Texas 78711-2668, within 30 days of publication.
The new rules are proposed under the Texas Health and Safety
Code, §532.015, which provides the Texas Mental Health and Mental Retardation
Board (board) with broad rulemaking authority, and §576.021, which states
that a patient receiving mental health services under Subtitle C has the right
to refuse to participate in a research program.
The proposed new rules would affect the Texas Health and Safety Code, §532.015
and §576.021.
§414.751.Purpose.
The purpose of this subchapter is to establish uniform guidelines for
the review, approval, conduct, and oversight of research in facilities that:
(1)
ensure the protection of the rights, privacy, and welfare
of human subjects involved in research;
(2)
provide for the creation and utilization of a designated
Institutional Review Board (IRB) for each facility electing to be involved
in the conduct of research;
(3)
provide for the investigation of allegations of misconduct
in science related to research conducted at a facility; and
(4)
conform with the requirements of Title 45, Code of Federal
Regulations, Part 46 (Protection of Human Subjects), Subparts A, B, and D.
§414.752.Application.
This subchapter applies to all research involving:
(1)
individuals receiving services from a facility; or
(2)
facility resources (e.g., employees, property, and non-public
information).
§414.753.Definitions.
The following words and terms, when used in this subchapter, have the
following meanings, unless the context clearly indicates otherwise:
(1)
Assent--Affirmative agreement of a prospective human subject
to participate in research, which is obtained when the subject does not have
capacity or legal authority to consent.
(2)
Authorization--The written permission given by an individual
who is participating in a research study or the individual's LAR to use or
disclose certain protected health information related to the research study.
(3)
Central Office--TDMHMR's administrative offices in Austin.
(4)
Designated institutional review board (IRB)--The IRB, chosen
by the facility and approved by the Office of Research Administration in accordance
with this subchapter, that will review, approve, and monitor all research
to be conducted at the facility.
(5)
Facility--A state mental health facility, a state mental
retardation facility, or Central Office.
(6)
Human subject--Consistent with 45 CFR §46.102(f),
referenced as Exhibit A in §414.763 of this title (relating to Exhibits),
a living individual about whom a key researcher conducting research obtains:
(A)
data through intervention or interaction with the individual;
or
(B)
identifiable private information.
(7)
Individual--A person who has received or is receiving mental
health or mental retardation services from a facility.
(8)
Informed consent--The knowing approval of an individual
or an individual's legally authorized representative (LAR) to participate
in a research study, given under the individual's or LAR's ability to exercise
free power of choice without undue inducement or any element of force, fraud,
deceit, duress, or other form of constraint or coercion.
(9)
Institutional review board (IRB)--A board whose membership
meets the requirements of §414.755(d) of this title (relating to Designated
Institutional Review Board (IRB)), and whose purpose is to review and approve
proposed research as well as oversee the conduct of approved research.
(10)
Investigation (of misconduct in science)--The formal examination
and evaluation of all relevant facts to determine if misconduct in science
has occurred.
(11)
Investigational medication or device--Any drug, biological
product, or medical device under investigation for human use that is not currently
approved by the Food and Drug Administration for the indication being studied.
(12)
Key researcher--A principal investigator, a co-investigator,
or a person who has direct and ongoing contact with human subjects participating
in a research study or with prospective human subjects.
(13)
Legally authorized representative (LAR)--A person or entity
authorized under applicable law to consent on behalf of a prospective human
subject to the subject's participation in a research study and to authorize
the use or disclosure of protected health information.
(14)
Limited data set--Protected health information that excludes
the following direct identifiers of an individual or of relatives, employers,
or household members of an individual:
(A)
names;
(B)
postal address information, other than town or city, state,
and zip code;
(C)
telephone numbers;
(D)
fax numbers;
(E)
electronic mail addresses;
(F)
social security numbers;
(G)
medical record numbers;
(H)
health plan beneficiary numbers;
(I)
account numbers;
(J)
certificate/license numbers;
(K)
vehicle identifiers and serial numbers;
(L)
device identifiers and serial numbers;
(M)
Web Universal Resource Locators (URLs);
(N)
Internet Protocol (IP) address numbers;
(O)
biometric identifiers, including finger and voice prints;
and
(P)
full face photographic images and comparable images.
(15)
Mental health priority population--Persons with mental
illness, including severe emotional disturbance, identified in TDMHMR's current
strategic plan as being most in need of mental health services.
(16)
Mental retardation priority population--Persons with mental
retardation identified in TDMHMR's current strategic plan as being most in
need of mental retardation services.
(17)
Minimal risk--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 psychical or psychological examination or tests.
