This code of practice for health professionals was prepared by a multi-professional group and reflects good clinical practice in encouraging dialogue about individuals' wishes concerning their future treatment. It has a broad practical approach, considers a range of advance statements, advises of dangers and benefits of making treatment decisions in advance and combines annotated code of practice with a quick pull out guide for easy reference.

Summary Principles Timely support for patients and people close to them, and effective, sensitive communication are essential. Decisions must be based on the individual patient's circumstances and reviewed regularly. Sensitive advance discussion should always be encouraged, but not forced. Information about CPR and the chances of a successful outcome needs to be realistic. Practical matters Information about CPR policies should be displayed for patients and staff. Leaflets should be available for patients and people close to them explaining about CPR, how (...) decisions are made and their involvement in decisions. Decisions about attempting CPR must be communicated effectively to relevant health professionals. In emergencies If no advance decision has been made or is known, CPR should be attempted unless: the patient has refused CPR; the patient is clearly in the terminal phase of illness; or the burdens of the treatment outweigh the benefits. Advance decision making Competent patients should be involved in discussions about attempting CPR unless they indicate that they do not want to be. Where patients lack competence to participate, people close to them can be helpful in reflecting their views. Legal issues Patients' rights under the Human Rights Act must be taken into account in decision making. Neither patients nor relatives can demand treatment which the health care team judges to be inappropriate, but all efforts will be made to accommodate wishes and preferences. In England, Wales and Northern Ireland relatives and people close to the patient are not entitled in law to take health care decisions for the patient. In Scotland, adults may appoint a health care proxy to give consent to medical treatment. Health professionals need to be aware of the law in relation to decision making for children and young people.IntroductionWhy policies are neededCardiopulmonary resuscitation can be attempted on any person whose cardiac or respiratory functions cease. Failure of these functions is part of dying and thus …. (shrink)

As Medicine shifts from a paternalistic practice to a patient-centered approach, the concept of medical informed consent (IC) has evolved to safeguard patient autonomy. However, its current implementation still presents many challenges in clinical practice. We assessed the knowledge and attitudes of the general Lebanese population regarding the IC process as well as their sociodemographic and medical correlates. An anonymous online survey was distributed to the Lebanese population using social media channels. A sample of 500 adults (...) with an average age of 36.2 ± 13.5 years, including 319 females and 181 males, was recruited. Most of the respondents had a university degree (85.8%), reported previous hospital admissions (75.9%) and had signed an IC for surgical procedures (40.7%). Few participants were knowledgeable about IC Lebanese law. Variability in knowledge level was significantly related to gender and a previous hospitalization history. Positive attitudes toward patient autonomy (53.1%) and shared decision-making (57.5%) correlated with older age, female gender, graduate education, and a previous history of signing an IC document. Males were more likely to believe that IC has positive effects on health than females. This is the first study that provides novel findings regarding Lebanese peoples’ awareness of the ethico-legal components of medical IC. (shrink)

Although Chinese law imposes informed consent for medical treatments, the Chinese understanding of this requirement is very different from the European one, mostly due to the influence of Confucianism. Chinese doctors and relatives are primarily interested in protecting the patient, even from the truth; thus, patients are commonly uninformed of their medical conditions, often at the family’s request. The family plays an important role in health care decisions, even substituting their decisions for the patient’s. Accordingly, instead (...) of personal informed consent, what actually exists is ‘family informed consent’. From a Western perspective, these features of Chinese law and Chinese culture might seem strange, contradicting our understanding of doctor-patient relationship and even the very essence of self-determination and fundamental rights. However, we cannot forget the huge influence of cultural factors in these domains, and that ‘Western’ informed consent is grounded on the individualistic nature of Western culture. This article will underline the differences between the Western and the Chinese perspectives, clarifying how each of them must be understood in its own cultural environment. But, while still respecting Chinese particularities, this paper advocates that China adopt patient individual informed consent because this is the only solution compatible with human dignity and human rights. (shrink)

In contemporary Western biomedical ethics, informed consent practices are commonly justified in terms of the intrinsic value of patient autonomy. James Stacey Taylor maintains that this conception of the moral grounding of medical informed consent is mistaken. On the basis of his reasoning to that effect, Taylor argues that medical informed consent is justified by the instrumental value of personal autonomy. In this article, I examine whether Taylor's justification of medical (...) class='Hi'>informed consent is plausible. (shrink)

Book reviewed in this article: Informed Consent in Medical Therapy and Research. By Bernard Barber.

