Consent ought to be required to withhold treatment that is in a patient’s best interests to receive. Do not resuscitate orders are examples of best interests assessments at the end of life. Such assessments represent value judgments that cannot be validly ascertained without patient input. If patient input results in that patient dissenting to the DNR order then individual physicians are not justified in overriding such dissent. To do so would give unjustifiable primacy to the (...) values of the individual physician. Therefore patient consent is effectively required to write a DNR order. Patient dissent to a DNR order should trigger a fair process mechanism to resolve the dispute. (shrink)

Background Rapid ethical access to personal health information to support research is extremely important during pandemics, yet little is known regarding patient preferences for consent during such crises. This follow-up study sought to ascertain whether there were differences in consent preferences between pre-pandemic times compared to during Wave 1 of the COVID-19 global pandemic, and to better understand the reasons behind these preferences. Methods A total of 183 patients in the pandemic cohort completed the survey via email, (...) and responses were compared to the distinct pre-pandemic cohort ; all were patients of a large Canadian cancer center. The survey covered broad versus study-specific consent; opt-in versus opt-out contact approach; levels of comfort sharing with different recipients; perceptions of commercialization; and options to track use of information and be notified of results. Four focus groups were subsequently conducted to elucidate reasons motivating dominant preferences. Results Patients in the pandemic cohort were significantly more comfortable with sharing all information and biological samples, sharing information with the health care institution, sharing information with researchers at other hospitals, sharing PHI provincially, nationally and internationally compared to the pre-pandemic cohort. Discomfort with sharing information with commercial companies remained unchanged between the two cohorts. Significantly more pandemic cohort patients expressed a wish to track use of PHI, and to be notified of results. Thematic analysis uncovered that transparency was strongly desired on outside PHI use, particularly when commercialization was involved. Conclusions In pandemic times, patients were more comfortable sharing information with all parties, except with commercial entities, where levels of discomfort remained unchanged. Focus groups identified that the ability to track and receive results of studies using one’s PHI is an important way to reduce discomfort and increase trust. These findings meaningfully inform wider discussions on the use of personal health information for research during global crises. (shrink)

Patient consent has been formulated in terms of radical individualism rather than shared benefits. Medical education relies on the provision of patient consent to provide medical students with the training and experience to become competent doctors. Pelvic examination represents an extreme case in which patients may legitimately seek to avoid contact with inexperienced medical students particularly where these are male. However, using this extreme case, this paper will examine practices of framing and obtaining consent as (...) perceived by medical students. This paper reports findings of an exploratory qualitative study of medical students and junior doctors. Participants described a number of barriers to obtaining informed consent. These related to misunderstandings concerning student roles and experiences and insufficient information on the nature of the examination. Participants reported perceptions of the negative framing of decisions on consent by nursing staff where the student was male. Potentially coercive practices of framing of the decision by senior doctors were also reported. Participants outlined strategies they adopted to circumvent patients’ reasons for refusal. Practices of framing the information used by students, nurses and senior doctors to enable patients to decide about consent are discussed in the context of good ethical practice. In the absence of a clear ethical model, coercion appears likely. We argue for an expanded model of autonomy in which the potential tension between respecting patients’ autonomy and ensuring the societal benefit of well-trained doctors is recognised. Practical recommendations are made concerning information provision and clear delineations of student and patient roles and expectations. (shrink)

The prevailing view in bioethics is that the relationship between doctors and their patients was largely a silent one before the landmark court decisions of the twentieth century. Some have proposed that this was not always the case. This paper provides historical evidence of consent and negotiation in one nineteenth century gynecological practice. The Clinical Records and writings of Dr. Alexander J.C. Skene, who practiced in Brooklyn, New York from 1863 to 1900, have been examined for evidence of discussion, (...) consent and even negotiation with patients. Although this evidence comes from only one practice, it is especially significant because it was largely a gynecological practice with women who were varied in socioeconomic status and ethnic origin. The importance of documenting physician-patient relationships which included patients in decision-making before Schloendorff established the legal doctrine of informed consent cannot be underestimated. (shrink)

This article explores the patient consent process in modern community pharmacy practice and discusses the related ethical dilemmas in this environment. The myth of appropriately informed consent, and irrefutable evidence as to a pharmacist’s intentions when advising a patient, are core issues for discussion. The objective is to clarify where such dilemmas may exist in the consent process and to ultimately form a framework against which ethical guidelines might facilitate resolution of the dilemma faced by (...) the pharmacist who is expected to simultaneously maintain legal and duty of care responsibilities in the patient consent process. (shrink)

