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Consent
Kinds of Consent Terms modified by Consent Selected AbstractsMODULE TWO: INFORMED CONSENTDEVELOPING WORLD BIOETHICS, Issue 1 2005PAMELA ANDANDA ABSTRACT The objective of this module is to familiarise you with the concept of informed consent, its ethical basis, its elements, and typical problems that are encountered even by the most well intentioned researchers when trying to achieve genuine informed consent. [source] CONSENT, COMMODIFICATION AND BENEFIT-SHARING IN GENETIC RESEARCH1DEVELOPING WORLD BIOETHICS, Issue 2 2004DONNA DICKENSON ABSTRACT The global value of the biotechnology industry is now estimated at 17 billion dollars, with over 1300 firms involved as of the year 2000.2 It has been said that ,What we are witnessing is nothing less than a new kind of gold rush, and the territory is the body.' As in previous gold rushes, prospectors are flooding into unexplored and ,wide open' territories from all over the world, with possible ramifications for exploitation of Third World populations. These territories are also the Wild West of bioethics insofar as the law has very little hold on them: existing medical and patent law, such as the Moore and Chakrabarty cases, exert little control over powerful economic interests in both the United States and Europe. In the absence of a unified and consistent law on property in the body, the focus is increasingly on refining the consent approach to rights in human tissue and the human genome, with sensitive and promising developments from the Human Genetics Commission and the Department for International Development consultation on intellectual property. These developments incorporate the views of vulnerable genetic communities such as Native Americans or some Third World populations, and should be welcomed because they recognise the power imbalance between such groups and First World researchers or firms. However, they also highlight the continued tension about what is really wrong with commodifying human tissue or the human genome. Where's the injustice, and can it be solved by a more sophisticated consent procedure? [source] WITHOUT CONSENT: PRINCIPLES OF JUSTIFIED ACQUISITION AND DUTY-IMPOSING POWERSTHE PHILOSOPHICAL QUARTERLY, Issue 237 2009Hugh Breakey A controversy in political philosophy and applied ethics concerns the validity of duty-imposing powers, that is, rights entitling one person to impose new duties on others without their consent. Many philosophers have criticized as unplausible any such moral right, in particular that of appropriating private property unilaterally. Some, finding duty-imposing powers weird, unfamiliar or baseless, have argued that principles of justified acquisition should be rejected; others have required them to satisfy exacting criteria. I investigate the many ways in which we regularly impose duties on one another without prior consent. I show that doing so is not weird, and I offer criteria which demarcate the reasonable from the worrisome aspects of duty-imposing powers. [source] IS INFORMED CONSENT IN CARDIAC SURGERY AND PERCUTANEOUS CORONARY INTERVENTION ACHIEVABLE?ANZ JOURNAL OF SURGERY, Issue 7 2007Marco E. Larobina Background: Medical and legal published work regularly discusses informed consent and patient autonomy before medical interventions. Recent discussions have suggested that Cardiothoracic surgeons' risk adjusted mortality data should be published to facilitate the informed consent process. However, as to which aspects of medicine, procedures and the associated risks patients understand is unknown. It is also unclear how well the medical profession understands the concepts of informed consent and medical negligence. The aims of this study were to evaluate patients undergoing coronary artery bypass surgery (CABG) and percutaneous coronary intervention (PCI) to assess their understanding of the risks of interventions and baseline level of understanding of medical concepts and to evaluate the medical staff's understanding of medical negligence and informed consent. Methods: Patients undergoing CABG or PCI at a tertiary hospital were interviewed with questionnaires focusing on the consent process, the patient's understanding of CABG or PCI and associated risks and understanding of medical concepts. Medical staff were questioned on the process of obtaining consent and understanding of medicolegal concepts. Results: Fifty CABG patients, 40 PCI patients and 40 medical staff were interviewed over a 6-month period. No patient identified any of the explained risks as a reason to reconsider having CABG or PCI, but 80% of patients wanted to be informed of all risks of surgery. 