The paper offers a solution to the problem of specifying computational systems that behave in accordance with a given set of ethical principles. The proposed solution is based on the concepts of ethical requirements and ethical protocols. A new conceptual tool, called the Control Closure of an operation, is defined and used to translate ethical principles into ethical requirements and protocols. The concept of Generalised Informational Privacy (GIP) is used as a paradigmatic example (...) of an ethical principle. GIP is defined in such a way as to (i) discriminate specific cases in which an individual’s GIP can be infringed without accessing the individual’s data; (ii) separate unauthorised accesses to data that do not respect the right to GIP from access that do; and (iii) distinguish different degrees of GIP. Finally a camera phone is used to illustrate the proposed solution. (shrink)

Introduction Currently, The nature and scope of Clinical Ethics Protocols in Madrid are not well understood.Objectives The main objective is to describe the features of ‘guideline/recommendation’ type CEPs that have been or are being developed by existing Clinical Ethics Committees in Madrid. Secondary objectives include characterisation of those CECs that have been the most prolific in reference to CEP creation and implementation and identification of any trends in future CEP development.Methods We collected CEPs produced and in process by CECs (...) accredited in the public hospitals in Madrid, Spain, from 1996 to 2008.Results CECs developed 30 CEPs, with 10 more in process. The most common topic is refusal of treatment . If CEPs addressing terminal illness, Do-Not-Resuscitate orders and advance directives are placed into a separate ‘ethical problems at the end of life’ category, this CEP subject emerges as the most common . There is a relationship between the age of the CEC and the development of CEPs . CECs now seem to be more likely to engage in CEP development.Conclusions The CECs in Madrid, Spain, have developed a significant number of CEPs and there is a trend towards continued development. The most frequent topics are ethical problems at the end of life and refusal of treatment by the patient. (shrink)

What does it look like when an organization tentatively steps away from an exclusively rules-based regime and begins to attend to both rules and principles? What insights and guidance can ethicists and ethical theory offer? This paper is a case study of an organization that has initiated such a transition. The American Institute of Certified Public Accountants has begun a turn toward the promotion of ethical principles and best practices by adding a “conceptual framework” to its existing Code (...) of Professional Conduct. This conceptual framework calls upon its members to intentionally increase their awareness of significant threats to their compliance with its rules of conduct and to establish safeguards to offset or eliminate those threats. To this end, each member is required to regard every questionable situation, circumstance, transaction or relationship by attempting to view it through the eyes of an imagined reasonable third party. This paper examines this protocol theoretically and practically. First, we frame this analysis within the principles and ethical concepts that inform the professional ethics of accountants. Second, we critique the AICPA’s long-standing rules-based approach to its Code. Third, we examine the new conceptual framework with a view toward its potential for the promotion of a more principles-based approach to the professional ethics of the accounting profession. Fourth, we give attention to the notion of the “reasonable and informed third party,” which has been embedded in the new conceptual framework, and consider how two schools of thought—Adam Smith’s modernist “impartial spectator” concept and Emmanuel Lévinas’ postmodern phenomenology in regard to “the Other”—may offer theoretical support and clarity for this epistemic exercise. Finally, we point out several ways in which the AICPA’s commitment to its new conceptual framework could be strengthened and enhanced. (shrink)

Ethical Considerations When Preparing a Clinical Research Protocol, Second Edition, provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, how to design appropriate research studies, how to consent and assent documents, how to get protocols approved, special populations, confidentiality issues, and the reporting of adverse events. The book's valuable appendix includes a listing of web resources (...) about research ethics, along with a glossary, making it an invaluable resource for scientists collaborating in clinical trials, physician investigators, clinical research fellows, and more. Walks investigators and trainees through the identification of the ethical aspects of each section of a clinical research protocol Includes case histories that illustrate key points Contains information on conducting clinical research within the pharmaceutical industry Includes internet resources and worldwide web addresses for important research ethics documents and regulations Contains a chapter on Study Design and Methodology that is purposely expanded to explicitly address biostatistical considerations. (shrink)

Contemporary security has expanded its meaning, content and structure in response to globalization and the emergence of greatly improved world-wide communication. This book addresses how and why the nature of security has changed and what this means for the security actors involved and the wider society. The expert contributors reflect upon new communication methods, post-modern concepts of warfare, technological determinants and cultural preferences to provide new theoretical and analytical insights into a changing security environment and the protocols of war (...) in the 21st century."--Provided by publisher. (shrink)

