Part 2.
TEXAS DEPARTMENT OF MENTAL HEALTH AND MENTAL RETARDATION
Chapter 401.
SYSTEM ADMINISTRATION
Subchapter E. CONTRACTS MANAGEMENT
25 TAC §§401.371 - 401.380, 401.387 - 401.399
The Texas Department of Mental Health and Mental Retardation
(TDMHMR) adopts the repeals of §§401.371 - 401.380 and §§401.387
- 401.399 of Chapter 401, Subchapter E, concerning contracts management, without
changes to the proposal as published in the December 29, 2000, issue of the
The repeals allow for the adoption of new and more current rules governing
the same matters.
No comment on the proposal was received.
These sections are repealed under the Texas Health and Safety
Code, §532.015, which provides the Texas Board of Mental Health and Mental
Retardation (board) with broad rulemaking authority; §533.016, which
allows TDMHMR to adopt rules relating to certain procurements of goods and
services; §533.034, which provides TDMHMR with the authority to contract
for community-based services; and §534.059(b), which requires TDMHMR's
contract rules to provide for sanctions if TDMHMR intends to sanction a local
mental health or mental retardation authority's for failing to comply with
its performance contract.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on June 8, 2001.
TRD-200103217
Andrew Hardin
Chairman, Texas MHMR Board
Texas Department of Mental Health and Mental Retardation
Effective date: July 1, 2001
Proposal publication date: December 29, 2000
For further information, please call: (512) 206-5216
Subchapter B. ABUSE, NEGLECT, AND EXPLOITATION OF PEOPLE SERVED BY PROVIDERS OF LOCAL AUTHORITIES
25 TAC §§404.41 - 404.55
The Texas Department of Mental Health and Mental Retardation
(TDMHMR) adopts the repeals of §§404.41 - 404.55 of Chapter 404,
Subchapter B, concerning abuse, neglect, and exploitation of people served
by providers of local authorities, without changes to the proposal as published
in the February 9, 2001, issue of the
Texas Register
(26TexReg1233). New §§414.551 - 414.564 of Chapter 414,
Subchapter L, concerning abuse, neglect, and exploitation in local authorities
and community centers, which replace the repealed sections, are contemporaneously
adopted in this issue of the
Texas Register
.
The repeals allow for the adoption of new sections governing the same matters.
The subchapter is repealed as part of the reorganization of the TDMHMR
rule base to reflect current operational and organizational relationships.
The contemporaneous repeal and adoption of these subchapters would fulfill
the requirements of the Texas Government Code, §2001.039, concerning
the periodic review of agency rules.
No comment was received on the proposed repeals.
These sections are repealed under the Texas Health and Safety
Code, §532.015, which provides the Texas Mental Health and Mental Retardation
Board with broad rulemaking authority; the Texas Human Resources Code, Chapter
48, which requires the reporting and investigations of abuse, neglect, and
exploitation of elderly and disabled persons; §48.255(c), which requires
TDMHMR and TDPRS to develop joint rules to facilitate the investigations in
community centers and local authorities; the Texas Family Code, Chapter 261,
which requires the reporting and investigations of abuse and neglect of a
child; and the Texas Civil Practice and Remedies Code, §81.006, which
requires the reporting of alleged sexual exploitation by a mental health services
provider to the county prosecuting attorney.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on June 8, 2001.
TRD-200103215
Andrew Hardin
Chairman, Texas MHMR Board
Texas Department of Mental Health and Mental Retardation
Effective date: July 1, 2001
Proposal publication date: February 9, 2001
For further information, please call: (512) 206-5216
Subchapter P. RESEARCH IN DEPARTMENT FACILITIES
25 TAC §§405.401 - 405.411, 405.414 - 405.417
The Texas Department of Mental Health and Mental Retardation
(TDMHMR) adopts the repeals of §§405.401 - 405.411 and 405.414 -
405.417 of Chapter 405, Subchapter P, concerning research in department facilities,
without changes to the proposal as published in the March 30, 2001, issue
of the
Texas Register
(26TexReg2478). New §§414.751
- 414.764 of Chapter 414, Subchapter P, concerning research in TDMHMR facilities,
which replace the repealed sections, are contemporaneously adopted in this
issue of the
Texas Register
.
The repeals allow for the adoption of new sections governing the same matters.
The subchapter is repealed as part of the reorganization of the TDMHMR
rule base to reflect current operational and organizational relationships.
The contemporaneous repeal and adoption of these subchapters would fulfill
the requirements of the Texas Government Code, §2001.039, concerning
the periodic review of agency rules.
No comment on the proposal was received.
These sections are repealed under the Texas Health and Safety
Code, §532.015, which provides the Texas MHMR Board (board) with broad
rulemaking authority, and §576.021, which states that a patient receiving
mental health services under the Texas Mental Health Code (Texas Health and
Safety Code, Title 7, Subtitle C) has the right to refuse to participate in
a research program.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on June 8, 2001.
TRD-200103213
Andrew Hardin
Chairman, Texas MHMR Board
Texas Department of Mental Health and Mental Retardation
Effective date: July 1, 2001
Proposal publication date: March 30, 2001
For further information, please call: (512) 206-5216
Subchapter B. CONSTRUCTION BIDDING PROCEDURES
25 TAC §§407.51 - 407.58
The Texas Department of Mental Health and Mental Retardation
(TDMHMR) adopts the repeals of §§407.51 - 407.58 of Chapter 407,
Subchapter B, concerning construction bidding procedures, without changes
to the proposal as published in the December 29, 2000, issue of the
The repeals allow for the adoption of new and more current rules governing
the same matters.
No comment on the proposal was received.
These sections are repealed under the Texas Health and Safety
Code, §551.007(c), which requires TDMHMR to adopt rules relating to awarding
contracts for the construction of buildings and improvements.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on June 8, 2001.
