[Is tacit consent more efficient than informed consent in cadaveric organ donation for transplantation?].
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Humans↗
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The doctrines of lack of consent and lack of informed consent in medical procedures in Louisiana.
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General Surgery↗
[Consenting to ambiguities: a documental analysis of informed consent forms used in assisted human reproduction clinics].
With the field of assisted human reproduction as a case study, this article presents the results of a study on informed consent forms, linking the understanding of the use of social languages - especially the language of risk - and its implications on the relationship between health professionals and clients. Informed by a social psychology perspective and aligned with the qualitative tradition in research, the study was oriented by a theoretical approach to discursive practice, whereby the language of risk is understood as a way of speaking of future control of risks. The analysis centered on the text of 27 informed consent forms provided by eight Brazilian clinics. Besides understanding the linguistic specificities, the analysis attempted to answer the question, "What is being consented to?" The results showed the ambiguity of a document which presupposes the use of the metaphor of taking versus not taking risks. That is, the document may be used in a democratic, bureaucratic, or even authoritarian way, while the communication of risks and benefits subsidizes both the decision-making and the dilution of responsibility throughout the relational network.
Decision Making↗
Informed consent and moral integrity.
Informed consent is required for any medical procedure although the situations in which it is given are beset by uncertainties and indeterminacies. These make medicolegal scrutiny of such situations very difficult. Although some people find the decision in the Sidaway case incomprehensible because of its continuing regard for a 'professional practice standard' in informed consent, I will argue that an important fact in many cases is the moral integrity of the doctor concerned and the pattern of his practice. This may provide the only morally principled and legally accessible evidence enabling a correct decision to be made in a difficult case. Although the epistemological significance of a professional practice standard is thereby defended the 'prudent patient standard' for what counts as consent is left intact.
Communication↗
Some limits of informed consent.
Many accounts of informed consent in medical ethics claim that it is valuable because it supports individual autonomy. Unfortunately there are many distinct conceptions of individual autonomy, and their ethical importance varies. A better reason for taking informed consent seriously is that it provides assurance that patients and others are neither deceived nor coerced. Present debates about the relative importance of generic and specific consent (particularly in the use of human tissues for research and in secondary studies) do not address this issue squarely. Consent is a propositional attitude, so intransitive: complete, wholly specific consent is an illusion. Since the point of consent procedures is to limit deception and coercion, they should be designed to give patients and others control over the amount of information they receive and opportunity to rescind consent already given.
Attitude to Health↗
Hospital informed consent for procedure forms: facilitating quality patient-physician interaction.
BACKGROUND: Informed consent forms should document and reflect the goals of informed consent and shared decision making. We conducted this study to examine the extent to which informed consent for procedure forms meet accepted informed consent standards, how well state informed consent statutes correlate with these standards, and whether existing forms can enhance the interactions between patients and physicians or other health care providers. HYPOTHESIS: Informed consent forms do not meet accepted standards. A different format may be more useful for patient-physician interactions. DESIGN: A content analysis was conducted of hospital informed consent for procedure forms from a random selection of hospitals in the 1994 American Hospital Association membership directory. Forms were examined for evidence of the basic elements of informed consent (nature of the procedure, risks, benefits, and alternatives) and items that might enhance patient-physician interactions and encourage shared decision making. UNIT OF ANALYSIS: From 157 hospitals nationwide, 540 hospital informed consent for procedure forms were examined. MEASUREMENTS AND MAIN RESULTS: Ninety-six percent of forms indicated the nature of the procedure, but risks, benefits, and alternatives were found less often. Only 26% of forms included all 4 basic elements, 35% included 3 of 4 elements, 23% had 2 of 4 elements, 14% had only 1 element, and 2% had none of the elements. Forms appear to authorize treatment (75%) or protect hospitals and caregivers from liability (59%) rather than clarify information about procedures (40%) or aid patients in decision making (14%). Forms from states with statutes that require that all 4 elements be provided were no more likely than other states to include them (Fisher exact test = 1.000). Fewer than 40% of forms supported models of shared decision making. CONCLUSIONS: The content of most forms did not meet accepted standards of informed consent or patient-physician interactions. We propose a form that more fully supports the models of ideal informed consent and shared decision making to enhance the applicability of informed consent in the clinical setting.
Ethics, Medical↗
Beyond informed consent.
The issue of informed consent ranks among the most heavily debated topics in health care. Nearly all health professionals, at some time in their practice, encounter situations in which they question their own involvement and responsibility in obtaining a consent for medical treatment. Such situations are becoming increasingly common for nurses as the structure of the health care system changes and nurses' roles become more diversified. Nurses are wise to try to understand the principles involved in informed consent and to recognize the potential for dilemmas involving ethics and hospital policies.