AimsThis study evaluates a protocol for early, routine ethics consultation for patients on extracorporeal membrane oxygenation to support decision-making in the context of clinical uncertainty with the aim of mitigating ethical conflict and moral distress.MethodsWe conducted a single-site qualitative analysis of EC documentation for all patients receiving ECMO support from 15 August 2018 to 15 May 2019. Detailed analysis of 20 ethically complex cases with protracted ethics involvement identifies four key ethical domains: limits of prognostication, bridge to nowhere, (...) burden of treatment and system-level concerns. There are three subthemes: relevant contextual factors, the role of EC and observed outcomes. Content analysis of transcripts from interviews with 20 members of the multidisciplinary ECMO team yields supplemental data on providers’ perceptions of the impact of the early intervention protocol.ResultsLimited outcome data for ECMO, unclear indications for withdrawal, adverse effects of treatment and an obligation to attend to programme metrics present significant ethical challenges in the care of this patient population. Upstream EC mitigates ethical conflict by setting clear expectations about ECMO as a time limited trial, promoting consistent messaging among multiple services and supporting surrogate decision-makers. When ECMO becomes a ‘bridge to nowhere’, EC facilitates decision-making that respects patient values yet successfully sets limits on non-beneficial use of this novel therapy.ConclusionData from this study support the conclusion that ECMO poses unique ethical challenges that necessitate a standardised protocol for early, routine EC—at least while this medical technology is in its nascent stages. (shrink)

At the height of the COVID-19 crisis in the Netherlands a shortness of intensive care beds was looming. Dutch professional medical organizations asked a group of ethicists for assistance in drafting guidelines and criteria for selection of patients for intensive care treatment in case of absolute scarcity, when medical selection criteria would no longer suffice. This article describes the Dutch context, the process of drafting the advice and reflects on the role of ethicists and lessons learned. We argue that timely (...) interaction between clinical and ethical expertise is necessary since the distinction between medical and non-medical considerations is not as clearcut as sometimes assumed. Furthermore, pragmatic considerations related to the specifics of an epidemic are of importance, for example, in relation to prioritizing health care workers. As a consequence, any protocol already present before the pandemic would need alterations to fit the current situation. The ‘fair innings’ criterion we proposed, rephrased as an argument of intergenerational solidarity, was considered reasonable by professionals as well as patient organizations. While it is desirable to draft ethical guidelines in ‘peacetime’ as a matter of pandemic preparedness, the pressure of an actual crisis facilitates decision-making, although it will also complicate a more democratic approach. (shrink)

Medical practice is ideally based on robust, relevant research. However, the lack of disease-modifying treatments for Alzheimer’s disease has motivated “innovative practice” to improve patients’ well-being despite insufficient evidence for the regular use of such interventions in health systems treating millions of patients. Innovative or new non-validated practice poses at least three distinct ethical questions: first, about the responsible application of new non-validated practice to individual patients ; second, about the way in which data from new non-validated practice are (...) communicated via the scientific and lay press ; and third, about the prospect of making new non-validated interventions widely available before more definitive testing. We argue that the authors of metabolic enhancement protocols for Alzheimer’s disease have overstated the evidence in favor of these interventions within the scientific and lay press, failing to communicate weaknesses in their data and uncertainty about their conclusions. Such unmeasured language may create false hope, cause financial harm, undermine informed consent, and frustrate the production of generalizable knowledge necessary to face the societal problems posed by this devastating disease. We therefore offer more stringent guidelines for responsible innovation in the treatment of Alzheimer’s disease. (shrink)

Volume 20, Issue 7, July 2020, Page 1-5.

BackgroundClinical ethics case consultations (CECCs) provide a structured approach in situations of ethical uncertainty or conflicts. There have been increasing calls in recent years to assess the quality of CECCs by means of empirical research. This study provides detailed data of a descriptive quantitative and qualitative evaluation of a CECC service in a department of cardiology and intensive care at a German university hospital.MethodsSemi-structured document analysis of CECCs was conducted in the period of November 1, 2018, to May 31, (...) 2020. All documents were analysed by two researchers independently.ResultsTwenty-four CECCs were requested within the study period, of which most (n = 22; 92%) had been initiated by physicians of the department. The patients were an average of 79 years old (R: 43–96), and 14 (58%) patients were female. The median length of stay prior to request was 12.5 days (R: 1–65 days). The most frequent diagnoses (several diagnoses possible) were cardiology-related (n = 29), followed by sepsis (n = 11) and cancer (n = 6). Twenty patients lacked decisional capacity. The main reason for a CECC request was uncertainty about the balancing of potential benefit and harm related to the medically indicated treatment (n = 18). Further reasons included differing views regarding the best individual treatment option between health professionals and patients (n = 3) or between different team members (n = 3). Consensus between participants could be reached in 18 (75%) consultations. The implementation of a disease specific treatment intervention was recommended in five cases. Palliative care and limitation of further disease specific interventions was recommended in 12 cases.ConclusionsTo the best of our knowledge, this is the first in-depth evaluation of a CECC service set up for an academic department of cardiology and intensive medical care. Patient characteristics and the issues deliberated during CECC provide a starting point for the development and testing of more tailored clinical ethics support services and research on CECC outcomes. (shrink)

