Problems of long-term informed consent

This study addresses problems arising with informed consent for long-term maintenance pharmacotherapy. Obtaining patient consent to neuroleptic treatment, with the risk of tardive dyskinesia, has raised questions about long-term recall and the competence of psychiatric patients as a special population. The subjects were 32 adult outpatients, 16 were followed in the psychiatric clinic and 16 in the rheumatology, pulmonary, and neurology clinics. Structured interviews with these patients dealt with knowledge about relevant short-term and long-term medication side effects. Interview results were used to compare psychiatric and medical groups with respect to overall levels of comprehension. Two results were striking. 1. There was a remarkable similarity in the degree of comprehension between psychiatric and medical outpatient groups; this suggests that psychiatric patients need not be considered any less competent than medical outpatients in assimilating necessary medication information. 2. Patients in both groups were knowledgeable about short-term side effects, usually as a consequence of personal experience with them. However, their knowledge was consistently inadequate with regard to potential long-term side effects from their maintenance medication. Current informed consent doctrine may presume a degree of recall and comprehension beyond the capabilities of most patients. The development of an appropriate doctor-patient relationship that reconciles the need for consent with patient limitations remains an important challenge for clinicians.     

The evolution of informed consent

Informed consent and the changes in what is expected over the 21st century provide an instructive case study of the mutual influence on one another of medical law and medical ethics. Over the years we have moved from a doctor-centred standard to a patient-centred standard and from a one-size-fits-all patient-centred standard to a more individual requirement that engages with the needs of a particular patient It is unreasonable to expect those changes to be reflected in anything less than an extended conversation in which the health care professional gives out some version of what a reasonable patient would expect to hear from an informed health care professional and then responds to the patient's questions as informatively and helpfully as he or she can. It is therefore convenient to refer to spontaneous and responsive disclosure as a very concrete implementation of the health care professional-patient partnership that is contemporary health care and at the heart of health care ethics.     

Medical: informed consent--designate health care professionals to obtain informed consent. Final rule

This document amends U.S. Department of Veterans Affairs (VA) medical regulations on informed consent. The final rule authorizes VA to designate additional categories of health care professionals to obtain the informed consent of patients or their surrogates for clinical treatment and procedures and to sign the consent form.     

Asylum seekers and informed consent--European perspective

For centuries, people of various nationalities from various States have sought asylum for varied reasons. These people seeking asylum can need medical care in the host country. In this article I would like to discuss to what extent informed consent is needed, and to what extent informed consent must be sought. The problem is discussed from the perspective of European international documents, mainly on those of the Council of Europe.     

Critical care research and informed consent

The doctrine of informed consent severely limits the ability of medical researchers to develop, evaluate, and refine investigational technologies for the treatment of patients suffering from heart attacks, strokes, and other "critical care" conditions. In this Article, Mr. Saver examines the current doctrine of informed consent as applied to critical care research and its various deficiencies. In addition, he analyzes recent reforms proposed by the Food and Drug Administration, which are intended to remove certain obstacles to critical care research posed by informed consent. While the proposed reforms address several of the current deficiencies, he asserts that they lack the breadth and scope necessary to advance the progress of critical care research in an ethical and sensible manner. Mr. Saver proposes several complementary and alternative reforms that would better accomodate the interests of all affected parties: the patients, their families, the researchers, and the general public.     

Research on medical records without informed consent

Observational research involving access to personally identifiable data in medical records has often been conducted without informed consent, owing to practical barriers to soliciting consent and concerns about selection bias. Nevertheless, medical records research without informed consent appears to conflict with basic ethical norms relating to clinical research and personal privacy. This article analyzes the scope of these norms and provides an ethical justification for research using personally identifiable medical information without consent.