(18)
Misconduct in science--The fabrication, falsification,
plagiarism, or other practices that seriously deviate from those that are
commonly accepted within the scientific community for proposing, conducting,
or reporting research. It does not include honest error or honest differences
in interpretations or judgments of data.
(19)
Notice of Privacy Practices--A written notice describing:
(A)
the uses and disclosures of protected health information
that may be made by a facility; and
(B)
individuals' rights and the facility's legal duties with
respect to protected health information.
(20)
Office of Research Administration (ORA)--The Central Office
department that is responsible for the duties described in §414.762 of
this title (relating to Responsibilities of the Office of Research Administration
(ORA)).
(21)
Principal investigator--The person identified as responsible
for conducting a research study.
(22)
Privacy coordinator--A member of the workforce of a facility
who is responsible for working with the TDMHMR Central Office Privacy Official
in developing and implementing the facility's policies and procedures relating
to state and federal medical privacy laws.
(23)
Protected health information (PHI)--
(A)
Any information that identifies or could be used to identify
an individual, whether oral or recorded in any form, that relates to:
(i)
the past, present, or future physical or mental health
or condition of the individual;
(ii)
the provision of health care to the individual; or
(iii)
the payment for the provision of health care to the individual.
(B)
The term includes, but is not limited to:
(i)
an individual's name, address, date of birth, or Social
Security number;
(ii)
an individual's medical record or case number;
(iii)
a photograph or recording of an individual;
(iv)
statements made by an individual, either orally or in
writing, while seeking or receiving services from or through a facility;
(v)
any acknowledgment that an individual is seeking or receiving
or has sought or received services from or through a facility;
(vi)
direct identifiers of relatives, employers, or household
members of the individual; and
(vii)
any information by which the identity of an individual
can be determined either directly or by reference to other publicly available
information.
(C)
The term does not include:
(i)
health information that has been de-identified in accordance
with 45 CFR §164.514(b); and
(ii)
employment records held by a facility as an employer.
(24)
Research--A systematic investigation, including research
development, testing and evaluation, designed to develop or contribute to
generalizable knowledge. Activities that meet this definition constitute research
for purposes of this subchapter whether or not they are conducted or supported
under a program which is considered research for other purposes. For example,
certain demonstration and service programs may include research activities.
(25)
Rights officer--An employee appointed by a facility CEO
to protect and advocate for the rights of persons receiving services from
the facility.
(26)
State mental health facility--A state hospital or a state
center with an inpatient component that is operated by TDMHMR.
(27)
State mental retardation facility--A state school or a
state center with a mental retardation residential component that is operated
by TDMHMR.
(28)
TDMHMR--The Texas Department of Mental Health and Mental
Retardation.
§414.754.General Principles.
(a)
Participation in research that can advance scientific knowledge
of mental disorders and conditions is integral to the mission of TDMHMR.
(b)
TDMHMR's guiding principle for all research involving human
subjects at its facilities is the protection of the personal rights, safety,
well-being, privacy, and dignity of the subjects.
(1)
To ensure the protection of human subjects involved in
research at its facilities, TDMHMR promulgates this subchapter and adopts
by reference Title 45, Code of Federal Regulations, Part 46 (Protection of
Human Subjects), Subparts A, B, and D, referenced as Exhibit A in §414.763
of this title (relating to Exhibits).
(2)
To ensure ethical principles are maintained when research
involving human subjects is conducted at its facilities, TDMHMR adopts by
reference "The Belmont Report: Ethical Principles and Guidelines for the Protection
of Human Subjects of Research, Report of the National Commission for the Protection
of Human Subjects of Biomedical and Behavioral Research" (April 18, 1979),
referenced as Exhibit B in §414.763 of this title (relating to Exhibits).
(3)
To ensure all research undertaken at its facilities is
conducted with a fundamental commitment to high ethical standards regarding
the conduct of scientific research, TDMHMR adopts by reference 42 CFR Part
50, Subpart A, (Responsibility of PHS Awardee and Applicant Institutions for
Dealing With and Reporting Possible Misconduct in Science), referenced as
Exhibit C in §414.763 of this title (relating to Exhibits).
(4)
To protect the privacy of human subjects involved in research
at its facilities, TDMHMR adopts by reference the Federal Standards for Privacy
of Individually Identifiable Health Information, Title 45, Code of Federal
Regulations, Part 160 and Part 164, Subparts A and E, promulgated by the U.S.
Department of Health and Human Services pursuant to the Health Insurance Portability
and Accountability Act of 1996 (HIPAA).
(c)
TDMHMR is committed to research conducted in a manner that
is consistent with the best interests and protection of personal rights and
welfare of human subjects involved in the research.
(1)
An individual may not be approached to participate in a
research study if the research conflicts with the individual's treatment goals.
