Decisionally Impaired Persons in Research: Refining the Proposed Refinements

1997 ◽  
Vol 25 (2-3) ◽  
pp. 139-149 ◽  
Author(s):  
Evan G. DeRenzo
Keyword(s):  
Mental Illness ◽  
Informed Consent ◽  
Research Ethics ◽  
Cognitive Impairments ◽  
Research Participation ◽  
Court Decisions ◽  
Public Attention ◽  
Research Involvement ◽  
Valid Consent ◽  
Vulnerable Subjects

The ethics of involving persons with cognitive impairments and/or mental illness in research continues to gain academic and public attention. Concerns about the ability of such persons to provide ethically and legally valid consent and about the appropriateness of their research involvement in certain categories of studies have resulted in publication of guidelines, position papers, standards, and court decisions. These analyses address not only when and from whom informed consent may be obtained but also under what conditions it is ethically permissible to involve persons in research who are too decisionally impaired to provide their own consent.It is an advance in research ethics that there is heightened appreciation of the need for greater protections for, and possibly research participation limitations on, persons unable to give their own consent. In our zeal to protect potentially vulnerable subjects, however, we must craft new protections carefully. Prudence is required in shaping and implementing any new protections.

Recall of participation in research projects in cancer genetics: some implications for research ethics

2008 ◽  
Vol 3 (4) ◽  
pp. 180-184 ◽  
Author(s):  
Sarah Cooke ◽  
Gillian Crawford ◽  
Michael Parker ◽  
Anneke Lucassen ◽  
Nina Hallowell
Keyword(s):  
Research Ethics ◽  
Cancer Genetics ◽  
Clinical Care ◽  
Research Participation ◽  
Research Projects ◽  
Dna Testing ◽  
Clinical Notes ◽  
Valid Consent ◽  
Different Types ◽  
Participation In Research

The aim of this study is to assess patients' recall of their previous research participation. Recall was established during interviews and compared with entries from clinical notes. Participants were 49 patients who had previously participated in different types of research. Of the 49 patients, 45 (92%) interviewees recalled 69 of 109 (63%) study participations. Level of recall varied according to the type of research, some participants clearly recalled the details of research aims, giving consent and research procedures. Others recalled procedures (e.g. DNA testing) but were unclear about their purpose. There was no significant effect of time on recall. Some types of research participation (e.g. DNA testing) may be recalled as clinical care. We argue that such misunderstandings may have the potential to undermine participants' ongoing consent, particularly in ongoing/longitudinal studies. Valid consent may be best achieved by re-assessing the scope of consent and relating it to the nature of the interventions themselves rather than the reasons for undertaking them.

Psychiatric Research Ethics

2014 ◽  
Author(s):  
Paul P. Christopher ◽  
Laura B. Dunn
Keyword(s):  
Mental Illness ◽  
Informed Consent ◽  
Research Ethics ◽  
Empirical Work ◽  
Empirical Ethics ◽  
Psychiatric Research ◽  
Work Related ◽  
Ethical Implications ◽  
People With Mental Illness ◽  
Decision Making Capacity

The nature of neuropsychiatric disorders raises questions and concerns that must be addressed for research on these disorders to proceed ethically. This chapter discusses the rationale for both conceptual and empirical ethics work related to psychiatric research, focusing in particular on informed consent, decision-making capacity, and voluntarism. The extant literature regarding the abilities of people with mental illness to provide informed consent to research is reviewed. Also discussed are the ethical implications of co-occurring problems frequently faced by people with mental illness. Finally, the types of conceptual and empirical work that are needed to move psychiatric research ethics forward are discussed.

scholarly journals Informed consent and mental health, mainly in Spain, EU

2020 ◽  
pp. 01-08
Author(s):  
Jose Manuel BERTOLIN-GUILLEN
Keyword(s):  
Mental Illness ◽  
Informed Consent ◽  
Severe Mental Illness ◽  
Elderly People ◽  
Psychiatric Treatment ◽  
Living Will ◽  
Involuntary Outpatient Treatment ◽  
Vulnerable People ◽  
Valid Consent ◽  
Sliding Scale

Introduction: Lawfully given, informed or valid consent is considered by Spanish jurisprudence a fundamental right and entails important repercussions. Method: Critical and theoretical examination of the matter, with special emphasis on the case of the most vulnerable people and those who require involuntary outpatient psychiatric treatment (IOT). Results: Valid informed consent must fulfil the requirements of capacitation, willingness, information and understanding. Timely knowledge and agreement regarding by whom and how this consent must be granted are important in biomedicine and psychology in general, as well as in the specialities of psychiatry and clinical psychology in particular. It is also important to ensure valid consent for any psychotherapy, as it generally also occurs in the case of psychopharmacological treatments. This article will revise the so-named “sliding scale” to determine mental degree of competence. This concept is especially important in order to consider whether a supposed valid consent is appropriate in vulnerable people. We will talk about living will and severe mental illness concerning valid consent. The current state of psychiatric involuntary outpatient treatment in Spain will be mentioned as well as the wills of legally incapacitated individuals, elderly people or when the carer, either an individual or institution, is the main beneficiary. Conclusions: Valid consent is necessary in every biomedical or sanitary action in general. The matter is potentially controversial if wrongful influences bear upon elderly people, incapacitated individuals and others. Keywords: Informed consent; Valid consent; Spain; Will; Severe mental illness

