Relevant Ethical Principles Research Articles

Conduct, Oversight, and Ethical Considerations of Clinical Trials in Companion Animals with Cancer: Report of a Workshop on Best Practice Recommendations.

Development of effective and safe treatments for companion animals with cancer requires the collaboration of numerous animal health professionals and the full engagement of animal owners. Establishing ‘Best Practice Recommendations’ for clinical trials in veterinary oncology represents an important step toward meeting the goal of rigorous clinical trial design and conduct that is required to establish valid evidence. Likewise, optimizing patient welfare and owner education and advocacy is crucial to meet the unique ethical obligations to both owners and animals enrolled in these clinical trials and to ensure trust in the team conducting the research. To date, ‘Best Practice Recommendations’ for clinical trial conduct have not been reported for veterinary oncology. This document summarizes the consensus of a workshop held in November, 2014 to identify relevant ethical principles and to ensure responsible conduct of clinical research in companion animals with cancer. It is intended as a working document that will be updated as advances in science and ethical considerations require. To the extent possible, existing guidelines for the conduct and oversight of clinical trials in humans have been adapted for veterinary trials to avoid duplicative effort and to facilitate integration of clinical trials such that translational research with benefits for both companion animals and humans are encouraged.

The Ethical Imperative to Move to a Seven-Day Care Model.

Whilst the nature of human illness is not determined by time of day or day of week, we currently structure health service delivery around a five-day delivery model. At least one country is endeavouring to develop a systems-based approach to planning a transition from five- to seven-day healthcare delivery models, and some services are independently instituting program reorganization to achieve these ends as research, amongst other things, highlights increased mortality and morbidity for weekend and after-hours admissions to hospitals. In this article, we argue that this issue does not merely raise instrumental concerns but also opens up a normative ethical dimension, recognizing that clinical ethical dilemmas are impacted on and created by systems of care. Using health policy ethics, we critically examine whether our health services, as currently structured, are at odds with ethical obligations for patient care and broader collective goals associated with the provision of publicly funded health services. We conclude by arguing that a critical health policy ethics perspective applying relevant ethical values and principles needs to be included when considering whether and how to transition from five-day to seven-day models for health delivery.

A principles-based model of ethical considerations in military decision making

When comparing alternative courses of action, modern military decision makers often must consider both the military effectiveness and the ethical consequences of the available alternatives. The basis, design, calibration, and performance of a principles-based computational model of ethical considerations in military decision making are reported in this article. The relative ethical violation (REV) model comparatively evaluates alternative military actions based upon the degree to which they violate contextually relevant ethical principles. It is based on a set of specific ethical principles deemed by philosophers and ethicists to be relevant to military courses of action. A survey of expert and non-expert human decision makers regarding the relative ethical violation of alternative actions for a set of specially designed calibration scenarios was conducted to collect data that was used to calibrate the REV model. Perhaps unsurprisingly, the survey showed that people, even experts, disagreed greatly amongst themselves regarding the scenarios’ ethical considerations. Despite this disagreement, two significant results emerged. First, after calibration the REV model performed very well in terms of replicating the ethical assessments of human experts for the calibration scenarios. The REV model outperformed an earlier model that was based on tangible consequences rather than ethical principles, that earlier model performed comparably to human experts, the experts outperformed human non-experts, and the non-experts outperformed random selection of actions. All of these performance comparisons were measured quantitatively and confirmed with suitable statistical tests. Second, although humans tended to value some principles over others, none of the ethical principles involved—even the principle of not harming civilians—completely overshadowed all of the other principles.

Regulation of Biobanks in South Africa.

The availability of biological samples and data is critical for the establishment of biobanks for health research purposes. Such availability should be ensured in accordance with relevant national legislation and ethical principles. In this article, we consider the extent to which the current legal and ethical regulatory frameworks in South Africa are capable of governing the use of stored biological samples in a manner that facilitates health research while at the same time protecting the interests of sample donors. These two attributes are essential for establishing biobanks in the country. Our evaluation of the frameworks is based on desk review of the current literature with a special focus on oversight mechanisms in place that ensure compliance with national legislation and ethical review processes to facilitate future and secondary uses of data, the extent to which informed consent policies foster sharing of research samples, data and protocols as well as mechanisms for safeguarding confidentiality. We established that there is an urgent need to streamline South Africa's legal and ethical frameworks because they are currently ambiguous and disjointed. There is equally a need to bring the frameworks in line with the current developments at the national and international levels.