(2)
No research involving human subjects may be conducted unless
the risks to human subjects are minimized and are reasonable in relation to
the anticipated benefits.
(3)
No undue inducement or coercion may be used to influence
human subjects to participate in a research study.
(4)
Unless scientifically justified, individuals may not be
excluded from participating in research on the basis of personal characteristics,
such as race, color, ethnicity, national origin, religion, sex, age, disability,
sexual orientation, or political affiliation.
(5)
Human subject participation in research studies must be
equitable with measures taken to ensure the research sample is adequately
representative of the population of interest. Within the population of interest
subject selection procedures must offer equitable opportunity for access to
participation in research and access to potential benefits of participation.
(6)
Individuals receiving mental health services under an order
of protective custody pursuant to the Texas Health and Safety Code, Chapter
574, may not be approached about participation in a research study involving
an investigational medication or device prior to the entry of an order for
temporary or extended mental health services.
(7)
Research may not be conducted with human subjects who are
involuntarily committed if the research involves:
(A)
placebos as the primary medication therapy;
(B)
medication or doses of medication as the primary medication
therapy which are known to be ineffective for the targeted disorder or condition;
or
(C)
an investigational medication or device that is proposed
to be undertaken when previous research on the medication or device with 100
human subjects or fewer has provided minimal or no documentation of the efficacy
and safety of the medication or device for the population with the targeted
disorder or condition.
(8)
Research may not be conducted at a facility if the protocol:
(A)
extends the use of a placebo or washout period unreasonably;
(B)
deprives the human subject of reasonable relief; or
(C)
extends a human subject's use of placebos as the primary
medication therapy after the subject is discharged from the facility.
(9)
Unless otherwise provided for in this subchapter, research
involving human subjects may not be conducted at a facility unless:
(A)
the research has been reviewed and approved by the facility's
designated IRB in accordance with §414.757 of this title (relating to
Review and Approval of Proposed Research);
(B)
the facility CEO has agreed to have the research conducted
at the facility; and
(C)
if required, the necessary assurance and certification
has been submitted to the appropriate federal agency, (e.g., Health and Human
Services, Food and Drug Administration) and the agency has indicated its approval.
(10)
Research conducted at a facility may not hinder the facility's
ability to accomplish its primary purpose.
(d)
Right to file a complaint.
(1)
A human subject involved in research or his/her LAR is
entitled to file a complaint about alleged mistreatment or other concerns
relating to the research with the facility's rights officer or with any other
applicable complaint mechanism in place.
(2)
An individual or his/her LAR is entitled to file a complaint
about violations of the Federal Standards for Privacy of Individually Identifiable
Health Information (45 CFR Part 160 and Part 164, Subparts A and E) with the
facility's privacy coordinator, the TDMHMR Consumer Services and Rights Protection/Ombudsman
Office, or the Office for Civil Rights at the U.S. Department of Health and
Human Services, as set forth in the Notice of Privacy Practices.
§414.755.Designated Institutional Review Board (IRB).
(a)
Each facility electing to participate in research must
have a designated IRB. The designated IRB is responsible for reviewing, approving,
and monitoring all research conducted at that facility, with the exception
of research involving multiple facilities as provided by subsection (c) of
this section.
(b)
A facility may choose one of the following options for
its designated IRB, which must be approved by the ORA as outlined in subsection
(f) of this section.
(1)
Facility IRB. An IRB, established and operated by a facility,
whose membership meets the requirements described in subsection (d) of this
section.
(2)
Another facility's IRB. A facility IRB as described in
paragraph (1) of this subsection.
(3)
University IRB. An IRB, established and operated by a university,
whose membership meets the requirements described in subsection (d) of this
section.
(4)
Central Office IRB. An IRB, established and operated by
Central Office, whose membership meets the requirements described in subsection
(d) of this section.
(c)
A facility's CEO may request that the Central Office IRB
act as the facility's designated IRB for a research study that involves multiple
facilities.
(d)
The membership of the IRB must comply with the requirements
in 45 CFR §46.107, referenced as Exhibit A in §414.763 of this title
(relating to Exhibits) and this subsection.
(1)
Facility IRB. Membership of a facility IRB must include
at least three members who are familiar with the mental disorders or conditions
and concerns of the population(s) served by the facility or facilities.
(A)
At least one of the three members described in this paragraph
must be a professional in the field of mental health or mental retardation,
as appropriate to the facility or facilities.
(B)
At least two of the three members described in this paragraph
must be:
(i)
a person who is or has been in the mental health priority
population or mental retardation priority population, as appropriate to the
facility or facilities;
(ii)
a family member of a person who is or has been in the
mental health priority population or mental retardation priority population,
as appropriate to the facility or facilities; or
(iii)
an advocate for persons who are or have been in the mental
health priority population or mental retardation priority population, as appropriate
to the facility or facilities.