Ethical issues regarding research biobanks continue to be a topic of intense debate, especially issues of confidentiality, informed consent, and child participation. Although considerable empirical literature concerning research biobank ethics exists, very little information is available regarding the opinions of medical professionals doing genetics research from the Middle East, especially Arabic speaking countries. Ethical guidelines for research biobanks are critically needed as some countries in the Middle East are starting to establish national research biobanks. Islam is the (...) dominant religion in these countries, and it affects people’s behavior and influences their positions. Moreover, communities in these countries enjoy a set of customs, traditions and social norms, and have social and familial structures that must be taken into account when developing research policies. We interviewed 12 medical professionals from the Middle East currently working with stored tissue samples to document their opinions. We found general agreement. Participants’ primary concerns were similar to the views of researchers internationally. Since children tend to represent a high percentage of Middle Eastern populations, and because children’s bodies are not just small adult bodies, the interviewed professionals strongly believed that it is imperative to include children in biobank research. Participants generally believed that protecting confidentiality is socially very important and that informed consent/assent must be obtained from both adult and child participants. This study provides a starting point for additional studies. (shrink)

Technological developments often bring about new risks. Informed consent has been proposed as a means to legitimize the imposition of technological risks. This principle was first introduced in medical practice to assure the autonomy of the patient.The introduction of IC in the field of technological practice raises questions about the comparability of the type of informed consent. To what extent are thepossibilities to include laypeople in making decisions regarding risks similar in the technological field to (...) giving informed consent in the medical field and whatdoes this imply for the design and implementation of IC in the technological field? Medical and the technological practice are clearly alike in that both fieldsare characterized by highly specialized, technical knowledge which can be quite inaccessible to the average layperson. However, a fundamental difference ariseswith regard to the aim, knowledge of risks and exclusiveness of the practices in each field. The differences in aim imply that the necessity for each practice isperceived differently by laypeople, thus leading them to assess the respective risks differently. The differences in knowledge of risks arise from the variabilityin the ways that can be used to describe a given risk. Definition of risk in medical practice is more homogenous in this respect than the risk definition intechnological fields. Futhermore, medical practice tends to be more exclusive, leading laypeople immersed in that practice to necessarily embrace most of thefundamental underlying that practice. These differences result in divergent recommendations for the implementation of informed consent in the technological field, basically: there is a need for more extensive procedure and for less decisive authority for the individual. (shrink)

In this article, it was aimed to determine the knowledge status of physicians about the forms used in obtaining informed consent and according to these determinations; It is aimed to provide information and suggestions to physicians that will contribute to obtaining consent in accordance with medical law and ethics. Material and Method: A questionnaire was created to determine the knowledge status of the physicians about the titles that should be included in the informed consent (...) form (such as the diagnosis of the patient, the harms, risks, benefits of the intervention, healing process, probability of success), and who should receive informed consent. This questionnaire was delivered to physicians online. The data obtained through the questionnaire were analyzed using the SPSS program. Descriptive statistical analyzes were used in the evaluation of personal information. In the evaluation of the data, frequencies and percentage distributions were taken. The analyzed data were evaluated in terms of compliance with legal regulations and medical ethics. Results: 139 physicians working in a private hospital participated in the survey voluntarily. Approximately 90% of the participants think that the complications that occur as a result of the diagnosis and intervention, approximately 85% of the benefits of the intervention and the problems of the recovery period, about 75% of the consequences of not performing the intervention, about 55% of the probability of success should be included in the form of informed consent.. More than 85% of the participating physicians expressed their opinion to agree with the article about the necessity of obtaining consent by the physician. Discussion and Conclusion: It can be accepted as a positive situation that physicians express their opinions in accordance with medical law about the information that should be included in the informed consent form. However, considering the legal values protected by informed consent, it was suggested to take measures to reduce the rates of disagreement and indecision by emphasizing the views of physicians on disagreement and indecision. (shrink)

