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

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.

2019 ◽  
Vol 14 (5) ◽  
pp. 472-474 ◽  
Author(s):  
Jakov Gather ◽  
Janice Kalagi ◽  
Ina Otte ◽  
Georg Juckel

In this case report, we report an ethical problem that we faced in the course of an interview study on open-door policies in psychiatry with persons under involuntary commitment. One of the interviewees was a young woman with bipolar disorder who was under involuntary commitment at the time of the interview. While the woman had been assessed as competent and gave informed consent to research participation, her manic symptoms increased when the interview became increasingly distressing for her. Because of this, we decided to break off the interview and resume it at a later point of time. Within the research team, we raised the following ethical questions: (1) Was the participant, contrary to the initial assessment, unable to give consent for the study? (2) Was the voluntariness of her research participation compromised by her manic symptoms and involuntary commitment? (3) Should the participant have been excluded from the study against her expressed wish? (4) Should we have refrained from interviewing persons who were still under involuntary commitment?


2021 ◽  
Vol 15 (1) ◽  
Author(s):  
S. Mezinska ◽  
L. Gallagher ◽  
M. Verbrugge ◽  
E.M. Bunnik

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.


2016 ◽  
Vol 27 (2) ◽  
pp. 191-212 ◽  
Author(s):  
Ragnhild Hedman ◽  
Ingrid Hellström ◽  
Britt-Marie Ternestedt ◽  
Görel Hansebo ◽  
Astrid Norberg

The sense of self is vulnerable in people with Alzheimer’s disease (AD), and might be positively and negatively influenced by research participation. The purpose of this study was to describe how people with AD express their experience of being a research participant with respect to their sense of self. Interviews and support group conversations involving 13 people with mild and moderate AD were analyzed using qualitative content analysis. Three themes were constructed: contributing to an important cause, gaining from participating, and experiencing risks and drawbacks. Participants described contributing to research as being in line with their lifelong values and lifestyles. They expressed contentment and pride about being research participants, emphasized their positive relationships with the researchers, and described participation as a meaningful activity. When research procedures threatened their sense of self, they were able to reason about risks and decline participation.


2019 ◽  
Author(s):  
Shoshana H Bardach ◽  
Kelly Parsons ◽  
Allison Gibson ◽  
Gregory A Jicha

Abstract Background and Objectives Recruitment and retention of research participant serve as a significant challenge in the search for ways to slow or prevent Alzheimer’s disease. While barriers to participation are well documented, less is known about motivations for Alzheimer’s disease clinical research participation. The purpose of this study was to explore what motivates individuals—who ultimately develop an ongoing connection to research and frequently participate—to engage and stay involved in Alzheimer’s disease research. Research Design and Methods Individuals who had participated in multiple Alzheimer’s disease-related clinical trials, or their study partners, were interviewed about their decisions to engage and remain in research. Findings Interviews were completed with 33 individuals, 28 research participants, and 5 study partners. All interviews were audio-recorded and transcribed verbatim for analysis. Respondents indicated learning about research opportunities through the media, community events, doctors, and other research participants. While many were initially motivated by a family history or knowing someone with Alzheimer’s disease, others had no personal exposure. Individuals in prevention studies were generally proactive and viewed research as a constructive way to address memory concerns. While several individuals acknowledged personal benefits of research participation, most indicated an understanding of the importance of research and being motivated to help others in the future, frequently referencing a sense of social responsibility or moral obligation to help. Positive relationships with personnel at the site encouraged continued involvement. Discussion and Implications These findings suggest that efforts to identify research participants should highlight the value of research and help illuminate how participation may contribute to well-being of future generations.


2008 ◽  
Vol 13 (4) ◽  
pp. 17-30 ◽  
Author(s):  
Hayley Davies

Informed consent is a key consideration in ethical research, particularly research conducted with children. Devising an approach to and obtaining informed consent is a complex task involving multiple considerations. The examples used in this paper are derived from a study investigating how children constitute family members and close relationships. The paper is divided into two sections. The first section suggests that researchers should take a reflexive approach to their professional research practice and addresses how a researcher's professional location determines their particular ethical approach. Consideration is given to how the researcher's particular ethical approach can be achieved in consultation with academic thought and research ethics guidelines, which often offer contradictory advice on important ethical issues. The second section of the paper addresses how researchers negotiate their approach to informed consent in particular research contexts which offer challenges to the researcher's thinking about research participants or chosen procedures for obtaining and maintaining that informed consent is upheld. The paper concludes by arguing that the researcher can incorporate academic thought and aspects of the research ethics guidelines in an approach to informed consent that simultaneously values the research participants and the ethical practices operating in the research setting. Such an approach involves careful negotiation and consideration of the interests of all stakeholders in the research process.


