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- Carol
I-Ping  Tsao, Joseph B. Layde, Laura Weiss Roberts, , A
review of ethics in psychiatric research –Â It was writen “to summarize
important recent contributions to the literature on the subject of ethics in
psychiatric research.”
- Alexander
Morgan Capron, Ethical and
Human-Rights Issues in Research on Mental Disorders That May Affect
Decision-Making Capacity – Article concerns topics like:Â problems of
therapeutic research, capacity to consent to participate in research, use of
patients in research to benefit other patients.
- Gwen
Adshead, Ethics
in psychiatric research and practice -Â “There are many ethical
implications in the psychiatric research process, from the scientific and
ethical coherence of the proposal, through the process of ethical committee
approval and the consent of the patients, to its submission, review and
publication.Concern still exists about the capacity for abuse within
psychiatric practice and research, which should give rise to professional
concern and a plan of action for prevention and education.”
- Laura
Weiss Roberts, Brian Roberts, Psychiatric
research ethics: an overview of evolving guidelines and current ethical
dilemmas in the study of mental illness – “The field of psychiatry has an
opportunity to construct a more refined, perhaps more enduring understanding of
the ethical basis of mental illness research. The aim of this paper is to help
advance this understanding by 1) tracing the evolution of the emerging ethic
for biomedical experimentation, including recent recommendations of the
President’s National Bioethics Advisory Commission, and 2) reviewing data and
concepts related to compelling ethical questions now faced in the study of
mental disorders. Empirical findings on informed consent, the ethical
safeguards of institutional review and surrogate decision making, and the
relationship between scientific and ethical imperatives are outlined.
Psychiatric researchers will increasingly be called upon to justify their
scientific approaches and to seek ways of safeguarding the well-being of people
with mental illness who participate in experiments. Most importantly,
psychiatric investigators will need to demonstrate their appreciation and
respect for ethical dimensions of investigation with special populations.
Further empirical study and greater sophistication with respect to the distinct
ethical issues in psychiatric research are needed. Although such measures
present many challenges, they should not interfere with progress in
neuropsychiatric science so long as researchers in our field seek to guide the
process of reflection and implementation.”
- Laura
Weiss Roberts, Ethical
dimensions of psychiatric research: a constructive, criterion-based approach to
protocol preparation. The research protocol ethics assessment tool (RePEAT)
– “Preparing experimental protocols that are ethically sound, possess
scientific merit, and meet institutional and national standards for human
subject protections is a key responsibility of psychiatric investigators. This
task has become increasingly complex due to developments in biomedical science,
bioethics, and society at large. Practical and constructive approaches to help
investigators in their efforts to create protocols that are ethically
acceptable have nevertheless received little attention. To better address this
gap, the Research Protocol Ethics Assessment Tool (RePEAT) was developed as an
educational instrument to help assure that ethically important elements,
including scientific design features, are explicitly addressed by investigators
in their work with protocols involving human participants. The RePEAT is a
brief evaluative checklist that reflects rigorous ethical standards,
particularly with respect to criteria for studies that may involve individuals
with compromised decisional abilities. For this reason, it may be especially
beneficial as a self-assessment tool for investigators and protocol reviewers
in psychiatry. To stimulate education and dialogue, this report presents the
RePEAT and outlines its content, format, use, and limitations.”
- K. W.
Fulford, K. Howse, Ethics
of research with psychiatric patients: principles, problems and the primary
responsibilities of researchers. – “In this paper some of the general
issues surrounding recently published guidelines for the practice of research
ethics committees are outlined, concentrating in particular on the difficulties
raised by research with psychiatric patients. Research is distinguished from
ordinary clinical practice by the intention to advance knowledge. So defined,
research with psychiatric patients should be governed by the same four
principles as research with any other group--knowledge, necessity, benefit and
consent. In applying these principles, however, particularly the principle of
consent, many acute difficulties are raised by psychiatric patients. A number
of proposals for addressing these difficulties are discussed. It is suggested
that, notwithstanding the value of published guidelines, and the help that may
be available from research ethics committees, the primary responsibility for
maintaining high standards of practice in research rests with research workers
themselves.”