(2)
University IRB. Membership of a university IRB must include
at least three members or ad hoc members who are familiar with the mental
disorders or conditions and concerns of the population(s) served by the facility
or facilities.
(A)
At least one of the three members described in this paragraph
must be a professional in the field of mental health or mental retardation,
as appropriate to the facility or facilities.
(B)
At least two of the three members described in this paragraph
must be:
(i)
a person who is or has been in the mental health priority
population or mental retardation priority population, as appropriate to the
facility or facilities;
(ii)
a family member of a person who is or has been in the
mental health priority population or mental retardation priority population,
as appropriate to the facility or facilities; or
(iii)
an advocate for persons who are or have been in the mental
health priority population or mental retardation priority population, as appropriate
to the facility or facilities.
(3)
Central Office IRB. Membership of the Central Office IRB
must include local representation from various regions of the state and at
least three members who are familiar with the mental disorders or conditions
and concerns of the population(s) served by TDMHMR.
(A)
At least one of the three members described in this paragraph
must be a professional in the field of mental health and mental retardation.
(B)
At least two of the three members described in this paragraph
must be:
(i)
a person who is or has been in the mental health priority
population, a family member of a person who is or has been in the mental health
priority population, or an advocate for persons who are or have been in the
mental health priority population; and
(ii)
a person who is or has been in the mental retardation
priority population, a family member of a person who is or has been in the
mental retardation priority population, or an advocate for persons who are
or have been in the mental retardation priority population.
(e)
Each IRB must have written policies and procedures that
are consistent with this subchapter and TDMHMR's rules governing the care
and protection of individuals as described in §414.764(5) of this title
(relating to References) and that address:
(1)
the functions and operations of the IRB as required by
45 CFR §46.103(b)(4) and (b)(5);
(2)
the review or screening process to determine whether proposed
research is exempt from the requirements of federal regulations made in accordance
with 45 CFR §46.101(b), including required documentation, and any necessary
approvals;
(3)
the process for ensuring that each IRB member and key researcher
involved in an approved research study receives documented training in applicable
ethics, laws, and regulations governing research involving human subjects;
and
(4)
the process for disclosing and considering potential conflicts
of interest, financial or otherwise, by IRB members and key researchers.
(f)
ORA approval of a designated IRB.
(1)
A facility seeking approval for its own facility IRB, another
facility's IRB, or a university IRB as its designated IRB, as described in
subsection (b)(1), (2), or (3) of this section, must submit the following
to the ORA:
(A)
IRB membership information in sufficient detail to determine
compliance with subsection (d) of this section and which describes each member's
chief anticipated contribution to IRB deliberations, and any employment or
other relationship between each member and the facility, university, or Central
Office, as appropriate;
(B)
the written policies and procedures described in subsection
(e) of this section;
(C)
the written policy for the communication of IRB deliberations,
recommendations, and decisions to the facility CEO and the ORA; and
(D)
if approval is for a university IRB or another facility's
IRB, a copy of the written agreement in which the university IRB or other
facility IRB accepts responsibility for reviewing, approving, and monitoring
all research to be conducted at the facility seeking approval; and
(E)
if approval is for a university IRB, a detailed description
of how the facility will collaborate with the university IRB to ensure compliance
with any requirement in this subchapter that is unique to TDMHMR (i.e., the
duties, activities, and responsibilities of both the facility and the university
IRB).
(2)
A facility seeking approval for the Central Office IRB
as its designated IRB, as described in subsection (b)(4) of this section,
must submit a written request from the facility CEO to the ORA.
(g)
The ORA shall review the information submitted by the facility
and will approve, disapprove, or enter into negotiations to attain approval
for the IRB as the facility's designated IRB. The ORA will provide written
notice of approval or disapproval to the requesting facility.
(h)
Any change in a designated IRB's membership, policies,
or procedures must be reported to and approved by the ORA.
(i)
The ORA may require that a designated IRB comply with additional
requirements related to documentation and approval if the ORA determines that
such requirements are necessary to ensure the protection of human subjects.
(j)
The ORA may revoke approval of a designated IRB at any
time the ORA determines the IRB fails to maintain standards in accordance
with federal regulations and this subchapter.
§414.756.IRB Functions and Operations.