TRD-200103218
Andrew Hardin
Chairman, Texas MHMR Board
Texas Department of Mental Health and Mental Retardation
Effective date: July 1, 2001
Proposal publication date: December 29, 2000
For further information, please call: (512) 206-5216
Subchapter L. ABUSE, NEGLECT, AND EXPLOITATION IN LOCAL AUTHORITIES AND COMMUNITY CENTERS
25 TAC §§414.551 - 414.564
The Texas Department of Mental Health and Mental Retardation
(TDMHMR) adopts new §§414.551 - 414.564 of Chapter 414, Subchapter
L, concerning abuse, neglect, and exploitation in local authorities and community
centers. Sections 414.553, 414.555, 414.559, 414.562, and 414.563 are adopted
with changes to the proposed text as published in the February 9, 2001, issue
of the
Texas Register
(26 TexReg 1233). Sections
414.551, 414.552, 414.554, 414.556 - 414.558, 414.560, 414.561, and 414.564
are adopted without changes. The repeals of §§404.41 - 404.55 of
Chapter 404, Subchapter B, concerning abuse, neglect, and exploitation of
people served by providers of local authorities, which the new sections replace,
are contemporaneously adopted in this issue of the
Texas Register
.
The subchapter describes the requirements for reporting allegations of
abuse, neglect, and exploitation of persons served in community centers, local
authorities, and their contractors; ensuring the safety and protections of
persons served involved in allegations; facilitating investigations; and ensuring
proper disciplinary or other action is taken when abuse, neglect, or exploitation
is confirmed.
The new subchapter is adopted as part of the reorganization of the TDMHMR
rule base to reflect current operational and organizational relationships.
The contemporaneous adoption and repeal of these subchapters fulfill the requirements
of the Texas Government Code, §2001.039, concerning the periodic review
of agency rules.
The definition of "investigatory agency" has been modified to clarify that
the Texas Department of Protective and Regulatory Services (TDPRS) investigates
allegations in intermediate care facilities for the mentally retarded or persons
with a related condition (ICF/MR or ICF/MR/RC) operated by a local authority
or community center. Language has also been added to the examples in the definition
to state that the Texas Commission on Alcohol and Drug Abuse (TCADA) investigates
allegations in TCADA-funded programs operated by a local authority or community
center pursuant to a contract with TCADA. The definition of "person served"
has been modified to be consistent with TDPRS companion rules, which were
contemporaneously proposed and recently adopted.
The phrase "(if appropriate)" has been deleted in §414.555(b) to eliminate
confusion regarding whether it is appropriate to notify the alleged victim
of an allegation. Language has been added to §414.559(c) to reference
a new exhibit, which is a copy of the federal statute cited in the subsection.
The exhibits and references sections have been modified to reflect changes
made to the subchapter upon adoption.
Written comment on the proposal was received from the Heart of Texas Region
Mental Health and Mental Retardation Center, Waco; the Parent Association
for the Retarded of Texas (PART), Austin; Life Management Center for MHMR,
El Paso; the parent of a state school resident, Garland; and two private citizens,
El Paso and Houston.
One commenter requested that the rules address the perpetrator's right
to appeal the investigatory agency's finding and the perpetrator's right to
review the investigative report. TDMHMR responds that it cannot adopt rules
governing matters in another agency's purview. Each investigatory agency is
responsible for determining whether it will provide a process for the perpetrator
to appeal its finding and review its investigative report.
Two commenters expressed concern that physicians, nurses, dentists, and
pharmacists are the only licensed staff to go through a peer review process.
The commenter stated that all licensed staff, including licensed professional
counselors (LPCs) and social workers (ACPs), should undergo peer review. TDMHMR
responds that pursuant to 25 TAC §412.312(e) (relating to Competency
and Credentialing), local mental health authorities are required to have a
peer review process for all licensed staff that promotes sound clinical practice
and professional growth. The section also directs the peer review process
to comply with applicable state laws. Currently state law requires
investigative
peer review for physicians, nurses, dentists, and pharmacists.
Neither TDMHMR rules nor TDPRS companion rules preclude a local authority
or community center from having an investigative peer review process for its
licensed staff who are not physicians, nurses, dentists, and pharmacists.
Regarding the definition of "investigatory agency" in §414.553(11),
two commenters suggested adding clarification that TDHS is the investigating
agency for ICFs/MR in the community and that TDPRS is the investigating agency
for state schools, which are also ICFs/MR. TDMHMR responds that TDHS investigates
allegations in all ICFs/MR that are not operated by TDMHMR, a local authority,
or community center. Language has been added to clarify that TDPRS investigates
allegations in ICFs/MR operated by a local authority or community center.
Regarding the definition of "person served" in §414.553(15), two commenters
suggested adding language to clarify that a person served has a disability
of mental retardation (or related condition) or mental illness. The commenters
expressed concern that no one outside of the TDMHMR service system would know
which persons are registered or assigned in the Client Assignment and Registration
(CARE) system. TDMHMR responds by adding language that responds to the commenters'
concerns.
Regarding notification of the victim or alleged victim in §414.555(b)
and (c), two commenters supported the use of "if appropriate" in subsection
(b) to reflect that it is not always appropriate to notify the victim or alleged
victim. The commenters also recommended adding "if appropriate" to subsection
(c) as well. TDMHMR responds that when an allegation of abuse, neglect, or
exploitation is made, alleged victims, as well as their guardians, should
be notified that the situation has been reported and will be investigated.
They also should be informed of the outcome of the investigation. TDMHMR supports
open communication between consumers and staff regardless of an alleged victim's
perceived level of functioning or understanding. In absence of evidence that
such notification is a harmful practice, TDMHMR declines to add language as
recommended. Additionally, the phrase "(if appropriate)" has been deleted
in §414.555(b) to eliminate confusion regarding the matter.
