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 ◽  
...  

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.

2020 ◽  
Vol 28 (2) ◽  
pp. 375-400
Author(s):  
Nola M Ries ◽  
Elise Mansfield ◽  
Rob Sanson-Fisher

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.


1983 ◽  
Vol 8 (2) ◽  
pp. 155-176

The purpose of these abstracts is to provide reference facilities in the management field. These abstracts have been sponsored by the Indian Council of Social Science Research. These abstracts cover books and articles on empirical studies, experiences of people involved in the management process, and concepts and theories based on Indian data and environment written by Indian or foreign authors and published in India or abroad. The following areas of management are covered: Financial Management, Management Accounting, and Control (FM) Marketing (M) Organization and Administration (OA) Personnel Management and Industrial Relations (PMIR) Production Management, Computers, and Operations Research (PMCOR) General Management: Environment, Policy, and Planning (GM) Policy, Planning, and Development (PPD) Books and articles published after January 1974 are covered in Vikalpa. Abstracts of publications between 1970 and 1973 have been published in two volumes by the Indian Institute of Management, Ahmedabad. For reprint of articles abstracted in Vikalpa please contact the original journals. For further details please write to Professor Shekhar Chaudhuri.


1992 ◽  
Vol 17 (4) ◽  
pp. 63-73

This section features abstracts of articles covering empirical studies, experiences, ideas, and theories published in Indian and international journals. Sponsored by the Indian Council of Social Science Research, New Delhi, this service is intended to facilitate Indian management research. Authors desirous of having their publications considered for inclusion in this feature may please send reprints of their articles to Vikalpa Editorial Office.


2022 ◽  
Author(s):  
Paul Bloom ◽  
Laurie Paul

Some decision-making processes are uncomfortable. Many of us do not like to make significant decisions, such as whether to have a child, solely based on social science research. We do not like to choose randomly, even in cases where flipping a coin is plainly the wisest choice. We are often reluctant to defer to another person, even if we believe that the other person is wiser, and have similar reservations about appealing to powerful algorithms. And, while we are comfortable with considering and weighing different options, there is something strange about deciding solely on a purely algorithmic process, even one that takes place in our own heads.What is the source of our discomfort? We do not present a decisive theory here—and, indeed, the authors have clashing views over some of these issues—but we lay out the arguments for two (consistent) explanations. The first is that such impersonal decision-making processes are felt to be a threat to our autonomy. In all of the examples above, it is not you who is making the decision, it is someone or something else. This is to be contrasted with personal decision-making, where, to put it colloquially, you “own” your decision, though of course you may be informed by social science data, recommendations of others, and so on. A second possibility is that such impersonal decision-making processes are not seen as authentic, where authentic decision making is one in which you intentionally and knowledgably choose an option in a way that is “true to yourself.” Such decision making can be particularly important in contexts where one is making a life-changing decision of great import, such as the choice to emigrate, start a family, or embark on a major career change.


Edukacja ◽  
2021 ◽  
Vol 2020 (1) ◽  
pp. 9-20
Author(s):  
Bibek Dahal ◽  

Research ethics is concerned with ethical issues that can arise while conducting research. Social science research entails a combination of three equal entities: process, context and human agency. In each study, these entities demand rich interaction with each other. Generally, research ethics questions the interrelation between the research context and the human involvement established within that context. The research context and interaction between researcher and research participants lead to variations in the construction of knowledge, while research ethics plays a major role throughout all undertakings. In this narrative review paper, I have critically reflected my arguments on behalf of research ethics as a context-specific issue. I argued that the one-size-fits-all approach of research ethics is not viable by presenting ethical practices from the South Asian perspective. The paper is organized in three specific sections – ethical theories, research ethics and its contextual practices. Research ethics is very much a private affair and directly linked to the personal outlook of the researcher towards others. The ethical issue in research is not generic, but specific to the research context, i.e. the context of the research determines what form of behaviour is ethical and what is not. I explore the idea that the South Asian context may have its own system to conduct research ethically, as in euro-western and indigenous systems.