(a)
Each designated IRB shall:
(1)
follow its written policies and procedures as described
in §414.755(e) of this title (relating to Designated Institutional Review
Board (IRB));
(2)
function in accordance with 45 CFR §46.108, referenced
as Exhibit A in §414.763 of this title (relating to Exhibits);
(3)
ensure proposed research is reviewed and approved in accordance
with §414.757 of this title (relating to Review and Approval of Proposed
Research);
(4)
except when an expedited review is used as described in
45 CFR §46.108(b), ensure proposed research is reviewed and approved
only at meetings in which at least one of each of the following members are
present, participating, and voting:
(A)
a member who satisfies the requirements of §414.755(d)(1)(A),
(2)(A), or (3)(A) of this title (relating to Designated Institutional Review
Board (IRB)), as appropriate to the IRB; and
(B)
a member who satisfies the requirements of §414.755(d)(1)(B),
(2)(B), or (3)(B) of this title (relating to Designated Institutional Review
Board (IRB)), as appropriate to the IRB, and in the case of the Central Office
IRB, as appropriate to the facility or facilities for which the research is
proposed.
(5)
exercise appropriate oversight to ensure that:
(A)
its policies and procedures designed for protecting the
rights, privacy, and welfare of human subjects are being effectively applied;
and
(B)
research is being conducted at the facility or facilities
in accordance with the approved protocol;
(6)
maintain records of its operations in accordance with 45
CFR §46.115;
(7)
submit to the ORA documentation of its continuing review
of all approved and active research protocols; and
(8)
immediately notify the ORA of any unanticipated serious
problems or events involving risks to the human subjects or others.
(b)
Each designated IRB has the authority to suspend or terminate
research that is not being conducted in accordance with the IRB's requirements
or that has been associated with significant unexpected harm to human subjects.
If an IRB suspends or terminates research, then the IRB must promptly notify
the following in writing of the suspension or termination and include a statement
of the reasons for the IRB's action:
(1)
the principal investigator;
(2)
appropriate facility or facilities officials; and
(3)
the ORA.
§414.757.Review and Approval of Proposed Research.
(a)
Proposed research must be submitted to the facility's designated
IRB and contain adequate written information for the IRB to determine whether
the requirements described in 45 CFR §46.111, referenced as Exhibit A
in §414.763 of this title (relating to Exhibits), are satisfied, including
the following:
(1)
A complete description of how the research protocol will
be implemented at the facility or facilities, including:
(A)
the process for recruiting, screening, and selecting human
subjects;
(B)
procedures for obtaining and documenting informed consent;
(C)
how many subjects are required at the facility or facilities;
(D)
the process for and level of clinical monitoring of human
subjects throughout the research period;
(E)
procedures for obtaining and documenting authorization
to use or disclose protected health information (PHI) or a request for a waiver
or alteration of authorization with justification; and
(F)
appropriate and sufficient information to enable the facility
to provide an accounting of disclosures as required in 45 CFR §164.528(b),
if the proposed research includes a request for a waiver or alteration of
authorization to use or disclose PHI or the proposed research involves using
or disclosing decedents' protected health information without an authorization.
(2)
A thorough justification of the research protocol and proposed
analyses, including;
(A)
a description of the procedures designed to minimize risks
to subjects; and
(B)
the scientific rationale for targeting the proposed population(s)
as human subjects.
(3)
If the proposed research would extend a human subject's
use of an investigational medication or device as the primary treatment after
the subject is discharged from the facility, then the research proposal must
also contain a memorandum of agreement between the principal investigator
and the local authority responsible for the subject's continuity of care which
states that, before the conclusion of the subject's participation in the research
study, the local authority agrees:
(A)
to make face-to-face contact with the subject to determine
whether the subject will need medication services when the subject's participation
in the research study has ended; and
(B)
to arrange for the provision of needed medication services
for the subject when the subject's participation in the research study has
ended.
(b)
Each designated IRB shall review all proposed research
at the facility in accordance with 45 CFR §46.109, concerning IRB review
of research.
(c)
Each designated IRB has the authority to approve, require
modifications to, or disapprove any proposed research. Approval of proposed
research shall be based on:
(1)
consideration of the information described in subsection
(a)(1) - (3) of this section;
(2)
the IRB's verification that the requirements in following
sections are met:
(A)
45 CFR §46.111, concerning criteria for IRB approval
of research;
(B)
§414.754 of this title (relating to General Principles);
and
(C)
§414.758 of this title (relating to Informed Consent);
and
(3)
the IRB's verification that procedures for obtaining and
documenting authorization to use or disclose PHI meet the requirements in
45 CFR §164.508, unless:
(A)
the IRB approves a waiver or alternation of the authorization
requirement as permitted in §414.760(b) of this title (relating to Using
and Disclosing Protected Health Information in Research); or
(B)
the IRB determines and documents that:
(i)
the data needed for the research is contained in a limited
data set and the researcher will comply with the requirements in 45 CFR §164.514(e),
including the execution of a data use agreement; or
(ii)
the data needed for the research is limited to decedents'
protected health information and documentation submitted by the researcher
meets the requirements in 45 CFR §164.512(i)(1)(iii).