Regarding Advocacy, Inc. having access to the records of persons served
in §414.559(c), two commenters objected to the rule's language because
it does not articulate the conditions under which Advocacy, Inc. could have
access to such records without consent from the person served or the person's
legally authorized representative (LAR). The commenters suggested TDMHMR use
the language proposed by TDPRS in 40 TAC, Part 19, §711.1201 relating
to Advocacy, Inc.'s access to records. TDMHMR responds that language proposed
by TDPRS does not address in enough detail all of the statutory conditions
under which Advocacy, Inc. could have access to records. To address the commenters'
concern, TDMHMR has added language to reference a new exhibit, which is a
copy of the federal statute cited that sets out all of the statutory conditions
under which Advocacy, Inc. could have access to records.
One commenter recommended a seamless complaint process instead of a process
involving two or more state agencies, Advocacy, Inc., local police departments,
and in some places, local investigations by the provider. The commenter noted
that with so many alternatives to pursuing a complaint, and with so many different
entities potentially involved, consumers are often confused. Given the respective
roles and procedures of local providers and the state, consumers are also
dispirited because they feel that nothing will be done. The commenter recommended
a central agency to accept every complaint and be responsible for tracking
its resolution. TDMHMR responds that allegations or complaints by consumers
may be reported to TDPRS, the rights protection officer, or both. TDPRS was
created to serve as the central agency for receiving and investigating allegations
and complaints that involve abuse, neglect, or exploitation in TDMHMR-operated
and-contracted programs. Complaints of a general nature that don't explicitly
involve abuse, neglect, or exploitation are received and investigated by the
rights protection officer. If TDPRS receives a complaint that does not involve
abuse, neglect, or exploitation, then TDPRS will instruct the caller to report
the complaint to the rights protection officer or will accept the report and
refer it to the administrator for resolution. If the rights protection officer
receives a complaint or allegation that involves abuse, neglect, or exploitation,
then the officer will refer the allegation to TDPRS.
A commenter made remarks concerning the inability of the alleged perpetrator
to have full access to information concerning allegations of abuse including,
but not limited to, the name of the accuser. The commenter stated that reports
that have been de-identified are meaningless. The commenter noted that an
allegation of abuse could result in criminal prosecution and that under the
United States Constitution, the alleged perpetrator should have the right
to know his or her accuser. TDMHMR responds that the commenter's concern relates
to the rules of the investigatory agency as limited by state statute. The
confidentiality of information related to TDPRS investigations is governed
by the Human Resources Code, §48.101, and recently adopted TDPRS rules.
Although §48.101(a)(2) protects the identity of persons who report an
allegation, presumably because of the potential for retaliation, §48.101(c)
permits a court to order the disclosure of any confidential information under
certain conditions.
The new sections are adopted under the Texas Health and Safety
Code, §532.015, which provides the Texas Mental Health and Mental Retardation
Board with broad rulemaking authority; the Texas Human Resources Code, Chapter
48, which requires the reporting and investigations of abuse, neglect, and
exploitation of elderly and disabled persons; §48.255(c), which requires
TDMHMR and TDPRS to develop joint rules to facilitate the investigations in
community centers and local authorities; the Texas Family Code, Chapter 261,
which requires the reporting and investigations of abuse and neglect of a
child; and the Texas Civil Practice and Remedies Code, §81.006, which
requires the reporting of alleged sexual exploitation by a mental health services
provider to the county prosecuting attorney.
§414.553.Definitions.
The following words and terms, when used in this subchapter, have the
following meanings, unless the context clearly indicates otherwise:
(1)
Abuse--For purposes of reporting allegations, the term
is defined by the investigatory agency. For purposes of classifying allegations
as part of the TDMHMR Client Abuse and Neglect Reporting System (CANRS), the
term is defined in CANRS Definitions, which is referenced as Exhibit A of §414.562
of this title (relating to Exhibits).
(2)
Administrator--The individual in charge of a local authority
or community center, or designee.
(3)
Agent--Any individual not employed by a local authority,
community center, or contractor, but working under the auspices of the local
authority, community center, or contractor (e.g., student, volunteer).
(4)
Allegation--A report by an individual suspecting or having
knowledge that a person served has been or is in a state of abuse, neglect,
or exploitation as defined by the investigatory agency or in CANRS Definitions,
which is referenced as Exhibit A in §414.562 of this title.
(5)
Clinical practice--Relates to the demonstration of professional
competence by a licensed professional.
(6)
Community center--A community mental health center, community
mental retardation center, or community mental health and mental retardation
center, established under the Texas Health and Safety Code, Title 7, Chapter
534, Subchapter A.
(7)
Confirmed--The finding of an investigation if there is
a preponderance of credible evidence to support that abuse, neglect, or exploitation
occurred.
(8)
Contractor--Any organization, entity, or individual who
contracts with a local authority or community center to provide mental health
or mental retardation services to a person served. The term includes a local
independent school district with which a local authority or community centers
has a memorandum of understanding (MOU) for educational services.
(9)
Contractor CEO--The individual in charge of a contractor
that has one or more employees excluding the CEO.
(10)
Exploitation--For purposes of reporting allegations, the
term is defined by the investigatory agency. For purposes of classifying allegations
as part of the TDMHMR CANRS, the term is defined in CANRS Definitions, which
is referenced as Exhibit A in §414.562 of this title.