Humans↗
Informed consent in pediatric neurology.
Informed consent remains an important but unpopular topic among physicians. It has the ring of a bothersome legal technicality coupled with a time-consuming, procedural requirement that must be obtained principally to satisfy external agencies and avoid malpractice suits. In fact, consent always has been an essential element in the physician-patient relationship, more important as an ethical duty than as a legal requirement, and continues to represent the most important forum of communication between patients and physicians. To explicate informed consent in pediatric neurology, this article begins with an account of consent in adult medical practice with competent patients. Then consent in incompetent patients is discussed and the standards of surrogate decision-making are defined. Next, the complex situation of consent in pediatrics is considered and the concept of assent and dissent of children and how it differs from consent and refusal in adults is introduced. Legal issues of consent are presented and how to resolve conflicts of assent, consent, and refusal between children and parents is discussed. Then, overriding parental refusals of treatment and consent issues in genetic testing are mentioned. Finally, there is a discussion of consent and assent by children for participation in clinical research studies.
Adolescent↗
Informed consent, competency, and the neurologist.
BACKGROUND: Obtaining informed consent to treatment is an important medical-legal and clinical aspect of neurological practice. REVIEW SUMMARY: This review discusses the doctrine of informed consent and its role in neurological practice. We first provide an overview of the informed consent doctrine and discuss its historical origins and current modern form. The three component elements of informed consent--being informed, voluntary, and competent--are presented, with a focus placed on the competency element. The increasingly important role of informed consent in everyday neurological practice is profiled, with particular emphasis on patients with dementia. Recent empirical research is presented on loss of consent capacity (competency) in patients with Alzheimer's disease and Parkinson's disease. Finally, a conceptually based approach to clinical assessment of competency is presented to assist neurologists dealing with these issues. CONCLUSIONS: The increasing prevalence of patients with neurodegenerative disorders in neurological practice heightens the importance of obtaining valid informed consent to treatment.
Journal Article↗
The concept of informed consent in qualitative research.
Informed consent is an essential part of all research endeavors that involve human participants. The human rights of research participants must be protected. It is incumbent upon the qualitative researcher to provide a dynamic informed consent when study outcomes change. The violation of privacy is more apt to occur with in-depth interviews, which has implications for researchers to protect human rights throughout data collection, analysis, and dissemination.
Ethics↗
[Informed consent on pain management].
Informed consent is an essential concern to provide medical services centered on patient's needs. Its significant role is not to avoid legal responsibility but to respect patient's individuality. It emphasizes the necessities for sharing medical information including its uncertainty, listening carefully to a patient about his/her questions and anxieties and being worried with him/her in regard to the best ways coping with sufferings. In this article we describe important aspects concerning informed consent on pain management at clinical situations. It is necessary for physicians not only to have knowledge for pain management but also to get technique for appropriate explanation about analgesics.
Analgesics↗
[Characteristics of patient informed consent in physician practice].
Informed consent as one of major problems of contemporary medical law and medical ethics is considered. Basic elements of this process are revealed. Standards determining patient's competence are described. The following issues are discussed: scope of information to be presented to patient; possible alternatives to particular treatment; risk degree, specifics and purpose of proposed treatment. Peculiarities of introducing principle of informed consent into pediatric practice are emphasized. Any child is most vulnerable patient therefore additional efforts are needed to protect his rights. Necessity to obtain child's approval to be examined and to be treated is issue of pressing importance.
Child↗
Conducting stroke research with an exception from the requirement for informed consent.
BACKGROUND: Obtaining viable informed consent from stroke patients for participation in clinical trials of acute stroke therapies is often problematic because of patients' neurological deficits. Furthermore, obtaining permission from surrogates is often not possible or not legally permissible. SUMMARY OF REVIEW: In 1996 the Food and Drug Administration and Department of Health and Human Services published regulations that allow investigators to conduct emergency research without patient consent under a narrowly defined set of circumstances. We review requirements of these regulations, paying particular attention to how they may be applied in a clinical trial of an acute stroke therapy. CONCLUSIONS: Acute stroke researchers should consider conducting clinical trials with an exception from the informed consent requirement permitted by this law.
Clinical Trials Data Monitoring Committees↗
[Informed consent in psychosomatic medicine].
