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Informed consent is an integral element of ethical medical practice. However, unlike gastrointestinal endoscopy, the consent process is not standardized. Moreover, informed consent is often viewed as a legal necessity rather than as an expression of patients' autonomy. Elevating informed consent to its rightful place can enhance doctor-patient relationship.
BACKGROUND: This article continues our medicolegal series that addresses issues affecting current dermatology practice. Informed consent and informed refusal have become cornerstones of modern American healthcare, and can serve to facilitate communication and trust between physician and patient. METHODS: A format with an initial discussion of legal concepts is followed by hypothetical problems and a review of actual cases to illustrate the principles of informed consent and informed refusal. RESULTS: A valid informed consent from a competent patient should be obtained before initiating most dermatologic treatment. When a competent patient refuses a recommended medical test or procedure, the physician should make sure the patient understands the potential negative consequences of refusal. Some form of written documentation in the medical record is advised in either situation. CONCLUSION: Failure to obtain a patient's informed consent prior to beginning treatment or failing to obtain an informed refusal before accepting a patient's decision to forego a test or procedure may subject the dermatologist to multiple later allegations, most commonly negligence.
Patients are asked to give informed consent for both treatment and research protocols. Yet, is their consent really informed? This article focuses on the information component of informed consent. The author discusses informed consent as it relates to the ethical principle of respect for autonomy, presents nurses' perceptions of informed consent, and makes several recommendations that nurses can use to ensure that consent is informed.
Informed consent has been the central model for ethical decision making in clinical care and research. The goal of informed consent is to protect the right of a competent person to make his or her own health care decisions based on personal values and goals. But changes in health care practices, systems, and research have challenged this well-established goal. This paper examines these changes to show that decisions about care and research directed to individual patients rely more and more upon a population perspective. As a result, efforts to promote patient choice should attend to the ethical decision-making processes of institutions that create and sustain this perspective.
Informed consent is a basic human right for any medical procedure. It is particularly important that women know what is involved in any sterilization method, and how it will affect their health and their emotional life. Over 140,000 QS procedures have been performed in 34 countries. In no country has there been any formal effort to advance the acceptance of this method. Instead, satisfied users have been the promoters. Thoroughly informed consent is vital to patient satisfaction. A working group undertook an initiative to create an ideal consent form. The product of that initiative is presented.
Informed consent hinges on educating patients about their proposed treatments.
Informed consent is vital to the conduct of clinical trials. The evolution of this process is reviewed. In the United States, specific steps must now be taken to assure institutional review bodies that all precautions have been taken to inform patients before they are enrolled in studies. These include (1) the procedure to be followed in the study, (2) the benefits for the individual, (3) the discomforts and risks that are reasonably expected, (4) the alternative methods of therapy, (5) the willingness of the investigator to answer inquiries, and (6) the right to refuse or to withdraw from the study without prejudice. The conditions are discussed in detail.
Informed consent is an issue preoccupying many in both the legal and medical professions. The author looks at what it means in the day-to-day clinical situation.
Informed consent (IC), a fundamental principle of ethics in medical research, is recognized as a vital component of HIV vaccine trials. There are different notions of IC, some legally based and others based on ethics. It is argued that, though legal indemnity is necessary, vaccine trials should be founded on fully ethical considerations. Various contentious aspects of IC are examined, especially the problem of social desirability and of adequate comprehension. The need for sensitivity to cultural norms in implementing IC procedures is critically reviewed, and some of the potential conflict between ethos and ethics is considered. The transmission of information is examined as a particular aspect of IC in HIV vaccine trials.
Informed consent (IC) is an indicator, or a pivotal point, in broader and more fundamental questions dealing with the way clinical experimentation and, more specifically, randomized controlled trials (RCTs) relate to routine clinical practice; the rules that characterize the doctor-patient relationship; the self-perception of medicine with respect to its capacity, duty, and autonomy in the production of new knowledge; and the role of medicine in society. The asymmetry of knowledge and power that characterizes the usual relationship between care providers and patients does not resolve when something experimental enters the relationship. The real world of clinical investigation is not uniformly distinct from clinical practice. Experimentation is more appropriately considered a continuum with respect to appropriate or recommended care. Fundamental patient rights come first and are more binding than compliance with procedures and regulations. The view that IC is the most important component of the "ethical" aspects of experimentation is highly misleading. The responsibility to foster well-informed decisions shapes the contents, the timing, the validity, and the credibility of IC. Documented, evaluable decisions are the natural substitute for individual IC when the patient is not able to handle information autonomously. Positive examples of IC practices and approaches suggest that IC may be important in improving the way medicine responds to its responsibilities and communicates with society.
This article traces the development of the informed consent concept, focusing on Texas case law and statutory provisions. We describe the proper use of the Texas Medical Disclosure Panel forms in establishing informed consent and illustrate common problems in proving that informed consent has been obtained. The need for effective physician-patient dialogue and communication is discussed.