Objective Cluster randomised trial (CRT) investigators face challenges in seeking informed consent from individual patients (cluster members). This study examined associations between reporting of patient consent in healthcare CRTs and characteristics of these trials. Study design Consent practices and study characteristics were abstracted from a random sample of 160 CRTs performed in primary or hospital care settings that were published from 2000 to 2008. Multivariable logistic regression was used to examine associations between reporting of patient (...) consent and methodological characteristics, as well as publication features such as date and journal of publication. Results 82 (53.8%) of 160 studies reported obtaining informed consent from individual patients. Reporting of patient consent was independently and positively associated with: smaller cluster size, the evaluation of experimental interventions targeted at patients, data collection from individual patients, publication later than 2004 and publication in higher-impact journals. Conclusions Reporting of consent practices in published CRTs should be improved. Consent practices in published CRTs appear to be related to the type of interventions under study, as well as journal impact and trends in research ethics practices. These findings will inform best practices in trial conduct and ethics review, remediation of errors in consent practices and ethics review and the development of regulatory guidance for CRTs. (shrink)

Background: Authors are required to describe in their manuscripts ethical approval from an appropriate committee and how consent was obtained from participants when research involves human participants.Objective: To assess the reporting of these protections for several study designs in general medical journals.Design: A consecutive series of research papers published in the Annals of Internal Medicine, BMJ, JAMA, Lancet and The New England Journal of Medicine between February and May 2003 were reviewed for the reporting of ethical approval and (...) class='Hi'>patient consent. Ethical approval, name of approving committee, type of consent, data source and whether the study used data collected as part of a study reported elsewhere were recorded. Differences in failure to report approval and consent by study design, journal and vulnerable study population were evaluated using multivariable logistic regression.Results: Ethical approval and consent were not mentioned in 31% and 47% of manuscripts, respectively. 88 papers failed to report both approval and consent. Failure to mention ethical approval or consent was significantly more likely in all study designs than in randomised controlled trials . Failure to mention approval was most common in the BMJ and was significantly more likely than in The New England Journal of Medicine. Failure to mention consent was most common in the BMJ and was significantly more likely than in all other journals. No significant differences in approval or consent were found when comparing studies of vulnerable and non-vulnerable participants.Conclusion: The reporting of ethical approval and consent in RCTs has improved, but journals are less good at reporting this information for other study designs. Journals should publish this information for all research on human participants. (shrink)

The legal requirements and justifications for collecting patient-identifiable data without patient consent were examined. The impetus for this arose from legal and ethical issues raised during the development of a population-based disease register. Numerous commentaries and case studies have been discussing the impact of the Data Protection Act 1998 and Caldicott principles of good practice on the uses of personal data. But uncertainty still remains about the legal requirements for processing patient-identifiable data without patient (...) class='Hi'>consent for research purposes. This is largely owing to ignorance, or misunderstandings of the implications of the common law duty of confidentiality and section 60 of the Health and Social Care Act 2001. The common law duty of confidentiality states that patient-identifiable data should not be provided to third parties, regardless of compliance with the DPA1998. It is an obligation derived from case law, and is open to interpretation. Compliance with section 60 ensures that collection of patient-identifiable data without patient consent is lawful despite the duty of confidentiality. Fears regarding the duty of confidentiality have resulted in a common misconception that section 60 must be complied with. Although this is not the case, section 60 support does provide the most secure basis in law for collecting such data. Using our own experience in developing a disease register as a backdrop, this article will clarify the procedures, risks and potential costs of applying for section 60 support. (shrink)

Volume 19, Issue 10, October 2019, Page 97-98.

