Advance Research Directives: Legal and Ethical Issues and Insights from a National Survey of Dementia Researchers in Australia

2020 ◽  
Vol 28 (2) ◽  
pp. 375-400
Author(s):  
Nola M Ries ◽  
Elise Mansfield ◽  
Rob Sanson-Fisher
Keyword(s):  
Decision Making ◽  
Ethical Issues ◽  
Empirical Studies ◽  
Research Participation ◽  
Ethics Committees ◽  
Blood Samples ◽  
Research Activities ◽  
Advance Research ◽  
Ethics Guidelines ◽  
Legal And Ethical Issues

Abstract Advance research directives (ARDs) are a means by which people can document their wishes about research participation in the event of future incapacity. ARDs have been endorsed in some ethics guidelines and position statements, however, formal legal recognition is limited. A few empirical studies have investigated the views of researchers and other stakeholders on ARDs and tested strategies to implement such directives. To further knowledge in this area, we undertook a survey of dementia researchers in Australia (n= 63) to examine their views on ARDs. Most of the survey respondents (>80%) thought ARDs would promote autonomy in decision-making and enable opportunities for people with cognitive impairment to be included in research. Respondents indicated concern about directives not being available when needed (71%) and that ethics committees would not accept ARDs (60%). Few respondents had used ARDs, but a majority (from 57–80%) would be willing to offer ARDs for a range of research activities, such as observing behaviour and taking measures, blood samples or scans. Nearly all respondents (92%) agreed that current dissent should override prior wishes stated in an ARD. The survey findings are contextualised with attention to ethics guidelines, laws and practices to support advance research planning.

scholarly journals Ethical issues in two parallel trials of personalised criteria for implantation of implantable cardioverter defibrillators for primary prevention: the PROFID project—a position paper

Open Heart ◽  
2021 ◽  
Vol 8 (2) ◽  
pp. e001686
Author(s):  
Dick Willems ◽  
Marieke Bak ◽  
Hanno Tan ◽  
Georg Lindinger ◽  
Ayca Kocar ◽  
...  
Keyword(s):  
Decision Making ◽  
Ethical Issues ◽  
Empirical Studies ◽  
Social Science Research ◽  
Science Research ◽  
Ethics Committees ◽  
Ethical Challenge ◽  
Implantable Cardioverter Defibrillators ◽  
Postmyocardial Infarction ◽  
Superiority Trial

AimTo discuss ethical issues related to a complex study (PROFID) involving the development of a new, partly artificial intelligence-based, prediction model to enable personalised decision-making about the implantation of an implantable cardioverter defibrillator (ICD) in postmyocardial infarction patients, and a parallel non-inferiority and superiority trial to test decision-making informed by that model.MethodThe position expressed in this paper is based on an analysis of the PROFID trials using concepts from high-profile publications in the ethical literature.ResultsWe identify ethical issues related to the testing of the model in the treatment setting, and to both the superiority and the non-inferiority trial. We underline the need for ethical-empirical studies about these issues, also among patients, as a parallel to the actual trials. The number of ethics committees involved is an organisational, but also an ethical challenge.ConclusionThe PROFID trials, and probably other studies of similar scale and complexity, raise questions that deserve dedicated parallel ethics and social science research, but do not constitute a generic obstacle. A harmonisation procedure, comparable to the Voluntary Harmonization Procedure (VHP) for medication trials, could be needed for this type of trials.

Legal and ethical issues

2020 ◽  
pp. 433-454
Keyword(s):  
Decision Making ◽  
Ethical Decision Making ◽  
Ethical Issues ◽  
Small Degree ◽  
Life Care ◽  
Difficult Decision ◽  
Mental Capacity Act 2005 ◽  
Mental Capacity Act ◽  
Legal And Ethical Issues ◽  
Care Withdrawal

Legal and ethical decision-making is highly relevant to many patients suffering acute and chronic neurological illness and brain injury. The Mental Capacity Act 2005 has provided a robust framework on which to support difficult decision-making. Advance directives have enabled individuals to take control of their lives to some small degree; however, research, genetic testing, and disclosure continue to cause anxiety for people and healthcare professionals. Decision-making around end of life care, withdrawal of care, and palliative care is a particularly complex, emotive, and challenging area of nursing practice.

scholarly journals The ESRC's 2010 Framework for Research Ethics: Fit for Research Purpose?