Background: The internationalization of clinical studies requires a shared understanding of the fundamental ethical values guiding clinical studies. It is important that these values are not only embraced at the legal level but also adopted by clinicians themselves during clinical studies. Objective: Our goal is to provide an insight on how clinicians in Germany and Poland perceive and identify the different ethical issues regarding informed consent in clinical studies. Methods: To gain an understanding of how clinicians view clinical (...) studies in the countries they work in, we carried out semi-structured problem-centered interviews per telephone in Poland (n = 6) and Germany (n = 6). Our interviewees concentrated on three main topics: an appraisal of the normative framework, challenges in the information process and the protection of all participants in clinical studies. Results: Clinicians generally supported the normative framework, even though they considered it quite complex. In the two study countries, a widely noted dilemma in the information process was whether to overburden participants with extensive information or risking leaving out important facts. Clinicians were ready to exclude larger population groups from participating in clinical studies when the information process could not be carried out with standard procedures or when their inclusion was ethically sensitive. Conclusion: Clinicians need to gain a better understanding of the consequences of excluding larger population groups form participating in clinical studies. They should seek assistance in improving the information process for the inclusion of underrepresented groups in clinical studies. (shrink)

Informed consent is a central topic in contemporary biomedical ethics. Yet attempts to set defensible and feasible standards for consenting have led to persistent difficulties. In Rethinking Informed Consent in Bioethics Neil Manson and Onora O'Neill set debates about informed consent in medicine and research in a fresh light. They show why informed consent cannot be fully specific or fully explicit, and why more specific consent is not always ethically better. They (...) argue that consent needs distinctive communicative transactions, by which other obligations, prohibitions, and rights can be waived or set aside in controlled and specific ways. Their book offers a coherent, wide-ranging and practical account of the role of consent in biomedicine which will be valuable to readers working in a range of areas in bioethics, medicine and law. (shrink)

The process of seeking the consent of a patient to a medical procedure is, arguably, one of the most important skills a doctor, or indeed any clinician, should learn. In fact, the very idea that doctors may institute diagnostic or treatment processes of any sort without a patient's consent is utterly counter-intuitive to the modern practice of medicine. It was not always thus, and even now it can be reliably assumed that consent is still not sought (...) and gained appropriately in every clinical encounter. To say that it should be sought and gained in this manner elevates the value of consent to a high level. It can be instructive to ask oneself why such a value might be held to be the case. The answer to this question lies in the philosophical underpinning of clinical consent, which sits within a notion of personal autonomy, and respect for autonomous decision making. (shrink)

What is informed consent in medicine? For more than a generation, this deceptively simple question has vexed the law, discomfited medicine, and generated much inspired, provocative, and even contentious commentary.The question has also spawned several lawsuits. On one side stand patients who claim that, at the time of consent, they were ignorant of a particular risk; who state that, with more or different information, they would have chosen a different treatment; and who argue that, because of an (...) adverse outcome, they now deserve remuneration. On the other side, doctors uneasily watch the lengthening list of suits. Some, troubled by the law's expectations, have reacted by variously describing informed consent as a myth, a fiction, an unattainable goal, or a snare to entrap physicians. They point to the legal commentary condemning informed consent law as ill-defined, diffuse, and fraught with inconsistency, hazy at its best and virtually indecipherable to physicians at its worst: and lacking a fair standard to determine when a patient has sufficient knowledge to give effective consent. (shrink)

What is informed consent in medicine? For more than a generation, this deceptively simple question has vexed the law, discomfited medicine, and generated much inspired, provocative, and even contentious commentary.The question has also spawned several lawsuits. On one side stand patients who claim that, at the time of consent, they were ignorant of a particular risk; who state that, with more or different information, they would have chosen a different treatment; and who argue that, because of an (...) adverse outcome, they now deserve remuneration. On the other side, doctors uneasily watch the lengthening list of suits. Some, troubled by the law's expectations, have reacted by variously describing informed consent as a myth, a fiction, an unattainable goal, or a snare to entrap physicians. They point to the legal commentary condemning informed consent law as ill-defined, diffuse, and fraught with inconsistency, hazy at its best and virtually indecipherable to physicians at its worst: and lacking a fair standard to determine when a patient has sufficient knowledge to give effective consent. (shrink)