In patients with schizophrenia, consent postmortem for organ donation for transplantation and research is usually obtained from relatives. By means of a questionnaire, the authors investigate whether patients with schizophrenia would agree to family members making such decisions for them as well as compare decisions regarding postmortem organ transplantation and brain donation between patients and significant family members. Study results indicate while most patients would not agree to transplantation or brain donation for research, a proportion would agree. Among patients (...) who declined organ donation for transplantation or brain research, almost half of family members would have agreed to brain donation for research and over 40% to organ transplantation. Male relatives are more likely to agree to organ donation from their deceased relatives for both transplantation and research. The authors argue that it is important to respect autonomy and interests of research subjects even if mentally ill and even if no longer living. Consent may be assisted by appropriate educational interventions prior to patient death. (shrink)

In an analysis of recent work on nudging we distinguish three positions on the relationship between nudging founded in libertarian paternalism and the protection of personal autonomy through informed consent. We argue that all three positions fail to provide adequate protection of personal autonomy in the clinical context. Acknowledging that nudging may be beneficial, we suggest a fourth position according to which nudging and informed consent are valuable in different domains of interaction.

Although informed consent is an integral part of clinical practice, its current doctrine remains mostly a matter of law and mainstream ethics rather than empirical research. There are scarce empirical data on patients’ perceived purpose of informed consent, which may include administrative routine/courtesy gesture, simple honest permission, informed permission, patient-clinician shared decision-making, and enabling patient’s self decision-making. Different purposes require different processes.

The legal doctrine of informed consent has overwhelmingly failed to assure that the medical treatment patients get is the treatment patients want. This Article describes and defends an ongoing shift toward shared decision making processes incorporating the use of certified patient decision aids.

Background Informed consent is an integral component of good medical practice. Many researchers have investigated measures to improve the quality of informed consent, but it is not clear which techniques work best and why. To address this problem, we propose developing a core outcome set to evaluate interventions designed to improve the consent process for surgery in adult patients with capacity. Part of this process involves reviewing existing research that has reported what is important to patients and (...) doctors in the informed consent process. Methods This qualitative synthesis comprises four phases: identification of published papers and determining their relevance; appraisal of the quality of the papers; identification and summary of the key findings from each paper while determining the definitiveness of each finding against the primary data; comparison of key themes between papers such that findings are linked across studies. Results Searches of bibliographic databases returned 11,073 titles. Of these, 16 studies met the inclusion criteria. Studies were published between 1996 and 2016 and included a total of 367 patients and 74 health care providers. Thirteen studies collected data using in-depth interviews and constant comparison was the most common means of qualitative analysis. A total of 94 findings were extracted from the primary papers and divided into 17 categories and ultimately 6 synthesised findings related to: patient characteristics, knowledge, communication, the model patient, trust and decision making. Conclusions This qualitative meta-aggregation is the first to examine the issue of informed consent for surgery. It has revealed several outcomes deemed important to capture by patients and clinicians when evaluating the quality of a consent process. Some of these outcomes have not been examined previously in research comparing methods for informed consent. This review is an important step in the development of a COS to evaluate interventions designed to improve the consent process for surgery. Registration The study protocol was registered on the international prospective register for systematic reviews. (shrink)

This chapter contains sections titled: The Moral Foundation The Legal Requirement for Consent in Therapeutic Settings The Exceptions References.

It is unclear whether the regulatory distinction between non-identifiable and identifiable information—information used to determine informed consent practices for the use of clinically derived samples for genetic research—is meaningful to patients. The objective of this study was to examine patients' attitudes and preferences regarding use of anonymous and identifiable clinical samples for genetic research. Telephone interviews were conducted with 1,193 patients recruited from general medicine, thoracic surgery, or medical oncology clinics at five United States academic medical centers. Wanting to (...) know about research being done was important to 72% of patients when samples would be anonymous and to 81% of patients when samples would be identifiable. Only 17% wanted to know about the identifiable scenario but not the anonymous scenario. Curiosity-based reasons were the most common among patients who wanted to know about anonymous samples. Of patients wanting to know about either scenario, approximately 57% would require researchers to seek permission, whereas 43% would be satisfied with notification only. Patients were more likely to support permission in the anonymous scenario if they had more education, were Black, less religious, in better health, more private, and less trusting of researchers. The sample, although not representative of the general population, does represent patients at academic medical centers whose clinical samples may be used for genetic research. Few patients expressed preferences consistent with the regulatory distinction between non-identifiable and identifiable information. Data from this study should cause policy-makers to question whether this distinction is useful in relation to research with previously collected clinically derived samples. (shrink)

Hastings Center Report, Volume 52, Issue 1, Page 28-31, January/February 2022.

