Informed consent

About: Informed consent is a research topic. Over the lifetime, 21319 publications have been published within this topic receiving 368719 citations. The topic is also known as: consent to research.

A history and theory of informed consent

Abstract: A History and Theory of Informed Consent, Faden, R.R., and Beauchamp, T.L. (Oxford University Press, New York, 1986), 392 pages, $29.95.

Four Models of the Physician-Patient Relationship

Abstract: During the last two decades or so, there has been a struggle over the patient's role in medical decision-making that is often characterized as a conflict between autonomy and health, between the values of the patient and the values of the physician. Seeking to curtail physician dominance, many have advocated an ideal of greater patient control.',' Others question this ideal because it fails to acknowledge the potentially imbalanced nature of this interaction when one party is sick and searching for security, and when judgments entail the interpretation of technical information.14 Still others are trying to delineate a more mutual relationship.5,6 This struggle shapes the expectations of physicians and patients as well as the ethical and legal standards for the physician's duties, informed consent, and medical malpractice. This struggle forces us to ask, What should be the ideal physician-patient relationship? We shall outline four models of the physicianpatient interaction, emphasizing the different understandings of (1) the goals of the physicianpatient interaction, (2) the physician's obligations, (3) the role of patient values, and (4) the conception of patient autonomy. To elaborate the abstract description of these four models, we shall indicate the types of response the models might suggest in a clinical situation. Third, we shall also indicate how these models inform the current debate about the ideal physician-patient relationship. Finally, we shall evaluate these models and recommend one as the preferred model. As outlined, the models are Weberian ideal types. They may not describe any particular physician-patient interactions but highlight, free from complicating details, different visions of the essential characteristics of the physician-patient interaction. 7 Consequently, they do not embody minimum ethical or legal standards, but rather constitute regulative ideals that are "higher than the law" but not "above the law."' THE PATERNALISTIC MODEL First is the paternalistic model, sometimes called the parental 9 or priestly model. In this model, the physician-patient interaction ensures that patients receive the interventions that best promote their health and well-being. To this end, physicians use their skills to determine the patient's medical condition and his or her stage in the disease process and to identify the medical tests and treatments most likely to restore the patient's health or ameliorate pain. Then the physician presents the patient with selected information that will encourage the patient to consent to the intervention the physician considers best. At the extreme, the physician authoritatively informs the patient when the intervention will be initiated. The paternalistic model assumes that there are shared objective criteria for determining what is best. Hence the physician can discern what is in the patient's best interest with limited patient participation. Ultimately, it is assumed that the patient will be thankful for decisions made by the physician even if he or she would not agree to them at the time." In the tension

What Makes Clinical Research Ethical

Abstract: Many believe that informed consent makes clinical research ethical. However, informed consent is neither necessary nor sufficient for ethical clinical research. Drawing on the basic philosophies underlying major codes, declarations, and other documents relevant to research with human subjects, we propose 7 requirements that systematically elucidate a coherent framework for evaluating the ethics of clinical research studies: (1) value-enhancements of health or knowledge must be derived from the research; (2) scientific validity-the research must be methodologically rigorous; (3) fair subject selection-scientific objectives, not vulnerability or privilege, and the potential for and distribution of risks and benefits, should determine communities selected as study sites and the inclusion criteria for individual subjects; (4) favorable risk-benefit ratio-within the context of standard clinical practice and the research protocol, risks must be minimized, potential benefits enhanced, and the potential benefits to individuals and knowledge gained for society must outweigh the risks; (5) independent review-unaffiliated individuals must review the research and approve, amend, or terminate it; (6) informed consent-individuals should be informed about the research and provide their voluntary consent; and (7) respect for enrolled subjects-subjects should have their privacy protected, the opportunity to withdraw, and their well-being monitored. Fulfilling all 7 requirements is necessary and sufficient to make clinical research ethical. These requirements are universal, although they must be adapted to the health, economic, cultural, and technological conditions in which clinical research is conducted. JAMA. 2000;283:2701-2711.

American Society of Clinical Oncology Recommendations on Fertility Preservation in Cancer Patients

Abstract: Purpose To develop guidance to practicing oncologists about available fertility preservation methods and related issues in people treated for cancer. Methods An expert panel and a writing committee were formed. The questions to be addressed by the guideline were determined, and a systematic review of the literature from 1987 to 2005 was performed, and included a search of online databases and consultation with content experts. Results The literature review found many cohort studies, case series, and case reports, but relatively few randomized or definitive trials examining the success and impact of fertility preservation methods in people with cancer. Fertility preservation methods are used infrequently in people with cancer. Recommendations As part of education and informed consent before cancer therapy, oncologists should address the possibility of infertility with patients treated during their reproductive years and be prepared to discuss possible fertility preservation options or refer appropriate and interested patients to reproductive specialists. Clinician judgment should be employed in the timing of raising this issue, but discussion at the earliest possible opportunity is encouraged. Sperm and embryo cryopreservation are considered standard practice and are widely available; other available fertility preservation methods should be considered investigational and be performed in centers with the necessary expertise.

Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2010 for the treatment of colorectal cancer

Abstract: Colorectal cancer is a major cause of death in Japan, where it accounts for the largest number of deaths from malignant neoplasms in women and the third largest number in men. Many new treatment methods have been developed over the last few decades. The Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2010 for the treatment of colorectal cancer (JSCCR Guidelines 2010) have been prepared to show standard treatment strategies for colorectal cancer, to eliminate disparities among institutions in terms of treatment, to eliminate unnecessary treatment and insufficient treatment, and to deepen mutual understanding between health-care professionals and patients by making these Guidelines available to the general public. These Guidelines have been prepared by consensuses reached by the JSCCR Guideline Committee, based on a careful review of the evidence retrieved by literature searches and in view of the medical health insurance system and actual clinical practice settings in Japan. Therefore, these Guidelines can be used as a tool for treating colorectal cancer in actual clinical practice settings. More specifically, they can be used as a guide to obtaining informed consent from patients and choosing the method of treatment for each patient. As a result of the discussions held by the Guideline Committee, controversial issues were selected as Clinical Questions, and recommendations were made. Each recommendation is accompanied by a classification of the evidence and a classification of recommendation categories based on the consensus reached by the Guideline Committee members. Here we present the English version of the JSCCR Guidelines 2010.