Informed consent and inadequate medical information.
Explore the source record for details and available documents.
Cause of Death↗
SEARCH · Search PubMed
Results for “informed consent”
Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.
Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.
[Information cards and informed consent. Proposal of 12 information cards for plastic and aesthetic surgery].
Obligation to deliver full information and obtaining enlightened assent are now, for the whole French practitioner, a necessary preliminary to each operation. Henceforth, in case of suit, the practitioner must prove the reality and the quality of preoperative information. The National Medical French Council (CNOM) called scientific societies attention to propose to their members some index standard cards, corresponding to main medical and surgical records. The National Agency for Accreditation and Evaluation in Health (Anaes) defined the main characteristics of these documents. The authors propose twelve information cards corresponding to the most currently operations of plastic and aesthetic surgery. They will being clear and simple, with a large agreement, strictly informative and yearly up to date. They have the label and therefore the scientific guaranty of French Society of Plastic Reconstructive and Aesthetic Surgery.
Ethics, Medical↗
Informed consent in the (mis)information age.
Explore the source record for details and available documents.
Female↗
Informed consent will require more informing.
Explore the source record for details and available documents.
Clinical Competence↗
The emerging debate over the shape of informed consent: can the doctrine bear the weight?
Informed consent has traditionally focused on treatment-related issues. However, since the mid-1990s, courts have debated whether informed consent should be stretched to accommodate other concerns. For example, some courts have considered whether economic limitations on treatment availability must be made known to a patient as part of the informed consent process. Other courts have considered whether characteristics of the treatment provider (e.g., experience with a particular procedure) should be disclosed as part of informed consent. Consideration of these issues turns in large part on whether the information in question would be considered "material" to a decision to accept or reject treatment. This article discusses these developments, and suggests that expanding informed consent beyond treatment-related issues in some circumstances may erode trust in the clinical relationship, thus undermining one of the central values of the informed consent doctrine. It concludes with some suggestions on how research could inform this debate.
Disclosure↗
[Informed consent in phase I trial].
Informed consent in phase I trials involves very difficult problems related to experimental factors of the phase I trial, a toxicity study conducted in human cancer patients. However, this is the first clinical step in new drug development, and patients must participate in phase I only when there is full disclosure of correct trial information. Disclosure should include the purpose of the trial, the procedure, and the risk/benefits related to the trial. Informing the patient of the cancer diagnosis and the extent of disease is also necessary before entry into a phase I trial. Although phase I trials are conducted with the precious contribution of patients, it is important that informed consent should not become a type of legal contract. Informed consent in phase I trials is an essential process, just like a roundtable discussion of patient and physician before fighting an incurable cancer.
Antineoplastic Agents↗
[Treatment with human tetanus immunoglobulins in the Emergency Department. Effects of informed consent].
BACKGROUND: The impact of informed consent to tetanus prophylaxis with human immunoglobulins on patients treated in the Emergency Department has been evaluated. METHODS: Tetanus vaccination history was investigated in 1435 patients in 1995 and in 1300 patients in 1996 with post-traumatic skin lesions. RESULTS: The study has shown that in 1995, 55% and in 1996 49.5% of the total patients studied had not received vaccine for tetanus or boosters for over 10 years. These patients had been proposed the treatment with human tetanus immunoglobulins (TIG). The research was performed comparing the consent obtained before (from 17/5 to 15/7/1995) and after (from 17/5 to 15/7/1996) the introduction of the informed consent. The survey was divided into 15-day periods. In 1995 prophylaxis with human immunoglobulins was refused by 42 patients out of 831 (5%) while, in the following year, by 284 out of 641 (44.3%). Every period examined has shown highly significant differences (p < 0.000). CONCLUSIONS: Informing the patients that tetanus prophylaxis with human immunoglobulins can expose them to the risk, at present remote, of transmission of viral infections, has caused a heavy rise of denials to the suggestion of treatment with human immunoglobulins. The amount of the treated patients and the time that was devoted to informed consent would make Emergency Department one of the main places for effective and widespread tetanus prophylaxis. However a greater activity of outer structures would also be hoped for.
Adolescent↗
The competency quagmire: clarification of the nursing perspective concerning the issues of competence and informed consent.
Selected issues involved in informed consent and the patient's competence to give it are examined. A discussion of tests of competence reveals some of the problems encountered in using them. There are differences in medical and nursing functions and responsibilities in the informed consent process. One nursing framework, self care, is used to discuss whether informed consent should be obtained from patients when they receive specific nursing care.
Attitude of Health Personnel↗
A linguistic model of informed consent.