Legal and ethical considerations for home-based telemedicine

Home-based telemedicine technology has facilitated the transition of care to home and community-based settings. Yet, there have been few studies that have evaluated the legal and ethical implications of the expansion of telemedicine use. This article examines the legal issues related to the practice of medicine across jurisdictional boundaries, licensing requirements, privacy protection, and reimbursement for telemedical services. It also discusses relevant ethical principles at stake: provider-patient relationships, privacy and confidentiality, distributive and family justice, and informed consent. By addressing the relevant legal and ethical concerns, we are more likely to construct a more prudent and considerate healthcare system and avert the unsatisfactory and unforeseen repercussions of cutting-edge technologies that are so essential to present-day healthcare.

A review of the risks and benefits associated with mobile phone applications for psychological interventions.

The rapid expansion of mobile phone applications is increasingly relevant to the field of professional psychology. This article highlights the ethical challenges related to the development and integration of mobile phone technologies into clinical practice with clients who suffer from a diagnosable mental illness, with an emphasis on the relevant ethical principles included in the Canadian Code of Ethics for Psychologists. The benefits and risks associated with mobile phone application interventions are reviewed, to provide psychologists with the information necessary to guide ethical decision-making. Preliminary guidelines for the ethical practice of mobile technology in psychology are proposed throughout the article (e.g., mobile applications that deliver treatment should be used to support an evidence-based intervention facilitated by a mental health professional), and areas for future research are recommended.Keywords: professional practice, ethics, technology, decision-making, mobile phone applicationsResumeL'expansion rapide des applications de telephonie mobile con- cerne de plus en plus le domaine de la psychologie professionnelle. Cet article met en relief les defis ethiques relies a l'expansion et a l'integration des technologies du telephone cellulaire dans la pra- tique clinique avec des clients presentant des troubles de sante mentale diagnosticables, en particulier les principes de deontologie qui sont inclus dans le Code canadien de deontologie profession- nelle des psychologues. Les avantages et les risques associes aux interventions realisees au moyen d'applications de telephonie mo- bile sont presentes afin de fournir aux psychologues de l'information qui les guidera dans la prise de decisions ethiques. Au fil de l'article sont proposees des lignes directrices prelimi- naires pour l'utilisation ethique de la technologie mobile en psy- chologie, par ex., les applications pour le traitement devraient etre utilisees en appui a une intervention fondee sur des donnees probantes mise en oeuvre par un professionnel de la sante mentale. L'article propose divers domaines pouvant faire l'objet d'etudes futures.Mots-cles : pratique professionnelle, deontologie, technologie, prise de decision, applications pour telephone mobile.There are a myriad of technologies available in the Western world, and their presence is ubiquitous. Technologies like the World Wide Web, smart mobile phones, computers, and smaller personal computing tablets such as the iPad are increasingly pop- ular. The advent of technological advances has revolutionized the ways in which people interact with one another. For example, personal communications can occur through cyberspace, and meet- ings that once required face-to-face contact are increasingly being conducted as virtual meetings, with people connecting through a Web-based platform, but from various physical locations.Advances in technology are progressively more relevant to the clinical practice of psychology and mental health services gener- ally. The rapid advances in technologies have profoundly influ- enced the mediums and methods of the delivery of mental health services. Psychology has incorporated new technologies to meet the demand for effective low-cost alternatives to traditional or face-to-face therapy. From early experience with telephone thera- pies (Mohr et al., 2012), online therapy is now available for individuals to seek treatment for a variety of ailments and disor- ders in the comfort of their homes, albeit these programs are currently limited in Canada (Andersson, Carlbring, Ljotsson, & Hedman, 2013). Recent developments in computer bandwidth, and the widespread availability of such computer applications as Skype, FaceTime and qq, now permit the easy transmission ofbotli voice and live video across space and time zones.In addition to telephone and online therapy, psychologists must now consider the impact of smart mobile phone technology on psychological assessment and intervention. …

Palliative and end-of-life care: precepts and ethics for the orthopaedic population.

