Bioethical Principles Of Autonomy Research Articles

Ethical, legal, and social implications (ELSI) and challenges in the design of a randomized controlled trial to test the online return of cancer genetic research results to U.S. Black women

BackgroundA central challenge to precision medicine research efforts is the return of genetic research results in a manner that is effective, ethical, and efficient. Formal tests of alternate modalities are needed, particularly for racially marginalized populations that have historically been underserved in this context. MethodsWe are conducting a randomized controlled trial (RCT) to test scalable modalities for results return and to examine the clinical utility of returning genetic research results to a research cohort of Black women. The primary aim is to compare the efficacy of two communication modalities for results return: 1) a conventional modality that entails telephone disclosure by a Board-certified genetic counselor, and 2) an online self-guided modality that entails results return directly to participants, with optional genetic counselor follow-up via telephone. The trial is being conducted among participants in the Black Women's Health Study (BWHS), where targeted sequencing of 4000 participants was previously completed. ResultsSeveral ethical, legal, and social implications (ELSI) and challenges presented, which necessitated substantial revision of the original study protocol. Challenges included chain of custody, re-testing of research results in a CLIA lab, exclusion of VUS results, and digital literacy. Bioethical principles of autonomy, justice, non-maleficence, and beneficence were considered in the design of the study protocol. ConclusionThis study is uniquely situated to provide critical evidence on the effectiveness of alternative models for genetic results return and provide further insight into the factors influencing access and uptake of genetic information among U.S. Black women.Clinicaltrials.gov: NCT04407611

Should the Food and Drug Administration Limit Placebo-Controlled Trials?

Should the Food and Drug Administration Limit Placebo-Controlled Trials?

"Just" Utility? A Bioethical Analysis of COVID-19 Resource Allocation

COVID-19 has brought into focus the bioethical challenge of resource allocation by straining healthcare delivery in limiting the availability of healthcare resources. While the bioethical principle of autonomy has typically taken precedence for medical practices, with the struggle of resource allocation, the bioethical principles emerging as front-line and conflicting have been utility and justice. Balancing these ideals has been challenging because while utility has demanded that society make decisions maximizing good and minimizing harm, justice has emphasized all people getting their due, despite if most efficient. Looking at how these principles could work without compromising each other, the question how a “just” utility, or a utility well-balanced with justice, could be attained has emerged because while utility has encouraged policies that would save the most lives in dire situations, it has inadvertently allowed for the magnification of pre-pandemic inequities disproportionately impacting the marginalized, marking an issue of justice. The conversation has proven complex when considering the ventilator crisis, showing the importance of resource allocation for public health emergencies. To grasp the scope of resource allocation challenges during COVID-19, the role of bioethical principles in making decisions, the concept of “just” utility, and the implications of resource allocation (including questions of accountability and use of innovative technologies) will be evaluated. Advocated for will be the consistent discussion of resource allocation strategies by diverse community members who take responsibility together, health officials being transparent during crisis situations, and using bioethical principles to predict and combat inequities that might be amplified during crises.

Social perceptions and bioethical implications of birth plans: A qualitative study

Background The birth plan is a tool that allows the self-learning and thoughtful analysis of the women during the birthing process, facilitating their making of decisions and participation, in agreement with the bioethical principles of autonomy and no malfeasance. Goal: To understand the perception and satisfaction of women who presented a birth plan. Methodology: Qualitative, descriptive, observational, retrospective and cross-sectional study. The population of the study was composed of 21 women who presented a birth plan regulated in a Hospital ever since the recording of the presentation of the birth plan was started (2011) until 2015. Place: Cartagena (Murcia, Spain). Techniques/methods: Semistructured interview. Results-Discussion: Most women considered the plan as a useful self-learning tool on the meaning of the birthing process, as it favored the communication between the expectant mothers/health professionals. Our informants sought information related to the birthing process from informal sources; most perceived a level of respect of their wishes during the process of giving birth. The use of the birth plan did not imply the perception of loss of the degree of control during the birth, although attention to the written document could be improved. Conclusions The use of the birth plan is a very satisfactory and useful experience for their involvement in their self-care, although in some cases, the births did not proceed according to their plans. Nevertheless, the prevalence of the principle of Non-Malfeasance over Autonomy was evidenced.