The current disclosure model of informed consent ignores the linguistic complexity of any act of communication, and the increased risk of difficulties in the special circumstances of informed consent. This article explores, through linguistic analysis, the specificity of informed consent as a speech act, a communication act, and a form of dialogue, following on the theories of J.L. Austin, Roman Jakobson, and Mikhail Bakhtin, respectively. In the proposed model, informed consent is a performative speech act resulting from a series of communication acts which together constitute a dialogic, polyphonic, heteroglossial discourse. It is an act of speech that results in action being taken after a conversation has happened where distinct individuals, multiple voices, and multiple perspectives have been respected, and convention observed and recognized. It is more meaningful and more ethical for both patient and physician, in all their human facets including their interconnectedness.
Communication↗
The informed consent treatment report.
A brief history of informed consent and introduction of the "Informed Consent Treatment Report" (ICTR) is presented. The ICTR is a document developed in 1984 that combines the requirements of informed consent and the elements of good treatment planning and presentation to achieved improved patient and practice management. An outline of the parts and sections of the ICTR is included as a guide for preparing an informed consent and treatment planning document.
Dental Records↗
Effect of informed consent for intravascular contrast material on the level of anxiety: how much information should be given?
PURPOSE: To compare the effect of two different informed consent forms on patients' anxiety level prior to intravenous contrast material (IVCM) injection. MATERIAL AND METHODS: Two different informed consent forms were randomly given to 265 consecutive patients referred for either intravenous pyelography or computed tomography requiring IVCM injections. Form 1 had brief information, including only the common risks and risk factors associated with IVCM, while Form 2 had more comprehensive information. Before being presented with the two different informed consent forms, 191 of the 265 patients filled out two other forms evaluating: 1: How they felt in that particular situation/moment (STAI-T); and 2: How they felt independently of the situation or condition at that moment (STAI-S). After the patients were informed, the STAI-T (measuring how they felt in that particular situation) was filled out once more to see if the anxiety level had changed. RESULTS: The anxiety level for 88 patients receiving Form 1 decreased after they were given the informed consent (P=0.033). However, among the 103 patients receiving Form 2, the anxiety level showed a significant increase (P=0.001) compared to the values obtained before Form 2 was given. CONCLUSION: These results indicate that informed consent, including brief information about the risk factors and potential adverse reactions of IVCM, reduces anxiety level, while detailed information before the procedure increases the anxiety level.
Adolescent↗
[Ethical issues of human experimentation with special reference to informed consent].
Human experimentation in order to develop new medical therapies creates very complex ethical problems: when is it possible to test a new therapy on a human subject? Is it always necessary his/her consent? Which information should be given to the subject before requesting his/her consent? How to behave in the case of minors, psychiatric patients and other subjects not perfectly free or able to understand the information provided? Is it right to subject a person to an experimentation from which he/she will not get any direct advantage? Which results can be published? In other words, which are the ethical limits of human experimentation? These are difficult questions, to which the authors tried to answer referring to some ethically significant human experimentations, such as those performed by Lind and Jenner in the XVIII century, and those carried out by the nazi doctors, from whose trial derived the Nuremberg Code, which introduced for the first time, at an international level, the principle of the informed consent. Some of the limits of this document, including the impossibility of doing research on subjects not able to give their informed consent, such as minors and psychiatric patients, were overcome by the Declaration of Helsinki, whose current version resulted from several subsequent revisions. According to this document, a major role is played by the Institutional Review Boards or Institutional Ethical Committees that have the heavy responsibility of evaluating the ethical connotations of human experimentations.
Ethics, Medical↗
A freedom to choose. The ethics of informed consent.
1. It is difficult to know how much information should be given to patients to help them give an informed consent. 2. Informed consent provides an avenue for the expression of the ethical themes of autonomy, respect for persons and truth. 3. Informed consent acknowledges patients' intrinsic right to decide what happens to their bodies.
Aged↗
Informed consent for pediatric leukemia research: clinician perspectives.
