The passage of the Patient Protection and Affordable Care Act in March 2010 represents a significant turning point in the evolution of health care law and policy in the United States. By establishing a legal infrastructure that seeks to achieve universal health insurance coverage in the United States, the ACA targets some of the major impediments to accessing needed health care for millions of Americans and by extension attempts to strengthen the health system to support key determinants of (...) health. Yet, like many newly passed legislative provisions, the ultimate effects and significance of the ACA remain uncertain. Those charged with implementing the ACA face formidable obstacles — indeed, some of the same obstacles that have been erected to impede other major pieces of social legislation in the past — including entrenched political opposition, constitutional challenges, and what will likely be a prolonged struggle over the content and direction of how the law is implemented. As these debates continue, it is nevertheless important to begin to assess the impact that the ACA has already had on health law in the United States and to consider the likely effects that the law will have on public health going forward. (shrink)

Responding to mounting public concern about the shift to managed care, legislation to grant patient protections has dominated the health policy agenda over the past two years. Although some policies, such as laws on maternity length of stay, can be easily dismissed as “body part by body part” micromanagement of medical practice, other initiatives offer substantive, new rights to patients across the spectrum of care. At both the state and the federal levels, the right of enrollees to appeal a (...) denial of treatment or to file grievances about other plan decisions has emerged as a centerpiece of patient protection legislation. Grievance and appeal rights have been embraced as a way to empower patients, to enhance access to treatment, and to improve the quality of care by providing an external mechanism to review treatment denials. (shrink)

The recent confirmation of the constitutionality of the Obama administration’s Patient Protection and Affordable Care Act (PPACA) by the US Supreme Court has brought to the fore long-standing debates over individual liberty and religious freedom. Advocates of personal liberty are often critical, particularly in the USA, of public health measures which they deem to be overly restrictive of personal choice. In addition to the alleged restrictions of individual freedom of choice when it comes to the question of whether (...) or not to purchase health insurance, opponents to the PPACA also argue that certain requirements of the Act violate the right to freedom of conscience by mandating support for services deemed immoral by religious groups. These issues continue the long running debate surrounding the demands of religious groups for special consideration in the realm of health care provision. In this paper I examine the requirements of the PPACA, and the impacts that religious, and other ideological, exemptions can have on public health, and argue that the exemptions provided for by the PPACA do not in fact impose unreasonable restrictions on religious freedom, but rather concede too much and in so doing endanger public health and some important individual liberties. (shrink)

In the nearly 40 years since implementation of federal regulations governing the protection of human participants in research, the number of clinical studies has grown exponentially. These studies have become more complex, with multisite trials now common, and there is increasing use of archived biospecimens and related data, including genomics data. In addition, growing emphasis on targeted cancer therapies requires greater collaboration and sharing of research data to ensure that rare patient subsets are adequately represented. Electronic records enable (...) more extensive data collection and mining, but also raise concerns about the potential for inappropriate or unauthorized use of data, bringing patient protections into a new landscape. There are also long-standing concerns about the processes and forms used to obtain informed consent from patients participating in clinical studies. These changes and challenges raise new ethical and practical questions for the oversight of clinical studies, and for protecting patients and their health information in an efficient manner that does not compromise the progress of biomedical research. Contemporary Issues for Protecting Patients in Cancer Research is the summary of a workshop convened by the National Cancer Policy Forum of the Institute of Medicine in February 2014 to explore contemporary issues in human subjects protections as they pertain to cancer research, with the goal of identifying potential relevant policy actions. Clinical researchers, government officials, members of Institutional Review Boards, and patient advocates met to discuss clinical cancer research and oversight. This report examines current regulatory provisions that may not adequately protect patients or may be hindering research, and discusses potential strategies and actions to address those challenges. (shrink)