(11)
Investigatory agency--An agency with statutory authority
to investigate abuse, neglect, and exploitation of a person served by a local
authority, community center, or contractor. For example, the Texas Department
of Protective and Regulatory Services investigates allegations in local authorities
and community centers (including intermediate care facilities for the mentally
retarded or persons with a related condition (ICF/MR or ICF/MR/RC) operated
by a local authority or community center) and all contractors of local authorities
and community centers except psychiatric hospitals; the Texas Department of
Health (TDH) investigates allegations in psychiatric hospitals; and the Texas
Commission on Alcohol and Drug Abuse (TCADA) investigates allegations in TCADA-funded
programs operated by a local authority or community center pursuant to a contract
with TCADA.
(12)
Local authority--An entity designated by the TDMHMR commissioner
in accordance with the Texas Health and Safety Code, §533.035(a).
(13)
Neglect--For purposes of reporting allegations, the term
is defined by the investigatory agency. For purposes of classifying allegations
as part of the TDMHMR CANRS, the term is defined in CANRS Definitions, which
is referenced as Exhibit A in §414.562 of this title.
(14)
Perpetrator--An individual who has committed an act of
abuse, neglect, or exploitation.
(15)
Person served--
(A)
Any person with mental illness or mental retardation receiving
services from a local authority or community center or through a contract
with a local authority or community center who is registered or assigned in
the Client Assignment and Registration (CARE) system; or
(B)
any child or disabled person as defined in the Human Resources
Code, Chapter 48, who is otherwise receiving services from a local authority
or community center or through a contract with a local authority or community
center.
(16)
Professional review--A review of clinical and/or professional
practice(s) by peer professionals.
(17)
Retaliatory action--Any action intended to inflict emotional
or physical harm or inconvenience on an employee, agent, or person served
that is taken because he or she has reported abuse, neglect, or exploitation.
Retaliatory action includes, but is not limited to, harassment, disciplinary
measures, discrimination, reprimand, threat, and criticism.
§414.555.Information To Be Provided to Victim or Alleged Victim and Others.
(a)
Each local authority and community center shall promulgate
and implement policies and procedures that meet the requirements of this section.
(b)
As soon as possible, but no later than 24 hours following
notification of an allegation by the investigatory agency, the administrator
or contractor CEO shall notify the alleged victim and the alleged victim's
guardian or parent (if the alleged victim is a minor) of the allegation.
(c)
The administrator or contractor CEO shall ensure that the
victim or alleged victim, guardian, or parent (if the victim or alleged victim
is a minor) is notified of:
(1)
the finding and any decisions made after review and/or
appeal of the finding;
(2)
the method to appeal the finding, if any;
(3)
how to receive a copy of the investigative report; and
(4)
if the allegation is confirmed, the disciplinary or other
action taken against the perpetrator.
§414.559.Confidentiality of Investigative Process and Report.
(a)
The reports, records, and working papers used by or developed
in the investigative process by an investigatory agency, and the investigatory
agency's resulting investigative report, are confidential and may be disclosed
only as allowed by law or rule.
(b)
Upon request, the administrator or contractor CEO will
provide a copy of the investigative report to the victim or alleged victim
or guardian with the identities of other persons served and any information
determined confidential by law concealed. The administrator or contractor
CEO may charge a reasonable fee for providing a copy of the investigative
report.
(c)
Advocacy, Inc. is entitled to access the records of persons
served in accordance with 42 USC §10805 and §10806 or §6042(a)(2)(I)
(Protection and Advocacy of Individuals with Mental Illness and Protection
and Advocacy of Individuals with Developmental Disabilities). A copy of 42
USC §10805, §10806, and §6042(a)(2)(I) are referenced as Exhibit
F in §414.562 of this title (relating to Exhibits).
§414.562.Exhibits.
The following exhibits are referenced in this subchapter:
(1)
Exhibit A--CANRS Definitions;
(2)
Exhibit B--"Guidelines for Securing Evidence";
(3)
Exhibit C--a copy of the Texas Civil Practice and Remedies
Code, §81.001 and §81.006;
(4)
Exhibit D--CANRS Classifications;
(5)
Exhibit E--Client Abuse and Neglect Report form (AN-1-A);
and
(6)
Exhibit F--a copy of 42 USC §10805, §10806, and §6042(a)(2)(I).
§414.563.References.
Reference is made to the following statutes and rules:
(1)
Texas Health and Safety Code, Chapter 534, Subchapter A,
and §533.035(a);
(2)
Texas Civil Practices and Remedies Code, Chapter 81;
(3)
Human Resources Code, §48.255(c);
(4)
42 USC §10805, §10806, and §6042(a)(2)(I);
and
(5)
Texas Administrative Code, Title 40, Chapter 711 (relating
to Investigations in TDMHMR Facilities and Related Programs).
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed with the Office of
the Secretary of State on June 8, 2001.
TRD-200103214
Andrew Hardin
Chairman, Texas MHMR Board
Texas Department of Mental Health and Mental Retardation
Effective date: July 1, 2001
Proposal publication date: February 9, 2001
For further information, please call: (512) 206-4516
25 TAC §§414.751 - 414.764
The Texas Department of Mental Health and Mental Retardation
(TDMHMR) adopts new §§414.751 - 414.764 of Chapter 414, Subchapter
P, concerning research in TDMHMR facilities. Sections 414.755, 414.757, 414.758,
414.760, and 414.761 are adopted with changes to the proposed text as published
in the March 30, 2001, issue of the
Texas Register
(26TexReg2480-2487). Sections 414.751 - 414.754, 414.756, 414.759,
414.762 - 414.764 are adopted without changes. The repeals of §§405.401
- 405.411 and 405.414 - 405.417 of Chapter 405, Subchapter P, concerning Research
in Department Facilities, which the new sections replace, are contemporaneously
adopted in this issue of the
Texas Register
.