(d)
The designated IRB may take into consideration deliberations
and reviews from another IRB that has approved the protocol for a specific
research proposal, but the designated IRB is ultimately responsible for approval
of the proposed research.
(e)
Research review and documentation process.
(1)
Facility IRB as the designated IRB. The research review
and documentation process for a facility IRB, as described in §414.755(b)(1)
and (2) of this title (relating to Designated Institutional Review Board (IRB)),
is generally as follows.
(A)
The research proposal is reviewed by the facility IRB and,
if approved, forwarded to the CEO of the facility where the research is to
be conducted.
(B)
The facility CEO is informed of the facility IRB's approval
or disapproval and recommendations, if any.
(C)
If the research proposal is approved by the facility IRB,
the facility CEO considers the facility IRB's recommendations, if any, and
either approves or disapproves the research proposal for implementation at
the facility.
(D)
If the research proposal is approved, the ORA is notified
in writing of the CEO's and IRB's approval including copies of the IRB's meeting
minutes concerning the review of the proposal, the proposal itself, and the
CEO's and IRB's documentation of approval.
(2)
University IRB as the designated IRB. The research review
and documentation process for a facility using a university IRB is generally
as follows.
(A)
The research proposal is screened by the facility CEO and,
if determined appropriate for implementation at the facility, forwarded to
the university IRB for review.
(B)
The research proposal is reviewed by the university IRB.
(C)
The facility CEO is informed of the university IRB's approval
or disapproval and recommendations, if any.
(D)
If the research proposal is approved by the university
IRB, the facility CEO considers the university IRB's recommendations, if any,
and either approves or disapproves the research proposal for implementation
at the facility.
(E)
If the research proposal is approved, the ORA is notified
in writing of the CEO's and IRB's approval including copies of the IRB's meeting
minutes concerning the review of the proposal, the proposal itself, and the
CEO's and IRB's documentation of approval.
(3)
Central Office IRB as the designated IRB. The research
review and documentation process for a facility using the Central Office IRB
is generally as follows.
(A)
The research proposal is screened by the facility CEO and,
if determined appropriate for implementation at the facility, forwarded to
the Central Office IRB.
(B)
The research proposal is reviewed by the Central Office
IRB.
(C)
The facility CEO is informed of the Central Office IRB's
approval or disapproval and recommendations, if any.
(D)
If the research proposal is approved by the Central Office
IRB, the facility CEO considers the Central Office IRB's recommendations,
if any, and either approves or disapproves the research proposal for implementation
at the facility.
(E)
If the research proposal is approved, the ORA is notified
in writing of the CEO's and IRB's approval including copies of the IRB's meeting
minutes concerning the review of the proposal, the proposal itself, and the
CEO's and IRB's documentation of approval.
(4)
Central Office IRB as a facility's designated IRB for research
studies involving multiple facilities. When a facility's CEO requests that
the Central Office IRB act as its designated IRB for a research study involving
multiple facilities, pursuant to §414.755(c) of this title (relating
to Designated Institutional Review Board (IRB)), then the research review
and documentation process is generally as follows.
(A)
The research proposal is reviewed and approved by:
(i)
each facility CEO;
(ii)
the Central Office IRB; and
(iii)
the appropriate Central Office director(s), (i.e., director
of state mental health facilities or director of state mental retardation
facilities).
(B)
If the research proposal is approved by the facility CEOs,
the Central Office IRB, and the appropriate Central Office director(s), the
ORA is notified in writing of the approval, including copies of the IRB's
meeting minutes concerning the review of the proposal, the proposal itself,
and documentation of approval of the CEOs and the Central Office IRB.
(f)
In addition to approval by the designated IRB and facility
CEO, review and approval by the TDMHMR medical director is required for any
research proposal involving:
(1)
a placebo as the primary medication therapy;
(2)
medication or doses of medication as the primary medication
therapy which are known to be ineffective for the targeted disorder or condition;
or
(3)
an investigational medication or device.
(g)
The review process for proposed research may require additional
steps as necessary, (e.g., in the event a proposal is initially rejected).
(h)
The facility CEO or designee is responsible for ensuring
that all key researchers are qualified to perform any clinical duties assigned
to them and are knowledgeable of TDMHMR's rules governing the care and protection
of individuals as described in §414.764(5) of this title (relating to
References).
§414.758.Informed Consent.
Requirements for approval of proposed research.