The Helsinki Declaration is a very important document regarding the protection of patients’ rights in clinical trials and one of the fundamental sources of operational principles for every ethics committee. Although they have been updated, the international guidelines for ethics committees continually fail to address certain issues pertaining to the protection of patients’ rights in clinical trials. These issues include, most significantly, the method of electing ethics committees (a free, secret ballot should be preferred to direct appointment), the (...) avoidance of conflict of interest during the election of ethics committee members, and the necessary insurance coverage for the participants of clinical trials. Polish law should, on the other hand, be developed in such way as to not limit the effectiveness of ethics committees in protecting patients’ rights in clinical trials. The ideal solution would be to draft a uniform law concerning not only clinical trials, but all medical experiments. The opinions of experts who have been reviewing medical research projects for several years may prove to be especially valuable in this setting. (shrink)

The first part of this paper examines the practice of informed treatment decisions in the protective medical system in China today. The second part examines how health care professionals in China perceive and carry out their responsibilities when relaying information to vulnerable patients, based on the findings of an empirical study that I had undertaken to examine the moral experience of nurses in practice situations. In the Chinese medical ethics tradition, refinement [jing] in skills and sincerity [cheng] in relating to (...) patients are two cardinal virtues that health care professionals are required to possess. This notion of absolute sincerity carries a strong sense of parental protectiveness. The empirical findings reveal that most nurses are ambivalent about telling the truth to patients. Truth-telling would become an insincere act if a patient were to lose hope and confidence in life after learning of his or her disease. In this system of protective medical care, it is arguable as to whose interests are being protected: the patient, the family or the hospital. I would suggest that the interests of the hospital and the family members who legitimately represent the patient's interests are being honoured, but at the expense of the patient's right to know. (shrink)

This paper demonstrates how ubuntu relational philosophy may be used to ground beneficial coercive care without necessarily violating a patient’s dignity. Specifically, it argues that ubuntu philosophy is a useful theory for developing necessary conditions for determining a patient’s potential dangerousness; setting reasonable limits to the duty to protect; balancing the long-term good of providing unimpeded therapy for patients who need it with the short-term good of protecting at-risk parties; and advancing a framework for future case law and (...) appropriate regulations in the care of psychotherapy patients. Issues regarding the decision to breach medical confidentiality in psychotherapeutic care are ultimately reserved for the courts. Professional assessment might be an important first step in this process, and court rulings govern most aspects of this assessment. However, current case law, especially in the United States, places an unreasonable expectation on psychotherapists to protect all at-risk parties or foresee that a patient intends to follow through on said threats. It has largely failed to guarantee psychotherapy patients unlimited access to care, while potentially inhibiting future honest communication between patients and health professionals and endangering the safety of others. Of these decisions, the two most prominent are the 1976 Tarasoff decision and the 2016 Volk decision. This paper argues for the possibility of grounding good laws in ubuntu African philosophy in a way that protects others from harm and ensures unimpeded access to care without necessarily breaching medical confidentiality. (shrink)

Despite recommendations from the Cartwright Report ethical review by health ethics committees has continued in New Zealand without health practitioners ever having to acknowledge their dual roles as health practitioners researching their own patients. On the other hand, universities explicitly identify doctor/research-patient relations as potentially raising conflict of role issues. This stems from the acknowledgement within the university sector itself that lecturer/research-student relations are fraught with such conflicts. Although similar unequal relationships are seen to exist between health researchers and (...) their patients, the patient/subjects are not afforded the levels of protection that are afforded student/subjects. In this paper we argue that the difference between universities and health research is a result of the failure of the Operational Standard Code for Ethics Committees to explicitly acknowledge the vulnerability of the patient and conflict of interests in the dual roles of health practitioner/researcher. We end the paper recommending the Ministry of Health consider the rewriting of the Operational Standard Code for Ethics Committees, in particular in the rewriting of section 26 of the Operational Standard Code for Ethics Committees. We also identify the value of comparative ethical review and suggest the New Zealand's Health Research Council's trilateral relationship with Australia's NHMRC (National Health and Medical Research Council) and Canada's CIHR (Canadian Institute of Health Research) as a useful starting point for such a process. (shrink)