Voluntariness of consent to HIV clinical research: A conceptual and empirical pilot study

2016 ◽  
Vol 22 (11) ◽  
pp. 1387-1404 ◽  
Author(s):  
Nicole Mamotte ◽  
Douglas Wassenaar
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Pilot Study ◽  
South African ◽  
Research Participation ◽  
Ethical Imperative ◽  
Voluntary Consent ◽  
Valid Consent ◽  
Voluntary Informed Consent ◽  
Hiv Clinical Trials

Obtaining voluntary informed consent for research participation is an ethical imperative, yet there appears to be little consensus regarding what constitutes a voluntary consent decision. An instrument to assess influences on participants’ consent decision and perceived voluntariness was developed and piloted in two South African HIV clinical trials. The pilot study found high levels of perceived voluntariness. The feeling of having no choice but to participate was significantly associated with lower perceived voluntariness. Overall the data suggest that it is possible to obtain voluntary and valid consent for research participants in ethically complex HIV clinical trials in a developing country context.

Ethics in Social Research

2018 ◽  
Author(s):  
Steve Bruce
Keyword(s):  
Informed Consent ◽  
Data Collection ◽  
Research Ethics ◽  
Social Research ◽  
Medical Interventions ◽  
Ethical Implications ◽  
Social Researcher ◽  
Naturally Occurring ◽  
The Social ◽  
Collection Phase

It is right that social researchers consider the ethical implications of their work, but discussion of research ethics has been distorted by the primacy of the ‘informed consent’ model for policing medical interventions. It is remarkably rare for the data collection phase of social research to be in any sense harmful, and in most cases seeking consent from, say, members of a church congregation would disrupt the naturally occurring phenomena we wish to study. More relevant is the way we report our research. It is in the disparity between how people would like to see themselves described and explained and how the social researcher describes and explains them that we find the greatest potential for ill-feeling, and even here it is slight.

scholarly journals Ethical issues in genomics research on neurodevelopmental disorders: a critical interpretive review

2021 ◽  
Vol 15 (1) ◽  
Author(s):  
S. Mezinska ◽  
L. Gallagher ◽  
M. Verbrugge ◽  
E.M. Bunnik
Keyword(s):  
Informed Consent ◽  
Neurodevelopmental Disorders ◽  
Cognitive Abilities ◽  
Social Impact ◽  
Mental Health Problems ◽  
Ethical Issues ◽  
Family Members ◽  
Genetic Diagnosis ◽  
Research Participation ◽  
Genomic Research

Abstract Background Genomic research on neurodevelopmental disorders (NDDs), particularly involving minors, combines and amplifies existing research ethics issues for biomedical research. We performed a review of the literature on the ethical issues associated with genomic research involving children affected by NDDs as an aid to researchers to better anticipate and address ethical concerns. Results Qualitative thematic analysis of the included articles revealed themes in three main areas: research design and ethics review, inclusion of research participants, and communication of research results. Ethical issues known to be associated with genomic research in general, such as privacy risks and informed consent/assent, seem especially pressing for NDD participants because of their potentially decreased cognitive abilities, increased vulnerability, and stigma associated with mental health problems. Additionally, there are informational risks: learning genetic information about NDD may have psychological and social impact, not only for the research participant but also for family members. However, there are potential benefits associated with research participation, too: by enrolling in research, the participants may access genetic testing and thus increase their chances of receiving a (genetic) diagnosis for their neurodevelopmental symptoms, prognostic or predictive information about disease progression or the risk of concurrent future disorders. Based on the results of our review, we developed an ethics checklist for genomic research involving children affected by NDDs. Conclusions In setting up and designing genomic research efforts in NDD, researchers should partner with communities of persons with NDDs. Particular attention should be paid to preventing disproportional burdens of research participation of children with NDDs and their siblings, parents and other family members. Researchers should carefully tailor the information and informed consent procedures to avoid therapeutic and diagnostic misconception in NDD research. To better anticipate and address ethical issues in specific NDD studies, we suggest researchers to use the ethics checklist for genomic research involving children affected by NDDs presented in this paper.

Commentary 1: Research with Persons Under Involuntary Commitment—Ethical Issues Surrounding Competence and Voluntariness

2019 ◽  
Vol 14 (5) ◽  
pp. 475-478
Author(s):  
Matthé Scholten ◽  
Jochen Vollmann
Keyword(s):  
Informed Consent ◽  
Ethical Issues ◽  
Research Participation ◽  
Research Participant ◽  
Involuntary Commitment ◽  
Proxy Consent ◽  
Undue Influence ◽  
Research Participants ◽  
Manic Symptoms ◽  
Prospective Research