Indonesia consists of more than 17,000 islands separated for hundreds of thousands of years making both the biodiversity and culture diverse. Strong connection between people and biodiversity form a vast array of traditional knowledges retaliated to the conservation and use of biological diversity. During the last 3 decades, tremendous advancement on science and technology has been able to uncover the intrinsic value of biodiversity. Many lead chemical compounds have been isolated and identified, and has opened up huge opportunities in developing (...) new business based on biodiversity. International cooperation between Japan and Indonesia successfully isolated more than 1,000 species of actinomycetes from diverse ecosystems and more than 30% are new species. This group of microbe is important for future pharmaceutical industries. The consciousness on intrinsic value of biodiversity is, however, only being understood by countries having high science and technology capacity. The intrinsic value of biodiversity remains abstract to most of the people in the developing and less developed nations. The Convention on Biological Diversity (UN-CBD), Cartagena and Nagoya Protocol are legal documents to ensure conservation, sustainable use and sharing of the benefit from the utilization of biodiversity and its components. There is a high demand for the developed nations on access to biodiversity to uncover its benefit. The mechanism on access, fair and equitable sharing of the benefit from the utilization of biodiversity and its component are certainly full of ethical dilemma. For this, there is a great need for the developing country having rich biodiversity find the most appropriate way to manage biodiversity and traditional knowledge for their prosperity. Trust between countries rich in biodiversity and countries having high science and technology capacity is a crucial factor. Greater transparency and the recognition on comprehensive rights of people providing biodiversity is a key element in maintaining trust. Ethical standards cannot depend solely on rules or guidelines. (shrink)

We explore the various ethical challenges that arise during the practical implementation of an emergency resource allocation protocol. We argue that to implement an allocation plan in a crisis, a hospital system must complete five tasks: (1) formulate a set of general principles for allocation, (2) apply those principles to the disease at hand to create a concrete protocol, (3) collect the data required to apply the protocol, (4) construct a system to implement triage decisions with those data, and (...) (5) create a system for managing the consequences of implementing the protocol, including the effects on those who must carry out the plan, the medical staff, and the general public. Here we illustrate the complexities of each task and provide tentative solutions, by describing the experiences of the Coronavirus Ethics Response Group, an interdisciplinary team formed to address the ethical issues in pandemic resource planning at the University of Rochester Medical Center. While the plan was never put into operation, the process of preparing for emergency implementation exposed ethical issues that require attention. (shrink)

This manual is a compendium of various health care policies, guidelines, protocols, and programs that concern clinical issues with ethical implications. The collection of policies, guidelines, and procedures are helpful in drafting and reviewing institutional procedures and helping policymakers develop useful mechanisms for assuring ethical treatment of patients and staff.

In this paper we discuss differing discourses of research ethics committees and the clinical research field. Reflections on our experience of conducting research in a nursing home are used to highlight the tensions and inconsistencies that arise from these discourses and the need to behave ethically in the field. While accepting the need for adherence to guiding principles of duty based ethics, we have found that practical moral decisions in the field required that, as individual researchers, we needed to exercise (...) discretionary judgement, informed by the ethic of care and the concern for the well‐being of research participants. (shrink)

The current coronavirus disease 2019 pandemic has led to essential adjustments in clinical research involving human subjects. The pandemic is substantially affecting most procedures of ongoing, as well as new clinical trials related to diseases other than COVID-19. Procedural changes and study protocol modifications may significantly impact ethically salient fundamentals, such as the risk-benefit profile and safety of clinical trial participants, which raise key ethical challenges the subject-matter experts must face. This article aims to acquaint a wide audience of (...) clinical research professionals, ethicists, as well as the general public interested in this topic with the legal, ethical and practical considerations in the field of clinical trials during the COVID-19 pandemic and to support the clinical researchers and study sponsors to fulfil their responsibilities in conducting clinical trials in a professional way that does not conflict with any legal or ethical obligations. (shrink)

Shortages of generic, injectable chemotherapeutics have been increasing in prevalence since 2006. Due to the lack of access to first-line, lifesaving treatments, physicians have been forced to ration chemotherapy between patients. Although the scarcity has been managed with good intentions, it has been done in an ad hoc manner, without the benefit of an ethically grounded and standardized schema. Using an approach based on the “accountability for reasonableness” method by Daniel and Sabin, I establish a framework and protocol for rationing (...) that is specific to chemotherapy. Prior to the state of true shortage, I present guidelines for the use of an adequate supply of chemotherapy with knowledge of upcoming scarcity. Within the rationing framework itself, I first prioritize emergency use of chemotherapeutics and those already receiving treatment at the time of shortage. I advocate for stratifying patients based on the prognostic indicators of their cancer type, using a combination of clinical-trial-based initial response and longer term survival, followed by the patients’ line of treatment. All patients who are not able to receive their “best” treatment must receive a sequent, next-best treatment, and their treatment team must have the ability to appeal to a rationing committee in special circumstances. I reject the ideas of stratification based on the intention of the treatment, perceived quality of life, pre-existing condition not impacting performance status, the classical “sickest first” argument, and giving preference to pediatric cases. Lastly, I advocate for any system of rationing to be transparent to those it affects and acknowledge the difficulties it presents to patients and physicians alike. (shrink)