80% of patients considered doctors obligated to discuss all risks of surgery. One patient (2%) expressed concern at the prospect of a trainee surgeon carrying out the operation. Stroke (40%) rather than mortality (10%) were the important concerns in patients undergoing CABG and PCI. The purpose of interventions was only partially understood by both groups; PCI patients clearly underestimated the subsequent need for repeat PCI or CABG. Knowledge of medical concepts was poor in both groups: less than 50% of patients understood the cause or consequence of an AMI or stroke and less than 20% of patients correctly identified the ratio equal to 0.5%. One doctor (2.5%) correctly identified the four elements of negligence, eight (20%) the meaning of material risk and four (10%) the meaning of causation. Thirty doctors (75%) believed that all complications of a procedure needed to be explained for informed consent. Less than 10% could recognize landmark legal cases. Conclusion: Patients undergoing both CABG and PCI have a poor understanding of their disease, their intervention, and its complications making the attaining of true informed consent difficult, despite their desire to be informed of all risks. PCI patients particularly were highly optimistic regarding the need for reintervention over time, which requires specific attention during the consent process. Medical staff showed a poor knowledge of the concepts of material risk and medical negligence requiring much improved education of both junior doctors and specialists. [source] Informed Consent and Clinician Accountability by STEVE CLARKE AND JUSTIN OAKLEYDERMATOLOGIC SURGERY, Issue 7 2009WILLIAM P. COLEMAN III MD No abstract is available for this article. [source] Informed Consent and Ethical Issues in Military Medical ResearchACADEMIC EMERGENCY MEDICINE, Issue 11 2005John McManus MD Abstract Informed consent in military research shares many of the same fundamental principles and regulations that govern civilian biomedical research. In fact, much of modern research ethics is grounded in events that occurred in the context of war or government-sponsored research. Despite these similarities and common origins, research in the military has additional requirements designed to preserve service members' informed consent rights. The special nature of the superior,subordinate relationship in the military necessitates careful protections to avoid perceptions of coercion or undue influence on a military subject. Additionally, current legal and regulatory requirements for advanced informed consent significantly restrict the flexibility of the military to conduct research using waiver of consent. This has implications on the ability of the nation to develop effective medical treatments for the global war on terrorism. Nevertheless, work is under way to realign defense research policy with the norms of civilian biomedical practice. Future directions include the adoption of waivers for military emergency research, and the cautious introduction of human subject studies on the battlefield. This paper discusses historical background, regulatory differences, and concerns and challenges of some of these regulatory differences for research personnel that apply to informed consent and waiver of said informed consent for emergency research conducted by the U.S. military. [source] Consent for Emergency Physician,Performed EchocardiographyACADEMIC EMERGENCY MEDICINE, Issue 10 2002Peter J. Mariani MD No abstract is available for this article. [source] French adaptation and preliminary validation of a questionnaire to evaluate understanding of informed consent documents in phase I biomedical researchFUNDAMENTAL & CLINICAL PHARMACOLOGY, Issue 1 2006Adeline Paris Abstract The content of informed consent documents (ICD) is a crucial element in the process of providing information to participants in biomedical research. Clear comprehension of the information, i.e. the ability to understand its meaning and its consequences, is of utmost importance. The objective of this study was to describe the different steps in the French adaptation and preliminary validation of the Qualité de Compréhension des Formulaires d'information et de consentement (QCFic) questionnaire (http://www.lyon.inserm.fr/cic-grenoble) based on the American Quality of Informed Consent (QuIC) questionnaire. Adaptation and preliminary validation of the QuIC for use in France was composed of five principal steps: translation, scientific validation, lexical validation, edition of gold-standard answers and a pilot study. Each stage was conducted by independent groups of experts, under the coordination of the study board. Thirteen questions were added and one was suppressed. Two steps were required for the scientific validation and for lexical validation, 21 modifications were proposed. Relative to gold-standard answers, the three experts gave the same answer for 24 questions and for nine other questions, two of the three gave identical answers, which were validated by the study board. Results of a pilot study showed a global QCFic score of 88.99 (84.13,90.92) and no specific commentary was made about the content of the questions, so no more modification needed to be made. A preliminary validated French questionnaire, the QCFic, is now available to evaluate the quality of an informed consent document in phase I clinical trials. It is quick and easy to use. [source] Consent as Resistance, Resistance as Consent: Re-Reading Part-Time Professionals' Acceptance of Their Marginal PositionsGENDER, WORK & ORGANISATION, Issue 6 2006Penny Dick The part-time employee has traditionally occupied a marginal position in organizations. The recent increase in the numbers of part-time professionals, however, has been seen as offering potential for the status of the part-time employee to improve. Evidence to date suggests that this improvement has not taken place and that the part-time professional is also marginalized. Interestingly, research suggests that part-time professionals may not experience their subordinate positions as problematic, often believing that the drawbacks of reduced hours working are a legitimate consequence of their ,choice' to work part-time. Such ,choices' are frequently attributed to part-timers' prioritization of non-work activities. In this article, using a Foucauldian approach to identity, we argue that choices need to be understood as both situated in time and space and constituted through discourse. Using these ideas we provide a re-reading of part-timers' consent to their marginalization, arguing that their responses to their positions at work can also be understood as resistance to some of the dominant norms of professionalism. We set out the conditions that might be implicated in translating subjective resistance into more material actions. [source] Consenting Adults: The Principle of Consent and Northern Ireland's Constitutional FutureGOVERNMENT AND OPPOSITION, Issue 4 2001Roger Mac Ginty First page of article [source] A Puzzle about Consent in Research and in PracticeJOURNAL OF APPLIED PHILOSOPHY, Issue 3 2010ERIC CHWANG abstract In this paper, I will examine a puzzling discrepancy between the way clinicians are allowed to treat their patients and the way researchers are allowed to treat their subjects: in certain cases, researchers are legally required to disclose quite a bit more information when obtaining consent from prospective subjects than clinicians are when obtaining consent from prospective patients. I will argue that the proper resolution of this puzzling discrepancy must appeal to a pragmatic criterion of disclosure for informed consent: that what needs to be disclosed in order for consent to be valid depends on what the patient/subject needs to know in order to make a decision. I will then use this pragmatic criterion of disclosure to argue that when obtaining consent researchers should be permitted to omit the same information clinicians are, given certain qualifications. I will also examine how this puzzle forces us to confront some perhaps surprising truths about valid consent. My broader aim in this paper is to examine, not so much the puzzle itself, but rather what this particular puzzle can teach us about more theoretical issues surrounding informed consent. [source] Informed Consent: Autonomy and Self-OwnershipJOURNAL OF APPLIED PHILOSOPHY, Issue 1 2008DAVID ARCHARD abstract Using the example of an unconsented mouth swab I criticise the view that an action of this kind taken in itself is wrongful in respect of its being a violation of autonomy. This is so much inasmuch as autonomy merits respect only with regard to ,critical life choices'. I consider the view that such an action is nevertheless harmful or risks serious harm. I also respond to two possible suggestions: that the action is of a kind that violates autonomy; and, that the class of such actions violates autonomy. I suggest that the action is wrongful in as much as it is a bodily trespass. I consider, and criticise, two ways of understanding how morally I stand to my own body: as owner and as sovereign. In respect of the latter I consider Arthur Ripstein's recent defence of a sovereignty principle. Finally I criticise an attempt by Joel Feinberg to explain bodily trespass in terms of personal autonomy. [source] Parents' Consent to the Post-mortem Removal and Retention of OrgansJOURNAL OF APPLIED PHILOSOPHY, Issue 3 2001Dudley Knowles First page of article [source] The challenges for nurses communicating with and gaining valid consent from adults with intellectual disabilities within the accident and emergency care serviceJOURNAL OF CLINICAL NURSING, Issue 9 2007Margaret Sowney MSc Aim., This paper reports the challenges experienced by nurses within accident and emergency departments in communicating with and gaining valid consent from adults with intellectual disabilities. Background., Consent is both a legal requirement and an ethical principle required to be obtained by health-care professionals, prior to the start of any examination, treatment and/or care. Central to the process of seeking consent is effective communication. However, evidence shows that people with intellectual disabilities are not viewed by professionals within acute general hospitals as a vital source of information, neither are they often communicated with directly, nor involved in discussions or decisions about their health care and are frequently not directly asked for their consent. Method., A purposive sample of nurses working within the accident and emergency departments of five general hospitals was recruited to participate in this qualitative study. Data