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.     

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.     

Adolescents' capacities to provide voluntary informed consent

Minors' capacities to provide a valid informed consent for the treatment of medical and psychological disorders are contingent in part on the determination of whether they can make voluntary treatment decisions. The gravity of a medical dilemma and the nature of parental influence are two factors hypothesized to effect and perhaps compromise the voluntariness of treatment decisions made by adolescents. In the present study 40 14- and 15-year-old subjects were asked to note their conviction for treatment decisions they had made in response to hypothetical medical dilemmas in which parental influence varied. It was found that adolescents making treatment decisions are generally deferent to parental influence, although they are more likely to resist parental influence when the consequences of the decision have serious implications for the hypothetical adolescent's health.This investigation was supported in part by a grant from the American Psychology-Law Society/ Division 41 of the American Psychological Association, whose assistance is gratefully acknowledged. Gratitude is also extended to the Albemarle County School District, the Blue Ridge School. and St. Anne's-Belfield for their kind cooperation. The authors wish to thank William Gardner, Jeanne Smith, and Edith Lawrence for their work on behalf of this project. Special recognition is due to Lois A. Weithorn for her guidance and support of this research endeavor.     

Reshaping informed consent in the biobanking context

In my article, I discuss the role of informed consent in the context of biobanking. I argue that the basic issue in understanding the role of the consent is one of identifying the interests at stake and determining which of these interests we intend to promote. The definition of the informational content represents only a consequential step. For this purpose, I analyse the legal status of human biological materials from three different perspectives: "material", "informational" and "relational". Informed consent produces different effects on each of these perspectives. From the material perspective, consent can influence the allocation of property rights over human tissue; from the informational point of view, consent is the legal instrument that permits control over personal data; while from the "relational" perspective, it is possible through consent to ensure that the person's personal beliefs are respected. The crucial point is that the legal effects that informed consent has on the three perspectives overlap. Therefore, in order to understand the role of informed consent holistically, in this article I analyse how these perspectives relate to each other. This analysis shows that the relationship between the perspectives can vary depending on the interests that we intend to promote. If we intend to promote the freedom of research, then the material dimension can prevail, whilst if we focus our attention on the interests of individuals then the informational and the relational dimensions will prevail. The challenge is to find a good balance between these two extremes.