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.

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)

BackgroundConsenting for retrospective medical records-based research (MR) and leftover tissue-based research (TR) continues to be controversial. Our objective was to survey Saudis attending outpatient clinics at a tertiary care hospital on their personal preference and perceptions of norm and current practice in relation to consenting for MR and TR.MethodsWe surveyed 528 Saudis attending clinics at a tertiary care hospital in Saudi Arabia to explore their preferences and perceptions of norm and current practice. The respondents selected one of 7 options from (...) each of 6 questionnaires.ResultsRespondents' mean (SD) age was 33 (11) years, 42% were males, 56% were patients, 84% had ≥ secondary school education, and 10% had previously volunteered for research. Respectively, 40% and 49% perceived that the norm is to conduct MR and TR without consent and 38% and 37% with general or proposal-specific consent; the rest objected to such research. There was significant difference in the distribution of choices according to health status (patients vs. companions) for MR (adjusted Kruskal-Wallis test P = 0.03) but not to age group, gender, education level, or previous participation in research (unadjusted P = 0.02 - 0.59). The distributions of perceptions of current practice and norm were similar (unadjusted Marginal Homogeneity test P = 0.44 for MR and P = 0.89 for TR), whereas the distributions of preferences and perceptions of norm were different (adjusted P = 0.09 for MR and P = 0.02 for TR). The distributions of perceptions of norm, preferences, and perceptions of current practice for MR were significantly different from those of TR (adjusted P < 0.009 for all).ConclusionsWe conclude that: 1) there is a considerable diversity among Saudi views regarding consenting for retrospective research which may be related to health status, 2) the distribution of perceptions of norm was similar to the distribution of perceptions of current practice but different from that of preferences, and 3) MR and TR are perceived differently in regard to consenting. (shrink)

It is generally held that doctors and researchers have an obligation to obtain informed consent. Over time there has been a move in relation to this obligation from a requirement to disclose information to a requirement to ensure that that information is understood. Whilst this change has been resisted, in this article I argue that both sides on this matter are mistaken. When investigating what information is needed for consent to be informed we might be trying to determine what information (...) a person would need in order to consent at all, or we might be trying to determine what information a person needs in order to make an informed choice about whether or not to consent. I argue that the obligation to ensure understanding only applies to information generated by the first type of enquiry; but that much of the information generally thought necessary in order for consent to be informed is only required if our concern is with the second type of enquiry. For this reason it is neither the case that doctors and researchers should ensure all the information they provide is understood, nor is it the case that their only obligation is to disclose it. (shrink)

Informed consent has passed through three stages. The first paternalistic stage lasted for many centuries: The doctor's diagnosis and healing arts were kept secret, and informing patients was regarded as professionally and ethically wrong. Second came the legal stage, when the right of patients to make informed decisions concerning their own treatment was imposed by the courts and reluctantly tolerated by medical professionals. The third informed consent stage emerged more recently: the general therapy stage. The therapeutic benefits of informed consent (...) have been well established, and informed consent is widely recognized as an important element in sound medical practice. When patients are effectively informed and can exert knowledgeable control over their own treatment decisions and therapy processes, that enhances recovery, strengthens the immune system, promotes better pain tolerance, prevents depression, and encourages patient cooperation and fortitude in treatment, rehabilitation, and preventative procedures. As the medical community has absorbed greater knowledge of this research, informed consent has been recognized as both ethically essential and therapeutically sound: the hallmark of the current general therapy stage of informed consent. (shrink)

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)

We review the current status of fuzzy-trace theory. The presentation is organized around five topics. First, theoretical ideas that immediately preceded the development of fuzzy-trace theory are sketched. Second, experimental findings that challenged those ideas are summarized. Third, the core assumptions that comprised the initial version of fuzzy-trace theory are described. Fourth, some modifications to those assumptions are explored that were necessitated by subsequent experimental findings. Fifth, four areas of experimentation are considered in which research under the aegis of fuzzy-trace (...) theory is in progress: suggestibility and false memories; judgment and decision making; the development of forgetting; and the development of retrieval. (shrink)

This book approaches ethical and legal issues in medicine from the patient's viewpoint and argues that many patients do not want the full burden of decision making that contemporary bioethics has thrust upon them.

Informed consent is a perennial topic in bioethics. It has given the field a place in clinical practice and the law and is often the starting point for introductory instruction in medical ethics. One would think that nearly everything has been said and done on this well-worn topic.

Informed consent is a perennial topic in bioethics. It has given the field a place in clinical practice and the law and is often the starting point for introductory instruction in medical ethics. One would think that nearly everything has been said and done on this well-worn topic.

Background Posthumous organ procurement is hindered by the consenting process. Several consenting systems have been proposed. There is limited information on public relative attitudes towards various consenting systems, especially in Middle Eastern/Islamic countries. Methods We surveyed 698 Saudi Adults attending outpatient clinics at a tertiary care hospital. Preference and perception of norm regarding consenting options for posthumous organ donation were explored. Participants ranked (1, most agreeable) the following, randomly-presented, options from 1 to 11: no-organ-donation, presumed consent, informed consent by donor-only, (...) informed consent by donor-or-surrogate, and mandatory choice; the last three options ± medical or financial incentive. Results Mean(SD) age was 32(9) year, 27% were males, 50% were patients’ companions, 60% had ≥ college education, and 20% and 32%, respectively, knew an organ donor or recipient. Mandated choice was among the top three choices for preference of 54% of respondents, with an overall median[25%,75%] ranking score of 3[2,6], and was preferred over donor-or-surrogate informed consent (4[2,7], p vs. 11[6,11], respectively, p = 0.002). Compared to females, males more perceived donor-or-surrogate informed consent as the norm (3[1,6] vs. 5[3,7], p vs. 8[4,9], p vs. 5[2,7], p Conclusions We conclude that: 1) most respondents were in favor of posthumous organ donation, 2) mandated choice system was the most preferred and presumed consent system was the least preferred, 3) there was no difference between preference and perception of norm in consenting systems ranking, and 4) financial (especially in females) and medical (especially in males) incentives reduced preference. (shrink)

Few issues affecting the therapeutic professions are as much discussed and as little understood as informed consent. This book, written from the combined perspectives of a physician, a lawyer, and a social scientist, is the first reference work to provide a concise overview of informed consent with particular emphasis on the practical issues facing professionals. After introducing the ethical theories behind this principle, the authors describe the history and current status of the law, detailing all legal requirements for practitioners. They (...) consider the problems faced when these theories and laws are applied in a clinical setting, offering suggestions for simplifying the interaction between doctor and patient and for making it clinically meaningful. The stress throughout is on ways to improve practitioners' performance in meeting these ethical and legal mandates. The book will be valuable for all professionals working in areas where issues of informed consent are likely to arise, including medicine, mental health care, social work, dentistry and law. (shrink)

We wanted to develop an informed consent document and process that would be culturally acceptable and comprehensible to women with little or no formal schooling in Lhasa, Tibet, where the illiteracy rate is high. To do this, we conducted initial, in-depth interviews to elicit Tibetan women’s notions of research. We incorporated the information gleaned from this qualitative research into a first draft of the informed consent document and pilot tested it, then made major modifications to the document based on the (...) results. A second round of pilot testing followed, which included recall testing for participants at the end of the review of the informed consent document. Finally, using the same document, we modified the process to ask questions after each major section of the document. Asking comprehension questions after each section resulted in statistically significant improvements in comprehension. This pilot study should be replicated with a larger, random sample of Tibetan women to see if such a simple, quick, low-cost approach will have equivalent results. (shrink)