The new sections establish uniform guidelines for the review, approval,
conduct, and oversight of research in TDMHMR facilities. The sections 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 new subchapter
adopts by reference Title 45, Code of Federal Regulations, Part 46 (Protection
of Human Subjects), to ensure the protection of human subjects involved in
research; 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), to ensure ethical principles are maintained
when research involving human subjects is conducted; and adopts by reference
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).
The new subchapter is adopted as part of the reorganization of the TDMHMR
rule base to reflect current operational and organizational relationships.
The contemporaneous adoption and repeal of these subchapters fulfill the requirements
of the Texas Government Code, §2001.039, concerning the periodic review
of agency rules.
Language has been modified in §414.755(d)(1)(B)(iii), (2)(B)(iii),
and (3)(B)(i)-(ii) to broaden the possible scope of the advocate's representation
on the IRB. Language has been added to §414.757(a) requiring research
proposals that extend human subjects' use of an investigational medication
or device as the primary treatment after discharge from the facility to contain
assurances that subjects receive appropriate continuity of care. Language
in §414.757(f) was modified to clarify that any research proposal described
in paragraphs (1)-(3) required approval by the TDMHMR medical director. The
proposed phrase "from prospective human subjects" in §414.758(a)(1) and
(2) has been deleted because it wrongly implied that informed consent could
not be obtained from the LAR. Language has been added to §414.758(b)(1)
clarifying that, before approaching potential subjects who have previously
objected to participating in a research protocol, the key researcher must
obtain approval of the subjects' LARs, if applicable. Language has been modified
in §414.760(b)(3) requiring the ORA to ensure that the agency funding
the research is notified of confirmed misconduct in science, rather than allegations
of misconduct in science. Language has been added to the same paragraph requiring
the ORA to ensure that the IRB that approved the research protocol is notified
of confirmed misconduct in science in the research study. Language has been
added to §414.761(5) requiring the ORA to report misconduct in science
information in accordance with 42 CFR 50, Subpart A.
Written comment on the proposal was received from Advocacy, Inc., Austin;
a private citizen, Heath; a professor and vice chair for research at the University
of Texas Medical School, Houston; a parent of a state school resident, Garland;
and Lubbock Regional MHMR Center, Lubbock.
One commenter stated that the proposed rules provide a fair compromise
between protecting the rights of the individual, including the right to informed
consent and freedom from coercion, without making the research environment
so cumbersome that it would impede much needed and valued research. TDMHMR
appreciates the commenter's support of the proposed rules.
One commenter expressed full agreement with the proposed rules. TDMHMR
appreciates the commenter's agreement.
Two commenters disagreed with the prohibition of research protocols that
extend a human subject's use of placebos into the community in §414.754(j)(3).
One of the commenters stated that situations exist in which an outpatient
placebo-controlled study is necessary in order to determine efficacy of a
maintenance treatment. The other commenter, who is an active clinical researcher,
stated that studies done in the community with a placebo do not always carry
high risk. The commenter noted that "the benefits of a subject's close supervision,
free medical care, and early withdrawal from such trials in the early phase
(to minimize distress) can often outweigh the small theoretical risk" and
"patients with stable psychotic conditions with no prior history of self-harm
or violence can safely be monitored in such a scenario." The commenter suggested
that the rules provide for a "second opinion from an outside consultant (who
is a practicing clinical or academic psychiatrist)" in cases in which Central
Office denies approval for the research study. TDMHMR responds that the rules'
prohibition of research protocols that extend a human subject's use of placebos
into the community is consistent with the rules' applicability and scope,
which are limited to research conducted in TDMHMR facilities. Although TDMHMR
agrees with the commenters that studies conducted in the community with a
placebo have value and do not always carry high risk, TDMHMR must consider
the effects that such studies would have on facility resources and the facility's
designated IRB, which is responsible for monitoring all research protocols
that it approves. Regarding a second opinion from an outside consultant when
Central Office denies approval for the research study, TDMHMR responds that
Central Office does not approve or deny research proposals; a facility's designated
IRB and the facility CEO are responsible for approving and denying research
proposals. If the commenter is referring to §414.757(f), in which certain
research proposals require additional approval from the TDMHMR medical director
in Central Office, then TDMHMR responds that, although the rules do not preclude
the medical director from seeking a second opinion, it declines to require
that a second opinion be obtained because the medical director is ultimately
responsible for making the final decision. TDMHMR notes that an outside consultant
would be unable to consider the varied issues that may be a consideration
in approval or disapproval by the medical director.
Regarding the definition of "assent" in §414.753(1), one commenter
asked how an individual who does not have capacity or legal authority to consent
could make an affirmative agreement to participate in research. The commenter
requested that the definition be deleted because "TDMHMR must have 'informed
consent' to allow individuals to participate in research." TDMHMR responds
that the subchapter's use of the term "assent" in §414.758 does not negate
the requirement to obtain informed consent. It merely requires that procedures
be in place to attempt, to the extent possible given the prospective subject's
capacity, to obtain the subject's assent to participation after the subject's
LAR has provided consent. TDMHMR declines to delete the definition.
Regarding TDMHMR's assurances of protection for human subjects in §414.754(e),
(m), and (n), one commenter stated that she did not trust TDMHMR to comply
with its rules because "the same people who allowed the QLS (Quality of Life
Study) violations to happen are the ones who are suppose(d) to see this protection
is done." The commenter stated she identified three violations related to
confidentiality and informed consent in the 1995-1996 research study. TDMHMR
responds that concerns raised by the Quality of Life Study were given major
consideration in the previous revision of the department's research rules.
The new rules governing research in facilities became effective in November
1996 after the QLS concluded. The new rules articulated TDMHMR's policy that
the guiding principle for all research involving human subjects is the safety,
well-being, and dignity of the subject. The rules also were revised to contain
additional safeguards and procedures that provided a higher level of scrutiny
of research proposals and greater protection for human subjects. The provisions
of this subchapter continue to provide for that high level of scrutiny of
research proposals and protection for human subjects.