Obtaining informed consent perfectly is very difficult from the view of psychosomatic medicine. Medical education regarding informed consent is generally of a low level. However as it is important to defend patients' human rights, we must educate them as to the precise meaning of both "informed" and "consent". In this report I have tried to demonstrate that both the education of medical students and their social consciousness are very important. I examined students' opinions regarding the care of a sudden case of hysterectomy (Porro's emergent operation). The following students were involved: 1st year medical students (N = 73), 4th year (N = 85) and 6th year (N = 119), and 3rd year nursing students (N = 42) and midwife students (N = 27). I examined their answers by transactional analysis. The answers of the 1st year medical students reflecting the view of the child ego state were significantly greater than those of the other students (P < 0.01). But following my lecture the answers of the same 1st year students altered to reflect the view of the adult ego more (P < 0.05). We opened "the key center of psychosomatic women's health in Japan" in our clinic two years ago. Since then we have talked every month to people in general about various women's diseases, and also discussed various problems of the doctor-patient relationships during these talks. I feel that public awareness concerning informed consent has increased gradually recently in Japan.
Adult↗
Observations of physician, patient and family perceptions of informed consent in Houston, Texas.
Informed consent is one of the most important ethical and legal principles in the United States, including Texas, and reflects a profound respect for individuals and their ability to make decisions in their own best interest. It is also a critical underpinning of medical practice, although how it is actually carried out has not been well studied. A survey was conducted in the private practices and a hospital in the Texas Medical Center in Houston, Texas to ascertain how physicians, patients and patient's family members perceive and demonstrate the elements of informed consent. In-depth interviews of twelve physicians, three patients and three family members were carried out. For physicians, consent was an explicit and implicit aspect of virtually all medical practice. Physicians would seek patient input concerning medical decisions whenever possible and might also discuss care choices with families. However, they often made decisions based upon what they perceived as the patient's best interests. Patients expected the physician to involve them in the decision process, but whether they turned to family members, or even others to assist them, varied considerably. Although Texas physicians respect the competent patient as the primary decision maker, they may bypass a formal surrogate decision maker to gain input from others, including their own view of what is in the patient's best interest.
Aged↗
The decision dynamics of clinical research: the context and process of informed consent.
This article explores the neglected dimensions of informed consent. In such documents as the that govern clinical research, it is explicitly stated that informed consent is a process, not a form to be signed. However, virtually all research on informed consent has proceeded as if informed consent is an event similar to a Miranda warning. The authors review what is known about the process of informed consent and ask what questions must be explored if the dynamics of the clinical decision-making process are to be better understood. Their investigation takes place in two parts. First, the authors survey what is known or not known about the effect and influence of two major parties to the decision-making process (ie, support groups in which the subject participates and the subject's primary care physician). Second, they focus on the cultural and demographic factors that contribute to the subject's identity. Although they do not propose that informed consent must become a complicated and burdensome process, they stress that understanding the process in any meaningful way will mean that one must understand these various influences to get beyond the voluminous, but often facile, research that has characterized work on informed consent.
Clinical Trials as Topic↗
Informed consent.
Physicians have an ethical and legal duty to obtain patients' informed consent before ordering testing and treatment. Informed consent encompasses informed refusal, the correlative right of patients to refuse tests and therapies they do not want. A patient's informed consent requires adequate information, capacity to decide, and absence of coercion. Informed consent is incorporated into a process of agreement between a patient and a physician called "shared decision making." The procedural requirements of informed consent vary as a function of the risks of the tests or treatments. Incompetent patients require surrogate decision makers to consent or refuse on their behalf. Older children and adolescents should be asked to provide their assent for treatment in addition to their parents' permission. Treatment may be provided in an emergency situation without consent if the treatment given represents the standard of emergency care. Consent of human subjects for participation in research requires that they fully understand their role and risks, not be coerced, and be allowed to withdraw at any time without penalty. Institutional review boards help guarantee the protection of human subjects. Vulnerable research subjects, such as children and the cognitively or mentally impaired, require additional protection.
Ethics, Medical↗
[Cards of information and informed consent. Proposal of 14 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 preoperatoire information. The National Medical French Council (CNOM) called scientific societies attention to propose to their members some index standard cards, corresponding to mail medical and surgical records. The National Agency for Accreditation and Evaluation in Health (Anaes) defined the main characteristics of these documents. The authors propose fourteen information cards corresponding to the most currently operations of plastic and aesthetic surgery. They will being clear and simple, wtih a large agreement, strictly informative and yearly up to date. They have the label and therefore the scientific guarantee of French Society of Plastic Reconstructive and Aesthetic Surgery.
France↗