Full Text PA-95-080

INFORMED CONSENT IN CLINICAL MENTAL HEALTH RESEARCH

NIH GUIDE, Volume 24, Number 27, July 28, 1995

PA NUMBER:  PA-95-080

P.T. 34

Keywords: 
  Mental Disorders 
  Clinical Medicine, General 
  Ethics/Values in Science & Technol 


National Institute of Mental Health

PURPOSE

The purpose of this program announcement (PA) is to stimulate
investigations into the informed consent process in research
involving individuals with mental disorders.  Voluntary informed
consent is an integral and defining aspect of interactions between
researchers and subjects.  There is an ethical as well as a legal
duty to ensure that individuals both consent to and understand their
participation in research.  Little empirical work exists to document
the degree of understanding achieved by research participants
regarding:  (1) comprehension of a study's methods and procedures;
(2) relative risks and benefits of participation; (3) confidentiality
and any exceptions to confidentiality; and (4) the implications of
withdrawal from a study.  Such data should be useful in designing
informed consent procedures that are readily comprehended by
prospective participants and impart all critical information.  Since
individuals with mental disorders may experience cognitive
difficulties, research to assess comprehension and remediate
difficulties in this population can be particularly important.  The
goal of the present initiative is to identify and validate methods
for improving the informed consent process in research involving
individuals with mental disorders.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This PA,
Informed Consent in Clinical Mental Health Research, is related to
the priority area of reducing the prevalence of mental disorders.
Potential applicants may obtain a copy of "Healthy People 2000" (Full
Report:  Stock No. 017-001-00474-0 or Summary Report:  Stock No.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by foreign and domestic, for-profit and
non-profit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal government.
Foreign institutions are not eligible for First Independent Research
Support and Transition (FIRST) awards (R29) and small grants (R03).
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

The mechanisms available for support of this program announcement are
the research project grant (R01), small grant (R03), FIRST award
(R29), and cooperative clinical research grant (R10).  Competitive
supplements to existing R01, R10, and research program projects and
centers (P01, P20, P30, P50) will also be available.  Because small
grants, FIRST awards, and Cooperative Clinical Research grants have
special eligibility requirements, application formats, and review
criteria, applicants are strongly encouraged to consult with program
staff (listed under INQUIRIES) and to obtain the appropriate
additional announcements for those grant mechanisms.

RESEARCH OBJECTIVES

Background

Full consideration of the components of informed consent is an
essential part of every research project involving human subjects.
Indeed, the Code of Federal Regulations (45 CFR, Subtitle A (10-1-90
Edition), Part 46.116) requires that "...no investigator may involve
a human being as a subject in research...unless the investigator has
obtained the legally effective informed consent of the subject or the
subject's legally authorized representative."  As stated in 45 CFR
46:

(a) ...in seeking informed consent, the following information shall
be provided to each subject:
1) A statement that the study involves research, an explanation of
the purposes of the research and the expected duration of the
subject's participation, a description of the procedures to be
followed, and identification of any procedures which are
experimental;
2) A description of any reasonably foreseeable risks or discomforts
to the subject;
3) A description of any benefits to the subject or to others which
may reasonably be expected from the research;
4) A disclosure of appropriate alternative procedures or courses of
treatment, if any, that might be advantageous to the subject; 5) A
statement describing the extent, if any, to which
confidentiality of records identifying the subject will be
maintained;
6) For research involving more than minimal risk, an explanation as
to whether any compensation and any medical treatments are available
if injury occurs and, if so, what they consist of or where further
information may be obtained;
7) An explanation of whom to contact for answers to pertinent
questions about the research and research subjects' rights, and whom
to contact in the event of a research-related injury to the subject;
8) A statement that participation is voluntary, refusal to
participate will involve no penalty or loss of benefits to which the
subject is otherwise entitled, and the subject may discontinue
participation at any time without penalty or loss of benefits to
which the subject is otherwise entitled.
(b) Additional elements of informed consent. When appropriate, one or
more of the following elements of information shall be provided to
each subject:
1) A statement that the particular treatment or procedure may involve
risks to the subject (or to the embryo or fetus, if the subject is or
may become pregnant) which are currently unforeseeable; 2)
Anticipated circumstances under which the subject's participation may
be terminated by the investigator without regard to the subject's
consent;
3) Any additional costs to the subject that may result from
participation in the research;
4) The consequences of a subject's decision to withdraw from the
research and procedures for orderly termination of participation by
the subject;
5) A statement that significant new findings developed during the
course of the research which may relate to the subject's willingness
to continue participation will be provided to the subject; and 6) The
approximate number of subjects involved in the study.

While 45 CFR 46 is quite specific about the content of informed
consent, the responsibility for ensuring that such complex
information is fairly presented and understood is left to the
researcher and his or her Institutional Review Board.  It is clear
that informed consent involves much more than a signature on a
consent form.  Willingness to participate in research may wax and
wane depending on a subject's expectations and satisfaction.  For
studies of mental disorders, this may be further complicated by
changes in cognitive abilities and judgment over time.  In some
instances, obtaining consent from a legally authorized representative
may be a requirement, as with research on children or older subjects
with advanced dementias.  The issues of substituted judgment and
surrogate consent can be germane to the mental disorders as well, if
an individual's competency to consent is in question.  Finally, the
research setting may play a role in the informed consent process.
For instance, the degree of risk is affected by whether a study
involves inpatients or outpatients, how closely these participants
are monitored, and by different legal requirements in community,
clinical, and institutional research settings.