Regarding membership of the facility IRB and the university IRB in §414.755(d)(1)(B)(ii)
and (iii) and §414.755(d)(2)(B)(ii) and (iii), one commenter requested
that references to family member and advocate be changed to LAR (legally authorized
representative). The commenter objected to "an advocate like Advocacy, Inc."
being a member of a designated IRB. TDMHMR responds that the role of the "family
member" or "advocate" as an IRB member is to provide input and perspectives
related to the mental disorders/conditions and concerns of the population(s)
served by the facility. TDMHMR declines to change the language as requested
because it would unnecessarily eliminate qualified persons from serving on
an IRB. TDMHMR notes that the rule requirement does not preclude an LAR from
being an IRB member, if the LAR were also a family member or advocate.
Regarding a description of the research protocol in §414.757(a)(1),
one commenter suggested adding two subparagraphs requiring the research protocol
description to include a process to protect confidentiality and a process
to obtain and document informed consent. TDMHMR responds that adding language
as suggested by the commenter is unnecessary because federal regulations,
specifically 45 CFR 46, §46.111 (which are adopted by reference), require
IRB approval to be dependent on the protocol meeting the regulations' criteria
for obtaining and documenting informed consent and for protection of confidentiality.
Regarding the research review and documentation process for the university
IRB and the Central Office IRB in §414.757(e)(2)-(4), one commenter objected
to the facility CEO having "all the control and approval." The commenter requested
that language be added requiring the facility IRB to review and approve the
research proposal in addition to the facility CEO. TDMHMR declines to add
language requiring the facility IRB to review and approve the research proposal
because the processes described in paragraphs (2)-(4) indicate that the facility
does not have a
facility IRB
. (The process
described in paragraph (1) indicates that the facility has a facility IRB.)
TDMHMR notes that §414.755(b) requires each facility that participates
in research to have a
designated IRB
, which
can be a facility IRB, another facility's IRB, a university IRB, or the Central
Office IRB. Additionally, TDMHMR does not agree that the facility CEO has
"all the control and approval" and notes that a facility CEO cannot approve
a research protocol that has been disapproved by the facility's designated
IRB. TDMHMR also notes that an IRB reviews research proposals using established
criteria related to ethical principles and protection of human subjects, while
a facility CEO reviews research proposals for their potential impact on the
facility's operations and resources.
Regarding informed consent in §414.758(a)(1)-(2), one commenter suggested
adding "or LAR" after the phrase "obtaining and documenting informed consent
from prospective human subjects." TDMHMR responds that, although the definition
of "informed consent" provides for an LAR's approval, it agrees with the commenter's
perception that the phrase "from prospective human subjects" in §414.758
seems to imply that informed consent cannot be obtained from the LAR. Rather
than adding "or LAR," TDMHMR has deleted the phrase "from prospective human
subjects" from §414.758(a)(1) and (2).
Regarding minors and informed consent in §414.758(a)(3), one commenter
requested that the requirement apply to individuals with LARs as well as minors.
TDMHMR declines to add language as requested by the commenter because the
paragraph requires compliance with 45 CFR 46, §46.408, which concerns
only minor children. TDMHMR notes that the specifically cited federal regulations
(i.e., 45 CFR 46, §46.408) do not provide additional protections for
minors as human subjects. The regulations mainly ensure that parents of minor
children are afforded their full rights and responsibilities, which are substantially
broader than the rights and responsibilities of parents of adult children
and for an LAR of an adult.
Regarding approaching individuals who previously objected or who have not
given actual consent in §414.758(b)(1), one commenter suggested adding
a sentence to state, "These approaches will only be attempted after obtaining
the consent of the individual's LAR." TDMHMR responds by modifying language
which addresses the commenter's concern.
Regarding assessing comprehension and capacity throughout the course of
the research protocol in §414.758(b)(2), one commenter stated that the
paragraph should be deleted because "it is already covered under (1)." TDMHMR
disagrees that paragraph (1) covers the same issues contained in paragraph
(2), and declines to delete paragraph (2). The circumstance in paragraph (2),
which concerns consumers who are participating in a research protocol, requires
action by key researchers to assess subjects' capacity and provide information
on an ongoing basis to assure maximum comprehension of the various aspects
of the research protocol that affect the subject.
Regarding the Office of Research Administration's (ORA's) actions when
it receives a report of alleged misconduct in science in §414.760(b),
one commenter recommended adding a requirement for the ORA to notify the human
subjects or their LARs of the allegation and the disposition. TDMHMR declines
to add a requirement as suggested because misconduct in science is generally
related to the integrity of research data. Notifying human subjects or their
LARs of alleged or confirmed misconduct in science that does not affect the
health, welfare, or rights of human subjects would serve no useful purpose.
TDMHMR supports the exchange of vital information between key researchers
and human subjects or their LARs that is related to the health, welfare, and
rights of human subjects and notes that federal regulations require such exchange
of information. Section 46.109(b) of 45 CFR 46 addresses the IRB's responsibility
for ensuring the provision of information to subjects and LARs that the IRB
determines would meaningfully add to the protection of their rights and welfare.
To ensure the IRB has access to information in which to make a determination,
language has been added to §414.760(b)(3) requiring the IRB that approved
the research protocol to be notified of confirmed cases of misconduct in science.
Additionally, §46.116(b)(5) of 45 CFR 46 requires that each subject or
LAR be notified of "significant new findings developed during the course of
the research which may relate to the subject's willingness to continue participation."