were collected from five focus groups. Findings., Effective communication was identified as the most challenging aspect in caring for adults with intellectual disabilities within this environment, having an impact on the assessment of needs, informing patients of their health status and seeking valid consent. Conclusions., Fundamental to the provision of quality care are the concepts communication, choice and control. However, these issues are perceived to be more challenging in the provision of health care to people with intellectual disabilities. Communication and consent, therefore, require further consideration within the educational and clinical areas to strengthen nurses' competence in caring for people with intellectual disabilities, with an emphasis and understanding that choice and control are key principles for all people, being central aspects to the provision of an inclusive service for people with intellectual disabilities. Relevance to clinical practice., All nurses need to have a greater awareness of learning disability, how to increase opportunities for effective communication and be very familiar with the issue and guidelines relating to consent, to ensure that people with learning disabilities have choice, control and are more active in decision making regarding their health. [source] Informed Consent and Issues Surrounding Lack of Capacity vs.JOURNAL OF FORENSIC NURSING, Issue 1 2006Incompetence Hospital personnel are often challenged to manage circumstances surrounding a patient's lack of capacity, incompetence, and advance directives. These situations result in undue stress to staff and can be somewhat alleviated by having clear communicaton on policy and law that affect decision-making processes. [source] Consent for direct access endoscopyJOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Issue 12 2007Anthony C Clarke [source] Survey of consent practices for inpatient colonoscopy and endoscopic retrograde cholangiopancreatography at a tertiary referral centerJOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Issue 8 2006Cynthia H Seow Abstract Background:, The purpose of the present paper was to determine informed consent practices for inpatient, open-access colonoscopy and endoscopic retrograde cholangiopancreatography (ERCP) at a tertiary referral center. Methods:, A two-part prospective study incorporating (i) an audit of consent practices for colonoscopy and ERCP; and (ii) a questionnaire directed at gastroenterologists and interns regarding information imparted to patients in the process of acquiring informed consent, was undertaken at Sir Charles Gairdner Hospital, Western Australia. Study subjects consisted of inpatients undergoing open-access colonoscopy and/or ERCP at the study center commencing May 2003; and gastroenterologists and interns at the study center. Results:, Written consent was obtained by junior medical staff in 89% of cases. Response rates for the questionnaire was 100% from interns, and 91% from gastroenterologists. Of interns surveyed, 93% had witnessed a colonoscopy, and 59% had witnessed an ERCP. For 12% of interns, colonoscopic bleeding or perforation were not always mentioned. Colonoscopy failure rate and perforation were overestimated by 51% and 63% of interns, respectively. Only 56% of interns always mentioned pancreatitis as a complication of ERCP. The rate of post-ERCP pancreatitis was overestimated by 25% of interns. Only 40% of gastroenterologists always provided additional information to patients whose consent was obtained by someone else. Written material was not routinely provided for patients. Consent was usually obtained on the day of the procedure. Conclusions:, Written consent for inpatients undergoing open-access colonoscopy and ERCP is rarely obtained by the proceduralist. There is substantial variability in the information provided to patients. Guidelines are required to ensure best practice in this area. [source] Obstacles in large-scale epidemiological assessment of sensory impairments in a Dutch population with intellectual disabilitiesJOURNAL OF INTELLECTUAL DISABILITY RESEARCH, Issue 8 2004H. Evenhuis Abstract Background A population-based epidemiological study on visual and hearing impairment was planned in a random sample of 2100 clients, drawn from a base population of 9012 users of Dutch residential and day-care intellectual disability (ID) services with the whole range of IDs. Stratification was applied for age 50 years and over and Down syndrome. Visual and hearing functions were assessed according to a standardized protocol, in cooperation with regular ophthalmologists and regional audiological centres. Anticipated obstacles in sample collection, random inclusion, informed consent, expertise of investigators, time and costs were eliminated by a careful preparation. However, inclusion and participation were incomplete. Method In a descriptive retrospective design, we collected data from our study files on inclusion and participation as well as reasons for non-participation, to identify unanticipated obstacles for this kind of research. Results Consent was