Submission of study protocols to research ethics committees constitutes one of the earliest stages at which planned trials are documented in detail. Previous studies have investigated the amendments requested from researchers by RECs, but the type of issues raised during REC review have not been compared by sponsor type. The objective of this study was to identify recurring shortcomings in protocols of drug trials based on REC comments and to assess whether these were more common among industry-sponsored or (...) non-industry trials. (shrink)

BackgroundThe expectation of pandemic-induced severe resource shortages has prompted authorities to draft and update frameworks to guide clinical decision-making and patient triage. While these documents differ in scope, they share a utilitarian focus on the maximization of benefit. This utilitarian view necessarily marginalizes certain groups, in particular individuals with increased medical needs.Main bodyHere, we posit that engagement with the disability critique demands that we broaden our understandings of justice and fairness in clinical decision-making and patient triage. We propose the capabilities (...) theory, which recognizes that justice requires a range of positive capabilities/freedoms conducive to the achievement of meaningful life goals, as a means to do so. Informed by a disability rights critique of the clinical response to the pandemic, we offer direction for the construction of future clinical triage protocols which will avoid ableist biases by incorporating a broader apprehension of what it means to be human.ConclusionThe clinical pandemic response, codified across triage protocols, should embrace a form of justice which incorporates a vision of pluralistic human capabilities and a valuing of positive freedoms. (shrink)

This article is a response to the letter from the Department of Health that was published in the previous edition of the Research Ethics Review upon the matter of the legal duty of the research ethics committees. It also deals briefly with the article published in the current edition of Research Ethics Review by Colin Parker on what appears to be the same topic.

The American Journal of Bioethics, Volume 11, Issue 9, Page 33-35, September 2011.

OBJECTIVES: To review the characteristics and performance of research ethics committees in Spain in the evaluation of multicentre clinical trial drug protocols. DESIGN: A prospective study of 100 applications. SETTING: Forty-one committees reviewing clinical trial protocols, involving 50 hospitals in 25 cities. MAIN MEASURES: Protocol-related features, characteristics of research ethics committees and evaluation dynamics. RESULTS: The 100 applications involved 15 protocols (of which 12 were multinational) with 12 drugs. Committees met monthly (except one). They had a mean (...) number of 12 members, requested a mean of six complete dossiers and nine additional copies of the protocol with a mean deadline of 14 days before the meeting. All applications were approved except three (two of the three were open-label long-term safety trials rejected by the same committee), which were approved by the other committees involved. The mean time from submission to approval was 64 days. The mean time from submission to arrival of the approval document at our offices was 85 days. Twenty-five committees raised queries for 38 of the 97 finally approved applications. Impact of evaluation fee, number of members, queries raised and experience of committees on timings were not statistically significant. CONCLUSION: Obtaining ethical approval is time-consuming. There is much diversity in the research ethics committees' performance. A remarkable delay (> 20 days) exists between the decision and the arrival of the written approval, suggesting administrative or organisational problems. (shrink)

Recruiting minorities into research studies requires special attention, particularly when studies involve “extra-vulnerable” participants with multiple vulnerabilities, e.g., pregnant women, the fetuses/neonates of ethnic minorities, children in refugee camps, or cross-border migrants. This study retrospectively analyzed submissions to the Ethics Committee of the Faculty of Tropical Medicine (FTM-EC) in Thailand. Issues related to the process and outcomes of proposal review, and the main issues for which clarification/revision were requested on studies, are discussed extensively.

In this paper, the author shows how research ethics committees must deal with illegality in the research protocol. He defines their legal duty by reference to the 2001 Clinical Trials Directive, and especially in the key areas of insurance, indemnity and no-fault compensation. The author is critical of the current GAfREC and recent guidelines issued by the Royal College of Physicians. He concludes that new rules are needed to replace the 2001 edition of GAfREC.

Our lives are increasingly intertwined with the digital realm, and with new technology, new ethical problems emerge. The academic field that addresses these problems—which we tentatively call ‘digital ethics’—can be an important intellectual resource for policy making and regulation. This is why it is important to understand how the new ethical challenges of a digital society are being met by academic research. We have undertaken a scientometric analysis to arrive at a better understanding of the nature, scope and (...) dynamics of the field of digital ethics. Our approach in this paper shows how the field of digital ethics is distributed over various academic disciplines. By first having experts select a collection of keywords central to digital ethics, we have generated a dataset of articles discussing these issues. This approach allows us to generate a scientometric visualisation of the field of digital ethics, without being constrained by any preconceived definitions of academic disciplines. We have first of all found that the number of publications pertaining to digital ethics is exponentially increasing. We furthermore established that whereas one may expect digital ethics to be a species of ethics, we in fact found that the various questions pertaining to digital ethics are predominantly being discussed in computer science, law and biomedical science. It is in these fields, more than in the independent field of ethics, that ethical discourse is being developed around concrete and often technical issues. Moreover, it appears that some important ethical values are very prominent in one field (e.g., autonomy in medical science), while being almost absent in others. We conclude that to get a thorough understanding of, and grip on, all the hard ethical questions of a digital society, ethicists, policy makers and legal scholars will need to familiarize themselves with the concrete and practical work that is being done across a range of different scientific fields to deal with these questions. (shrink)