Background Protecting a person’s right to privacy and confidentiality is important in healthcare services. As future health professionals, nursing students should bear the same responsibility as qualified health professionals in protecting patient privacy. Objectives To investigate nursing students’ practices of patient privacy protection and to identify factors associated with their practices. Research design A cross-sectional study design was adopted. A two-part survey was used to collect two types of data on nursing students: (1) personal characteristics, including demographics, (...) clinical experience and use of information and communication technology and social media and (2) practice of patient privacy protection, collected using the Patient Privacy Scale. Participants and research context: A total of 319 nursing students aged 18 or above, studying pre-registration nursing programmes and who had attended at least one block of clinical placement, were recruited from a university in Hong Kong. Ethical considerations The study received ethical approval from the Survey and Behavioural Research Ethics Committee of the Chinese University of Hong Kong. The participants were informed of the study aim and written consent was obtained before completing the survey. Findings: The mean total score on the Patient Privacy Scale was 119.7 out of 135. Nursing students who were regular users of Instagram and those who had never taken photographs with patients and hence did not need to obtain patient consent were associated with better practices of patient privacy protection (higher total scores on the Patient Privacy Scale). Conclusions The findings improve our understanding of nursing students’ practice of patient privacy protection and the associated factors. This will inform the development and revision of current strategies to enhance nursing students’ practice of patient privacy protection, especially their use of social media. (shrink)

Healthcare providers have a professional obligation to protect vulnerable patients from harm. An extension of that obligation is the legal mandate in the United States to report any concerns about...

The world famous Eltroxin saga of 2009–2011, which ignited heated public debates in Europe, Canada, and Australia, reveals the problematic nature of standalone autonomy protection cases. Eltroxin is a life-sustaining thyroid hormone replacement medicine used by millions worldwide; it was reformulated in 2008, and around 10% of patients were badly affected. Poor communication and lack of professional information triggered public hysteria as a global wave of complaints about harmful side effects, including hair loss, weight gain, extreme fatigue, headaches, diarrhoea, (...) and heightened heart rates, flooded the media. Israeli Eltroxin users (around 250 thousand people) were similarly unaware. Following many media reports and ministerial regulations, a high-profile consumer class action was launched against Perrigo, the distributor. Ten years of court proceedings culminated in a compensation settlement of approximately US$ 14 million. This relatively low sum covered the injuries of those patients who were physically affected; compensation for standalone autonomy injuries to all patients (who were denied information about changes to their life-sustaining medicine) was refused. The monetary settlement and court decision were hugely disappointing to the class plaintiffs, and a negative signal was sent to the proponents of consumers' and patients' personal autonomy. However, the class action still marked a positive change in pharmaceutical protocols for relations between health authorities, commercial pharmacy entities, and patients/consumers as seen by the proactive communication around a subsequent Eltroxin reformulation in 2020 in Israel, Europe, and South Africa (Aspen Pharmacare, 2020).1 This paper highlights the vast potential value of consumer class action proceedings, and pharmaceutical consumer (patient) class actions in particular, for public welfare and private autonomy. The paper will explain leading Israeli case law related to consumer autonomy protection in tort law and will argue that this law still holds the unique protection of autonomy as a basic human right and accordingly recognises harm to autonomy as a viable form of damage. Additionally, it illustrates why and how consumer protection class actions are an important tool for protection of human rights in general and of patients' rights in particular. (shrink)

This book proposes an alternative to the consent model which is currently at the heart of patient self-determination and which is shown here to have fundamental flaws that constrain its effectiveness. The proposed model is a property model in which the patient’s bodily integrity is protected from unauthorised invasion, and their legitimate expectation to be provided with the relevant information to make an informed decision is taken to be a proprietary right. This model enables the courts to overcome (...) the requirement to prove causation in consent cases and offers a complementary approach to patient self-determination. (shrink)