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)

We explored the comprehension of the informed consent in 77 cancer patients previously enrolled in randomised phase II or phase III clinical trials, between March and July 2011, at the San Raffaele Scientific Institute in Milano. We asked participants to complete an ad hoc questionnaire and analysed their answers. Sixty-two per cent of the patients understood the purpose and nature of the trial they were participating in; 44% understood the study procedures and 40% correctly listed at least one of (...) the major risks or complications related to their participation in the trial. We identified three factors associated with comprehension of the informed consent: age, education and type of tumour/investigator team. We suggest several possible improvements of how to obtain informed consent that will increase patient awareness, as well as the validity and effectiveness of the clinical trials. (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)

In the practice of medicine there has long been a conflict between patient management and respect for patient autonomy. In recent years this conflict has taken on a new form as patient management has increasingly been shifted from physicians to insurers, employers, and health care bureaucracies. The consequence has been a diminshment of both physician and patient autonomy and a parallel diminishment of medical record confidentiality. Although the new managers pay lip service to the rights of (...) patients to confidentiality of their records, in fact they advocate very liberal medical records access policies. They argue that a wide range of parties has a need to know the contents of individually identifiable medical records in order to control costs, promote quality of care, and undertake research in the public interest. Broad interpretations of the need to know, however, are at odds with strict interpretations of the right to confidentiality. Strict confidentiality policies require that, with few exceptions, patient consent be obtained whenever a patient's record is used outside the treatment context. The traditional criterion for overriding the consent requirement has been that without the override some harm would directly result. This rule is now challenged by the claim that patients have a duty to make their records available for a wide range of research and public health purposes. The longstanding tension between physician responsibility for patient welfare and respect for patient autonomy is being replaced by a debatable requirement that both physician and patient autonomy be subordinated to the goals of data collection and analysis. (shrink)

Informed consent is reviewed as it applies to psychiatric patients. Although new legislation, such as the Mental Health Act 1983, provides a useful safeguard for the protection of the civil rights of patients, it could actually reduce their humane care unless applied with sensitivity for the nature of their unique difficulties. In order to guard against this possibility, we suggest that legal requirements should be considered in light of the ethical principles which underlie them. Three principles are considered: those (...) of autonomy (freedom); beneficence (paternalism); and the fiduciary principle (partnership). Psychotherapy is offered as a model for informed consent, which might be generalised to other clinical situations. (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)

The rule that a patient should give a free, fully-informed consent to any therapeutic intervention is traditionally thought to express merely a right of the patient against the physician, and a duty of the physician towards the patient. On this view, the patient may waive that right with impugnity, a fact sometimes expressed in the notion of a right not to know. This paper argues that the rule also expresses a duty of the patient (...) towards the physician and a right of the physician against the patient. The argument turns, first, on the truism that a physician has no obligation to commit a battery, or unauthorized touching, and, second, on the thesis that a patient necessarily cannot consent to something that is unknown to him. The conclusion is drawn that a patient is not free to receive treatment voluntarily without knowledgeably authorizing it. CiteULike Connotea Del.icio.us What's this? (shrink)

Background: Biological products are widely used in the treatment of burns, chronic wounds, and other forms of acute injury. However, the religious and ethical issues, including consent, arising from their use have never been addressed in the medical literature.Aims: This study was aimed to ascertain the views of religious leaders about the acceptability of biological products and to evaluate awareness among healthcare professionals about their constituents.Methods: The religious groups that make up about 75% of the United Kingdom population were (...) identified and a questionnaire on 11 biological products was sent to its leaders. Another questionnaire concerning 17 products was sent to 100 healthcare professionals working in seven specialist units in the UK.Results: All religious leaders replied, some after consultation with international bodies. Among them, 77% said that patients should be informed of the constituents of the biological products and consent obtained. Some leaders expressed concerns about particular products including the transmission of viral and prion diseases, cruelty to animals, and material derived from neonates. None of the healthcare professionals surveyed knew the constituents of all the products correctly.Conclusion: Ignoring religious sensitivities and neglecting consent in the usage of biological products could have very serious implications, including litigation. Hospitals and manufacturers should take immediate measures to enlighten healthcare professionals of the constituents of these products so that they can obtain informed consent from patients. (shrink)