The ethics of refusing to care for patients during the coronavirus pandemic: A Chinese perspective.

As a result of the coronavirus (COVID‐19) pandemic, health professionals are faced with situations they have not previously encountered and are being forced to make difficult ethical decisions. As the first group to experience challenges of caring for patients with coronavirus, Chinese nurses endure heartbreak and face stressful moral dilemmas. In this opinion piece, we examine three related critical questions: Whether society has the right to require health professionals to risk their lives caring for patients; whether health professionals have the right to refuse to care for patients during the coronavirus pandemic; and what obligations there are to protect health professionals? Value of care, community expectations, legal obligations, professional and codes of practice may compel health professionals to put themselves at risks in emergency situations. The bioethical principles of autonomy, justice, beneficence and non‐maleficence, as well as public health ethics, guide nurses to justify their decisions as to whether they are entitled to refuse to treat COVID‐19 patients during the pandemic. We hope that the open discussion would support the international society in addressing similar ethical challenges in their respective situations during this public health crisis.

Regulatory, Legal, and Ethical Considerations of Telemedicine.

Sleep telemedicine practitioners must ensure their practice complies with all applicable institutional, state, and federal regulations. Providers must be licensed in any state in which they provide care, have undergone credentialing and privileging procedures at outside facilities, and avoid real or perceived conflicts of interest while providing that care. Internet-based prescribing remains limited to certain circumstances. Whether or not a malpractice insurance policy covers telemedicine depends on the insurer, especially if interstate care is provided. All telemedicine programs must protect patient health information. Similarly, bioethical principles of autonomy, beneficence, nonmaleficence, and justice apply to both in-person and telemedicine-based care.

Failed ability to donate under donation after circulatory death protocol

Summary A shortage of donor organs exists in many countries around the world, including the United States. In the past two decades, there has been resurgencein the use of donation after circulatory death (DCD) donor organs in an attempt to try to help meet this need. The four bioethical principles of autonomy, beneficence, non-maleficence, and social justice are each fundamentally important when discussing the rationale for the use of DCD organ donors. We sought to explore the percentage of potential DCD organ donors at Mayo Clinic and our regional organ procurement organization (OPO) who were unable to donate because the patients did not expire within the allowed time frame. At Mayo Clinic, 30% of our potential DCD donor pool failed to donate compared to 14% of patients at other hospitals within our OPO due to this time restriction. Without a more certain means of predicting the death of patients over a relatively short time period, any concrete exploration of premortem procurement from patients failing to meet DCD criteria to increase the number of transplantable organs would further risk public trust in transplantation practices and may lead to more harm than good.

Developing Psychologically Compelling Understanding of the Involvement of Humans in Research

Research conducted on humans has a long history of ethical protections, with the Nuremberg trials in 1945 and 1946 triggering stronger protection across most jurisdictions. While there have been many reorientations and corrections in the emphasis of codes protecting human research participants, all have implicitly assumed a conception of human decision-making and the person that are psychologically not feasible. In this paper, we examine two problematic assumptions dominant in many research ethics guidelines: (1) implicit reliance on a model of classical rationality in conceptualizing the process whereby individuals make a decision of whether to give consent to participate in a study and (2) the assumption of autonomous subjects in the bioethical principle of autonomy and in operationalizing informed consent processes. For both of these problems, we outline theoretical psychological work that provides more compelling accounts of (1) human decision-making and rationality as bounded and ecological and (2) of personhood and agency as relational and emergent. We conclude by considering approaches to bioethics that are compatible with such conceptions of personhood and therefore provide a more satisfactory framework for a relational ethics.

Will CRISPR Germline Engineering Close the Door to an Open Future?