Background Informed consent is a process in which a healthcare provider obtains permission from an individual prior to surgery. Patient satisfaction with the informed consent process is one of the main indicators of healthcare service quality. This study aimed to assess patient satisfaction with surgical informed consent at Jimma Medical Center, Ethiopia, in 2020. Methods A facility-based cross-sectional study was conducted from April 1 to June 30, 2020, at Jimma Medical Center. Face-to-face (...) interviews were conducted using structured questionnaires. A systematic sampling technique was used to select the study participants. The collected data were coded, entered into Epi data version 3.1, and analyzed using SPSS version 25. Bivariate and multivariate regression analyses were performed to determine the association between patient satisfaction and socio-demographic and facility-related factors. In multivariate regression, predictors with a P-value of < 0.05 were considered statistically significant. Results Totally 372 study participants were interviewed with a response rate of 97.8%. Nearly two-fifths (43%) of patients were satisfied with surgical informed consent. Living in an urban area (AOR: 2.279, 95% CI 1.257–4.131), having current referred history (AOR: 1.856, 95% CI 1.033–3.337), consent form version (AOR: 2.076, 95% CI 1.143–3.773), time spent on the provision of informed consent (AOR: 5.227, 95% CI 2.499–10.936) and having better patient-health providers relationship (AOR: 5.419, 95% CI 3.103–9.464) predictors were positively associated with patient satisfaction. Conclusion Patient satisfaction with the surgical informed consent process was relatively low. Therefore, Health care professionals need to emphasize a way of delivering informed consent, patients' needs and obey a standard informed consent to improve patient satisfaction. (shrink)

Many high-risk medical devices earn US marketing approval based on limited premarket clinical evaluation that leaves important questions unanswered. Rigorous postmarket surveillance includes registries that actively collect and maintain information defined by individual patient exposures to particular devices. Several prominent registries for cardiovascular devices require enrolment as a condition of reimbursement for the implant procedure, without informed consent. In this article, we focus on whether these registries, separate from their legal requirements, have an ethical obligation to obtain (...) informed consent from enrolees, what is lost in not doing so, and the ways in which seeking and obtaining consent might strengthen postmarket surveillance in the USA. (shrink)

Although the principle of informed consent is well established and its importance widely acknowledged, it has met with criticism for decades. Doubts have been raised for a number of different reasons. In particular, empirical data show that people regularly fail to reproduce the information provided to them. Many critics agree, therefore, that the received concept of informed consent is no more than a myth. Strategies to overcome this problem often rest on a flawed concept of (...) class='Hi'>informed consent. In this paper, it is suggested that informed consent is a communicative act between two persons. The challenge is to elucidate the norms and constraints for successfully performing such a communicative act. The view developed here has major consequences with regard to the standards for information disclosure as well as for the general scope of informed consent. (shrink)

In recent years, an old challenge to informed consent has been rediscovered: the challenge of ignorance. Several authors argue that due to the presence of irreducible ignorance in certain treatments, giving informed consent to these treatments is not possible. The present paper examines in what ways ignorance is believed to prevent informed consent and which treatments are affected by that. At this, it becomes clear that if the challenge of ignorance truly holds, it poses (...) a major problem to informed consent. The paper argues, however, that from both an empirical and a theoretical point of view, it is not convincing that ignorance prevents informed consent. Still, it seems important that the presence of irreducible ignorance is openly discussed during the informed consent process. (shrink)

Name der Zeitschrift: Jahrbuch für Wissenschaft und Ethik Jahrgang: 19 Heft: 1 Seiten: 107-114.

It was not until the nineteenth century that Western nations came to replace mutilation, corporal punishment, and banishment as the favored method of criminal punishment with the more humane concept of imprisonment. Even then, however, a convicted inmate was viewed as nothing more than a slave of the state, entitled only to the most basic of human rights and subject to the whim and peril of his jailor's desire. The shift to imprisonment gradually was accompanied by the additional humanitarian demand (...) that prisons avail their charges of some minimum standard of human decency and necessity, which, by the early part of the twentieth century, had come to encompass the provision of medical care. The courts later came to acknowledge this as a fundamental right grounded in the Eighth Amendment's proscription against cruel and unusual punishments.Although the scope of a prisoner's constitutional right to medical care has been the subject of much debate before the courts, the majority of cases have focused only on the circumstances under which the deprivation of care will amount to a violation of the rights guaranteed by the Eighth Amendment. (shrink)