(1)
The procedures for obtaining and documenting informed consent
meet the requirements in 45 CFR §46.116 and §46.117, referenced
as Exhibit A in §414.763 of this title (relating to Exhibits), and adequately
address:
(A)
any extension of the subject's length of stay at the facility
as a result of participation in the research;
(B)
if the research involves an investigational medication
or device, the subject's ability to receive the medication or device after
the research has concluded;
(C)
whether the research involves the use of a placebo and
the likelihood of assignment to the placebo condition;
(D)
whether the research involves medication or doses of medication
which are known to be ineffective for the targeted disorder or condition and
the likelihood of assignment to such medication or doses of medication; and
(E)
any risk of deterioration in the subject's condition and
the potential consequences of such deterioration (e.g., an extension in the
length of stay, the use of interventions such as restraint, seclusion, or
emergency medications).
(2)
For research protocols that present greater than minimal
risk, there are procedures to ensure prospective human subjects are adequately
assessed for capacity to consent and:
(A)
provide for a qualified professional, who is independent
of the research study, to assess prospective human subjects for capacity to
consent;
(B)
describe who will conduct the assessments; and
(C)
describe the nature of the assessment and justification
if less formal procedures to assess capacity will be used.
(3)
If minors are the proposed human subjects, the requirements
in 45 CFR §46.408 (concerning Requirements for Permission by Parents
or Guardians and for Assent by Children) have been met.
(4)
There are procedures to ensure that:
(A)
before obtaining consent, each prospective human subject
or the subject's LAR understands the information provided; and
(B)
if consent is obtained from the subject's LAR, attempts
are made, to the extent possible given the prospective subject's capacity,
to obtain the subject's assent to participation.
(5)
There are adequate safeguards to minimize the possibility
of coercion or undue influence. For example, the possible advantages of the
subject's participation in the research may not be so valuable as to impair
the subject's ability to weigh the risks of the research against those advantages.
Possible advantages within the limited choice environment of a facility may
include enhancement of general living conditions, medical care, quality of
food, or amenities; opportunity for earnings; or change in commitment status.
(6)
There are procedures to ensure that a prospective human
subject's objection to enrollment in research or a human subject's objection
to continued participation in a research protocol is heeded in all circumstances,
regardless of whether the subject or the subject's LAR has given consent.
Objection may be conveyed verbally, in writing, behaviorally, or by other
indications or means. The procedures may, however, provide for a key researcher,
with approval of the LAR (if appropriate) and acting with a level of sensitivity
to avoid the possibility or the appearance of coercion, to approach an individual
who has previously objected to ascertain whether the individual has changed
his/her mind or to approach an individual who has not given consent to ascertain
whether the individual wants to enroll in the research protocol.
(7)
Because informed consent is an ongoing process, there are
procedures to ensure that, throughout the course of the research study, human
subjects' comprehension and capacity are assessed and enhanced.
§414.759.Research Involving Offenders as Human Subjects.
(a)
Definition of offender. "Offender" means any individual
involuntarily confined or detained in a penal institution, including:
(1)
individuals sentenced to a penal institution under criminal
or civil statute;
(2)
individuals detained in other facilities by virtue of statutes
or commitment procedures that provide alternatives to criminal prosecution
or incarceration in a penal institution; and
(3)
individuals detained pending arraignment, trial, or sentencing.
(b)
IRB membership. In addition to the requirements in §414.755(d)
of this title (relating to Designated Institutional Review Board (IRB)), membership
of an IRB that will review proposed research involving offenders or alleged
offenders as human subjects must include at least one member who is an offender
advocate or representative with appropriate background and experience to serve
in that capacity.
(c)
Permitted research. Research at a facility may involve
offenders or alleged offenders as human subjects only if, in the judgment
of the designated IRB, the proposed research involves solely the following:
(1)
study of the possible causes, effects, and processes of
criminal commitment or criminal confinement, or of criminal behavior, provided
that the study presents no more than minimal risk and no more than inconvenience
to the subjects;
(2)
study of facilities as institutional structures or of individuals
criminally committed to a facility, provided that the study presents no more
than minimal risk and no more than inconvenience to the subjects;
(3)
research on conditions particularly affecting individuals
criminally committed to a facility as a class; or
(4)
research on treatments or practices, both innovative and
accepted, which have the intent and reasonable probability of improving the
health or well-being of the subjects.
§414.760.Using and Disclosing Protected Health Information (PHI) in Research.
(a)
Except as provided by this section, in order to use or
disclose protected health information (PHI), an authorization is required
that:
(1)
conforms with the requirements of 45 CFR §164.508;
and
(2)
if the research includes treatment, includes a statement
that the subject's right to access his or her PHI created or obtained during
the course of research may be temporarily suspended for as long as the research
is in progress, and will be reinstated upon completion of the research.