University and school preparation of new teachers should include work on the ethical and policy quandries of professional work. As it is, teacher education institutions too rarely tackle questions of protocol, ethics, policy, principles, and procedures. Professors may discuss matters of protocol, especially ethical conflicts arising from school and university practices and routines. But they rarely give in-depth treatment to ethics and policy in the teaching life. Moreover, treatment of these matters is often sparse in ethical theory (...) or in reasoned analyses of protocol and policies. This leaves the new teacher without initiation into centrally important elements of teaching. The appropriate treatment of protocol, ethical, and policy matters in education programs warrants a separate course of instruction. Here, students would be encouraged to improve their ethical reasoning and to learn ethical theory. They would learn various ways to assess protocol and policy problems likely to arise in classrooms and schools. Minimally, teacher education professors should draw attention to important protocol, ethical, and policy aspects of course content and do so in vigorous, educationally sound ways. In this article, I show how my treatment of protocol, ethics, and policies would apply more widely in general postsecondary education. (shrink)

The Kyoto Protocol became law in February 2005—eight years after its conception as a framework for reducing emissions and a full four years after the United States abandoned it. But while President George W. Bush embarrassed much of the scientific community by challenging the veracity of the greenhouse effect, and thus the impetus for Kyoto, officials elsewhere expressed far different concerns. _Reading the Kyoto Protocol_ explores their qualms and objections to everything from Kyoto's controversial policies on emissions trading to the (...) question of a "post-Kyoto era." Contributors include internationally known philosophers, researchers, and environmentalists. (shrink)

Randomized controlled trial trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, an explanatory approach to trial design emphasizes hypothesis testing about the mechanisms of action of treatments under ideal conditions, whereas a pragmatic approach emphasizes testing effectiveness of two or more available treatments in real-world conditions. Interest in, and the number of, pragmatic trials has grown substantially (...) in recent years, with increased recognition by funders and stakeholders worldwide of the need for credible evidence to inform clinical decision-making. This increase has been accompanied by the onset of learning healthcare systems, as well as an increasing focus on patient-oriented research. However, pragmatic trials have ethical challenges that have not yet been identified or adequately characterized. The present study aims to explore the views of key stakeholders with respect to ethical issues raised by the design and conduct of pragmatic trials. It is embedded within a large, four-year project that seeks to develop guidance for the ethical design and conduct of pragmatic trials. As a first step, this study will address important gaps in the current empirical literature with respect to identifying a comprehensive range of ethical issues arising from the design and conduct of pragmatic trials. By opening up a broad range of topics for consideration within our parallel ethical analysis, we will extend the current debate, which has largely emphasized issues of consent, to the range of ethical considerations that may flow from specific design choices. Semi-structured interviews with key stakeholders, across multiple jurisdictions, identified based on their known experience and/or expertise with pragmatic trials. We expect that the study outputs will be of interest to a wide range of knowledge users including trialists, ethicists, research ethics committees, journal editors, regulators, healthcare policymakers, research funders and patient groups. All publications will adhere to the Tri-Agency Open Access Policy on Publications. (shrink)

Vulnerabilities often characterize the availability of immigrant populations of interest in social behavioral science, public health, and medical research. Refugees, asylum seekers, and undocumented immigrants present unique vulnerabilities relevant to protocol development as well as ethics review procedures and criteria. This paper describes vulnerable populations in relation to the Belmont Report and US federal regulations for the protection of human subjects, both of which are commonly used in international research contexts. It argues for safeguards for immigrants comparable to protections for (...) such populations as pregnant women, prisoners, and children. The paper further presents a two-part model for the review of protocols that involve immigrants. The model is intended to help identify the risks to immigrants associated with participation in research, and to suggest how researchers can responsibly frame studies and access to research participant immigrants through community-based, and/or non-governmental organizations that serve immigrants and immigrant communities. (shrink)

The combination of genuine ethical concerns and fear of learning to use germ-line therapy for human disease must now be confronted. Until now, no established techniques were available to perform this treatment on a human. Through an integration of several fields of science and medicine, we have developed a nine step protocol at the germ-line level for the curative treatment of a genetic disease. Our purpose in this paper is to provide the first method to apply germ-line therapy to (...) treat those not yet born, who are destined to have a life threatening, or a severely debilitating genetic disease. We hope this proposal will initiate the process of a thorough analysis from both the scientific and ethical communities. As such, this proposal can be useful for official groups studying the advantages and disadvantages of germ-line therapy. (shrink)