Since the emergence of reports such as the and the , there continues to be a growing recognition of the multiple adverse effects of serious illness and chronic conditions, as well as the potential benefits of receiving palliative or end-of-life care. As modern technology expands its ability to support life, ethical dilemmas may be encountered in the provision of palliative or end-of-life care. Through integration of the precepts of palliative care and consideration of the relevant ethical principles, orthopaedic nurses may best meet their patients' comprehensive needs at an exceedingly difficult time.

Committee Opinion No. 583

: Arbitration is a form of dispute resolution that is an alternative to 'taking a case to court.' Weighing the potential advantages and disadvantages, predispute arbitration may represent a valid alternative dispute resolution strategy for physicians and patients. When correctly prepared, contractual agreements between patients and physicians for predispute, voluntary, binding arbitration can satisfy both individual and societal needs and, at the same time, meet relevant ethical principles.

The Legal Politics of Growth Attenuation

In this article, we consider the implications of growth attenuation should it ever arise in the Canadian context. While parental autonomy to make crucial health care decisions and exercise control over minors is not a right that should be lightly dismissed, we argue that growth attenuation is entirely inappropriate and should never be regarded as ethically permissible for children. We ground our perspective in the social model of disablement which stands for the proposition that it is structural barriers that are chiefly responsible for the marginalization experienced by people with disabilities in every area of social life including employment, transportation, and housing. Critical disability theory applies the social model to new public policy problems and we regard our intervention as a modest attempt at rethinking a bioethical dilemma through the prism of critical disability theory. We do so through a review of the case law and through a consideration of relevant ethical principles, paying particular attention to the scholarship of Martha Nussbaum’s theories of equality for people with intellectual disabilities.

Ethical, Legal and Risk Management Considerations in the Neuropsychological Assessment of Veterans

This article examines the ethical and regulatory issues facing neuropsychologists practicing within the Department of Veterans Affairs (VA) system, either as Veteran Health Administration neuropsychologists or as consultants. The focus is proactive, with an emphasis on preparation consistent with a positive approach to ethical practice and risk management. Given the sheer magnitude of applicable Federal regulations and guidelines, the scope is limited to an overview of select ethical complexities involved in the professional practice of neuropsychology with veterans within VA settings. The article uses a top-down structure, with each section (a) identifying the relevant core biomedical ethical principles, followed by (b) an elaboration of the relevant ethical requirements as defined by the American Psychological Association’s Code of Ethics, and (c) applicable Federal regulations. Suggestions for translating core ethical principles and relevant ethical requirements into pragmatic action consistent with Federal regulation follow. Topics include (a) establishing professional competence, (b) understanding the type of assessment, (c) understanding consent requirements, and (d) understanding the ethical and regulatory issues in assessing veteran symptom presentation.

Development and pilot testing of an online module for ethics education based on the Nigerian National Code for Health Research Ethics

BackgroundThe formulation and implementation of national ethical regulations to protect research participants is fundamental to ethical conduct of research. Ethics education and capacity are inadequate in developing African countries. This study was designed to develop a module for online training in research ethics based on the Nigerian National Code of Health Research Ethics and assess its ease of use and reliability among biomedical researchers in Nigeria.MethodologyThis was a three-phased evaluation study. Phase one involved development of an online training module based on the Nigerian Code of Health Research Ethics (NCHRE) and uploading it to the Collaborative Institutional Training Initiative (CITI) website while the second phase entailed the evaluation of the module for comprehensibility, readability and ease of use by 45 Nigerian biomedical researchers. The third phase involved modification and re-evaluation of the module by 30 Nigerian biomedical researchers and determination of test-retest reliability of the module using Cronbach’s alpha.ResultsThe online module was easily accessible and comprehensible to 95% of study participants. There were significant differences in the pretest and posttest scores of study participants during the evaluation of the online module (p = 0.001) with correlation coefficients of 0.9 and 0.8 for the pretest and posttest scores respectively. The module also demonstrated excellent test-retest reliability and internal consistency as shown by Cronbach’s alpha coefficients of 0.92 and 0.84 for the pretest and posttest respectively.ConclusionThe module based on the Nigerian Code was developed, tested and made available online as a valuable tool for training in cultural and societal relevant ethical principles to orient national and international biomedical researchers working in Nigeria. It would complement other general research ethics and Good Clinical Practice modules. Participants suggested that awareness of the online module should be increased through seminars, advertisement on government websites and portals used by Nigerian biomedical researchers, and incorporation of the Code into the undergraduate medical training curriculum.

