Informed Consent for Scholarly Articles during the COVID-19 Pandemic.

The coronavirus disease 2019 pandemic has caused a breakdown in the healthcare system worldwide. The need to rapidly update guidelines in order to control the transmission in the population and for evidenced-based healthcare care has led to the need for timely, voluminous and valid research. Amid the quest for a vaccine and better therapies, researchers clamouring for information has led to a wide variety of ethical issues due to the unique situation. This paper aims to examine the positive and negative aspects of recent changes in the process of obtaining informed consent. The article outlines the various aspects, from history, previously described exemptions to consenting as well as those implemented during the pandemic and the current impact of virtual methods. Further, the authors make recommendations based on the outcome of suggested adjustments described in the literature. This article looks into increasing the awareness of physicians and researchers about ethical issues that need to be addressed to provide optimal care for patients while assuring their integrity and confidentiality.

Illness and disease: an empirical-ethical viewpoint.

BACKGROUND: The concepts of disease, illness and sickness capture fundamentally different aspects of phenomena related to human ailments and healthcare. The philosophy and theory of medicine are making manifold efforts to capture the essence and normative implications of these concepts. In parallel, socio-empirical studies on patients' understanding of their situation have yielded a comprehensive body of knowledge regarding subjective perspectives on health-related statuses. Although both scientific fields provide varied valuable insights, they have not been strongly linked to each other. Therefore, the article aims to scrutinise the normative-ethical implications of patient perspectives in building a bridge to the empirical ethics debates. MAIN TEXT: Three potential fields of tension between the illness and the disease perspective are presented. Consequently, findings from empirical research examining patient perspectives on illness are displayed and the practical implications and associated ethical issues which arise are discussed. This leads to the conclusion that an explicit and elaborate empirical-ethical methodology is needed to deal appropriately with the complex interaction between patients' views and the medico-professional view of disease. Kon's four-stage model of normative-empirical collaboration is then applied against the background of empirical data on patient perceptions. Starting from this exemplary approach, the article suggests employing empirical-ethical frameworks for further research on the conceptual and normative issues, as they help to integrate perspectives from the philosophy of medicine with socio-empirical research. CONCLUSION: The combination of theoretical and empirical perspectives suggested contributes to a more nuanced discussion of the normative impact of patients' actual understanding of illness. Further empirical research in this area would profit from explicitly considering potential ethical issues to avoid naturalistic fallacies or crypto-normative conclusions that may compromise healthcare practice. Vice versa, medico-theoretical debates could be enriched by integrating subjective views of those people who are immediately affected.

How to effectively obtain informed consent in trauma patients: a systematic review.

BACKGROUND: Obtaining adequate informed consent from trauma patients is challenging and time-consuming. Healthcare providers must communicate complicated medical information to enable patients to make informed decisions. This study aimed to explore the challenges of obtaining valid consent and methods of improving the quality of the informed consent process for surgical procedures in trauma patients. METHODS: We conducted a systematic review of relevant English-language full-text original articles retrieved from PubMed (1961-August 2018) that had experimental or observational study design and involved adult trauma patients. Studies involving informed consent in clinical or research trials were excluded. Titles and abstracts of searched articles were reviewed and relevant data were extracted with a structured form. Results were synthesized with a narrative approach. RESULTS: A total of 2044 articles were identified in the initial search. Only eight studies were included in the review for narrative synthesis. Six studies involved orthopedic surgeries, one involved nasal bone surgeries, and one involved trauma-related limb debridement. Only one study was conducted in an emergency department. Information recall was poor for trauma patients. Risk recall and comprehension were greater when written or video information was provided than when information was provided only verbally. Patient satisfaction was also greater when both written and verbal information were provided than when verbal information alone was provided; patients who received video information were more satisfied than patients who received written or verbal information. CONCLUSIONS: Many articles have been published on the subject of informed consent, but very few of these have focused on trauma patients. More empirical evidence is needed to support the success of informed consent for trauma patients in the emergency department, especially within the necessarily very limited time frame. To improve the informed consent process for trauma patients, developing a structured and standardized informed consent process may be necessary and achievable; its effectiveness would require evaluation. Adequately educating and training healthcare providers to deliver structured, comprehensive information to trauma patients is crucial. Institutions should give top priority to ensuring patient-centered health care and improved quality of care for trauma patients.

[Placebo Nocebo Ethics in Communicating with Patients How Anaesthesiologists Should Handle the Psychosomatic Dimension of Briefing]. / Placebo-Nocebo-Ethik für die Patientenkommunikation.