BACKGROUND: Good, fully informed consent is critical to the ethical conduct of clinical cancer research. The authors examined clinician perspectives on informed consent for pediatric research by surveying clinicians at five major medical centers that routinely enroll patients in Children's Cancer Group studies. METHODS: Building on a pilot study, a questionnaire was designed to elicit clinicians' general opinions, approaches, and suggestions related to informed consent in pediatric leukemia trials. Questionnaires were mailed to 132 clinicians. Eighty-nine questionnaires were returned, along with 13 nonparticipant forms notifying us of the clinician's inability to participate because of a lack of experience in pediatric informed consent. The response rate was 75%. RESULTS: Providing information so that families can decide about study entry was ranked as the most important goal of the informed consent process, whereas parents' state of shock was rated the most significant obstacle to good informed consent. Clinicians cited high levels of parental comprehension of key aspects of clinical research studies and reported information overload and increased anxiety as effects of the informed consent process on parents. Several key items were associated with clinicians' gender, race, and professional experience. Finally, one open-ended question yielded 126 suggestions for how to improve the informed consent process that were grouped into 10 meaningful categories. CONCLUSIONS: Clinicians report a range of approaches, opinions, concerns, and suggestions for improving the informed consent process. The article proposes that their views and suggestions be integrated with those of parents and patients in attempts to survey and improve informed consent in pediatric oncology.
Adult↗
On the Ottoman consent documents for medical interventions and the modern concept of informed consent.
Information for patients prior to medical intervention is one of the principles of modern medical practice. In this study, we looked at an earlier practice of this principle. Ottoman judges had record books called sicil. One of the categories in sicils was the consent documents called riza senedi, which was a patient-physician contract approved by the courts. These contracts were especially for the protection of physicians from punishment if the patient dies. It is not clear whether patients were informed properly or not. Consent for minors was obtained from parents. However, a situation where an adult does not have the capacity to consent, was not clear in these documents. Any sign of free withdrawal of consent was not found in these records. Due to the legal system of Ottoman State, these contracts were related to Islamic law rather than modern civil law. We aim, in this paper, to present a legal practice, which is possible to consider as an early example of the informed consent practice.
Delivery of Health Care↗
A duty to disclose. Issues to consider in securing informed consent.
BACKGROUND: This article reviews the historical development of informed consent law and highlights factors dentists must consider when deciding how to obtain valid informed consent from patients. CONCLUSIONS: Informed consent laws vary from state to state. Dentists should review the laws in their states to determine when they are legally required to obtain informed consent, what information must be disclosed for the consent to be valid and how to secure consent for minor patients and adult patients who are not legally competent. PRACTICE IMPLICATIONS: Dentists should ensure that they are familiar with and in compliance with the informed consent laws in their states. ADA-member dentists also should be mindful of their ethical obligation to inform patients of proposed treatment and reasonable alternatives.
Adolescent↗
Informed consent and the elderly patient.
Achieving a moral informed consent from a patient is certainly no easy task for the physician. Patient autonomy has become a watchword of the medical profession and has promoted to some extent an emphasis on the idea of noninterference with the patient as the essential feature of the physician's respect for this autonomy. This is unfortunate because noninterference in many instances really does not take into account the transforming effects of illness and their impact on informed consent. In illness, the body is interposed between us and reality, and it impedes our choices and actions and is no longer fully responsive. Illness forces a reappraisal and in doing so opens up old anxieties and imposes new ones, often including the real threat of death or drastic alterations in lifestyles, such as becoming ventilator-dependent. Fear alone may cripple the ability of the patient to choose. In any consideration of informed consent, the extent of the patient's illness and suffering must always be considered. Adequate interaction with the elderly patient that is necessary for an informed consent consists of a combination of "objectivity" and "cooperation." Cooperation is shown by psychologically reproducing in the mind of the doctor, insofar as possible, the meaning the patient's illness has for him. Without such knowledge, the physician cannot assist a patient in restoring some control over his life, or in understanding his values, both of which are so essential in the decision-making process. The meaning of informed consent is vacuous at best without this objectivity and cooperation. Along with this interaction, the elderly patient must be placed in such a position that throughout his illness he maintains a free choice to decide while he is mentally able to do so. Simply knowing that this freedom exists removes many of the doubts and fears constraining the patient's own sense of autonomy. As a final statement regarding informed consent, we should note that any success by the physician in dealing with problems surrounding the patient's informed consent is always central to the strength of the physician's relationship with the patient. Because of the changing features of this relationship today, the physician should always be ready to implement the steps necessary to maintain the integrity of that relationship. The covenant of faithfulness demands nothing less.
Aged↗
Informed consent for endoscopy.
The process of informed consent is an ethical and legal mandate. The medical informed consent doctrine enables adult patients to make their own treatment decisions based on adequate disclosure of information by the endoscopist. The physician must disclose to the patient the nature, benefits, risks, and alternatives of the procedure being performed. It is incumbent upon the endoscopist to know the standard of disclosure in his or her jurisdiction. The process of informed consent will strengthen the physician-patient relationship and can be used as a valuable risk management tool.
Endoscopy, Digestive System↗