2010 ◽  
Vol 15 (4) ◽  
pp. 106-115 ◽  
Author(s):  
Liz Stanley ◽  
Sue Wise
Keyword(s):  
Research Ethics ◽  
Ethical Issues ◽  
Ethics Committees ◽  
Professional Associations ◽  
Consultation Process ◽  
Ethics Framework ◽  
Science Community ◽  
Set Up ◽  
Ethics Guidelines ◽  
Research Ethics Guidelines

The ESRC's (2010) Framework for Research Ethics extends the remit of its 2005 research ethics framework in three significant ways: the system is to be fully mandatory and it will no longer be possible to make the case that no out of the ordinary ethical issues arise; the Research Ethics Committees (RECs) set up under the ESRC's 2005 document have extended remit, including reviewing all research proposals accepted by the ESRC and other funding bodies; and funding will depend on the REC review, with its purview extending through a project's life. The 2010 document is reviewed in detail and the conclusion is drawn that it is not fit for purpose. Six wider issues raised by the FRE document are discussed: the consultation process by the ESRC was insufficient and the informed consent of the social science community was not obtained; the ethics creep involved will involve unnecessary bureaucratisation; the RECs will operate without expert discipline-specific knowledge using unethical generalist criteria; the overall effects long-term will be deleterious to the research base; the FRE document unacceptably ignores the professional associations and their research ethics guidelines; and the ESRC's system of the expert peer review of funding applications will be undermined.

scholarly journals OC 8474 ASSESSMENT OF ETHICS REVIEW FRAMEWORKS FOR HEALTH RESEARCH IN EAST AFRICA FOR PURPOSES OF HARMONISATION

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A8.3-A9
Author(s):  
Gibson S Kibiki ◽  
Novat Twungubumwe ◽  
Francis Kombe ◽  
Carel IJsselmuiden ◽  
Prince N Bahati ◽  
...  
Keyword(s):  
Health Research ◽  
Qualitative Interviews ◽  
Ethics Committees ◽  
Research Subjects ◽  
East African ◽  
East African Community ◽  
Ethics Review ◽  
Research Ethics Review ◽  
Research Activities ◽  
Ethics Guidelines

BackgroundCapacity in health research ethics review is key in Africa, given the increase in research activities, complexity, and use of advanced technologies. Harmonising ethics review frameworks can address challenges attributable to these complexities. Establishing an effective harmonised framework that is optimum or protection of the research subjects requires assessment of review capacity.The East African Health Research Commission commissioned a study to assess the capacity of Review Ethics Committees (RECs) in the East African Community (EAC) countries, as a step towards strengthening and harmonising the regions’ capacity and review frameworks.MethodsA desktop review of documentation (national and institutional guidelines, policies and SOPs) was conducted in five EAC countries. Semi-structured questionnaires were used to collect data from key informants. Qualitative interviews were used to collect views on stakeholders’ perception of benefits, opportunities and challenges of harmonisation.ResultsSixty-nine (69) accredited RECs were mapped. All countries had national ethics guidelines and National Research Regulatory Authorities, whose mandates varied across countries. 57% of RECs reviewed local and international research, 43% reviewed local studies only. On average, 91 protocols were reviewed annually across all RECs (range 15 to 200). Membership ranged from 6 to 22 members per REC, with age range of 29 to 75 years.Annual budget allocation ranged from $3000 to $2.9 mil„lion financed through review fees (84%) or/and institutional budget (14%). 71% of RECs had education policy but 41%had members with training in ethics. Review turn-around time ranged from 14 to 90 days. All RECs supported harmonisation and attributed it to improved efficiency, quality and standardised costs.ConclusionSimilarities and dissimilarities were noted in the EAC countries’ ethics review frameworks. Harmonisation should consider 1) harmonisation of policy frameworks and tools; 2) institutionalisation of regional joint review mechanisms, 3) standardisation of training and capacity strengthening, 4) Review of the REC operational and financing models.

Techno-Research and Cyber-Ethics: Challenges for Ethics Committees

2007 ◽  
Vol 3 (3) ◽  
pp. 80-83 ◽  
Author(s):  
Carol Haigh ◽  
Neil Jones
Keyword(s):  
Ethical Issues ◽  
Ethical Dilemmas ◽  
New Technology ◽  
Ethics Committees ◽  
Ethics Committee ◽  
The Past ◽  
Communications Technologies ◽  
Worldwide Web ◽  
Ethics Guidelines ◽  
Cyber Ethics

The development of the internet and other communications technologies over the past decade have seen a corresponding growth in the development and use of technologically-based research methodologies. This paper explores issues arising from the new technology which impact on ethics committees and how these might be addressed. Whilst some ethical issues are comparable in both online and offline worlds there are some elements of the techno-research which require extra consideration. Although ethics guidelines can be found on the worldwide web the onus remains upon techno-researchers and ethics committee members to collaborate in deciding upon the ethical dilemmas and the rigour of proposed techno-research solutions.

Ongoing Consent in Situations of Cognitive Vulnerability

2019 ◽  
pp. 3-14 ◽  
Author(s):  
Lauren R. Sankary ◽  
Paul J. Ford
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Ethical Issues ◽  
Cognitive Vulnerability ◽  
Research Participation ◽  
Proxy Consent ◽  
Decision Making Capacity ◽  
Research Oversight ◽  
Vulnerable Patient ◽  
Study Participants

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.