- Paul
S. Appelbaum, Missing the
Boat: Competence and Consent in Psychiatric Research  - “This is a time of
great concern about the ethics of psychiatric research. The doubts that have
been expressed fall into two broad categories: 1) that some research
methods—e.g., medication wash-out periods, placebo-controlled designs, symptom
provocation studies—may sometimes or always present unacceptable risk-benefit ratios
and 2) that many psychiatric patients who are recruited as research subjects
may lack the capacity to make acceptable decisions about their participation. I
focus here on the second of these issues.”
- D.Cyril D’Souza,
Robert M Berman, John H Krystal, Dennis S Charney, Symptom
provocation studies in psychiatric disorders: scientific value, risks, and
future – “Several lines of investigation have contributed to the increasing
recognition of the biological basis of psychiatric disorders. Symptom provocation
studies have made important contributions toward this. With the emergence of
novel methodologies, the role of symptom provocation studies has come under
increasing scrutiny and debate. The scientific contributions and risks of
symptom provocation studies are discussed using the psychostimulant paradigm in
schizophrenia research as the prototypical study. The application of studies in
other areas of medicine that carry risks similar to those associated with
symptom provocation studies, are also reviewed. The authors draw on the
parallel of cardiac stress testing to highlight risks:benefits issues. Finally,
the authors discuss the future of symptom provocation studies and emphasize
that these studies will need to meet the highest scientific standards, ethical
standards and safeguards.”
- Laura
B. Dunn, Sahana Misra, Research
Ethics Issues in Geriatric Psychiatry  - “With an aging population and with
the prevalence of psychiatric illness in the older population expected to rise
dramatically in coming decades, advances in geriatric psychiatry research are
urgently needed. Ethical issues in the design, conduct, and monitoring of
research involving older adults parallel the same issues as related to human
subjects research generally. However, a number of special issues relevant to
geriatric psychiatry research merit further discussion. These special issues
include: the assessment of capacity in populations where cognitive disorders
are more prevalent; the role of surrogate decision makers; the legal status of
surrogate consent; the use of advanced directives for research participation;
and research involving suicidal individuals.”
- Â Benedetto Vitiello,
Peter S Jensen, Kimberly Hoagwood, - Integrating
science and ethics in child and adolescent psychiatry research – “Research
to elucidate the biological bases of psychopathology in children and
adolescents is needed to understand pathogenesis and to develop effective and
safe treatment and preventive interventions. Because of the effect of
development, data collected in adults are not always applicable to youth, and
direct participation of children in research is necessary. Many medications are
currently used in the community to treat children and adolescents with
neuropsychiatric disorders without adequate data about their safety and
efficacy. Conducting research in children requires attention to specific
ethical and regulatory factors. In deciding whether minors can participate in a
study with potential direct benefit to the research subjects, the most
important variable to consider is the balance between risks and potential benefit,
in the context of the severity of the child’s condition and the available
alternatives. Research with no potential benefit to the participants is guided
by the concepts of minimal risk (which may apply more to normal children) and minor
increase over minimal risk (perhaps more relevant to children affected by
psychopathology). Recently conducted studies relevant to this issue are
reviewed. Of paramount importance is the ratio of risk/scientific value of the
proposed experiment. In fact, no research is justifiable, no matter how low the
risk may be, unless the potential yield of the study is important and may help
advance our understanding of normal functioning and mental illness.”
- Ethical
Issues in Biological Psychiatric Research with Children and Adolescents – “This
article reviews, discusses, and elaborates considerations and recommendations
summarized by the biological research working group at the May 1993 NIMH conference
on ethical issues in mental health research on children and adolescents.”