The briefing of patients is part of the daily routine of clinical anaesthesiologists and a central element for justification of medical treatment. It is increasingly apparent that such conversations can significantly affect the success of treatment by eliciting placebo and nocebo effects. Placebo effects are psychosocially caused clinical improvements, mediated by neurobiological mechanisms, which would be omitted in the case of hidden application. Nocebo effects are deteriorations, caused by the same mechanism. Anesthesiologists can make use of the knowledge about placebo and nocebo effects to increase positive impact on the outcome of treatment and to reduce negative effects at the same time. To do so legitimately, physicians have to balance the respect for patients' autonomy, the benevolence, and the non-maleficence for their patients. Patient's autonomy remains the supreme principle of the briefing about treatment and is institutionalized by the informed consent paradigm. Positive and negative expectations are to be handled by patient-oriented communication, but hard paternalistic deceptions and omissions are ethically unjustifiable. We will examine the practical strategies that could be used to deal with the imminent conflict between profound information and optimising placebo and nocebo responses. One key stone of these strategies is the pilot model. It helps to shape briefings as individually required and to promote the wellbeing and autonomy of our patients at the very same time.

Identity change and informed consent.

In this paper, I focus on a kind of medical intervention that is at the same time fascinating and disturbing: identity-changing interventions. My guiding question is how such interventions can be ethically justified within the bounds of contemporary bioethical mainstream that places great weight on the patient's informed consent. The answer that is standardly given today is that patients should be informed about the identity effects, thus suggesting that changes in identity can be treated like 'normal' side effects. In the paper, I argue that this approach is seriously lacking because it misses important complexities going along with decisions involving identity changes and consequently runs into mistakes. As a remedy I propose a new approach, the 'perspective-sensitive account', which avoids these mistakes and thus provides the conceptual resources to systematically reflect on and give a valid consent to identity-changing interventions.

Informed consent to HIV cure research.

Trials with highly unfavourable risk-benefit ratios for participants, like HIV cure trials, raise questions about the quality of the consent of research participants. Why, it may be asked, would a person with HIV who is doing well on antiretroviral therapy be willing to jeopardise his health by enrolling in such a trial? We distinguish three concerns: first, how information is communicated to potential participants; second, participants' motivations for enrolling in potentially high risk research with no prospect of direct benefit; and third, participants' understanding of the details of the trials in which they enrol. We argue that the communication concern is relevant to the validity of informed consent and the quality of decision making, that the motivation concern does not identify a genuine problem with either the validity of consent or the quality of decision making and that the understanding concern may not be relevant to the validity of consent but is relevant to the quality of decision making. In doing so, we derive guidance points for researchers recruiting and enrolling participants into their HIV cure trials, as well as the research ethics committees reviewing proposed studies.

Ethical Dimensions of Counseling about the Clinical Management of Gestational Diabetes.

Gestational diabetes is associated with both short- and long-term adverse outcomes for the mother and the child. Glycemic control to improve perinatal outcomes is consistent with the best available evidence and should be recommended. The evidence for interventions to improve long-term outcomes is less robust. Therefore, patients need to be informed of the data, have the limitations explained, and be supported in decision-making. Theoretical risks do not need to be revealed to patients. Enthusiasm for interventions not supported by evidence should not be promoted. This article provides an ethical framework for counseling patients about the management of gestational diabetes.

[Organisational challenges of community information offices for the elderly in Switzerland : A qualitative study with ethical reflections]. / Strukturelle Herausforderungen kommunaler Altersstellen in der Schweiz : Eine qualitative Studie mit ethischer Reflexion.

BACKGROUND: Current Swiss politics concerning age and ageing are orientated towards the principle "out-patient before in-patient". As part of new regulations, in 2011 all communities were required to set up information offices to answer questions about out-patient and in-patient care. OBJECTIVES: The aim of this qualitative study was to analyse in which form and under which conditions such information offices are run. METHODS: A qualitative study was conducted which consisted of semistructured interviews with managers of information offices. They were analysed using qualitative content analysis. RESULTS: The analysis shows that on the one hand the information offices have the potential to serve an important role in the communities and that they have a highly complex, demanding and responsible function. On the other hand the results illustrate that in organisational respects the situation is highly heterogeneous and unregulated. CONCLUSION: For the running of the information offices, there is need for action such as the definition of general framework, quality standards, qualifications and values profiles, objectives, mission, responsibility and legitimation, instruments for networking and cooperations.

Emerging ethical issues in digital health information.