Background: With increased attention to patient privacy and autonomy, privacy protection and information provision for patients are becoming increasingly important. Objectives: The aim of this study was to identify and analyse nurses’ and patients’ perceptions of the importance and performance of protecting patients’ privacy and providing them with relevant information. Research design: This study is a descriptive cross-sectional investigation. Participants and research context: Participants were 168 patients hospitalised in medical and surgical wards and 176 nurses who cared for (...) them. Ethical consideration: This study was approved by the Chung-Ang University Bioethics Committee, and informed written consent was collected from all participants. Findings: Nurses’ recognition of the importance of protecting patients’ privacy and providing adequate information was higher compared to their actual performance, and the nurses’ level of performance was higher in comparison with the patients’ recognition of its importance. Discussion: Although a holistic approach to patient privacy protection and information provision is needed, the medical field has not embraced this model of care. Conclusions: These findings provide empirical data to create an ethical environment for the future, as considerable attention has been devoted to patients’ rights and medical institutions’ liability for providing explanations to patients. (shrink)

The American Journal of Bioethics, Volume 12, Issue 1, Page W1-W2, January 2012.

Registered nurses in psychiatric-mental health nursing continuously balance the ethical principles of duty to do good (beneficence) and no harm (non-maleficence) with the duty to respect patient choices (autonomy). However, the problem of nurses’ level of control versus patients’ choices remains a challenge. The aim of this article is to discuss how nurses accomplish their simultaneous responsibility for balancing patient safety (beneficence and non-maleficence) with patient choices (autonomy) through the theory of protective empowering. This is done by (...) reflecting on interview excerpts about caring from 17 registered nurses taking part in a grounded theory study conducted in three acute urban psychiatric hospital settings in Canada. The interplay between the protective and empowering dimensions of the theory of protective empowering was found to correspond with international, national, and local nursing codes of ethics and standards. The overall core process of protective empowering, and its associated reflective questions, is offered as a new lens for balancing patient safety with choices. (shrink)

Recent studies reported the development of psychological distress symptoms in patients who recovered from COVID-19. However, evidence is still scarce and new data are needed to define the exact risk and protective factors that can explain the variability in symptoms manifestation. In this study, we enrolled 257 patients who recovered from COVID-19 and we evaluated the levels of psychological distress through the Symptoms Checklist-90-R scale. Data concerning illness-related variables were collected from medical records, while the presence of subjective cognitive difficulties, (...) both before and after the illness, as well as the level of the cognitive reserve, were assessed over a clinical interview. Results revealed that being female and reporting the presence of subjective cognitive difficulties after COVID-19 were associated with higher levels of psychological distress. At the same time, being admitted to the hospital and having a high CR were protective factors. Adding new information to this emerging research field, our results highlight the importance of a complete psychological and cognitive assessment in patients with COVID-19. (shrink)

Implementation of guidelines regarding breaches of electronic health information requires an anticipatory stance and physician and patient education regarding security and monitoring measures and methods of redress. Adopting a preventive ethics, rather than a crisis management, model may also increase physician awareness of how the information they choose to include and privilege within the health record may expose patients to added harms if not done mindfully.

This article argues that the Supreme Court’s decision in Dobbs is likely to impact medical decision-making by pregnant patients in a variety of contexts. Of particular concern are situations where a patient declines treatment recommended for its potential benefit to the fetus and situations where treatment is withheld due to potential risk to the fetus. The Court’s elevation of fetal interests, combined with a history of courts using abortion jurisprudence to guide their reasoning in compelled treatment cases, means that (...) Dobbs has the potential to limit patient autonomy in a wide array of clinical settings. The article calls on professional medical associations to issue ethical guidance affirming the duty to respect the medical self-determination of pregnant patients. (shrink)

Despite recommendations from the Cartwright Report ethical review by health ethics committees has continued in New Zealand without health practitioners ever having to acknowledge their dual roles as health practitioners researching their own patients. On the other hand, universities explicitly identify doctor/research-patient relations as potentially raising conflict of role issues. This stems from the acknowledgement within the university sector itself that lecturer/research-student relations are fraught with such conflicts. Although similar unequal relationships are seen to exist between health researchers and (...) their patients, the patient/subjects are not afforded the levels of protection that are afforded student/subjects. In this paper we argue that the difference between universities and health research is a result of the failure of the Operational Standard Code for Ethics Committees to explicitly acknowledge the vulnerability of the patient and conflict of interests in the dual roles of health practitioner/researcher. We end the paper recommending the Ministry of Health consider the rewriting of the Operational Standard Code for Ethics Committees, in particular in the rewriting of section 26 of the Operational Standard Code for Ethics Committees. We also identify the value of comparative ethical review and suggest the New Zealand's Health Research Council's trilateral relationship with Australia's NHMRC (National Health and Medical Research Council) and Canada's CIHR (Canadian Institute of Health Research) as a useful starting point for such a process. (shrink)