It is commonly accepted in American law that an adult of sound mind has the right of self-determination, that is, the right to say what is to be done to his or her own body. This includes the right to accept and refuse treatment for most medical problems or disorders. During the perinatal period, the woman may be asked to submit to procedures and medications for herself and her fetus/ neonate. Nurses must be sure that patients or parents have given valid consent to any type of touching done in the course of nursing care. Furthermore, nurses must be certain that women have given informed consent to the certified nurse-midwife, nurse practitioner, or physician for any treatments or procedures that have inherent risks. The article defines and describes the concepts of consent and informed consent and examines the roles and responsibilities of perinatal nurses in these processes.
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Documentation of informed consent by patients entering clinical trials is an ethical and legal necessity. Federal regulations and judicial opinions have led to increasingly lengthy, detailed "consent" forms, yet published studies demonstrate that patients remain confused about the nature and anticipated consequences of study entry. It has been suggested that more detail may even alarm or further confuse patients. Seventy-five women undergoing chemotherapy for advanced breast cancer participated in this study which assessed patient preference for long-, medium-, or short-form length, and whether form length preference correlated with patient characteristics or indicators of patient autonomy in decision-making or physician dependency. Patient preferences for information were not predicted by the patient autonomy or physician dependency scores or by age, marital status, or level of education. The majority of patients expressed a preference for more detailed information about their treatment, yet a majority of patients given detailed forms answered questions basic to the study design incorrectly, irrespective of educational level. The increased detail included in the long forms was not reported to increase stress compared to the short forms. Patient information forms are a principal tool for informing patients for consent but if they are to perform their desired function they must be designed more carefully and evaluated more thoroughly than in the past.
BACKGROUND: By casual interaction with patients our impression was that patients lacked adequate knowledge about their ailments and surgical treatment. There is now increasing educational exposure and legal awareness in the society. AIM: To reassess the extent of the practice of "informed consent" expose failures if any, and make appropriate recommendation. METHODS: A written questionnaire, randomly distributed to patients, sought to find out to what extent patients admitted into the University of Port Harcourt Teaching Hospital (UPTH) were adequately informed about their ailments and the implications of surgical treatment. RESULTS: One hundred and fifty patients were randomly recruited into the study and all responded to the questionnaire. Majority of the patients (75%) knew their diagnoses. Most patients (63%) did not know the problems that could be associated with their surgery while 75% did not know the complications of anaesthesia. CONCLUSION: There is need for a closer interaction in communication between patients and their surgeons. This will facilitate the participation of patients in decisions on treatment options and consequently help to maintain a satisfactory standard of practice and reduce litigation following an unfavourable outcome of surgical treatment.
Since World War II, all sorts of protective measures have been taken for people who receive medical care or who are involved in scientific research. More and more, informed consent has become the standard. In the field of experimental therapeutical research, informed consent is still a controversial subject; the individual person's interests versus general interests. But informed consent appears to have become such an absolute prerequisite for all types of observational research that the future of epidemiological research based on existing data is threatened. According to both the Declaration of Helsinki and the Dutch Law for Protection of Persons, it is possible to omit asking individual informed consent under certain circumstances. Permission for research could then be given by a supervisory board or a medical-ethical commission. After all, informed consent was never meant to be a goal of its own, but a means for self-protection and securing the right to autonomy. In situations where this right is curbed for other reasons, it appears that insisting on informed consent misses its target completely.
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Information to make patients fully aware of all the details of treatments is an important part of the medical practice before obtaining patient's signature in the consent form. Explanation may be detailed enough to make patients understand the process of treatment. However, sometime it may not be inclusive enough to cover all major statements that give pros and cons of the treatment. Perhaps detailed explanation may reveal too much information that may discourage patients to receive treatments and cause fear, anxiety, and hopelessness. If health care personnels do not mention all the risks involved in medical treatments, they may be subjected to an accusation of concealing the truth that should be made known to patients. This is one of many ways of looking at the problems. There is no easy answer to the problem of what 'appropriate' explanation should be. Most of our patients are from all walks of life which are not medical profession, and they do not have knowledge to understand technical terms. How should we approach patients in order to be safe from an accusation of that we are not over supporting, not giving the patients false hope? Therefore, we would like to present a guideline for informing and explaining to the patients under the following headings (15): 1. Diseases or major symptoms which are diagnosed. 2. The necessity to receive treatments for the benefits of patients or fetus. 3. If possible, determine the duration of treatments. 4. Methods of treatment, evaluation, and schedule for next appointment. 5. Inform about necessary investigations. 6. Inform about complications of risks, and cost of investigations 7. Usefulness and results of investigations. 8. If options of treatments are available, they should be explained in details, the pros and cons, the risks, and the costs, etc. 9. Maintaining medical confidentiality and the use of patient chart by medical personnel and other related health care providers, for instance, hospital staffs from all levels, medical students, technical medical students, and social workers, etc.