The notion of consent which rose to the forefront in biomedical ethics as an attempt to safeguard patients' autonomy, is relatively new. The notion itself requires qualification, for it precludes neither duress nor ignorance. More seriously, I argue here that consent is redundant except in situations where paternalism prevails. Paradoxically, these are the very situations where it may be difficult to uphold or to verify voluntary consent. I suggest that a request-based relationship has the potential to overcome (...) these difficulties. It enhances patients' participation in decision making, requires that the patients remain in command and avoids their subordination. Request is also more conducive to treatments that are representative of patients' own values and perceptions. In practice, what one wants and what one agrees to, often concur. But these are not conceptually identical issues, and they carry important differences of emphasis. (shrink)

Functional MRI shows promise as a candidate prognostication method in acutely comatose patients following severe brain injury. However, further research is needed before this technique becomes appropriate for clinical practice. Drawing on a clinical case, we investigate the process of obtaining informed consent for this kind of research and identify four ethical issues. After describing each issue, we propose potential solutions which would make a patient’s participation in research compatible with her rights and interests. First, we defend the (...) need for traditional proxy consent against two alternative approaches. Second, we examine the impact of the intensive care unit environment on the informed consent process. Third, we discuss the therapeutic misconception and its potential influence on informed consent. Finally, we deal with issues of timing in recruiting participants and related factors which may affect the risks of participation. (shrink)

BackgroundThe Life Extension Medical Decision law enacted on February 4, 2018 in South Korea was the first to consider the suspension of futile life-sustaining treatment, and its enactment caused a big controversy in Korean society. However, no study has evaluated whether the actual implementation of life-sustaining treatment has decreased after the enforcement of this law. This study aimed to compare the provision of patient consent before and after the enforcement of this law among cancer patients who visited a (...) tertiary university hospital's emergency room to understand the effects of this law on the clinical care of cancer patients.MethodsThis retrospective single cohort study included advanced cancer patients aged over 19 years who visited the emergency room of a tertiary university hospital. The two study periods were as follows: from February 2017 to January 2018 (before) and from May 2018 to April 2019 (after). The primary outcome was the length of hospital stay. The consent rates to perform cardiopulmonary resuscitation (CPR), intubation, continuous renal replacement therapy (CRRT), and intensive care unit (ICU) admission were the secondary outcomes.ResultsThe length of hospital stay decreased after the law was enforced from 4 to 2 days (p = 0.001). The rates of direct transfers to secondary hospitals and nursing hospitals increased from 8.2 to 21.2% (p = 0.001) and from 1.0 to 9.7%, respectively (p < 0.001). The consent rate for admission to the ICU decreased from 6.7 to 2.3% (p = 0.032). For CPR and CRRT, the consent rates decreased from 1.0 to 0.0% and from 13.9 to 8.8%, respectively, but the differences were not significant (p = 0.226 and p = 0.109, respectively).ConclusionAfter the enforcement of the Life Extension Medical Decision law, the length of stay in the tertiary university hospital decreased in patients who established their life-sustaining treatment plans in the emergency room. Moreover, the rate of consent for ICU admission decreased. (shrink)

Obtaining informed consent, an ethical obligation of nurses and other health care providers, occurs routinely when patients make health care decisions. The values underlying informed consent (promotion of patients’ well-being and respect for their self-determination) are embedded in the dominant American culture. Nurses who apply the USA’s cultural values of informed consent when caring for patients who come from other cultures encounter some ethical dilemmas. This descriptive study, conducted with Latino, Chinese and Anglo-American cancer patients in a (...) large, public, west-coast clinic, describes constraints on the informed consent process in a multicultural setting, including language barriers, the clinical environment, control in decision making, and conflicting desired health outcomes for health care providers and patients, and suggests some implications for nursing practice. (shrink)