Research Goals and Topics

Since a number of complex issues have an impact on informed consent,
there is much to be learned and understood about this process.
Modern cognitive science has greatly increased our understanding of
how humans learn, process, comprehend, and retain information, and
these advances in knowledge can be applied to the informed consent
process. The purpose of this program announcement is to gather
empirical data on the informed consent process, particularly with
respect to studies involving subjects with mental illnesses.
Inclusion of subjects with non-psychiatric illness for comparison
purposes would be appropriate in many instances.  This program
announcement is focused on clinical research populations, but the
application of research methods developed to study normal cognitive
processes will play an important role in meeting the goals of this
initiative.

The following list contains possible research topics, but should not
be considered exhaustive:

o  Evaluating the degree of comprehension and reasoning ability
required to understand and consent to specific experimental
procedures, and to differentiate between clinical research and
individualized treatment

o  Applying existing knowledge in cognitive neuroscience to develop
methods for efficiently assessing comprehension and reasoning ability
in a research mental health setting

o  Identifying the cognitive processes underlying complex decision
making by individuals with mental disorders.  (If impairments in
these processes can be detected, are they stable or do they change
over time and with the course of the mental disorder?  Can
impairments be remediated?)

o  Identifying the determinants for subject participation in mental
health research (e.g., altruism, hopes for new or better treatment,
closer follow up, free care, interest in science)

o  Determining which, if any, aspects of the informed consent process
predict subsequent subject retention and satisfaction

o  Developing and assessing innovative methods for clearly and
efficiently conveying consent information (e.g., audio-visual aids,
computer-assisted instruction)

o  Assessing whether a participant understands experimental
procedures over time, including assessment throughout the full
duration of participation and over possible changes in mental status

o  Determining how specific changes in affective or cognitive state
in patients with mental illness affect the informed consent process
and interactions with treatments

o  Determining if appropriate inclusion of a patient's relatives or
friends in the consent process changes participation and retention
rates within a study or alters the reported satisfaction with
participation in research

o  Determining the impact of proxy or surrogate consent as well as
durable powers of attorney and advance directives on research
participation and outcomes

o  Identifying and determining the impact of special issues related
to informed consent in research involving children and adolescents
(e.g., parental responsibilities and consent, autonomy issues in
adolescents, emancipated minors, additional protections from risk)

o  Identifying and determining the impact of special issues related
to informed consent in geriatric research (e.g., worsening of
dementia over the course of a study, durable power of attorney,
methods for proxy consent)

o  Examining the role of ethnicity and gender on participation in
clinical mental health research and the informed consent process

o  Examining how research setting, timing, and the individual
obtaining informed consent affect the process

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS

It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990. The new policy contains some
provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 20, 1994 (FR 59 14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.

Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS
398 (rev. 5/95) and will be accepted at the standard application
deadlines as indicated in the application kit.  Application kits are
available at most institutional offices of sponsored research and may
be obtained from the Office of Grants Information, Division of
Research Grants, National Institutes of Health, 6701 Rockledge Drive,
Room 3034 - MSC 7762, Bethesda, MD 20892-7762, telephone
301/435-0714.  The title and number of the program announcement must
be typed in Section 2 on the face page of the application.

Applications for the FIRST award (R29) must include at least three
sealed letters of reference attached to the face page of the original
application.  FIRST award (R29) applications submitted without the
required number of reference letters will be considered incomplete
and will be returned without review.

The completed original application and five legible copies must be
sent or delivered to:

DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for courier/overnight mail service)

REVIEW CONSIDERATIONS

Applications that are complete will be evaluated for scientific and
technical merit by an appropriate peer review group convened in
accordance with the standard NIH peer review procedures.  As part of
the initial merit review, all applications will receive a written
critique and undergo a process in which only those applications
deemed to have the highest scientific merit, generally the top half
of applications under review, will be discussed, assigned a priority
score, and receive a second level review by the appropriate national
advisory council or board, when applicable.

Review Criteria for Research Project Grant Applications

o  scientific, technical, or medical significance and originality of
proposed research;

o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;

o  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;

o  availability of the resources necessary to perform the research;

o  appropriateness of the proposed budget and duration in relation to
the proposed research;

o  adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects will also be
evaluated.

The initial review group will also examine the provisions for the
protection of human subjects and the safety of the research
environment.

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications.  The following will be considered in making funding
decisions:  Quality of the proposed project as determined by peer
review, availability of funds, and program priority.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or
answer questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

John K. Hsiao, M.D.
Division of Clinical and Treatment Research
National Institute of Mental Health
Parklawn Building, Room 18C-14
Rockville, MD  20857
Telephone:  (301) 443-3525
FAX:  (301) 443-6000
Email:  jhsiao@helix.nih.gov

Direct inquiries regarding fiscal matters to:

Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
Parklawn Building, Room 7C-08
Rockville, MD  20857
Telephone: (301) 443-3065
FAX:  (301) 443-6885
EMAIL:  Diana_Trunnell@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.242.  Awards are made under authorization of the
Public Health Service Act, Title IV, Part A (Public Law 78-410, as
amended by Public Law 99-158, 42 USC 241 and 285) and administered
under PHS grants policies and Federal Regulations 42 CFR 52 and 45
CFR Part 74.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency
review. Awards will be administered under PHS grants policy as stated
in the Public Health Service Grants Policy Statement (rev. 4/94).

The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routing education,
library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.

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