It was not until the nineteenth century that Western nations came to replace mutilation, corporal punishment, and banishment as the favored method of criminal punishment with the more humane concept of imprisonment. Even then, however, a convicted inmate was viewed as nothing more than a slave of the state, entitled only to the most basic of human rights and subject to the whim and peril of his jailor's desire. The shift to imprisonment gradually was accompanied by the additional humanitarian demand (...) that prisons avail their charges of some minimum standard of human decency and necessity, which, by the early part of the twentieth century, had come to encompass the provision of medical care. The courts later came to acknowledge this as a fundamental right grounded in the Eighth Amendment's proscription against cruel and unusual punishments.Although the scope of a prisoner's constitutional right to medical care has been the subject of much debate before the courts, the majority of cases have focused only on the circumstances under which the deprivation of care will amount to a violation of the rights guaranteed by the Eighth Amendment. (shrink)

In the operating room, patient safety is of paramount importance. Medical students and junior trainees, despite their primary role as students, may play active roles in assessing patient safety and reporting suspected errors. Active consent is one layer of patient safety that is continuously assessed by several team members. This article examines an instance where patient consent may have been violated. Through the lens of trainee and senior perspectives, we discuss the ethical principles at stake and provide (...) recommendations for medical student and junior trainee involvement in patient care when an error is suspected. (shrink)

Ghostwriting in its various forms has received critical scrutiny from medical ethicists, journal editors, and science studies scholars trying to explain where ghostwriting goes wrong and ascertain how to counter it. Recent analyses have characterized ghostwriting as plagiarism or fraud, and have urged that it be deterred through stricter compliance with journal submission requirements, conflict of interest disclosures, author-institutional censure, legal remedies, and journals' refusal to publish commercially sponsored articles. As a supplement to such efforts, this paper offers a (...) critical assessment of medical ghostwriting as contrary to good patient care, on the grounds that it contradicts established general principles guiding clinical ethics. Specifically, I argue that ghostwriting undermines trust relationships between authors and their readers, and between these readers and their trusting patients, and in so doing contradicts the duty of respect for patient autonomy by obstructing informed consent. For this reason, complicity in ghostwriting practices should be understood as a violation of the professional ethical duties of physicians and other healthcare workers. (shrink)

Background The rise in genomic and biobanking research worldwide has led to the development of different informed consent models for use in such research. This study analyses consent documents used by investigators in the H3Africa (Human Heredity and Health in Africa) Consortium. Methods A qualitative method for text analysis was used to analyse consent documents used in the collection of samples and data in H3Africa projects. Thematic domains included type of consent model, explanations of genetics/genomics, (...) data sharing and feedback of test results. Results Informed consent documents for 13 of the 19 H3Africa projects were analysed. Seven projects used broad consent, five projects used tiered consent and one used specific consent. Genetics was mostly explained in terms of inherited characteristics, heredity and health, genes and disease causation, or disease susceptibility. Only one project made provisions for the feedback of individual genetic results. Conclusion H3Africa research makes use of three consent models—specific, tiered and broad consent. We outlined different strategies used by H3Africa investigators to explain concepts in genomics to potential research participants. To further ensure that the decision to participate in genomic research is informed and meaningful, we recommend that innovative approaches to the informed consent process be developed, preferably in consultation with research participants, research ethics committees and researchers in Africa. (shrink)

Substantial efforts have recently been made to reform the physician-patient relationship, particularly toward replacing the `silent world of doctor and patient' with informed patient participation in medical decision-making. This 'new ethos of patient autonomy' has especially insisted on the routine provision of informed consent for all medical interventions. Stronly supported by most bioethicists and the law, as well as more popular writings and expectations, it still seems clear that informed consent has, at best, (...) been received in a lukewarm fashion by most clinicians, many simply rejecting what they commonly refer to as the `myth of informed consent'. The purpose of this book is to defuse this seemingly intractable controversy by offering an efficient and effective operational model of informed consent. This goal is pursued first by reviewing and evaluating, in detail, the agendas, arguments, and supporting materials of its proponents and detractors. A comprehensive review of empirical studies of informed consent is provided, as well as a detailed reflection on the common clinician experience with attempts at informed consent and the exercise of autonomy by patients. In the end, informed consent is recast as a management tool for pursuing clinically and ethically important goods and values that any clinician should see as meriting pursuit. Concurrently, the model incorporates a flexible, anticipatory approach that recognizes that no static, generic ritual can legitimately pursue the quite variable goods and values that may be at stake with different patients in different situations. Finally, efficiency of provision is addressed by not pursuing the unattainable and ancillary. Throughout, the traditional principle of beneficence is appealed to toward articulating an operational model of informed consent as an intervention that is likely to change outcomes at the bedside for the better. (shrink)