This paper begins with a discussion of the value of privacy,especially for medical records in an age of advancing technology.I then examine three alternative approaches to protection ofmedical records: reliance on governmental guidelines, the useof corporate self-regulation, and my own third hybrid view onhow to maintain a presumption in favor of privacy with respectto medical information, safeguarding privacy as vigorously andcomprehensively as possible, without sacrificing the benefitsof new information technology in medicine. None of the threemodels I examine are unproblematic, (...) yet it is crucial to weighthe strengths and weaknesses of these alternative approaches. (shrink)

The Emergency Medical Treatment and Active Labor Act in 1986 was intended to bring an end to incidents of “patient dumping.” However, due to the conflation of various federal legislative provisions, hospitals faced with the prospect of long‐term unreimbursed care of an immigrant patient, whether legally present in the United States or not, are in some cases having such patients transported to another country. These transfers are often being effectuated without patient consent. After an overview of the (...) flaws in the legal system that have effectively encouraged such patient transfers, this essay uses a clinical case to demonstrate how physicians can collaborate with an interdisciplinary team and with family members to ensure that the best interests of immigrant patients are met. Finally, the essay calls on physicians to advocate for the development of hospital policies and practices that will protect patients from international patient dumping. (shrink)

Background: The concept of patient advocacy is still poorly understood and not clearly conceptualized. Therefore, there is a gap between the ideal of patient advocacy and the reality of practice. In order to increase nursing actions as a patient advocate, a comprehensive and clear definition of this concept is necessary. Research objective: This study aimed to offer a comprehensive and clear definition of patient advocacy. Research design: A total of 46 articles and 2 books published between (...) 1850 and 2016 and related to the concept of patient advocacy were selected from six databases and considered for concept analysis based on Rodgers’ evolutionary approach. Ethical considerations: This study was approved by the Research Ethics Committee of Tarbiat Modares University. Findings: The attributes of patient advocacy are safeguarding (track medical errors, and protecting patients from incompetency or misconduct of co-workers and other members of healthcare team), apprising (providing information about the patient’s diagnosis, treatment, and prognosis, suggesting alternatives of healthcare, and providing information about discharge program), valuing (maintaining self-control, enabling patients to make decisions freely, maintaining individualization and humanity, maintaining patient privacy, and acting in the patients’ values, culture, beliefs, and preferences), mediating (liaison between patients, families, and healthcare professionals, being patients’ voice, and communicate patient preferences and cultural values to members of the healthcare team), and championing social justice in the provision of healthcare (confronting inappropriate policies or rules in the healthcare system, identifying and correcting inequalities in delivery of health services, and facilitating access to community health services and health resources). Discussion and conclusion: The analysis of this concept can help to develop educational or managerial theories, design instruments for evaluating the performance of nurses in patient advocacy, develop strategies for enhancing patient advocacy, and improve the safety and quality of nursing care in the community and healthcare system. (shrink)

Background Medical research so flawed as to be retracted may put patients at risk by influencing treatments. Objective To explore hypotheses that more patients are put at risk if a retracted paper appears in a journal with a high impact factor (IF) so that the paper is widely read; is written by a ‘repeat offender’ author who has produced other retracted research; or is a clinical trial. Methods English language papers (n=788) retracted from the PubMed database between 2000 and 2010 (...) were evaluated. Only those papers retracting research with humans or freshly derived human material were included; 180 retracted primary papers (22.8%) met inclusion criteria. Subjects enrolled and patients treated were tallied, both in the retracted primary studies and in 851 secondary studies that cited a retracted primary paper. Results Retracted papers published in high-IF journals were cited more often (p=0.0004) than those in low-IF journals, but there was no difference between high- and low-IF papers in subjects enrolled or patients treated. Retracted papers published by ‘repeat offender’ authors did not enrol more subjects or treat more patients than papers by one-time offenders, nor was there a difference in number of citations. However, retracted clinical trials treated more patients (p=0.0002) and inspired secondary studies that put more patients at risk (p=0.0019) than did other kinds of medical research. Conclusions If the goal is to minimise risk to patients, the appropriate focus is on clinical trials. Clinical trials form the foundation of evidence-based medicine; hence, the integrity of clinical trials must be protected. (shrink)