Public Health Accreditation and Metrics for Ethics

As public health departments around the country undergo accreditation using the Public Health Accreditation Board standards, the process provides a new opportunity to integrate ethics metrics into day-to-day public health practice. While the accreditation standards do not explicitly address ethics, ethical tools and considerations can enrich the accreditation process by helping health departments and their communities understand what ethical principles underlie the accreditation standards and how to use metrics based on these ethical principles to support decision making in public health practice. We provide a crosswalk between a public health essential service, Public Health Accreditation Board community engagement domain standards, and the relevant ethical principles in the Public Health Code of Ethics (Code). A case study illustrates how the accreditation standards and the ethical principles in the Code together can enhance the practice of engaging the community in decision making in the local health department.

Simulated Patient Studies: An Ethical Analysis

In connection with health care reform, the U.S. Department of Health and Human Services commissioned a "mystery shopper," or simulated patient study, to measure access to primary care. But the study was shelved because of public controversy over "government spying" on doctors. Opponents of the study also raised ethical concerns about the use of deception with human subjects without soliciting their informed consent. We undertook an ethical analysis of the use of simulated patient techniques in health services research, with a particular focus on research measuring access to care. Using a case study, we explored relevant methodological considerations and ethical principles relating to deceptive research without informed consent, as well as U.S. federal regulations permitting exceptions to consent. Several relevant considerations both favor and oppose soliciting consent for simulated patient studies. Making research participation conditional on informed consent protects the autonomy of research subjects and shields them from unreasonable exposure to research risks. However, scientific validity is also an important ethical principle of human subjects research, as the net risks to subjects must be justified by the value to society of the knowledge to be gained. The use of simulated patients to monitor access is a naturalistic and scientifically sound experimental design that can answer important policy-relevant questions, with minimal risks to human subjects. As interaction between researchers and subjects increases, however, so does the need for consent. As long as adequate protections of confidentiality of research data are in place, minimally intrusive simulated patient research that gathers policy-relevant data on the health system without the consent of individuals working in that system can be ethically justified when the risks and burdens to research subjects are minimal and the research has the potential to generate socially valuable knowledge.

What Are the Ethical Obligations of a Dentist Who Suspects That His or Her Partner May Be Impaired by an Addiction to Pain Medication?

What Are the Ethical Obligations of a Dentist Who Suspects That His or Her Partner May Be Impaired by an Addiction to Pain Medication?

Ethical Issues Concerning Vaccination Requirements

Vaccinations are one of public health’s greatest achievements. However, an ethical dilemma lies in the balance of personal autonomy and choice versus protection of the entire at risk population. Vaccines have become readily available in most parts of the world, yet debates continue as to the appropriateness of requirements for vaccinations, including legal mandates of vaccinations during public health emergencies and more routinely for school entry. This paper addresses ethical issues concerning vaccination requirements in the context of historical as well as current immunization program activities. Five important programmatic focus areas for immunization programs are identified for minimizing conflicts among the relevant ethical principles when developing and implementing vaccination requirements; namely: 1) reviewing and evaluating current vaccination mandates in the relevant health jurisdiction; 2) increasing the use of non-compulsory vaccination strategies; 3) addressing parent/guardian vaccine safety concerns; 4) enhancing public awareness of vaccine-preventable disease risks; and 5) promoting a better public understanding of herd immunity. We suggest that strengthening these programmatic focus areas can lead to a greater public acceptance of vaccination requirements.