obtained for 1660 clients, and 1598 clients participated in the data collection (76% of intended sample of 2100). Inclusion and participation rates were especially lower in community-based care organizations, resulting in unintentional skewing of the sample towards more severe levels of ID. Complete and reliable data to diagnose visual impairment were obtained for 1358/1598 (85%) and to diagnose hearing impairment for 1237/1598 participants (77%). Unanticipated obstacles had to do with the quality of coordination within care organizations, with characteristics of screening methods, and with collaboration with the regular health care system. Assessments of visual function were more easy to organize than were those of hearing. Based on our current experience, practical recommendations are given for future multicentre research, especially in community-based settings. [source] Consent for the Aegus: When black is whiteJOURNAL OF MEDICAL IMAGING AND RADIATION ONCOLOGY, Issue 3 2004P Graham No abstract is available for this article. [source] The Principle of Assumed Consent: The Ethics of GatekeepingJOURNAL OF PHILOSOPHY OF EDUCATION, Issue 3 2001Roger Homan The obligation to inform and obtain the consent of human subjects is axiomatic in social and medical research. Yet educational researchers are often reluctant to inform their subjects: class teachers and headteachers, for example, are often used as gatekeepers, and investigators sometimes do not so much seek consent as assume it. This chapter discusses the principle of informed consent, in particular that of children. It proposes guidelines for gatekeepers who may be called upon to authorise research and to grant to investigators access to children in their care. [source] Consent and long-term neuroleptic treatmentJOURNAL OF PSYCHIATRIC & MENTAL HEALTH NURSING, Issue 4 2002N. R. Harris phd bsc(hons) rmn The involvement of clients in the process of developing their care and treatment package is well established. If a genuine collaboration in treatment is achieved one of the fundamental bases of this process lies with ,informed consent'. Neuroleptic medication forms the basis of relapse prevention treatment for people suffering from schizophrenia with non-adherence to treatment seen as the largest cause of relapse. This paper reviews the complex and difficult issues in obtaining informed consent for this client group from within the context of the nurse's role and the problems that arise as a consequence of the blurring of professional boundaries. Throughout the paper reference is made to the expectations made by the UKCC, which provides clarification of nurses' practice in this area. [source] Active Parent Consent for Health Surveys With Urban Middle School Students: Processes and Outcomes,JOURNAL OF SCHOOL HEALTH, Issue 2 2010Molly Secor-Turner PhD BACKGROUND: To achieve high participation rates and a representative sample, active parent consent procedures require a significant investment of study resources. The purpose of this article is to describe processes and outcomes of utilizing active parent consent procedures with sixth-grade students from urban, ethnically diverse, economically disadvantaged K-8 public schools involved in an evaluation of a middle school service-learning program. METHODS: As part of the evaluation of the Lead Peace-Plus service-learning program, active parent consent was obtained for participation in school-based health surveys conducted with sixth graders in 3 schools. To achieve acceptable rates of parent permission, we employed multiple procedures including regular communication with school staff, incentives for involved schools and teachers, a multipronged approach for reaching parents, and direct encouragement of students to return forms through repeated classroom visits, individual and classroom incentives. We used Fisher's exact tests to compare selected characteristics among students whose parents weren't reached, those whose parents refused, and those whose parents consented to survey participation. RESULTS: We achieved a parent response rate of 94.6% among sixth-grade students. No significant differences in student gender, race/ethnicity, school, or free/reduced lunch status were identified across parent consent status groups. Rates of absenteeism were significantly higher (p = .03) among students whose parents weren't reached compared to other groups. CONCLUSIONS: Employing a multifaceted active parent consent campaign can result in high rates of parental response with limited sampling bias among an urban, ethnically diverse and economically disadvantaged group of middle school students. [source] Judicial Waivers of Parental Consent for Abortion: Tennessee's Troubles Putting Policy into Practice,LAW & POLICY, Issue 3 2005HELENA SILVERSTEIN According to the U.S. Supreme Court, minors seeking abortions are entitled to petition for relief from state-mandated parental consent. To facilitate the actualization of this right, Tennessee included procedural mechanisms that go beyond those in effect in most states in its parental consent statute. This paper examines