One of the most recent controversies to arise in the field of bioethics concerns the ethics for the Groningen Protocol: the guidelines proposed by the Groningen Academic Hospital in The Netherlands, which would permit doctors to actively euthanise terminally ill infants who are suffering. The Groningen Protocol has been met with an intense amount of criticism, some even calling it a relapse into a Hitleresque style of eugenics, where people with disabilities are killed solely because of their handicaps. The purpose (...) of this paper is threefold. First, the paper will attempt to disabuse readers of this erroneous understanding of the Groningen Protocol by showing how such a policy does not aim at making quality-of-life judgements, given that it restricts euthanasia to suffering and terminally ill infants. Second, the paper illustrates that what the Groningen Protocol proposes to do is both ethical and also the most humane alternative for these suffering and dying infants. Lastly, responses are given to some of the worries expressed by ethicists on the practice of any type of non-voluntary active euthanasia. (shrink)

In their article, Nielsen Busch and Mjaaland defend the moral permissibility of cDCD, suggesting that much of the controversy around this donation practice has been the result of a misinterpretatio...

While principle-based ethics is well known and widely accepted in psychiatry, much less is known about how decisions are made in clinical practice, which case scenarios exist, and which challenges exist for decision-making. Protocols of the central ethics committee responsible for four psychiatric hospitals over 7 years (N=17) were analysed. While four cases concerned suicide risk in the case of intended hospital discharge, the vast majority (N=13) concerned questions of whether the responsible physician should or should not initiate the (...) use of coercion in patients lacking mental capacity. The committee’s recommendations were non-uniform. Forced feeding and electroconvulsive therapy were endorsed in each one case. In two cases of intermittent loss of capacity due to heavy drinking or intermittent severe suicidal ideation, a self-binding contract was recommended and the use of coercion was considered as justified for a very limited period. In all other cases, most of which involved involuntary treatment, the use of coercion was not endorsed. Without exception, the recommendations were accepted with relief by the physicians and their treatment teams, who feared liability in the event of harm to the patient. Eventually, a model of a decision algorithm was derived from the ethical arguments in the protocols. (shrink)

Background The post-trial period is the time period after the end of study drug administration. It is unclear whether post-trial arrangements for patient surveillance are routinely included in study protocols and consents, and whether research ethics boards (REB) consider the post-trial period. Objectives The objective was to determine whether trial protocols and consent forms reviewed by the REB describe procedures for post-trial period surveillance. Methods An observational study of protocols of randomised trials of chronic therapies for cardiac (...) conditions, approved by the REB of two academic institutions affiliated with the University of Toronto in Canada (University Health Network and Mount Sinai Hospital) from 1995 to 2007. Plans for patient surveillance in the post-trial period described in the protocol or in the consent form before and after REB approval were recorded. Results 42 studies were identified including 18 heart failure and 15 coronary artery disease trials. Only four studies planned a clinical visit after trial termination, and an additional three planned a telephone contact after trial completion. Five trials submitted consent forms to the REB with a discussion of the post-trial period. Conclusions The majority of protocols and consent forms did not discuss plans for post-trial period surveillance. The post-trial period and the REB approval process could be improved by systematic follow-up being described in the protocol and consent form. The small number of trial protocols evaluated in the study may impair the degree to which the results can be generalised. (shrink)

BackgroundOver the past two decades, Uganda has experienced a significant increase in clinical research driven by both academia and industry. This has been combined with a broader spectrum of research proposals, with respect to methodologies and types of intervention that need evaluation by Research Ethics Committees (RECs) with associated increased requirement for expertise. We assessed the competencies of REC members regarding review of research protocols with complex and emerging research study designs. The aim was to guide development of a (...) training curriculum to improve the quality of scientific and ethical review.MethodsThis was a cross-sectional study design, with quantitative data collection methods. Research Ethics Committee members completed a structured pre-coded questionnaire on current competence with complex and emerging study design. REC members were asked to outline a list of additional topics for which they needed training. Data from coded questions were entered into Epidata Version 3.1 and then exported to STATA Version14.1 for analysis. Descriptive analysis was performed and findings are presented using percentages and frequencies.ResultsWe enrolled 55 REC members from 6 RECs who have a total of 97 members. The majority of whom were males (56.4%, n = 31/55). The level of competence for review of selected study design was lowest for Controlled Human Infection Model (10.9%, n = 6) and reverse pharmacology design (10.9%, n = 6), and highest for cluster randomized study design (52.7%, n = 29) and implementation science research (52.7%, n = 29).ConclusionCompetence for review of research protocols with complex and emerging study design was low among participating REC members. We recommend prioritising training of REC members on complex and emerging study designs to enhance quality of research protocol review. (shrink)

