Informed consent and patient decision making: two decades of research

Patient consent to medical treatment has been a subject of concern within the United States professional communities for over two decades. This paper traces the development of research literature on patient decision making and informed consent to medical treatment in three fields of research: medicine, law and the social sciences. A general model for stages in the development of scientific specialties is applied as a test for the development of informed consent as a specialty interest in each research field. Results indicate a relatively advanced stage of development within medicine and law. Research in the social science disciplines tend to lag behind in terms of cumulative number of publications. In addition, social science research which is potentially relevant to the ethical and policy issues of consent in medical treatment appears to lack a clear programmatic thrust, with little attention given to the policy implications of the work. In contrast, the medical and legal literatures indicate a direct concern with social policy and reflect attempts on the part of physicians and lawyers to influence the policy making process.     

Informed consent documents do not encourage good-quality decision making

ObjectiveInformed consent for research has emphasized information provision over support to people making a difficult decision. We assessed the extent to which existing informed consent documents (ICDs) conform to the International Patient Decision Aid Standards for supporting decision making.Study Design and SettingOne hundred thirty-nine ICDs for trials registered with ClinicalTrials.gov were obtained from study investigators. Using a four-point scale, two raters assessed each ICD on 32 items.ResultsOverall agreement between raters was 95.1% (linear weighted kappa—0.745). For 12 items focused on providing enough information, conformity was above 50% for three, and 0% for another four. For all eight items focused on how to present outcome probabilities, conformity was below 20%. For two items focused on clarifying and expressing values, conformity was below 10%. For two items focused on improving structured guidance, conformity was below 5%. For four items focused on using evidence, one item showed conformity of 74%; all others showed conformity below 5%. For four items focused on transparency, conformity was high (above 60% for two, above 80% for the others).ConclusionsExisting ICDs do not meet most validated standards for encouraging good decision making. These standards make clear predictions about how one might improve ICDs ensure that research participants are fully informed.     

Informed consent and incompetent medical patients

The mentally incapacitated patient is frequently encountered in the general medical hospital. Incapacity is the clinical state in which a patient is unable to participate in a meaningful way in medical decisions. Mentally incapacitated patients relinquish the authority, that is the competent patient's right, to choose among professionally acceptable alternative treatments. Such patients, therefore, require a surrogate decision-maker. There are certain clinical situations in which questions of incapacity are especially important to consider. In a study for the President's Commission for the Study of Ethical Problems in Medical Biomedical and Behavioral Research, the most common problem in recognizing incapacity was found with previously capable patients who became transiently incapacitated during the course of hospitalization. Questions of incapacity or the authority of surrogate decision-makers also arose with comatose, mentally retarded, mentally ill, and physically handicapped patients. While standards to determine capacity remain unclear, a practical approach is to demonstrate that a patient is able to describe the physician's view of the situation and to understand the physician's opinion as to the best intervention. When a patient is deemed to be incapacitated, the physician should turn to family members, whenever possible, to make decisions.     

Informed consent in clinical practice and medical research

The present paper deals with the basic aspects, influences and elements that constitute Informed Consent seeing it as a process and not only as an administrative format. Both the patient-physician relationship, as well as the research subject-investigator relationship, should be seen in the same manner, in spite of recognizing specific objectives for each one. For this reason, Informed Consent should not be different regarding both clinical as well as research activities. The patient-physician relationship presents a disbalance of power within the relationship in favor of the physician; this adds to the moral considerations that take place within both participants. Informed Consent should be defined in a broad sense as all those actions that promote a process of communication and dialogue which facilitates a person in order to make decisions with respect of an action, practice or product that have an impact on his/her body, intimacy or other vital spaces. Informed Consent has influences that originate in basic bioethical principles (autonomy, beneficience, non-maleficence, justice), professional and international declarations (Hippocratic Oath, Declaration of Helsinki), as well as legal considerations pertinent to each country. In our country legality emmanates from the General Health Law which, unfortunately, only contemplates Informed Consent as part of the relation established in clinical research. However, the Official Medican Norm on the Clinical Record establishes the conditions where Informed Consent must be obtained during clinical as well as research activities. Primary components of Informed Consent (revelation, capacity to understand and voluntariness), can be better understood when divided into several elements: information, voluntariness, risks and benefits, confidentiality, return of information, utility of the process and management of fragility. Informed Consent should be legally instrumented in an explicit written manner (administrative formats). However, it is important to recognize the limitations of these formats when used outside the context of a continuous communication process with the patient. For this reason, ultimate instrumentation is through continuous dialogue between patient and physician. Finally, Informed Consent might help improve the patient-physician relationship which, in the end, might be the best way to counteract the influence of the establishment of health management services.     

East meets West: Cross-cultural perspective in end-of-life decision making from Indian and German viewpoints

Culture creates the context within which individuals experience life and comprehend moral meaning of illness, suffering and death. The ways the patient, family and the physician communicate and make decisions in the end-of-life care are profoundly influenced by culture. What is considered as right or wrong in the healthcare setting may depend on the socio-cultural context. The present article is intended to delve into the cross-cultural perspectives in ethical decision making in the end-of-life scenario. We attempt to address the dynamics of the roles of patient, family and physician therein across two countries from East and West, namely, India and Germany. In India, where illness is more a shared family affair than an individual incident, a physician is likely to respect the family's wishes and may withhold the [Symbol: see text]naked truth' about the diagnosis of a fatal disease to the patient. In Germany, a physician is legally required to inform the patient about the disease. In India, advance directive being virtually non-existent, the family acts as the locus of the decision-making process, taking into account the economic cost of available medical care. In Germany, advance directive is regarded as mandatory and healthcare is covered by insurance. Family and the physician appear to play larger roles in ethical decision making for patients in India than for those in Germany, who place greater emphasis on autonomy of the individual patient. Our study explicates how culture matters in ethical decision-making and why the bioethical discourse is necessary in the concrete realities of the socio-cultural context. To explore the possibility of finding a common ground of morality across different cultures while acknowledging and respecting cultural diversity, thus remains a formidable challenge for the bioethicists.