Ethical Issues in Adult Cognitive Disorders

2019 ◽  
pp. 864-880
Author(s):  
Andrea Horwege ◽  
Thomas Hammek ◽  
Anita Sue Jwa ◽  
Allyson C. Rosen
Keyword(s):  
Decision Making ◽  
Incidental Findings ◽  
Ethical Issues ◽  
Cognitive Disorders ◽  
Research Participation ◽  
Treatment Decision ◽  
Treatment Decision Making ◽  
The Past ◽  
Effort Testing ◽  
Tremendous Progress

During the past few decades, there has been tremendous progress in the diagnosis and treatment of cognitive disorders. With these opportunities to advance diagnosis and care, there are new ethical and practical concerns. This chapter provides a general overview of ethical issues related to patients with diminished cognitive functioning. It describes essential concepts and issues that clinicians must know, such as treatment decision-making, limitations on independence, protection from harm, and interpretive issues surrounding effort testing. It then describes ethical issues related to clinical research, such as informed consent and assent for research participation, and considerations when conducting clinical trials. Finally, the chapter describes some issues surrounding neuroethics, such as preparing for and dealing with incidental findings, early detection of disorders, neuroenhancement, and the use of deception.

Ethical issues in palliative care research

2021 ◽  
pp. 1312-1317
Author(s):  
Tyler Tate ◽  
David Casarett
Keyword(s):  
Decision Making ◽  
Palliative Care ◽  
End Of Life ◽  
Ethical Issues ◽  
Research Participation ◽  
Ethical Aspects ◽  
Care Research ◽  
Qualitative And Quantitative ◽  
Decision Making Capacity ◽  
Potential Benefits

Recent growth in palliative care research has created a heterogeneous field that encompasses both qualitative and quantitative techniques, and descriptive as well as interventional studies. Despite the valuable knowledge that has been produced by this research, and the promise of future important advances, its progress has been impeded by a persistent uncertainty about the ethics of these studies. For instance, there have been concerns raised about whether patients near the end of life should ever be asked to participate in research, although others have objected to this extreme position. Nevertheless, the combination of ethical and practical issues can create substantial barriers to palliative care research. This chapter discusses five ethical aspects of palliative care research that investigators and clinicians should consider in designing and conducting palliative care research. These include (1) the study’s potential benefits to future patients, (2) the study’s potential benefits to subjects, (3) the study’s risks to subjects, (4) subjects’ decision-making capacity, and (5) the voluntariness of subjects’ choices about research participation.

scholarly journals Research consent from young people in resource-poor settings

2014 ◽  
Vol 100 (5) ◽  
pp. 438-440 ◽  
Author(s):  
Phaik Yeong Cheah ◽  
Michael Parker
Keyword(s):  
Decision Making ◽  
Young People ◽  
Low Income ◽  
Research Participation ◽  
Ethics Committees ◽  
Direct Benefit ◽  
Resource Poor ◽  
Valid Consent ◽  
Default Position ◽  
Do So

Authoritative international guidelines stipulate that for minors to participate in research, consent must be obtained from their parents or guardians. Significant numbers of mature minors, particularly in low-income settings, are currently being ruled out of research participation because their parents are unavailable or refuse to provide consent despite the possibility that they might wish to do so and that such research has the potential to be of real benefit. These populations are under-represented in all types of clinical research. We propose that, for research with a prospect of direct benefit that has been approved by relevant ethics committees, the default position should be that minors who are able to provide valid consent and meet the following criteria should be able to consent for themselves regardless of age and whether they have reached majority: the minor must be competent and mature relative to the decision; their consent must be voluntary and they must be relatively independent and used to decision making of comparable complexity. In addition, the context must be appropriate, the information related to the research must be provided in a manner accessible to the minor and the consent must be obtained by a trained consent taker in surroundings conducive for decision making by the minor. In this paper, we have argued that consent by mature minors to research participation is acceptable in some situations and should be allowed.

Medical Research and Alzheimer's Disease: A Study of the Hazards of Conducting Research on the Incompetent Patient

1997 ◽  
Vol 2 (4) ◽  
pp. 291-313
Author(s):  
Peter Moodie ◽  
Moira Wright
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Ethical Issues ◽  
Ethics Committees ◽  
Legal Issues ◽  
Pharmaceutical Companies ◽  
Incompetent Patient ◽  
Conducting Research ◽  
Legal And Ethical Issues ◽  
Local Research

Following a review of legal issues concerning the significance of capacity and consent in the context of clinical research involving groups of patients where some may be incompetent, the question is addressed how those involved in this area resolve the problems. Responses from 101 Local Research Ethics Committees, 13 pharmaceutical companies and 10 researchers engaged in work involving patients with Alzheimer's Disease indicate a considerable variation in approaches to the legal and ethical issues, as well as a degree of conflict concerning the assessment of patients' capacity to consent. The conclusion is that recent proposals from the Law Commission in this area need further consideration and elaboration in several respects.

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