ABSTRACT In this paper we argue that the standard focus on problems of informed consent in debates about the ethics of human experimentation is inadequate because it fails to capture a more fundamental way in which such experiments may be wrong. Taking clinical trials as our case in point, we suggest that it is the moral offence of using people as mere means which better characterizes what is wrong with violations of personal autonomy in certain kinds of clinical (...) trials. This account also helps bring out another important way in which the autonomy of the participants in clinical trials my be violated, even in cases where they have given informed consent to their involvement. Where relevant information about the trial is framed in such a way as to induce a patient's participation by appeal to their nonrational preferences, this is also a violation of their autonomy, and one which is distinct from a failure of informed consent. The underlying wrongness of both kinds of violations, we argue, is plausibly captured by the moral offence of using people as mere means. (shrink)

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. (shrink)

As our powerful medical technology continues rapidly to develop, we seem to be confronted by fresh bioethical dilemmas at an ever increasing rate. This volume provides an introduction to modern thinking on these issues, concentrating particularly on paternalism, informed consent and euthanasia.

BackgroundThe issue of stigma is very important in the battle against HIV/aids in Africa since it may affect patient attendance at healthcare centres for obtaining antiretroviral medications and regular medical check-ups. Stigmatization creates an unnecessary culture of secrecy and silence based on ignorance and fear of victimization. This study was designed to determine if there is external stigmatization of people living with HIV and AIDS by health care workers at a tertiary hospital in KwaZulu-Natal province, South Africa. The study (...) investigated the impact of knowledge of HIV/aids by HCWs on treatment of patients, as well as the comfort level and attitude of HCWs when rendering care to PLWHA.MethodsA descriptive cross sectional study was designed to collect data using an anonymous self-administered structured questionnaire from 334 HCWs. The study was conducted in clinical departments of a large multidisciplinary 922-bed tertiary care teaching hospital in Durban, KZN.ResultsOverall HCWs had an above average knowledge about HIV/aids although some gaps in knowledge were identified. Tests of statistical significance showed that there was association between level of education and knowledge of HIV/aids ; occupation and knowledge of HIV/aids ; and gender and knowledge of HIV/aids. Test for comfort level was only significant for gender, with males showing more comfort and empathy when dealing with PLWHA. The study also revealed that patients were sometimes tested for HIV without informed consent before surgery, due to fear of being infected, and there was some gossiping about patients' HIV status by HCWs, thereby compromising patient confidentiality. The majority of HCWs showed a willingness to report incidents of stigmatization and discrimination to higher authorities, for better monitoring and control.ConclusionsAlthough knowledge, attitude and comfort level of HCWs taking care of PLWHA was above average, enforcement of existing antidiscrimination laws and continuing education in medical ethics and healthcare law, would greatly improve the performance of HCWs taking care of PLWHAs. More psychological support and counselling should be provided to HCWs, to further reduce the impact of stigmatization and discrimination against PLWHA. (shrink)

BackgroundThe research shows a growing trend in using an electronic platform to supplement or replace traditional paper-based informed consent processes. Instead of the traditionally written informed consent document, electronic informed consent may be used to assess the research subject’s comprehension of the information presented. By doing so, respect for persons as one of the research ethical principles can be upheld. Furthermore, these electronic methods may reduce potential airborne infection exposures, particularly during the pandemic, thereby (...) adhering to the beneficence and nonmaleficence principle. This scoping review aims to identify the ethics related criteria that have been included in electronic informed consent processes and to synthesize and map these criteria to research ethics principles, in order to identify the gaps, if any, in current electronic informed consent processes.MethodsThe search was performed based on internet search and three main databases: PubMed, SCOPUS and EBSCO. PRISMA Extension for Scoping Reviews : Checklist and Explanation guideline was used to report this work.ResultsOf 34 studies that met the inclusion criteria, 242 essential original constructs were collated, and 7 concepts were derived. Digital content showed the highest percentage of collated original constructs followed by accessibility, comprehension engagement, autonomy, confidentiality, language, and parental consent. Twenty-five new items were synthesized for eConsent criteria which may provide guidance for ethical review of research involving eConsent.ConclusionThe current study adds significant value to the corpus of knowledge in research ethics by providing ethical criteria on electronic informed consent based on evidence-based data. The new synthesized items in the criteria can be readily used as an initial guide by the IRB/rec members during a review process on electronic informed consent and useful to the future preparation of a checklist. (shrink)