Informed consent is an essential step in helping patients be aware of consequences of their treatment decisions. With surgery, it is vitally important for patients to understand the risks and benefits of the procedure and decide accordingly. We explored whether a written IC form was provided to patients; whether they read and signed it; whether they communicated orally with the physician; whether these communications influenced patient decisions. Adult postsurgical patients in nine general hospitals of Italy’s Campania Region were (...) interviewed via a structured questionnaire between the second and seventh day after the surgery at the end of the first surgical follow up visit. Physicians who were independent from the surgical team administered the questionnaire. The written IC form was given to 84.5% of those interviewed. All recipients of the form signed it, either personally or through a delegate; however, 13.9% did not know/remember having done so; 51.8% said that they read it thoroughly. Of those who reported to have read it, 90.9% judged it to be clear. Of those receiving the written consent form, 52.0% had gotten it the day before the surgery at the earliest 41.1% received it some hours or immediately before the procedure. The written IC form was explained to 65.6% of the patients, and 93.9% of them received further oral information that deemed understandable. Most attention was given to the diagnosis and the type of surgical procedure, which was communicated respectively to 92.8 and 88.2% of the patients. Almost one in two patients believed that the information provided some emotional relief, while 23.2% experienced increased anxiety. Younger patients and patients with higher levels of education were more likely to read the written IC form. The written IC form is not sufficient in assuring patients and making them fully aware of choices they made for their health; pre-operative information that was delivered orally better served the patients’ needs. To improve the quality of communication we suggest enhancing physicians’ communication skills and for them to use structured conversation to ensure that individuals are completely informed before undergoing their procedures. (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)

Very few attempts have been made to survey patient opinions, particularly regarding the use of residual biospecimens and health information in research, to clarify their values. We conducted a questionnaire survey that targeted outpatients of a university hospital to gauge their awareness levels and understand patient perspectives on research that uses these items. Few patients felt that obtaining individual consent for each research study was necessary. Most patients expressed the view that researchers should be obligated to inform (...) them about the research use of their items and be subject to self-directed rules. The research community should try to obtain “societal consent regarding an opt-out system” from the public. A salient value-sharing-based governance structure is necessary for obtaining public trust. (shrink)

Informed consent is the practical application of the principle of autonomy, and two of the five core features of informed consent are related to information. Researchers have reported on patients’ expressed needs for information, such as their stated desires for the quantity of and the source of information. A separate body of research has examined patients’ unexpressed needs for information from the perspective of cognitive psychology, such as the emotional tone and order of information. This article suggests that (...) the autonomy of patients is best served by meeting their expressed and unexpressed information needs in tandem. (shrink)

Background Ethically, informed consent regarding randomised controlled trials (RCTs) should be understandable to patients. The patients can then give free consent or decline to participate in a RCT. Little is known about what patients really understand in consultations about RCTs. Methods Cancer patients who were asked to participate in a randomised trial were surveyed using a semi-standardised interview developed by the authors. The interview addresses understanding, satisfaction and needs of the patients. The sample included eight patients who participated (...) in a trial and two who declined. The data were analysed on the basis of Mayring's qualitative analysis. Results Patients' understanding of informed consent was less developed than anticipated, especially concerning key elements such as randomisation, content and procedure of RCTs. Analysing the result about satisfaction of the patients, most of the patients described their consultations as hectic and without advance notice. Health limitations due to cancer played a decisive role. However, most of the patients perceived their physician to be sympathetic. Analysing the needs of patients, they ask for a clear informed consent consultation with enough time and adequate advance notice. Conclusion This study fills an important empirical research gap of what is ethically demanded in an RCT consultation and what is really understood by patients. The qualitative approach enabled us to obtain new results about cancer patients' understanding of informed consent, to clarify patients' needs and to develop new ideas to optimise the informed consent. (shrink)

A growing body of evidence suggests that the informed consent process, in which patients are warned about potential side effects of a treatment, can trigger a nocebo effect where expectations about side effects increase side effect occurrence. This has sparked an ethical debate about how much information patients ought to receive before a treatment while trying to balance the moral principles of patient autonomy and nonmaleficence. In keeping with the principle of patient autonomy, the opinion of patients (...) themselves in relation to how much information they want about side effects is of utmost relevance in this debate. The literature was searched to identify surveys assessing patient attitudes towards side effect information. Across a broad variety of patient populations, treatment types, and countries, the majority of patients wished to be fully informed of potential side effects, particularly in relation to frequent and severe side effects, while only a small minority wanted minimal or no information at all. Results from this review suggest that nocebo research should focus on methods of avoiding nocebo effects of informed consent while ensuring that patients are well-informed about potential side effects. (shrink)