- Â Dilip
V. Jeste, Barton W. Palmer, M. Jackuelyn Harris, Neuroleptic
discontinuation in clinical and research settings: scientific issues and
ethical dilemmas – “The ethics of neuroleptic discontinuation in clinical
and research settings are currently a topic of much discussion. The issues
underlying this debate are complicated by the fact that these medications can
be fairly effective in managing the symptoms and preventing relapse in
schizophrenia and other psychotic disorders, yet these drugs have therapeutic
limitations and their prolonged use is associated with a risk of serious,
potentially persistent side-effects such as tardive dyskinesia. Over the past
47 years, the public perception about the value of neuroleptics has undergone
dramatic shifts, based partly on the data available at different time periods.
The risk-benefit ratio is better for the atypical antipsychotics compared to
the conventional ones, but long-term experience with the newer agents has been
limited. At present, a prudent strategy for most clinical and research purposes
is to gradually taper the medications in clinically stable, carefully selected,
consenting subjects to the lowest doses on which individual patients can be
effectively maintained. In this article we discuss clinical, research, and
ethical aspects of neuroleptic discontinuation. It is critical to protect
potentially vulnerable patients with serious mental illnesses, while allowing
them to benefit from appropriate investigations.”
- Donna
T. Chen, Curricular
approaches to research ethics training for psychiatric investigators – “Training
in research ethics is crucial for psychiatric investigators. Addressing ethical
dimensions of human subjects research requires knowledge about the rules and
norms governing research; sensitivity to ethical implications of actions; and
skills in ethics problem solving. Investigators in training who are physicians
have the additional challenge of developing identities as investigators that
sometimes conflict with their identities as physicians.”
- Franklin
G Miller, Placebo-controlled
trials in psychiatric research: an ethical perspective – “The
placebo-controlled trial is widely regarded as the gold standard for testing
the efficacy of new treatments; however, this research design is subject to
ethical controversy, especially when standard treatments of proven efficacy
exist. After examining regulatory standards and ethical codes relevant to
placebo-controlled trials, I offer a critique of arguments against the use of
placebo control groups in psychiatric research. An absolute ethical prohibition
of placebo-controlled trials in psychiatric disorders for which standard,
effective treatments exist is rejected because it is based on a flawed
conception of research ethics, ignores important contextual factors
characteristic of psychiatric research, and could lead to the approval and use
of new medications that appear equivalent in efficacy to standard treatments
but may be no more effective than placebos. Four standards governing the
ethical use of placebos in psychiatric clinical trials are explicated: 1)
placebo-controlled trials should have scientific and clinical merit; 2) risks
should be minimized and justified by the anticipated benefits of generating
clinically relevant scientific knowledge and the expected benefits, if any, to
individual patient volunteers; 3) patient volunteers should give informed
consent; and 4) investigators should offer short-term treatment optimization to
patient volunteers after completion of research participation.”
- Laura
Weiss Roberts, John Lauriello, Cynthia Geppert, Samuel
J Keith, Placebos
and paradoxes in psychiatric research: an ethics perspective – “The use of
placebos in clinical trials, particularly in research with mentally ill people,
has emerged as a subject of considerable controversy. We first outline ethical
aspects of the primary scientific arguments for and against placebo use in
research. Three examples of paradoxical aspects of the ethical use of placebos
are discussed: involvement of relatively more vulnerable populations, use of
apparently “less than standard” therapy, and the omission of information in
placebo comparisons. In the current scientific and regulatory context, placebo
use in psychiatric research may be necessary for scientific reasons, and when
certain conditions are present, it may be justified on ethical grounds. Four
key recommendations to facilitate the ethical use of placebos in research
trials are presented. We conclude that placebo trials should be undertaken only
after careful evaluation of alternative scientific strategies and, as with all
human research, with great respect and genuine consideration for the
individuals who choose to participate in these protocols.”