The practice of obtaining informed consent has its history in, and gains its meaning from, medicine and biomedical research. Discussions of disclosure and justified nondisclosure have played a significant role throughout the history of medical ethics, but the term “informed consent” emerged only in the 1950s. Serious discussion of the meaning and ethics of informed consent began in medicine, research, law, and philosophy only around 1972.

Recently, there have been several illuminating discussions highlighting a connection between the appropriate conditions for morally responsible agency and for valid informed consent in health care (including for personal medical decisions and for participation in clinical trials). In this chapter, I begin by drawing parallels between debates in both areas (e.g. “substantive” versus “procedural” accounts, “capacity” versus “flow” accounts) and then briefly defend the idea that we should focus on a particular family of substantive views that appeal (...) to high-enough quality opportunities for decision-making which are determined by both agents’ reasons-responsive capacities and situational factors. Notably, even if reasons-responsiveness conditions feature in both accounts of responsible agency and of informed consent, it remains an open question just how similar the conditions are in each area. In particular, since the basis for and the quality of our reasons-responsive capacities come in degrees, there is a question of when a threshold is met so that a person can be said to have a capacity, or a sufficiently high-quality capacity, which is a difficult question to answer in both realms. In this chapter, I assess possible answers and consider how constrained those answers should be by independent reasons to treat responsible agency and eligibility for informed consent similarly. (shrink)

BackgroundThe principles of informed consent, confidentiality and privacy are often neglected during patient care in developing countries. We assessed the degree to which doctors in Lahore adhere to these principles during outpatient consultations.Material & MethodThe study was conducted at medical out-patient departments (OPDs) of two tertiary care hospitals (one public and one private hospital) of Lahore, selected using multi-stage sampling. 93 patients were selected from each hospital. Doctors' adherence to the principles of informed consent, privacy (...) and confidentiality was observed through client flow analysis performed by trained personnel. Overall patient perception was also assessed regarding these practices and was compared with the assessment made by our data collectors.ResultsSome degree of informed consent was obtained from only 9.7% patients in the public hospital and 47.8% in the private hospital. 81.4% of patients in the public hospital and 88.4% in the private hospital were accorded at least some degree of privacy. Complete informational confidentiality was maintained only in 10.8% and 35.5% of cases in public & private hospitals respectively. Informed consent and confidentiality were better practiced in the private compared to the public hospital (two-sample t-test > 2, p value < 0.05). There was marked disparity between the patients' perspective of these ethical practices and the assessment of our trained data collectors.ConclusionObservance of medical ethics is inadequate in hospitals of Lahore. Doctors should be imparted formal training in medical ethics and national legislation on medical ethics is needed. Patients should be made aware of their rights to medical ethics. (shrink)

The use of informed consent for surgery or research has been widely studied; however, its use in other areas of clinical practice has received less attention. This study investigates how doctors and nurses understand informed consent in relation to the prescription and administration of medicines in secondary care. It uses a qualitative analysis of semi-structured in-depth interviews with 19 doctors and 6 nurses recruited from various specialties in a teaching hospital. The results indicate a striking gap (...) between official and actual standards of practice. Providing information, assuring adherence and communication about potential treatment harms were raised as key issues instead of the principal goals of informed consent. Rather than simply treating these findings as support for a 'deficit' account of professionalism, the paper concludes that we need a richer and more grounded account of exactly when hospital medication decisions need to be subjected to the highest standards of informed consent. (shrink)