The allocation of scarce medical treatments, such as antivirals and antibody therapies for COVID-19 patients, has important legal dimensions. This Essay examines a currently debated issue: how will courts view the consideration of characteristics shielded by equal protection law, such as race, sex, age, health, and even vaccination status, in allocation? Part II explains the application of strict scrutiny to allocation criteria that consider individual race, which have been recently debated, and concludes that such criteria are unlikely to succeed (...) under present Supreme Court precedent. Part III analyzes the use of sex-based therapy allocation criteria, which are also in current use, and argues that they also face substantial legal obstacles, despite only being subject to intermediate scrutiny. Parts IV and V examine the use of age and health status in allocation. Part VI discusses how the nascent law on “vaccination status” discrimination might apply to therapy allocation. (shrink)

As the median age of practicing physicians increases, ethical dilemmas due to age-related cognitive decline among clinicians will become ever more pressing. Compelling data show that despite acknowledgement of their duty to protect the public, physicians often fail to report themselves, their colleagues, or their physician-patients when cognitive decline appears to impact medical practice adversely. As such, efforts to educate physicians about ethical obligations and various tactful methodologies to report themselves or others seem ineffective. Illustrated by a case report of (...) age-related cognitive decline in a practicing physician, practical recommendations are made both to develop and validate cognitive screening in middle-aged physicians, presumably before the onset of age-related cognitive decline. (shrink)

Definition of the problem. Voluntary active euthanasia is, in certain circumstances, morally permissible and should be permitted by law. Autonomous persons may have a fundamental interest in experiencing ”death in dignity” in accordance with their own preferences. This interest is protected by the concept of human dignity assumed by German law. Some prerequisites being met, the moral and legal autonomy right to determine the time and manner of one’s own death includes a right to secure active euthanasia from a willing (...) physician, and a physician’s acceding to the patient’s request be may morally the right thing to do. Arguments and conclusion: Most arguments against the justifiability of voluntary active euthanasia unveil their weakness when scrutinized. However, insofar as legalized voluntary active euthanasia would be subject to intolerable abuse, our policy options are dilemmatic, and the concept of human dignity as it has been taken for granted in German legal discourse, is questioned. There is no option other than seeking safety in legal procedures for every single case. (shrink)

Volume 19, Issue 10, October 2019, Page 99-101.

This article presents a study on the ethical dilemma of whistleblowing in physical therapy, and suggests some lines for further research on this topic as well as ways for integrating it in the physical therapy curriculum. The study examines the self-reported willingness of physical therapy students to report misconduct, whether internally or externally, to protect the patient's interests. Internal disclosure entails reporting the wrongdoing to an authority within the organisation. External disclosure entails reporting the offence to an outside agency, (...) such as the police, professional organisation, or press. The findings indicate that the students view the acts that are detrimental or cause injustice to the patient in a very serious light. In dilemma situations such as these, the students reported a willingness to act. The students also report considerably greater likelihood of whistleblowing internally than externally. The pattern reveals a desire to correct the misconduct coupled with a marked decline in the willingness to blow the whistle as this act moved from the workplace to an external authority. (shrink)