In this case commentary, we analyze ethical concerns that were raised in response to an interview with a woman with bipolar disorder who was under involuntary commitment. We focus on competence and voluntariness as two prerequisites for valid informed consent. We recommend that judgments of competence be based on whether prospective research participants sufficiently possess certain decision-making abilities. Based on this functional approach, we argue that manic symptoms need not undermine competence and that, even if we were to assume that the research participant became incompetent during the interview, this would not invalidate her consent retroactively. It would, however, compromise her ability to revoke her consent. We furthermore show that obtaining additional proxy consent for research participation may compromise the autonomy of service users who are competent to consent. Then we turn to the issue of voluntariness. Arguing that neither the great strength nor the external etiology of a desire compromises voluntariness, we propose that the voluntariness of a decision instead depends on whether the decision-maker endorses it on reflection. The researchers disclosed that prospective research participants’ decision about study participation would have no influence on the duration of the commitment or the quality of care. We contend that because of this neither coercion nor undue influence was exerted in the informed consent process. Nevertheless, there is an increased likelihood of perceived coercion and undue influence under conditions of involuntary commitment, and we close by suggesting some safeguards to prevent this.

scholarly journals Nursing Faculties’ Knowledge of and Attitudes Toward Research Ethics According to Demographic Characteristics and Institutional Environment in Korea

SAGE Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. 215824402091454
Author(s):  
Sukhee Ahn ◽  
Geum Hee Jeong ◽  
Hye Sook Shin ◽  
Jeung-Im Kim ◽  
Yunmi Kim ◽  
...  
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Nursing Faculty ◽  
Institutional Environment ◽  
Conflicts Of Interest ◽  
Training Needs ◽  
Faculty Members ◽  
Intensive Training ◽  
The Republic ◽  
Difficulty Index

This study, conducted in the Republic of Korea, analyzed nursing faculty members’ knowledge of and attitudes toward research ethics according to their characteristics and the institutional environment. A survey was conducted from April 24 to July 23, 2017. The participants were 210 nursing professors from 57 universities in Korea. The survey questionnaire gathered information on participants’ characteristics, their knowledge of and attitudes toward research ethics, and their perceived training needs. A relatively low difficulty index was found for knowledge items dealing with conflicts of interest (0.66), copyright (0.65), and plagiarism and duplicate publications (0.17) than for the other six items. Of the 12 items assessing attitudes toward research ethics, use of a plagiarism-checking program and reviewing manuscripts from members of one’s own research group had the lowest scores. The knowledge level of participants whose institutions provided a plagiarism-checking program was higher than those whose institutions did not. Former group also showed better attitudes toward research ethics. High-priority training needs were obtaining institutional review board (IRB) approval, writing informed consent forms, and obtaining informed consent for studies on children and pregnant women. A more intensive training program for nursing faculty is required on specific topics, including conflicts of interest, copyright, plagiarism, duplicate publications, IRB approval, and informed consent. Furthermore, all nursing institutions in Korea should provide a plagiarism-checking program to faculty members.

Research Ethics Committees in Europe — Living with Diversity

2007 ◽  
Vol 3 (3) ◽  
pp. 101-102
Author(s):  
Frank Wells
Keyword(s):  
Research Ethics ◽  
Working Party ◽  
Ethics Committees ◽  
Good Clinical Practice ◽  
Ethics Committee ◽  
Research Ethics Committees ◽  
European Forum ◽  
Working Groups ◽  
Vulnerable Subjects ◽  
The Eu

This paper presents a review, conducted by the ethics working party of the European Forum for Good Clinical Practice, of the structures and functions of research ethics committees across the member states of the EU. The findings demonstrate widespread differences, and further working groups have been established to develop thinking across Europe, in respect of the training of REC members, ethics committee quality assurance and the involvement of vulnerable subjects in research. In practical terms the differences do not matter, but they should be recognized. The review itself is considered a dynamic document and will be updated every six months.

From Rogers to Rivers: The Rights of the Mentally Ill to Refuse Medication

1987 ◽  
Vol 13 (1) ◽  
pp. 7-52
Author(s):  
Ellen Wright Clayton
Keyword(s):  
Mental Illness ◽  
Psychotropic Drugs ◽  
Mentally Ill ◽  
United States Supreme Court ◽  
Federal Courts ◽  
State Courts ◽  
Court Decisions ◽  
Marked Contrast ◽  
Patients Rights ◽  
Treatment Refusals

AbstractMany individuals with mental illness wish to avoid psychotropic drugs, a type of treatment that may relieve their symptoms only at the risk of unpleasant, even permanent, side effects. In marked contrast to the widely-held view that most patients may refuse any treatment and that even patients with mental illness may reject other psychoactive interventions such as electroconvulsive therapy and psychosurgery, the courts and legislatures have been slow to recognize any right to refuse psychotropic drugs. This Article demonstrates that many of the justifications offered for forcing patients to take unwanted medications are inadequate and that unless treatment refusals are reviewed outside mental institutions, patients’ rights will rarely receive appropriate deference. The author analyzes the federal and state litigation to determine whether the courts have fashioned meaningful relief for the mentally ill. The Article concludes that two recent United States Supreme Court decisions have made it impossible for the federal courts to provide adequate protection. By contrast, several state courts have responded to the needs and rights of patients with mental illness.

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