The problems of poor or biased information and of misleading health and well-being advice on the Internet have been extensively documented. The recent decision by the Internet Corporation for Assigned Names and Numbers to authorize a large number of new generic, top-level domains, including some with a clear connection to health or healthcare, presents an opportunity to bring some order to this chaotic situation. In the case of the most general of these domains, ".health," experts advance a compelling argument in favor of some degree of content oversight and control. On the opposing side, advocates for an unrestricted and open Internet counter that this taken-for-granted principle is too valuable to be compromised, and that, once lost, it may never be recovered. We advance and provide evidence for a proposal to bridge the credibility gap in online health information by providing provenance information for websites in the .health domain.

[Patient autonomy and informed consent - ethical and legal issues]. / Patientenautonomie und Aufklärung - Ethische und rechtliche Aspekte der Aufklärung.

Informing patients about the benefits and risks of and alternatives to proposed medical or surgical procedures is crucial to the patient-physician relationship. It is a legal and ethical precondition to a patient's informed consent to a course of action. Particularly in cases of serious illness and when there are far reaching implications for a patient's lifestyle, this process entails much more than just imparting information. Indeed, it is a dialogue through which the physician empowers the patient to reach a decision which reflects the patient's life situation and system of values. This process promotes patient autonomy. Studies have shown that this approach builds trust, increases patient satisfaction with health care and results in a higher degree of professional fulfilment for the physician.

[Patients' rights--doctors' duties]. / Patientenrechte--Arztpflichten (I).

On 26 February 2013 the new "Law on Patients' Rights" (hereinafter also the "Law") became effective. This Law strengthens patients' rights vis-à-vis the insurdnce company and also regulates patients' rights regarding their relation to the doctor. This has consequences for the laws on medical liability all doctors must consider. The doctor's performance is and remains a service and such service does not hold any guarantee of success. Nevertheless, this Law primarily reads as a "law on the duties of physicians". To duly take into account these duties and to avoid mistakes and misinterpretation of the Law, the Ethics Committee of the Consortium of Osteosynthesis Trauma Germany (AOTRAUMA-D) has drafted comments on the Law. Brief summaries of its effects are to be found at the end of the respective comment under the heading "Consequences for Practice". The text of the law was influenced particularly by case law, as continuously developed by the German Federal Court of Justice ("BGH"). The implementation of the Law on Patients' Rights was effected by the newly inserted sections 630a to 630h of the German Civil Code (the "BGB"), which are analysed below. The following comments are addressed to physicians only and do not deal with the specific requirements and particularities of the other medical professions such as physiotherapy, midwifery and others so on. Special attention should be paid to the comments on the newly inserted Duty to inform, which has to be fullfilled prior to any diagnostic or therapeutic procedure (sec. 630c para 2 sentence 1 BGB). Under certain conditions the doctor also has to inform the patient about the circumstances that lead to the presumed occurance of a therapeutic or diagnostic malpractice (sec. 630c para. 2 sentence 2 BGB), based on the manifestation of an undesired event or an undesired outcome. As before, the patient's valid consent to any procedure (sec. 630d BGB) is directly linked to the comprehensive and timely provision of information (sec. 630e BGB). Comprehensive documentation obligations regarding all procedures are stipulated in sec. 630f BGB. As before, the burden of proof still rests with the patient, unless a severe malpractice has been established (sec. 630h BGB). The definition of "severe malpractice" remains unchanged and is based on the case law of the Federal Court of Justice (BGH). The patient's obligations to preserve his or her health and to actively support the process of recovery and securing a positive outcome of the treatment are not explicitly mentioned in the Law. Nevertheless, the patient and the physician need to work closely together to achieve a successful result of the treatment. In case the patient does not give his or her cooperation, the physician should consider terminating the treatment relationship.

The extent of surgical patients' understanding.

The notion that consent to surgery must be informed implies not only that information should be provided by the surgeon but also that the information should be understood by the patient in order to give a foundation to his or her decision to accept or refuse treatment and thus, achieve autonomy for the patient. Nonetheless, this seems to be an idyllic situation, since most patients do not fully understand the facts offered and thus the process of surgical informed consent, as well as the patient's autonomy, may be jeopardized. Informed consent does not always mean rational consent.

How much information do patients want or need.

Based on literature and personal experience, this paper address the question of how much information patients want or need prior to surgery. It underlines the importance of not only answering patients' questions but also making them aware of information available, to help them go through this difficult process. Aspects such as obtaining a second opinion and use of the Internet are also covered.

From 'Image Gently' to image intelligently: a personalized perspective on diagnostic radiation risk.