2021 ◽  
Author(s):  
Ugur Sener ◽  
Elizabeth C Neil ◽  
Amy Scharf ◽  
Alan C Carver ◽  
Justin B Buthorn ◽  
...  

Abstract Background Management of patients with brain tumors can lead to ethical and decisional dilemmas. The aim of this study was to characterize ethical conflicts encountered in neuro-oncologic patients. Methods Retrospective review of ethics consultations performed upon patients with primary and metastatic brain tumors at a tertiary cancer center. An ethics consultation database was examined to characterize ethical conflicts, contextual factors, and interventions by the consultation team. Results Fifty consultations were reviewed; 28(56%) patients were women, median age 54 (range 4-86); 27(54%) patients had a primary central nervous system malignancy; 20(40%) had brain metastasis. At the time of consultations, 41(82%) patients lacked decisional capacity; 48(96%) had a designated surrogate decision maker; 3(6%) had an advance directive outlining wishes regarding medical treatment; 12(24%) had a Do Not Attempt Resuscitation (DNAR) order. Ethical conflicts centered upon management of end-of-life (EOL) circumstances in 37(72%) of cases; of these, 30 did not have decisional capacity. The most common ethical issues were DNAR status, surrogate decision making, and request for non-beneficial treatment. Consultants resolved conflicts by facilitating decision making for incapacitated patients in 30(60%) cases, communication between conflicting parties in 10(20%), and re-articulation of patients’ previously stated wishes in 6(12%). Conclusions Decisional capacity at EOL represents the primary ethical challenge in care of neuro-oncologic patients. Incomplete awareness among surrogate decision makers of patients’ prognosis and preferences contributes to communication gaps and dilemmas. Early facilitation of communication between patients, caregivers, and medical providers may prevent or mitigate conflicts and allow enactment of patients’ goals and values.


Author(s):  
John R. Harrald

A significant body of social science research has concluded that improvisation in distributed, collaborative, open systems is the key to success in responding to and recovering from extreme events. The evolution of emergency management in the United States since the 9-11 attacks has emphasized the development of doctrine, process, and structure. In earlier work I concluded that both the agility desired by the social sciences and the discipline created by the professional practitioners are essential. This article explores how agility can be developed within a disciplined system and concludes that the keys are the development of outcome based goals, adaptive leadership, and technology that supports collaborative sense-making and decision making in open, organizational systems.


2008 ◽  
pp. 1443-1450
Author(s):  
Lynne D. Roberts ◽  
Leigh M. Smith ◽  
Clare M. Pollock

The rapid growth of the Internet has been accompanied by a growth in the number and types of virtual environments supporting computer-mediated communication. This was soon followed by interest in using these virtual environments for research purposes: the recruitment of research participants, the conduct of research and the study of virtual environments. Early research using virtual environments raised a number of ethical issues and debates. As early as 1996, a forum in the The Information Society (vol. 12, no. 2) was devoted to ethical issues in conducting social science research online. The debate has continued with more recent collaborative attempts to develop guidelines for ethical research online (Ess & Association of Internet Researchers, 2002; Frankel & Siang, 1999).


2019 ◽  
pp. 1-8
Author(s):  
Vanessa A. Edkins ◽  
Allison D. Redlich

While a great deal of psycho-legal research has focused on the trial process—and the decision making of jurors and juries, in particular—trials are not reflective of the current system of justice in the United States. Instead, we find ourselves within a system of pleas (Lafler v. Cooper, 2012) with a scarcity of social science research available to guide us. With this volume, we hope to integrate the current plea bargaining research that informs the field, from charging and defendant decision making, to attorney influences, to the ramifications at the larger system and institutional levels. Spanning multiple disciplines, the research and theories related to plea bargaining have much to contribute to public policy and to changes that individual actors (e.g., defense attorneys, prosecutors, and judges) may decide to incorporate in their daily interactions within our system of pleas.


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