Patenting stem cells in Europe: The challenge of multiplicity in European Union law

The recent judgment by the European Court of Justice in Brüstle ended the long-standing controversy concerning the patentability of inventions involving human embryonic stem cells in European patent law as harmonized by the Biotechnology Directive (Directive 98/44/EC). The Court of Justice, in line with EPO practice, confirmed that Article 6 of the Biotechnology Directive excluding the patentability of industrial or commercial uses of human embryos prevents patenting human embryonic stem cells. The judgment is open to criticism on account of its interpretation of the relevant ethical principles laid down in the Biotechnology Directive in an environment characterized by moral pluralism and by a multiplicity of legal fora with jurisdiction to interpret those principles.

Should we perform deceased donor liver transplantation after living donor liver transplantation has failed?

2011 AASLD.Received February 16, 2011; accepted April 27, 2011.By asking whether we should perform deceased donorliver transplantation (DDLT) after living donor livertransplantation (LDLT) has failed, we appear to bequestioning the generally accepted current practice ofretransplantation for transplant failure. However, wewill also consider in this analysis that LDLT may havebeen performed for patients whose tumors werebeyond the local criteria for listing or increased prior-ity on the deceased donor (DD) wait list (ie, thepatients were not eligible for DDLT originally). Toarrive at a recommendation, we will analyze the out-comes and ethical implications of retransplantationby considering the following 4 questions:1. Should we perform DDLT after the failure ofDDLT?2. Should we perform DDLT after the failure ofLDLT in a patient without hepatocellular carci-noma (HCC)?3. Should we perform DDLT after the failure ofLDLT in a patient with HCC who fulfills the localcriteria for listing and increased priority on thewait list?4. Should we perform DDLT after the failure ofLDLT in a patient with HCC who does not fulfillthe local criteria for listing or increased priorityon the wait list (ie, the patient failed to meet thecriteria for DDLT originally)?With questions 1 to 3, we will consider the ethicalfoundation for the current practice of retransplanta-tion for graft failure, and this discussion will serve asthe basis for question 4, which is more controversial.

Focusing, Situating, and Grounding Micro–Level Evaluation Field Experiences

Evaluator training field experiences seek to reinforce applicable content knowledge and promote applied skills. For students, even a small-scale field experience focusing on limited components of a larger evaluation process can seem particularly challenging. Students often do not recognize the relevance of established evaluation resources capable of focusing, situating, and guiding their early professional practice efforts. For example, anticipating relevant evaluation standards and ethical principles and understanding the potential guidance they offer—in the context of student’s field experiences—requires more than their cursory acknowledgment. This article identifies the challenges that students encountered with course-embedded, small-scale field experiences and introduces the development and application of an instructional tool to help them: (a) more strategically focus evaluation field experiences; (b) situate experiences in terms of the larger evaluation to which it is contributing; as well as (c) ground experiences in terms of relevant evaluation standards, ethical principles, and evaluator competencies.

Ethics Commentary: Ethical Considerations in Caring for People Living With Addictions

Ethics Commentary: Ethical Considerations in Caring for People Living With Addictions

Evaluation of nursing students’ training in medical law

There is no co-ordinated focus on liabilities arising from nurses' medical interventions in terms of occupational, administrative, civil legal and criminal activities. However, the Turkish Criminal Code, the Turkish Medical Ethics Code of Practice, and guidelines for patients' rights offer some framework for the relevant ethical principles and responsibilities of nurses. The aim of this study was to investigate the evaluation of nursing students' training in their legal liabilities. The sample consisted of 309 students who were taking a course entitled 'Nurses' legal liabilities under Turkish criminal and civil law arising from medical interventions'. Data were obtained by means of self-administered questionnaires and McNemar's test was used to evaluate the answers. In conclusion, after their training, a great majority of the students demonstrated an improvement in terms of their percentage of correct answers relating to malpractice. This does not, however, mean that they will not face malpractice charges after graduating, but their increased awareness of the issue may encourage them to make more effort to reduce the risk of mistakes. It is recommended that nursing faculty carry out studies into medical malpractice, that they focus more on this subject in nursing education, and that all nursing schools review their curricula from the point of view of malpractice.