The risk of ionizing radiation from diagnostic imaging has been a popular topic in the radiology literature and lay press. Communicating the magnitude of risk to patients and caregivers is problematic because of the uncertainty in estimates derived principally from epidemiological studies of large populations, and alternative approaches are needed to provide a scientific basis for personalized risk estimates. The underlying patient disease and life expectancy greatly influence risk projections. Research into the biological mechanisms of radiation-induced DNA damage and repair challenges the linear no-threshold dose-response assumption and reveals that individuals vary in sensitivity to radiation. Studies of decision-making psychology show that individuals are highly susceptible to irrational biases when judging risks. Truly informed medical decision-making that respects patient autonomy requires appropriate framing of radiation risks in perspective with other risks and with the benefits of imaging. To follow the principles of personalized medicine and treat patients according to their specific phenotypic and personality profiles, diagnostic imaging should optimally be tailored not only to patient size, body region and clinical indication, but also to underlying disease conditions, radio-sensitivity and risk perception and preferences that vary among individuals.

Social vulnerability in paediatric dentistry: an overview of ethical considerations of therapeutic patient education.

Dental caries is a multifactorial condition that remains a major public health issue in high income countries. The prevalence of dental caries in children has markedly declined in most countries over the past 30 years. However, the disease continues to affect a vulnerable population defined as a high-risk group. As many public health policies are inefficient in dealing with this underprivileged group, it is necessary to find other strategies to decrease the incidence and the burden of dental caries. Defining dental caries as a chronic disease enables us to develop the concept of 'therapeutic patient education.' It is meant to train patients to self-manage or adapt treatment to their particular chronic disease and to cope with new processes and skills. The purpose of this paper is to propose a new approach to dental caries, in particular to early childhood caries. That should decrease the gravity and prevalence of the disease in this specific population. As a result, this new approach could increase the quality of life of many children both in terms of function and aesthetics.

[Ethics of biomedical research: questions about patient information]. / Éthique de la recherche biomédicale - Quelles questions sur l'information des patients ?

All recommendations and laws concerning biomedical research, including the most recent in France in 2012, emphasize the quality of patient information to justify its participation. To optimize practices, it is important to take into account the central issues: what limits of information? What role for the relatives and family in the decision in case of disability or vulnerability of a patient? What need for specific information for long protocol and follow-up cohort? What information about research results?

[Current medicolegal and ethical issues in pathology]. / Aktuelle medizinrechtliche und -ethische Herausforderungen der Pathologie.

The increase in density of information available in relation to patients and research participants, in particular in the context of genetic diagnostics and analysis, results in an increased potential for uncovering details which were unexpected but are of particular significance for the patient. Deciding how this information is dealt with and who is entitled to receive this information, is a medicolegal and ethical balancing act. Incidental findings and the challenges posed by the advent of personalised medicine are but two areas which increasingly impact medical disciplines that do not conventionally work directly with patients. Both areas raise questions of what is legally required and morally necessary. The authors briefly sketch these two areas and the medicolegal and ethical implications for diagnostics and research in pathology.

Evaluation of an educational program to improve communication with patients about early-phase trial participation.

BACKGROUND: Discussing early-phase cancer trials is challenging; most offer little personal benefit to patients with life-limiting illnesses who frequently have a poor understanding of and misconceptions about the therapeutic aims. We evaluated an evidence-based training program aimed at enhancing communication. METHODS: Prior to and after the intervention, 47 health care professionals (HCPs) experienced in early-phase trial recruitment were audio taped discussing trials with patient simulators who completed postinterview evaluations. Coders rated the interviews for the presence of information areas required to elicit ethical consent. HCPs reported their self-confidence on 15 different aspects of trial discussion. RESULTS: Significant objective and subjective improvements in communication were found after the workshop. Analyses of audio tapes showed positive shifts in: establishing the patient's knowledge of their prognosis (odds ratio [OR], 2.7; p = .002), discussing symptomatic care (OR, 3.8; p < .001), the aims of the trial (OR, 2.6; p =.002), and the unlikelihood of medical benefit (OR, 3.0; p = .021). Patient simulator ratings showed improvements in: the awareness of palliative care and symptom control (OR, 2.1; p = .004), the voluntariness of participation (OR, 3.7; p = .015), the opportunity to ask questions (OR, 2.9; p = .044), and the time to consider participation (OR, 6.1; p = .009). HCPs' self-confidence increased significantly for all 15 items (OR range, 1.5-2.9; p ≤ .001). CONCLUSION: This short, intensive workshop changed communication skills competency and self-efficacy in ways likely to promote valid, ethically informed consent from patients contemplating trial entry.