whether these additional mechanisms allow Tennessee to succeed where other states have failed. Our findings indicate that these mechanisms mitigate to some extent the sort of implementation failure observed in other states. However, the magnitude of this mitigation is not sufficient to establish that parental consent statutes can be implemented in accordance with Supreme Court requirements. [source] Communication and Miscommunication in Informed Consent to ResearchMEDICAL ANTHROPOLOGY QUARTERLY, Issue 4 2004PAMELA SANKAR Biomedical ethics require that research subjects be aware that the drugs they take or procedures they undergo are designed to fulfill the conditions of the experiment and not to benefit a subject's health. This apparently straightforward distinction between research and treatment is a source of much controversy and misunderstanding. Ethicists have labeled this problem the "therapeutic misconception." This misconception and, more broadly, informed consent have been studied extensively. Nonetheless, the therapeutic misconception persists among research subjects. This paper argues that one factor overlooked in the persistence of the therapeutic misconception is the effect of the theoretical paradigm that guides the practice and analysis of informed consent. The paradigm poses an idealized model of communication that ignores social context. This paper examines informed consent practices associated with a cancer research trial to demonstrate an alternative approach to studying informed consent to research. Through analysis of informed consent session transcripts, it demonstrates the importance of taking account of not only what is said, but how and by whom it is said. [source] Consent: what are the issues for training postgraduate doctors?MEDICAL EDUCATION, Issue 7 2008Jennifer Heathcote No abstract is available for this article. [source] The ethics of reusing archived tissue for researchNEUROPATHOLOGY & APPLIED NEUROBIOLOGY, Issue 5 2000R. Ashcroft Pathologists have been establishing archives of human organs and tissue for research use for many years now. Controversy has arisen recently over these collections, particularly with regard to the right of patients or relatives to consent to removal and retention of tissue, genetic research using stored tissue samples, and commercial exploitation of tissue collections and genetic material. This paper discusses the ethics of reusing existing archives of tissue. New archives are established under much more stringent conditions than in the past. What rules should apply to existing archives? Guidelines to regulate such use are useful, but face serious difficulties in balancing the variety of public and private interests relating to tissue banking. Consent cannot be obtained retrospectively, but public trust can be established by open acknowledgement of the evolution of ethical standards and strict adherence to current best practice. Guidelines and standards vary from country to country, but ethical principles should not. The implications of this view for pathologists worldwide are discussed. [source] Legislation as Strategy to Intimidate, Silence and Manipulate ConsentNORTH AMERICAN DIALOGUE (ELECTRONIC), Issue 2 2004Alisse Waterston [source] Rapes Without Rapists: Consent and Reasonable MistakeNOUS, Issue 2001Douglas N. Husak First page of article [source] Prudence and Constitutional RightsAMERICAN JOURNAL OF ECONOMICS AND SOCIOLOGY, Issue 1 2004Edward F. McClennen ABSTRACT. In The Calculus of Consent, Buchanan and Tullock argue for institutional safeguards to ensure maximal benefit for all members of a community against the potential tyranny of the majority. I extend this idea by introducing prudential concerns and argue that they ought to be factored into the decision making that constructs such safeguards. Specifically, I see the safeguarding of prudential concerns for all members of society as a matter that should be secured from the random fate of the political process by constitutional provisions. [source] Comments on McClennen's "Prudence and Constitutional Rights"AMERICAN JOURNAL OF ECONOMICS AND SOCIOLOGY, Issue 1 2004Or How Do You Turn Words Into Action? ABSTRACT. In The Calculus of Consent, Buchanan and Tullock argue, among other things, that institutional safeguards are required to ensure maximal benefit for all members of a community against the potential tyranny of the majority. McClennen extends this idea by introducing prudential concerns and argues that they ought to be factored into the decision making that constructs such safeguards. Specifically, McClennen sees the safeguarding of prudential concerns for all members of society as a matter of distribution that should be secured from the random fate of the political process through constitutional means. His method for ensuring the constitutional mandate is to place the responsibility for achieving this result in the hands of the judiciary. I argue that there are two problems with his solution: (1) it is ahistorical; and (2) it assumes the judiciary is without politics. [source] | |||||||||||||||||||||||||||||||||||||||||||