Background: Medical tourism, thought of as patients seeking non-emergency medical care outside of their home countries, is a growing industry worldwide. Canadians are amongst those engaging in medical tourism, and many are helped in the process of accessing care abroad by medical tourism brokers - agents who specialize in making international medical care arrangements for patients. As a key source of information for these patients, brokers are likely to play an important role in communicating the (...) risks and benefits of undergoing surgery or other procedures abroad to their clientele. This raises important ethical concerns regarding processes such as informed consent and the liability of brokers in the event that complications arise from procedures. The purpose of this article is to examine the language, information, and online marketing of Canadian medical tourism brokers' websites in light of such ethical concerns. Methods: An exhaustive online search using multiple search engines and keywords was performed to compile a comprehensive directory of English-language Canadian medical tourism brokerage websites. These websites were examined using thematic content analysis, which included identifying informational themes, generating frequency counts of these themes, and comparing trends in these counts to the established literature. Results: Seventeen websites were identified for inclusion in this study. It was found that Canadian medical tourism broker websites varied widely in scope, content, professionalism and depth of information. Three themes emerged from the thematic content analysis: training and accreditation, risk communication, and business dimensions. Third party accreditation bodies of debatable regulatory value were regularly mentioned on the reviewed websites, and discussion of surgical risk was absent on 47% of the websites reviewed, with limited discussion of risk on the remaining ones. Terminology describing brokers' roles was somewhat inconsistent across the websites. Finally, brokers' roles in follow up care, their prices, and the speed of surgery were the most commonly included business dimensions on the reviewed websites. Conclusion: Canadian medical tourism brokers currently lack a common standard of care and accreditation, and are widely lacking in providing adequate risk communication for potential medical tourists. This has implications for the informed consent and consequent safety of Canadian medical tourists. (shrink)

ABSTRACT In this paper we argue that the standard focus on problems of informed consent in debates about the ethics of human experimentation is inadequate because it fails to capture a more fundamental way in which such experiments may be wrong. Taking clinical trials as our case in point, we suggest that it is the moral offence of using people as mere means which better characterizes what is wrong with violations of personal autonomy in certain kinds of clinical (...) trials. This account also helps bring out another important way in which the autonomy of the participants in clinical trials my be violated, even in cases where they have given informed consent to their involvement. Where relevant information about the trial is framed in such a way as to induce a patient's participation by appeal to their nonrational preferences, this is also a violation of their autonomy, and one which is distinct from a failure of informed consent. The underlying wrongness of both kinds of violations, we argue, is plausibly captured by the moral offence of using people as mere means. (shrink)

Valid Informed consent to medical treatment or research participation has traditionally been viewed as consisting of the following requirements: the person has t...

Informed consent in medical practice is essential and a global standard that should be sought at all the times doctors interact with patients. Its intensity would vary depending on the invasiveness and risks associated with the anticipated treatment. To our knowledge there has not been any systematic review of consent practices to document best practices and identify areas that need improvement in our setting. The objective of the study was to evaluate the informed consent (...) practices of surgeons at University teaching Hospitals in a low resource setting. (shrink)

The legal basis of informed consent in Texas may on first examination suggest an unqualified affirmation of persons as the source of authority over themselves. This view of individuals in the practice of informed consent tends to present persons outside of any social context in general and outside of their families in particular. The actual functioning of law and medical practice in Texas, however, is far more complex. This study begins with a brief overview of (...) the roots of Texas law and public policy regarding informed consent. This surface account is then contrasted with examples drawn from the actual functioning of Texas law: Texas legislation regarding out-of-hospital do-not-resuscitate (DNR) orders. As a default approach to medical decision-making when patients lose decisional capacity and have failed to appoint a formal proxy or establish their wishes, this law establishes a defeasible presumption in favor of what the law characterizes as “qualified relatives” who can function as decision-makers for those terminal family members who lose decisional capacity. The study shows how, in the face of a general affirmation of the autonomy of individuals as if they were morally and socially isolated agents, space is nevertheless made for families to choose on behalf of their own members. The result is a multi-tier public morality, one affirming individuals as morally authoritative and the other recognizing the decisional standing of families. (shrink)

Since its advent in the 20th century, informed consent has become a cornerstone of ethical healthcare, and obtaining it a core obligation in medical contexts. In my dissertation, I aim to examine the theoretical underpinnings of informed consent and identify what values it is taken to protect. I will suggest that the fundamental motivation behind informed consent rests in something I’ll call bodily self-sovereignty, which I argue involves a coupling of two groups of (...) values: autonomy and non-domination on the one hand, and self-ownership and personal integrity on the other. I will then go on to consider two 'case studies' I take to shed light on what is at stake in securing informed consent - consent in psychiatrically ill populations, and consent to interventions that involve the modification of the genetic germline. (shrink)