This paper presents four arguments in favour of respecting Ulysses Contracts in the case of individuals who suffer with severe chronic episodic mental illnesses, and who have experienced spiralling and relapse before. First, competence comes in degrees. As such, even if a person meets the usual standard for competence at the point when they wish to refuse treatment (time 2), they may still belesscompetent than they were when they signed the Ulysses Contract (time 1). As such, even if competent at (...) time 1andtime 2, there can still be a disparity between thelevelsof competence at each time. Second, Ulysses Contracts are important to protect people’smost meaningfulconcerns. Third, on the approach defended, the restrictions to people’s liberty would be temporary, and would be consistent with soft paternalism, rather than hard paternalism: the contracts would be designed in such a way that individuals would be free to change their minds, and to change or cancel their Ulysses Contracts later. Finally, even if one rejects the equivalence thesis (the claim that allowing harm is as bad as doing harm), this is still consistent with the claim that, inparticular cases, it can be as wrong toallowa harm as to do a harm. Nevertheless, controversies remain. This paper also highlights several safeguards to minimise risks. Ultimately, we argue that people who are vulnerable to spiralling deserve a way to protect their autonomy as far as possible, using Ulysses Contracts when necessary. (shrink)

In their article, van Gils Schmidt and Salloch defend the claim that physicians have a duty to protect the climate. The logic of the argument in broad terms is that (i) there is a relationship between climate change and the burden of disease, (ii) the healthcare sector is a significant emitter of global greenhouse gasses, thereby enhancing the burden of disease and (iii) since doctors are advocates of health and stakeholders in the healthcare sector, they have a duty to respond (...) to climate change. The authors recognise the ‘ethical basis for the claim of healthcare professionals having a special responsibility in climate change is far from being obvious’. The theoretical framework they choose for making this tentative link more apparent is Korsgaard’s theory of practical identities. The main argument of the authors seems to be that practical identities are pluralistic—a person can identify as a physician and environmentalist simultaneously—and the normative positions attributable to these identities may come into conflict. More than that, they claim that being an environmentalist is increasingly becoming …. (shrink)

This paper concerns itself with the concept of diminished competence with particular regard to the problems and options that mentally compromised patients raise for medical management. It proceeds through three general stages: (1) a restatement of the sense and grounds of the new patients' rights ethos which the existence of such patients calls into question; (2) a consideration of what expanded responsibilities and tactics physicians should embrace to protect and enhance such patients' autonomy; and (3) the standards, criteria, and mechanisms (...) by which paternalistic interventions might be justified in cases when the diminishment remains too substantial to merit acceptance of the patients' directives. (shrink)

The processing of sensitive information in the health field is subject to rigorous standards that guarantee the protection of information confidentiality. Recently, the Italian Data Protection Authority (Garante per la Protezione dei Dati Personali) stated their formal opinion on a standard procedure in dental offices involving the submission of a questionnaire that includes the patient's health status. HIV infection status is included on the form. The Authority has stated that all health data collection must be in accordance (...) with the current Italian normative framework for personal data protection and respect the patient's freedom. This freedom allows the patient to decide, in a conscious and responsible way, whether to share health information with health personnel without experiencing any prejudice in the provision of healthcare requested. Moreover, data collection must be relevant and cannot exceed the principles of treatment goals with reference to the specific care of the concerned person. However, the need for recording information regarding HIV infection at the first appointment, regardless of the clinical intervention or therapeutic plan that needs to be conducted, should not alter the standard protection measures of the healthcare staff. In fact, these measures are adopted for every patient. (shrink)

A non-inferiority design accepts the possibility of some efficacy loss, as part of a “successful”, statistically significant result. That loss may be excessive when the non-inferiority threshold is lenient. However, even stringent significance thresholds and safety monitoring may fail to adequately protect study participants when the primary outcome is death. The OPTIMAAL trial, a large randomized clinical trial performed in high-risk patients, is discussed as an example, using the Belmont Report principles as an ethical frame of reference. OPTIMAAL compared losartan, (...) a new drug, to captopril, a drug known to reduce the risk of death in patients with heart failure after a myocardial infarction. Serious ethical challenges occurred in that study. Firstly, subjects had to tolerate captopril to participate, meaning that participation implied the possibility of higher risk of death if randomized to the losartan arm, as compared to the standard of care. Additionally, the stopping rules had to ensure enough powe... (shrink)