Background: There is a significant discourse in the literature that opines that people who use illicit opiates are unable to provide informed consent due to withdrawal symptoms and cognitive impairment as a result of opiate use. Aims: This paper discusses the issues related to informed consent for this population. Ethical considerations: Ethical approval was obtained from both the local REB and the university. Written informed consent was obtained from all participants. Method: This was a qualitative interpretive descriptive (...) study. 22 participants were interviewed, including 18 nurses, 2 social workers and 2 clinic support workers. The findings were analyzed using thematic analysis, which is a way of systematically reducing the complexity of the information to arrive at generalized explanations. Results: The staff at the clinic were overwhelming clear in their judgment that people who use opiates can and should be able to participate in research and that their drug use is not a barrier to informed consent. Conclusions: It is important to involve people who use opiates in research. Protectionist concerns about this population may be overstated. Such concerns do not promote the interests of research participants. People who use heroin need to be able to tell their story. (shrink)

Aim: To assess, against a checklist of specific areas of required information and using standard published criteria, to what extent leaflets given before cataract surgery provided patients with enough information to give adequately informed consent.Method: Twelve ophthalmology departments in the West Midlands region were asked to submit the cataract information leaflets given to their patients at the preoperative assessment for analysis. Using criteria published by the General Medical Council, British Medical Association, and Medical Defence Union the leaflets were assessed (...) for their contribution to informed consent for patients considering cataract surgery. Leaflets were scored according to the information they provided on: diagnosis, prognosis, treatment options, costs to the patient, details about the procedure, its purpose, likely benefits, how to prepare for it, what to expect during and after the operation, and the common as well as serious complications that may occur. The readability of the information was also assessed.Results: All the units’ leaflets provided information on diagnosis, the lifestyle changes required postoperatively, and cost involved to the patient. Only five units had leaflets that mentioned the risks involved in cataract surgery. The other areas of information were covered by 50–75% of the leaflets. Fifty per cent of the leaflets included a diagram. The average SMOG readability score was high.Conclusion: Although present cataract information leaflets make some contribution to the process of informed consent, most do not address important areas outlined by the General Medical Council. Many of the areas of information that are required for informed consent could easily be covered, and should be borne in mind when designing patient information leaflets. Resources are available on the internet including toolkits, guides, and means of assessment for the production of patient information leaflets. (shrink)

This paper addresses the problem of ‘premature consent’. The term ‘premature consent’ denotes patient decisions that are: formulated prior to discussion with the appropriate healthcare professional ; based on information from unreliable sources ; and resolutely maintained despite the HCP having provided alternative reliable information. HCPs are not obliged to respect premature consent patients’ demands for unindicated treatments. But why? What is it that premature consent patients do or get wrong? Davis has argued that premature (...) consent patients are incompetent and misinformed. We argue that this view is not sustainable. A more plausible position asserts that premature consent threatens the integrity of the medical profession. We argue that this gives rise to a negative patient duty which premature consent patients fail to honour. We argue for a further positive duty of good faith engagement in shared decision-making. This implies willingness to potentially revise or justify one’s evaluative bases. Fundamentally, the problem with premature consent patients is that certain of their evaluative bases are not open to revision. They therefore fail in their duty to participate faithfully in the shared decision-making process. (shrink)

This chapter contains sections titled: The Standard Models of Decision‐making Capacity and Surrogate Decision‐making References Further reading.

This paper examines the case for an expanded interpretation of the concept of “material risk” such that it necessitates voluntary disclosure of physician inexperience with a specific medical procedure. Informed consent law in the United States, Canada, and most commonwealth jurisdictions has become a driver of standards of risk disclosure by physicians during the informed consent process. The legal standard of risk disclosure expected of a physician hinges on the interpretation of the entity called “material risk.” Any impairment (...) of the physician related to drug usage, disease, or alcohol which compounds the risk of a procedure is very likely to be considered material by a patient. This paper argues that physician inexperience is a factor that a reasonable patient would attach significance to and that it should therefore be viewed as a “material risk” requiring disclosure. (shrink)

The Canadian law governing informed consent was significantly influenced by the decision of its Supreme Court in Reibl v. Hughes, a case that involved a physician’s failure to warn the patient about the risk of stroke after carotid endarterectomy. Even though most Canadian plaintiffs after Reibl have continued to lose informed consent cases, it is likely that the judgement in this case has significantly influenced the manner in which physicians now approach the discussion of risk while obtaining (...) consent not only in Canada but also in several other jurisdictions.The development of informed consent law in the United States similarly became one of the drivers for change in physicians’ practices of information disclosure to their patients. The effect of Reibl on clinical practice is an outstanding example of the law’s positive influence on medical practice, especially in protecting patient autonomy during collaborative medical decision-making. (shrink)