The bioethical principle of autonomy is problematic regarding the future of the embryo who lacks the ability to self-advocate but will develop this defining human capacity in time. Recent experiments explore the use of clustered regularly interspaced short palindromic repeats (CRISPR)/Cas9 for germline engineering in the embryo, which alters future generations. The embryo's inability to express an autonomous decision is an obvious bioethical challenge of germline engineering. The philosopher Joel Feinberg acknowledged that autonomy is developing in children. He advocated that to reserve this future autonomy, parents should be guided to make ethical decisions that provide children with open futures. Here, Feinberg's 1980 open future theory is extended to the human embryo in the context of CRISPR germline engineering. Although the embryo does not possess the autonomous decision-making capacity at the time of germline engineering, the parental decision to permanently change the unique genetic fabric of the embryo and subsequent generations disregards future autonomy. Therefore, germline engineering in many instances is objectionable considering Feinberg's open future theory.

Bioethical analysis to the therapeutic use of Cannabis: Integrative review.

Despite being considered as a contravention under some countries' legislation, the therapeutic use of Cannabis sativa has been growing in Brazil, due to the promising results observed in many pathologies. Such a scenario has fostered the need to deepen discussions on the subject and possibly revise legislation governing the substance use and access. Identify the types of stigma related to the therapeutic use of Cannabis and describe the strategies people use to overcome stigma. This integrative review was carried out in the databases PubMed, Scopus, CINAHL, MEDLINE, PsycINFO, Web of Science, and Cochrane Library, with 565 articles being retrieved. Triads' cross-check were done, first maintaining the "cannabis" and "therapeutic use" pair, added by "stigma," "bioethics," "ethics," "social consequences," and "legal consequences." The final selection resulted in six articles. However, the ethical issues that pervade and regulate decisions on this subject must be considered. Different dimensions and types of stigma related to the therapeutic use of Cannabis have been identified. The bioethical principle of autonomy was an expression of citizenship and human rights, mitigating internal conflicts related to self-stigma and the effects of external stigma on the person's life. It was possible to identify the types of stigma related to the therapeutic use of Cannabis is an internal dimension represented (self-stigma) and an external dimension, represented (social and structural stigmas) and to identify strategies adopted to face this stigma: skills training group for users, elaboration of laws and specific programs to clarify the therapeutic use of Cannabis with a greater social scope, and support for family members. Thus, contributing to the building of people's autonomy in a broader context of decision-making autonomy and executive autonomy will provide the development of people's capacity to perform complex tasks of self-management and, consequently, to continue promoting and preserving their decision-making process and their capacity to plan and perform tasks associated with managing their lives and their treatments.

Biotech & JUSTICE: Catching up with the Real World Order

Since its inception in 1990, the Human Genome Project has spurred almost as many ethical and social questions as it has start-up biotech companies. Yet one of the most perplexing challenges of the new genomics is how to guide and govern the use of genetic knowledge in an era of economic globalization. Diagnostic and predictive testing, gene-based therapies, pharmacogenomics, and genetic enhancement are already available or speeding toward reality, leading to ever greater levels of private investment and international marketing. Many share Francis Fukuyama's concern about what genomics portends for our posthuman future, (1) and not only because human nature as we have known it may be at stake. Commercial genetics threatens to exacerbate greatly the rising levels of inequality that already burden the globalization age. (2) Two issues are important: first, defining ethics or justice in a pluralistic and often conflicted world; and second, putting ethical relations or social justice into practice. U.S. law, policy, and even philosophy tend to frame social justice questions in terms of individual rights, civil liberties, procedural solutions to conflict, and equality of opportunity. And, frequently, both individuals and organizations in the United States approach the social aspects of genetics by prioritizing freedom and self-determination--of scientists, corporations, consumers, and even of the nation as an international actor with particular values and interests. The focus on liberal rights obscures the social and economic bases of health and disease and the effect on social institutions and patterns of individual choices and enterprise. (3) African, Asian, Latin American, and to an extent European cultures put a higher priority on social and economic rights within a community than they do on privacy and choice. While genetics research and development spans borders and cultures, principles like autonomy and informed consent bear a distinctive legal and cultural stamp. The philosophical framework within which U.S. bioethics addresses the new international context of genetics needs to be restructured, both to expand the basic moral criteria and to consider how ethical behavior, relationships, and institutions can be defined, created, and maintained globally. This essay will argue that bioethics can find resources for this task in political science literature on globalization, on the still weakening sovereignty of the nation-state, and on the quest for a normative and constructive approach to governance in what has been hailed as the new world order. International research ethics and the recent struggle over the availability of AIDS drugs will show how developing models of governance might apply to the control of biotechnology. The Priority of Autonomy According to anthropologist Sandra Lane and colleagues, individualism, so intrinsic to American culture, is a core principle which organizes the practices and representations--the habitus--of the bioethics community. (4) In their view, the analysis of individual decisions has predominated over social relations, community needs and values, and public health. Moreover, self-determination itself has been considered largely in relation to relatively privileged consumers and even a fairly narrow range of exotic or highly technological interventions. The medically marginalized have been neglected. The four bioethical principles of autonomy, non-maleficence, beneficence, and justice, which were first enumerated in the Nuremberg Code and were then adapted in the Belmont Report and in the bioethics literature spanning decades, are more often than not applied at the individual level. Of the four principles, autonomy continues to receive by far the most attention. And while the pressing question of universal access to health care in the United States has raised the profile of distributive justice in recent years, even adding a global perspective, (5) it is still the case that procedural justice, focused on ethical and legal protections of autonomy, privacy, and confidentiality for those receiving health care in the United States, has been the predominant justice concern. …

