If they are able to do so, consent is usually given by the patients themselves. It can be difficult to assess whether a patient has really understood the information provided and often little information is stored (see chapter Practical aspects). This leaves physicians in doubt as to whether their patient`s consent is truly informed. Consent based on partial information may be invalid, but this may go unnoticed by the patient and the attending physician. Since Montgomery, several attempts have been made to introduce a consent right to cases pending prior to the decision. Such an attempt in Scotland has so far failed.20 In two English cases, applications for consent could be added after Montgomery.21 22 Some cases have been allowed on the basis of Montgomery;23 We (AA) understand that others have settled before the litigation even commences or is concluded, as claims could not be answered in light of Montgomery. We (ESC) found that a significant proportion of obstetric neglect cases raised since Montgomery involve consent, in addition to standard complaints of substandard care. These issues are not always addressed, but the practice of obstetric processes has changed significantly, making professional training and clear guidelines an even higher priority. Shaw v. Kovac (October 2015)24 involved a patient who died in 2007 as a result of transaortic valve implantation, which was still in clinical trials at the time and was not fully approved. The plaintiff`s argument was to use Montgomery to establish a claim for damages for loss of life without informed consent. The court dismissed this request on the basis that Montgomery did not create a right to informed consent as a separate plea, but merely set a new legal standard for disclosure. Note that you can send to the @free.kindle.com or @kindle.com variant.
« @free.kindle.com » emails are free, but can only be sent to your device when it`s connected to Wi-Fi. « @kindle.com » emails can be sent even when you are not connected to Wi-Fi, but note that service charges apply. Informed consent is a process of obtaining permission before performing a health procedure on an individual or disclosing personal information. A health care provider may ask a patient to consent to treatment before offering it, or a clinical researcher may ask a research participant before enrolling that person in a clinical trial. Informed consent is based on guidelines in the fields of medical ethics and research ethics. The practice of obtaining informed consent has its history in medicine and biomedical research and derives its importance from it. Discussions about disclosure and justified non-disclosure have played an important role in the history of medical ethics, but the term « informed consent » did not appear until the 1950s. A serious discussion about the meaning and ethics of informed consent did not begin until around 1972 in medicine, research, law and philosophy. 1. Habiba MA (2000) Investigation of consent within the patient-doctor relationship. Zeitschrift für medizinische Ethik 26: 183-872. The Oxford Dictionary of new English, Oxford.
Oxford University Press, 19983. GMC (1998) Seeking patients` consent: The ethical considerations, General Medical Council, Londres4. King J (1986) Consentement éclairé : examen des preuves empiriques. Bulletin de l`Institut d`éthique médicale supp 3: 1-175. Kour NW, Rauff A (1992) Consentement éclairé – perspective historique et point de vue d`un clinicien. Singapore Medical Journal 33:44-466. Nelson-Marten P, Rich RA (1999) A historical perspective of informed consent in clinical practice and research. Oncological Nursing 15:81-87. Dalla-Vorgia P, Lascaratos J, Skiadas P et coll. (2001) Is Consent in Medicine a Modern Era Concept Only? Journal of Medical Ethics 27: 59-618. Gillon R.
Medical ethics: four principles plus consideration of scope. BMJ 1994; 309:184-8
9. MRA Guidelines (2007): www.mhra.gov.uk; Retrieved 01.06.200810. Re C (refusal of treatment in adults) [1994] 1WLR 29011. Samata A, Samata B (2006) Advance Directives, Best Interest and Clinical Judgment: Quicksand at the End of Life. Clinical Medicine 6: 274-7812. Re MB (one adult: medical treatment) [1997] 2 FLR 42613. On B (consent to treatment: capacity) [2002] EWCH 42914. Mental Performance Act, 2005.
The Inpatient Office, 200515. Mental Health Act 1983. Public Health (Disease Control) Act 198316 1984 on the Office of Inpatients, 1984. The hospital office, 198417. Crook A (2007) TB patient under guard. Manchester Evening News 10.09.200718. GMC (2004) Confidentialité: Protection et fourniture d’informations, General Medical Council, Londres19. Loi de 2005 sur la performance mentale.