2019 ◽  
Vol 45 (5) ◽  
pp. 299-303 ◽  
Author(s):  
Tommaso Bruni ◽  
Mackenzie Graham ◽  
Loretta Norton ◽  
Teneille Gofton ◽  
Adrian M Owen ◽  
...  

Functional MRI shows promise as a candidate prognostication method in acutely comatose patients following severe brain injury. However, further research is needed before this technique becomes appropriate for clinical practice. Drawing on a clinical case, we investigate the process of obtaining informed consent for this kind of research and identify four ethical issues. After describing each issue, we propose potential solutions which would make a patient’s participation in research compatible with her rights and interests. First, we defend the need for traditional proxy consent against two alternative approaches. Second, we examine the impact of the intensive care unit environment on the informed consent process. Third, we discuss the therapeutic misconception and its potential influence on informed consent. Finally, we deal with issues of timing in recruiting participants and related factors which may affect the risks of participation.


1980 ◽  
Vol 14 (1) ◽  
pp. 40-43
Author(s):  
Dev S. Pathak ◽  
Thomas S. Foster ◽  
Cynthia L. Raehl

The continued growth of hospital and clinical pharmacy should be paralleled by the development of sound research methods justifying innovative practices. Such research will, on occasion, require experimentation involving human subjects. The principal means of assuring that the welfare of research participants is not compromised is through the procurement of effective informed consent. Pharmacists, like many other health professionals, have had relatively little exposure to methodology involved in the writing of an informed consent instrument. A comprehensive document must not only conform to the requirements of federal regulatory agencies, but must also satisfy various institutional guidelines. Past instances of unethical human experimentation are discussed, and a format for preparation of an informed consent instrument is examined. Circumstances requiring informed consent and identification of the basic elements of consent are also explained.


2007 ◽  
Vol 44 (7) ◽  
pp. 489-496 ◽  
Author(s):  
David G. Scherer ◽  
Robert D. Annett ◽  
Janet L. Brody

Author(s):  
Lauren R. Sankary ◽  
Paul J. Ford

This chapter explores ethical issues in obtaining ongoing consent for clinical research involving cognitively vulnerable patient populations. Stakeholders in these challenges include researchers, sponsors, study participants, caregivers and other legally authorized representatives, and research oversight boards. First, this chapter examines existing conceptual frameworks and proposed safeguards for the protection of cognitively vulnerable research participants, including double consent, proxy consent with participant assent, advance consent, and process consent. This chapter then proposes an inclusionary approach to obtaining ongoing consent to research participation when cognition could fluctuate over the course of research participation. Proposed safeguards and modifications to the consent process should address duration of research participation, the nature and timing of research-related risks, expected and unexpected fluctuations in decision-making capacity, and the process of exiting a clinical trial. The proposed framework is then applied to the specific context of implanted neural device trials, with special attention to considerations for device explant.


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Eleanor Coleman ◽  
Lydia O’Sullivan ◽  
Rachel Crowley ◽  
Moira Hanbidge ◽  
Seán Driver ◽  
...  

Abstract Background In line with Good Clinical Practice and the Declaration of Helsinki, it is the investigator’s responsibility to ensure that research participants are sufficiently informed, to enable the provision of informed consent. The Participant Information Leaflet/Informed Consent Form is key to facilitating this communication process. Although studies have indicated that clinical research Participant Information Leaflets/Informed Consent Forms are not optimal in terms of accessibility, there is little or no specific guidance available. The aim of this research was to propose and agree a set of guidelines for academic researchers and sponsors for preparing accessible and understandable Participant Information Leaflets/Informed Consent Forms. Methods A literature review identified guidance for the preparation of patient-facing documents. Following critical appraisal, key recommendations were extracted and a set of recommendations which can be applied to clinical research Participant Information Leaflets/Informed Consent Forms were prepared. These recommendations were evaluated and amended by an Expert Consensus Conference consisting of a group of key stakeholders. The stakeholders included members of a Research Ethics Committee (both lay and expert), a patient advocate, experienced clinical researchers, a plain English editor and a Data Protection Officer. Consensus was reached regarding a final set of recommendations. Results 44 recommendations were agreed upon and grouped into five categories: Layout, Formatting, Content, Language and Confirming Readability. These recommendations aimed to maximize accessibility for lay participants, including readers with dyslexia, literacy or numeracy challenges, thereby improving the quality of the consent process. Conclusions More empirical research is needed to further improve the informed consent process for research participants. However, these recommendations are informed by the current literature and have been ratified by expert stakeholders. It is hoped that these recommendations will help investigators and sponsors to consistently and efficiently produce more accessible clinical research Participant Information Leaflets/Informed Consent Forms.


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