Ethical issues in genetic testing. The experiences of one family diagnosed with an inherited cancer syndrome.

This article describes selected ethical issues faced by members of a family with genetic predisposition to the cancer syndrome multiple endocrine neoplasia type 2a. The bioethical principles of autonomy, nonmaleficence, beneficence, and justice are the moral guides for nurses and other health professionals, who may apply them to help patients, family members and peers resolve ethical issues and moral dilemmas. Sometimes, however, issues that are morally problematic cannot be settled by simply referring to standards of practice and bioethical norms. In these cases all stakeholders must struggle together to resolve the conflict.

Do adolescents' bioethical decisions differ from those of experts?

If our students are to become well-informed decision makers then they need to be aware of the practical applications of current developments in biotechnology, and appreciate the social and bioethical implications of this relatively new and controversial science. In this study, Year 10 (14 – 15 year old) science students in two schools were taught biotechnology courses that introduced them to bioethics. At the conclusion of the course, students completed a survey in which they made a decision about three bioethical dilemmas, and gave reasons to support their decision. The students' responses and reasons were compared with those of three experts. Although there was variation amongst students, the results of the survey suggested that the majority of students tended to resolve and justify their decisions in a way that was naive, idealistic, and rights based. Compared to the experts, the students seemed to give undue emphasis to the bioethical principle of autonomy. In addition, the reasons supplied by many of the students to support their decisions suggested that they did not consider long term consequences. These findings have ramifications for teachers who wish to include bioethical dilemmas in their teaching.

Compulsory community treatment: ethical considerations.

Compulsory community treatment (CCT) of people with serious mental health problems is analysed using the bioethical principles of autonomy and beneficence. Feminist ethical theory is then used to clarify these principles as they relate to community commitment of the severely and persistently mentally ill. Finally, a model of practice is proposed as an alternative to CCT in which both autonomy and beneficence are better served.

Conflicts of Interest

Conflicts of interest and other ethical dilemmas occur in Alzheimer disease (AD) patient care and research but often are underrecognized by physicians. One or more bioethical principles of autonomy, confidentiality, truth telling, beneficence, and justice, which apply to demented individuals as they do to other patients, may conflict in everyday clinical situations. For example, when demented patients wish to continue driving, autonomy (the patient's right to self-determination) conflicts with beneficence (the duty to promote the patient's welfare). Cognitively impaired patients depend on others for ethical decision making in the resolution of these dilemmas. It is essential that clinicians and investigators involved in the decision-making process do so without bias or conflict of interest. Full disclosure of financial interests increasingly is an accepted requirement in the conduct of biomedical research. In AD, less obvious potential conflicts of interest arise when physicians recruit their patients for antidementia drug trials sponsored by a pharmaceutical company (that provides the physician with research funding) or when investigators fail to acknowledge the patient's withdrawal of assent when attempting to complete a research protocol. The recognition of both financial and nonfinancial conflicts should lead to measures to reduce bias, which in turn will improve the integrity of research findings and promote patient welfare.