- Laura
B. Dunn, Philip J. Candilis, Laura Weiss Roberts, Emerging
Empirical Evidence on the Ethics of Schizophrenia Research – “Many
challenging ethical questions come with the scientific efforts to understand
the nature and treatment of schizophrenia. The empirical study of ethical
aspects of schizophrenia research has sought to clarify and resolve many of
these questions. In this article we provide an overview of the existing data-based
literature on schizophrenia research ethics and outline directions for future
inquiry. We examine 5 broad categories of inquiry into the ethics of
schizophrenia research: (1) Scientific designs (eg, placebo-controlled studies
and medication-free intervals, prodromal and high-risk research, and genetics
research); (2) informed consent and decision-making capacity, including
assessment of decisional abilities, as well as intervention studies; (3)
understanding and perceptions of risk and benefit (including the therapeutic
misconception); (4) influences on research participation (including
voluntarism, altruism, and other motivations); and (5) key participant
safeguards, such as protocol review and participant advocates. We discuss how
empirical work in each of these areas answers certain questions and raises new
ones. Finally, we highlight important gaps in our understanding of ethically
relevant aspects of schizophrenia research and offer a specific research agenda
for empirical ethics.”
- William
T Carpenter, Robert R Conley, Sense
and nonsense:an essay on schizophrenia research ethics – “In this essay,
the authors select topics from the current debate on the ethics of schizophrenia
research. Accepting competent and voluntary informed consent as essential for
most projects, the authors discuss the relation of diagnosis to deisional
capacity, the respective roles of psychosis and cognitive impairments in
decsional capacity, and whether impairments in capacity can be remediated. The
roles of investigator, external agent, patient subject, and family or suroogate
in the informed consent process are reviewed. A lack of understanding of the
treatment of persons with schizophrenia has distorted and inflamed public
dicussion of issues such as `withholding treatment`. A standard, based in
common sense, is proposed: for viweing protocols; for allowing autonomy and
altruism despite diagnostic class; and, for a meaningful discussion of what is
meant by and what should be done about ‘risk without direct benefit’ protocols.”
- Laura
Weiss Roberts, Teddy D. Warner, Janet L. Brody, Perspectives
of Patients With Schizophrenia and Psychiatrists Regarding Ethically Important
Aspects of Research Participation  - “Significant controversy surrounds the
ethics of psychiatric research. Nevertheless, few data have been gathered to
improve our understanding of how individuals with serious mental illness and
psychiatrists view ethically important aspects of biomedical research
participation”
- Robert
B Zipursky, Padraig Darby, Placebo-controlled
studies in schizophrenia—ethical and scientific perspectives: an overview of
conference proceedings – “Much controversy has surrounded the issue of
whether clinical trials of new antipsychotic medications for the treatment of
schizophrenia ought to include a placebo control group. On 18 September 1997, the authors co-chaired a symposium at the University of Toronto devoted to
elucidating the issues relevant to this debate. Speakers with expertise in the
areas of schizophrenia research, clinical trials methodology, medical ethics
and informed consent presented their perspectives. This paper aims to summarize
the major scientific and ethical issues raised during the symposium.”
- Charles Weijer,
Placebo-controlled
trials in schizophrenia: Are they ethical? Are they necessary? - “The
current controversy as to the proper role of the placebo control in the
evaluation of new treatments for schizophrenia requires an analysis that is sensitive
to both ethical and scientific issues. Clinical equipoise, widely regarded as
the moral foundation of the randomized controlled trial (RCT), requires the use
of best available treatment as the control in RCT. Scientific criticisms of the
use of an active control are examined and none present an insuperable barrier
to the use of an active control. Indeed, scrutiny of the most recent argument
for the use of placebo controls, `assay sensitivity`, suggests that the use of
placebo may be the cause of the problem pointed to. Scientific, regulatory,
ethical and legal advantages of the use of an active control are described.
While the use of a placebo control may be acceptable in carefully defined
circumstances, in most cases the use of an active control in schizophrenia
research is ethically and scientifically preferable.”
- Richard
Jed Wyatt, Ioline D Henter, John J Bartko, The
long-term effects of placebo in patients with chronic schizophrenia – “It
has been hypothesized that placebo periods may increase long-term morbidity for
patients with schizophrenia. In this study, the long-term effect of a placebo
period was evaluated in a group of relatively treatment-refractory patients
with chronic schizophrenia.”
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