BackgroundThe use of genetic test results in risk-rated insurance is a significant concern internationally, with many countries banning or restricting the use of genetic test results in underwriting. In Australia, life insurers’ use of genetic test results is legal and self-regulated by the insurance industry (Financial Services Council (FSC)). In 2018, an Australian Parliamentary Inquiry recommended that insurers’ use of genetic test results in underwriting should be prohibited. In 2019, the FSC introduced an industry self-regulated moratorium on the use of (...) genetic test results. In the absence of government oversight, it is critical that the impact, effectiveness and appropriateness of the moratorium is monitored. Here we describe the protocol of our government-funded research project, which will serve that critical function between 2020 and 2023.MethodsA realist evaluation framework was developed for the project, using a context-mechanism-outcome (CMO) approach, to systematically assess the impact of the moratorium for a range of stakeholders. Outcomes which need to be achieved for the moratorium to accomplish its intended aims were identified, and specific data collection measures methods were developed to gather the evidence from relevant stakeholder groups (consumers, health professionals, financial industry and genetic research community) to determine if aims are achieved. Results from each arm of the study will be analysed and published in peer-reviewed journals as they become available.DiscussionThe A-GLIMMER project will provide essential monitoring of the impact and effectiveness of the self-regulated insurance moratorium. On completion of the study (3 years) a Stakeholder Report will be compiled. The Stakeholder Report will synthesise the evidence gathered in each arm of the study and use the CMO framework to evaluate the extent to which each of the outcomes have been achieved, and make evidence-based recommendations to the Australian federal government, life insurance industry and other stakeholders. (shrink)

When confronted by the novel ethical challenges posed by a pandemic, it is helpful to turn to history for guidance and direction. In this essay, the author revisits Thucydides's description of the Plague of Athens from The Peloponnesian War as he considers the New York State Task Force on Life and the Law's 2015 guidelines on ventilator allocation. Confronted by the exigencies of the Covid‐19 surge that struck New York, he questions the task force's decision not to give any (...) degree of preference to health care workers who might become ill. He posits that they are due a compensatory ethic and some deference given the risks they have assumed, often with inadequate protective gear. Reflecting on his ambivalence, he asks if his change of heart reflects the impact of experiential learning or the erosion of nomos—or governing norms—described by Thucydides when the plague struck Athens. (shrink)

Substance-abusing women are vulnerable to specific kinds of epistemic injustice, including stigmatization and discrimination. This article examines the development of the epistemic agency of female substance abusers by asking: How does the use of a formal discussion protocol in community rehabilitation interaction alleviate epistemic injustice and strengthen the epistemic agency of substance abusers? The data were collected in a Finnish rehabilitation center by videotaping six group discussions between social workers, peer support workers, and rehabilitation clients with substance abuse problems. Of (...) these data, one recorded group discussion between four female participants—two rehabilitation clients, a peer support worker, and a social adviser—was used in this paper. Using conversational analysis, the findings indicate that, through the collaborative activities of sharing experiential knowledge about substance abuse and discussing the experiences of abuse in the rehabilitation interaction, substance abusers can develop novel ways to strengthen their epistemic agency by enhanced self-awareness. The discussion protocol is an epistemic tool that professionals and clients can learn to use in ethically and epistemologically successful ways in interaction. The use of a discussion protocol is an example of social professionals’ clinical knowledge of intensifying collaboration and sharing experiential knowledge in community rehabilitation and other substance abuse services. (shrink)

Background: Both anxiety and depression in family caregivers of advanced cancer patients are common, and they have a negative influence on both the FCs and the patients. Some studies suggested that a variety of interventions could alleviate the psychological symptoms of FCs. However, there is no consensus on much more effective methods for intervention, and relatively high-quality research is blank in psychological problems of these population in China. The validity of mindfulness-based stress reduction and psychological consultation guided by the needs (...) assessment tool in the psychological status of caregivers will be compared in this study to select a more suitable intervention for the FCs of advanced cancer patients in China.Methods and Analysis: A randomized N-of-1 trial would be conducted at the Cancer Hospital, Chinese Academy of Medical Sciences. Fifty eligible FCs of advanced cancer patients will be recruited, and all will receive three cycles of psychological intervention treatment, with each cycle including both of MBSR and psychological consultation guided by the NST. MBSR and psychological consultation guided by the NST will be compared with each other in each cycle, and the intervention sequence will be based on the random number table generated after the informed consent has been completed. Each treatment period is 2 weeks, and the interval between different treatment cycles or treatment periods is 1 week. The self-reported scales are measured at the beginning and end of each treatment period, including the Self-Rating Anxiety Scale, the Self-Rating Depression Scale, Distress Thermometer, Zarit Burden Interview, Chinese version of the Medical Outcomes Study 12-item Short Form, and Family Carer Satisfaction with Palliative Care scale.Dissemination: The protocol of the study was approved by the Institutional Review Board of the Ethical Committee of the Cancer Hospital, Chinese Academic of Medical Science. The results will be published in a peer-reviewed medical journal. The study is registered at Chinese Clinical Trials Registry with the trial registration number chiCTR2000033707. This study employs an innovative methodological approach on the effectiveness of MBSR and psychological consultation guided by the NST for psychological status of FCs of advanced cancer patients. The findings of the study will be helpful to provide high-quality evidence-based medical data for psychological intervention of FCs of advanced cancer patients, and guide clinicians on best quality treatment recommendations. (shrink)