Regarding the ORA in §414.761, one commenter asked "Did this exist
in 1995-1996?" The commenter mentioned the Quality of Life Study conducted
in 1995-1996 and three violations she identified. TDMHMR responds that the
ORA did not exist in 1995-1996. TDMHMR notes that the adoption of the previous
subchapter governing research (Chapter 405, Subchapter P), which became effective
November 1, 1996, contained additional safeguards and procedures that provided
a higher level of scrutiny of research proposals and greater protection for
human subjects. The provisions of this subchapter continue to provide for
that high level of scrutiny of research proposals and protection for human
subjects.
The new rules are adopted under the Texas Health and Safety Code, §532.015,
which provides the Texas MHMR Board (board) with broad rulemaking authority,
and §576.021, which states that a patient receiving mental health services
under the Texas Mental Health Code (Texas Health and Safety Code, Title 7,
Subtitle C) has the right to refuse to participate in a research program.
§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 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;
(4)
conform with the requirements of Title 45, Code of Federal
Regulations, Part 46 (Protection of Human Subjects), which is adopted by reference
and referenced as Exhibit A in §414.762 of this title (relating to Exhibits).
§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)
Central Office - TDMHMR's administrative offices in Austin.
(3)
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.
(4)
Facility - Any state hospital, state school, state center,
or any other entity which is now or hereafter made a part of TDMHMR.
(5)
Facility rights officer - An employee appointed by a facility
CEO to protect and advocate for the rights of persons receiving services from
the facility.
(6)
Human subject - Consistent with §46.102(f) of 45 CFR
46, referenced as Exhibit A in §414.762 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
judicial or other body authorized under applicable law to consent on behalf
of a prospective human subject to the subject's participation in a research
study.
(14)
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.
(15)
Mental retardation priority population - Persons with
mental retardation identified in TDMHMR's current strategic plan as being
most in need of mental retardation services.
(16)
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.
(17)
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.
(18)
Office of Research Administration (ORA) - The Central
Office department that is responsible for the duties described in §414.761
of this title (relating to Responsibilities of the Office of Research Administration
(ORA)).
(19)
Principal investigator - The person identified as responsible
for conducting a research study.
(20)
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.
(21)
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 is integral to the mission of TDMHMR. TDMHMR recognizes
and accepts its obligation to protect the rights of human subjects involved
in research and supports, as a minimum standard, the preservation of those
rights that are constitutionally and legally guaranteed and protected, and
adopts the policy that the guiding principle for all research involving human
subjects is the safety, well-being, and dignity of the subject.
(b)
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), referenced as Exhibit A in §414.762 of this title (relating
to Exhibits).
(c)
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 §414.762 of this title (relating to Exhibits).
(d)
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.
(e)
TDMHMR recognizes and expresses a commitment to conducting
research in a manner that is consistent with the best interests and protection
of confidentiality and the personal rights of human subjects involved in the
research. This includes conducting research in a manner that protects individuals
from participating in research activities that conflict with their individual
treatment goals.
(f)
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.
(g)
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.
(h)
No undue inducement or coercion may be used to encourage
human subjects to participate in a research study.
(i)
Research may not be conducted with human subjects who are
involuntarily committed if the research involves:
(1)
placebos 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 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.
(j)
Research may not be conducted at a facility if the protocol:
(1)
extends the use of a placebo or washout period unreasonably;
(2)
deprives the human subject of reasonable relief; or
(3)
extends a human subject's use of placebos as the primary
medication therapy after the subject is discharged from the facility.
(k)
Research conducted at a facility may not hinder the facility's
ability to accomplish its primary purpose.
(l)
Unless otherwise provided for in this subchapter, research
involving human subjects may not be conducted at a facility unless:
(1)
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);
(2)
the facility CEO has agreed to have the research conducted
at the facility; and
(3)
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.
(m)
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.
(n)
All research undertaken at facilities must be conducted
with a fundamental commitment to high ethical standards regarding the conduct
of scientific research. Any evidence of allegations of misconduct in science
shall be reviewed and investigated promptly and thoroughly in accordance with
42 CFR 50, Subpart A, (Responsibility of PHS Awardee and Applicant Institutions
for Dealing With and Reporting Possible Misconduct in Science), which is adopted
by reference and referenced as Exhibit C in §414.762 of this title (relating
to Exhibits), and §414.760 of this title (relating to Investigation of
Allegations of Misconduct in Science).
§414.755.Designated Institutional Review Board (IRB).
(a)
Each facility electing to participate in research must
have a designated IRB for the purpose of 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
and 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 or a facility's designated IRB 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 §46.107 of 45 CFR 46, referenced as Exhibit A in §414.762 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/conditions
and concerns of the population(s) served by the facility or facilities.
(A)
At least one of the three members described in paragraph
(1) of this subsection 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 paragraph
(1) of this subsection 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/conditions and concerns of the population(s) served by the facility
or facilities.
(A)
At least one of the three members described in paragraph
(2) of this subsection 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 paragraph
(2) of this subsection 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/conditions
and concerns of the population(s) served by TDMHMR.
(A)
At least one of the three members described in paragraph
(3) of this subsection must be a professional in the field of mental health
and mental retardation.
(B)
At least two of the three members described in paragraph
(3) of this subsection 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 §414.763(4) of this title
(relating to References) and that address:
(1)
the functions and operations of the IRB as required by §46.103(b)(4)
and (b)(5) of 45 CFR 46 (Exhibit A);
(2)
the review or screening process to determine whether proposed
research is exempt from the requirements of federal regulations made in accordance
with §46.101(b) of 45 CFR 46 (Exhibit A), 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), (b)(2), or (b)(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.