(b)
During the review of proposed research, the designated
IRB has the authority to approve a waiver or alteration of the authorization
requirement in accordance with 45 CFR §164.512(i).
(c)
The designated IRB has the authority to approve the use
or disclosure of PHI for purposes preparatory to research if the IRB obtains
from the researcher adequate representations as required by 45 CFR §164.512(i)(1)(ii).
(d)
For a research study approved prior to April 14, 2003,
the PHI of a human subject participating in the study may be used or disclosed
for the research study if one of the following was obtained prior to April
14, 2003:
(1)
an authorization or other express legal permission from
the subject or the subject's LAR to use or disclose PHI for the research study;
(2)
informed consent of the subject to participate in the research
study or informed consent from the subject's LAR for the subject to participate
in the research study; or
(3)
a waiver of informed consent by the designated IRB for
the research study.
§414.761.Investigation of Allegations of Misconduct in Science.
(a)
All research undertaken at facilities shall be conducted
with a fundamental commitment to high ethical standards regarding the conduct
of scientific research.
(b)
Reports of alleged misconduct in science are made to the
ORA, who shall ensure that:
(1)
each allegation is reviewed and investigated by an appropriate
entity in accordance with 42 CFR 50, Subpart A, referenced as Exhibit C in §414.763
of this title (relating to Exhibits);
(2)
the investigating entity submits to the ORA information
documenting the disposition of each allegation; and
(3)
the following are notified of confirmed incidents of misconduct
in science:
(A)
the IRB that approved the research protocol; and
(B)
the agency funding the research.
§414.762.Responsibilities of the Office of Research Administration (ORA).
The ORA is responsible for:
(1)
approving the establishment or utilization of an IRB by
a facility as the facility's designated IRB;
(2)
providing staff support to the Central Office IRB;
(3)
reviewing and developing TDMHMR rules and policies governing
the conduct of research at facilities;
(4)
maintaining all documentation regarding a designated IRB's
review of research for a facility;
(5)
receiving reports of misconduct in science, ensuring each
allegation of misconduct in science is reviewed and investigated, and maintaining
and reporting information regarding misconduct in science as required by the
Office of Research Integrity in accordance with 42 CFR 50, Subpart A, referenced
as Exhibit C in §414.762 of this title (relating to Exhibits); and
(6)
providing technical assistance and interpretation of policies,
procedures, TDMHMR rules, and regulations concerning the conduct of research
involving human subjects at facilities.
§414.763.Exhibits.
The following exhibits are referenced in this subchapter, copies of
which are available by contacting TDMHMR, Office of Policy Development, P.O.
Box 12668, Austin, TX 78711-2668:
(1)
Exhibit A--Title 45, Code of Federal Regulations, Part
46 (Protection of Human Subjects), Subparts A, B, and D;
(2)
Exhibit B--"The Belmont Report: Ethical Principles and
Guidelines for the Protection of Human Subjects of Research, Report of the
National Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research" (April 18, 1979); and
(3)
Exhibit C--Title 42, Code of Federal Regulations, Part
50, Subpart A (Responsibility of PHS Awardee and Applicant Institutions for
Dealing With and Reporting Possible Misconduct in Science).
§414.764.References.
The following statutes and TDMHMR rules are referenced in this subchapter:
(1)
Title 45, Code of Federal Regulations, Part 46 (2002) (Protection
of Human Subjects), Subparts A, B, and D;
(2)
Title 42, Code of Federal Regulations, Part 50, Subpart
A (2002) (Responsibility of PHS Awardee and Applicant Institutions for Dealing
With and Reporting Possible Misconduct in Science);
(3)
Title 45, Code of Federal Regulations, Part 160 and Part
164, Subparts A and E (2002) (Standards for Privacy of Individually Identifiable
Health Information);
(4)
Texas Health and Safety Code, Chapter 574 and §533.035;
and
(5)
TDMHMR rules governing the care and protection of individuals,
which address:
(A)
rights and protection of persons receiving services in
TDMHMR facilities;
(B)
consent to treatment with psychoactive or psychotropic
medication;
(C)
interventions involving persons receiving services in TDMHMR
facilities; and
(D)
abuse, neglect, and exploitation of persons receiving services
in TDMHMR facilities.
§414.765.Distribution.
This subchapter is distributed to:
(1)
all members of the Texas Mental Health and Mental Retardation
Board;
(2)
executive, management, and program staff of Central Office;
(3)
CEOs of all facilities; and
(4)
advocacy organizations.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on December 18, 2003.
TRD-200308644
Rodolfo Arredondo
Chairman, Texas MHMR Board
Texas Department of Mental Health and Mental Retardation
Earliest possible date of adoption: February 1, 2004
For further information, please call: (512) 206-4516