Objective—Consultation of another physician is an important method of review of the practice of euthanasia. For the project “support and consultation in euthanasia in Amsterdam” which is aimed at professionalising consultation, a protocol for consultation was developed to support the general practitioners who were going to work as consultants and to ensure uniformity. Participants—Ten experts (including general practitioners who were experienced in euthanasia and consultation, a psychiatrist, a social geriatrician, a professor in health law and a public prosecutor) and the (...) general practitioners who were going to use the protocol. Evidence—There is limited literature on consultation: discursive articles and empirical studies describing the practice of euthanasia. Consensus—An initial draft on the basis of the literature was commented on by the experts and general practitioners in two rounds. Finally, the protocol was amended after it had been used during the training of consultants. Conclusions—The protocol differentiates between steps that are necessary in a consultation and steps that are recommended. Guidelines about four important aspects of consultation were given: independence, expertise, tasks and judgment of the consultant. In 97% of 109 consultations in which the protocol was used the consultant considered the protocol to be useful to a greater or lesser extent. Although this protocol was developed locally, it also employs universal principles. Therefore it can be of use in the development of consultation elsewhere. (shrink)

Background Clinical trials throughout the world must be evaluated by research ethics committees. No one has yet attempted to clearly quantify at the national level the activity of ethics committees and describe the characteristics of the protocols submitted. The objectives of this study were to describe 1) the workload and the activity of Research Ethics Committees in France, and 2) the characteristics of protocols approved on a nation-wide basis. Methods Retrospective cohort of 976 protocols approved by a (...) representative sample of 25/48 of French Research Ethics Committees in 1994. Protocols characteristics (design, study size, investigator), number of revisions requested by the ethics committee before approval, time to approval and number of amendments after approval were collected for each protocol by trained research assistant using the committee's files and archives. Results Thirty-one percent of protocols were approved with no modifications requested in 16 days (95% CI: 14–17). The number of revisions requested by the committee, and amendments submitted by the investigator was on average respectively 39 (95% CI: 25–53) and 37 (95% CI: 27–46), per committee and per year. When revisions were requested, the main reasons were related to information to the patient (28%) and consent modalities (18%). Drugs were the object of research in 68% of the protocols examined. The majority of the research was national (80%) with a predominance of single-centre studies. Workload per protocol has been estimated at twelve and half hours on average for administrative support and at eleven and half hours for expertise. Conclusion The estimated workload justifies specific and independent administrative and financial support for Research Ethics Committees. (shrink)

The so-called Istanbul Protocol, a Manual on the Effective Investigation and Documentation of Torture and other Cruel, Inhumane or Degrading Treatment or Punishment was adopted by the United Nations soon after its completion in 1999 and since then has become an acknowledged standard for documenting cases of alleged torture and other forms of severe maltreatment. In 2009 the “Forum for medicine and human rights” at the Medical Faculty at the University Erlangen-Nuremburg has provided the first German edition of this manual. (...) The article traces back the development of the protocol taking into account the general background as well as the factual occasion of its initiation. The main ethical and legal principles of the manual are introduced as well as the projects for implementing the rules provided in the protocol that have been carried out so far. From this the urgent need for implementation of the Istanbul Protocol guidelines also in Europe and in German-speaking countries and here not exclusively but especially within asylum procedures becomes clear. (shrink)

Objective: To examine how research ethics boards review research projects in emerging disciplines such as functional neuroimaging.Design: To compare the criteria applied and the decisions reached by REBs that reviewed the same mock research protocol in functional neuroimaging.Participants: 44 Canadian biomedical REBs, mostly working in public university or hospital settings.Main measurements: The mock research protocol “The Neurobiology of Social Behavior” included several ethical issues operating at all three levels: personal, institutional and social. Data consisting of responses to closed questions (...) were analysed quantitatively. Qualitative analysis of open-question responses used mixed classification.Results: Similar criteria were used by most participating REBs. Yet the project was unconditionally approved by 3 REBs, approved conditionally by 10 and rejected by 30.Conclusions: The results point to the difficulty for REBs of reviewing all kinds of research projects, regardless of field, by relying on international and national norms framed in general terms and a possible variation between REBs in the interpretation of their mandate for the protection of research subjects. (shrink)