Le bureau fixe, 200520. Lecouturier J, Rodgers H, Ford GA, et coll. (2008) Clinical research without consent in adults in the emergency setting: a review of patient and public views. BMC Medical Ethics 9:921. GMC (2008) Withholding and Withdrawal of Life-Prolonging Treatments: Good Practice in Decision Making, General Medical Council, Londres22. Re (Burke) v General Medical Council (défendeur) and Disability Rights Commission (partie intéressée) et Official Solicitor [2004] EWHC 187923. Human Rights Act (1998). The Stationary Office, 199824.
Airedale NHS Trust v Bland [1993] A.C. 78925. Graber MA, Tansey JF (2005) Autonomie, consentement et limitation des coûts des soins de santé. Journal of Medical Ethics 31: 424-42626. Howard JM, DeMets D (1981) How informed is informed consent: the BHAT experience. Controlled Clinical Trials 2: 287-30327. Fortun P, West J, Chalkley L, Shonde A, Hawkey C (2008) Recall of informed consent information by healthy volunteers in clinical trials. QJM, an international journal of printed medicine, available online at: qjmed.oxfordjournals.org/cgi/content/abstract/hc28. Flory J, Emanuel E (2004) Interventions to improve research participants` understanding of informed consent to research. Journal of the American Medical Association 292:1593-1601 Informed consent requires the ability to understand and weigh information. Several studies have addressed the issue of understanding and storing the information provided.
Even in a research setting where strict consent measures are applied, serious shortcomings were found: in a randomized drug trial, 44% of participants did not know they had been randomly assigned to a treatment or placebo.26 A capsule endoscopy study recruited healthy subjects, of which 90% had a university education and 60% were medical students. Nevertheless, only about 20% of important information (drugs used, potential risks) provided during consent was fully accessed.27 These examples show that most patients or research participants are not able to understand and/or retrieve the information provided by standard consent procedures. Nevertheless, treating physicians and researchers had treated or included patients on the basis of this « informed » consent. Most authors describe consent as a relatively new principle in medicine.4-6 However, this is incorrect, as even Plato and Hippocrates used consent in their medical practice.7 Although the above regulations are clearly established by law, a physician may encounter situations where no clear instruction is given. If a patient confesses to a crime or planned crime to a physician, it is up to the patient to decide whether or not to share that information with the police. This decision requires careful consideration of whether the right to consent to the disclosure of information is more important than the public`s right to protection. The GMC guidelines (Confidentiality: Protecting and Providing Information, 2004) provide general advice on disclosure, but leave the final decision to the physician.18 « We are pleased that the Court has endorsed the approach advocated in our document Consent, Good Medical Practices and Consent: Patients and Physicians Make Decisions Together, which makes it clear that physicians should provide person-centred care. They need to work in partnership with their patients, listen to their views and give them the information they want and need to make decisions. The situation is similar in research involving human beings. There is little evidence that, until recently, informed consent requirements have had a significant impact on investigator practice. In the nineteenth century, for example, it was common for research on slaves and servants to be conducted without the consent or consent of the subject. In contrast, the yellow fever experiments conducted by U.S.
Army surgeon Walter Reed at the turn of the century involved formal procedures to obtain approval from potential subjects. While these procedures are deficient in relation to contemporary standards of disclosure and consent, they recognize the right of individuals to refuse or authorize participation in research. The extent to which this principle was enshrined in research ethics in the mid-twentieth century is historically controversial. Although it has often been reported that obtaining informed and voluntary consent is essential to research ethics and common in biomedical investigations, it is not clear whether obtaining consent from researchers is a common practice. Anecdotal evidence suggests that biomedical research was often conducted without sufficient consent, at least in the 1960s. The doctrine of informed consent is generally implemented through good health practices: preoperative conversations with patients and the use of medical informed consent in hospitals. However, the use of a signed form should not undermine the doctrine by giving the patient the opportunity to weigh and respond to the risk. In one British case, a doctor performing routine surgery on a woman noticed that she had cancerous tissue in her uterus.