(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 §46.108 of 45 CFR 46 (Exhibit
A);
(3)
ensure proposed research is reviewed and approved in accordance
with this subchapter;
(4)
except when an expedited review is used as described in §46.108(b)
of 45 CFR 46 (Exhibit A), 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),
(d)(2)(A), or (d)(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),
(d)(2)(B), or (d)(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 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 §46.115
of 45 CFR 46 (Exhibit A);
(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.
Any suspension or termination of research shall be in writing and include
a statement of the reasons for the IRB's actions and shall be reported promptly
to the principal investigator, appropriate facility or facilities officials,
and the ORA.
§414.757.Review and Approval of Proposed Research.
(a)
All 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 §46.111 of 45 CFR 46, referenced
as Exhibit A in §414.762 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 and screening human subjects;
(B)
how many subjects are required at the facility or facilities;
and
(C)
the process for and level of clinical monitoring of human
subjects throughout the research period.
(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 human subjects' use
of an investigational medication or device as the primary treatment after
the subjects are discharged from the facility, then the research proposal
must also contain a memorandum of agreement between the principal investigator
and each local authority responsible for subjects' continuity of care that
delineates responsibility for each continuity of care activity, as required
by TDMHMR rules, including how these activities will be coordinated and communicated.
The delineated responsibilities must ensure subjects receive appropriate care
after their discharge from the facility and following the conclusion of their
participation in the research study.
(b)
Each designated IRB shall review all proposed research
at the facility in accordance with §46.109 of 45 CFR 46 (Exhibit A) and §414.758
of this title (relating to Informed Consent).
(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)
the requirements described in §46.111 of 45 CFR 46
(Exhibit A), concerning criteria for IRB approval of research;
(2)
the requirements described in §414.758 of this title
(relating to Informed Consent);
(3)
the requirements described in §414.759 of this title
(relating to Human Subject Selection); and
(4)
consideration of the information described in subsection
(a)(1)-(2) of this section.
(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 designated IRB or
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 §414.763(4) of this title (relating to
References).
§414.758.Informed Consent.
(a)
Designated IRB's review of proposed research.
(1)
The designated IRB's review must verify that procedures
for obtaining and documenting informed consent meet the requirements in §46.116
and §46.117 of 45 CFR 46, referenced as Exhibit A in §414.762 of
this title (relating to Exhibits). Additionally, informed consent must also
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 for 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, the designated IRB's review must verify that the procedures for obtaining
and documenting informed consent:
(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 designated
IRB's review must verify that the requirements in §46.408 (concerning
Requirements for Permission by Parents or Guardians and for Assent by Children)
of 45 CFR 46 (Exhibit A) have been met.
(4)
The designated IRB's review must determine that there are
adequate procedures to ensure that each prospective human subject understands
the information provided before obtaining consent and if the subject cannot
understand the information that there are provisions for obtaining informed
consent from the subject's LAR. If consent is obtained from the subject's
LAR then procedures must be in place to attempt, to the extent possible given
the prospective subject's capacity, to obtain the subject's assent to participation.
(5)
The designated IRB's review must determine whether there
are safeguards to minimize the possibility of coercion or undue influence.
The research proposal may be approved only if the possible advantages of the
subject's participation in the research do not impair the subject's ability
to weigh the risks of the research against the value of 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.
(b)
Obtaining informed consent.
(1)
A prospective human subject's objection to enrollment in
research or a human subject's objection to continued participation in a research
protocol must be 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. This does not
preclude a key researcher, with approval of LARs, if appropriate, and acting
with a level of sensitivity that avoids the possibility or the appearance
of coercion, from approaching individuals who previously objected to ascertain
whether they have changed their minds or approaching individuals who have
not given actual consent to ascertain whether they want to enroll in the research
protocol.
(2)
Because informed consent is an ongoing process, each human
subject's comprehension and capacity must be assessed and enhanced throughout
the course of the research protocol.
§414.759.Human Subject Selection.
The designated IRB's review of proposed research shall ensure that
the human subject selection process is equitable and that measures are taken
to ensure the research sample is adequately representative of the population
of interest. Subject selection procedures must offer equitable opportunity
for access to participation in research and access to potential benefits of
participation.
§414.760.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 §414.762
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.
§414.761.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.
§414.762.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);
(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).
§414.763.References.
The following statutes and TDMHMR rules are referenced in this subchapter:
(1)
Title 45, Code of Federal Regulations, Part 46 (Protection
of Human Subjects);
(2)
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);
(3)
Texas Health and Safety Code, Chapter 574 and §533.035;
and
(4)
TDMHMR rules governing the care and protection of individuals,
which address:
(A)
rights and confidentiality of persons receiving services
in TDMHMR facilities;
(B)
consent to treatment with psychoactive or psychotropic
medication;
(C)
voluntary and involuntary interventions involving persons
receiving services in TDMHMR facilities; and
(D)
abuse, neglect, and exploitation of persons receiving services
in TDMHMR facilities.
§414.764.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;
(4)
advocacy organizations; and
(5)
upon request, to any interested person.
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed with the Office of
the Secretary of State on June 8, 2001.
TRD-200103212
Andrew Hardin
Chairman, Texas MHMR Board
Texas Department of Mental Health and Mental Retardation
Effective date: July 1, 2001
Proposal publication date: March 30, 2001
For further information, please call: (512) 206-5216
Subchapter B. CONTRACTS MANAGEMENT FOR TDMHMR FACILITIES AND CENTRAL OFFICE
Chapter 404.
PROTECTION OF CLIENTS AND STAFF
Chapter 405.
CLIENT (PATIENT) CARE
Chapter 407.
INTERNAL FACILITIES MANAGEMENT
Chapter 414.
PROTECTION OF CONSUMERS AND CONSUMER RIGHTS
Subchapter P. RESEARCH IN TDMHMR FACILITIES
Chapter 417.
AGENCY AND FACILITY RESPONSIBILITIES