Mechanistic reasoning and informed consent

Evidence‐based medicine (EBM) proponents have argued that mechanistic evidence concerning medical treatments should be considered secondary to evidence derived from randomized controlled trials (RCTs). One common criticism of RCTs is that they often do not yield results that are generalizable to clinical practice, and that for clinical practice application, mechanistic evidence is needed. However, proponents of EBM have argued that mechanistic reasoning is often unreliable and thus not very useful. Here we suggest an important role of mechanistic explanation that has been left out of this discussion entirely, namely, its importance in a patient’s decision of whether or not to take certain drugs. We argue that in certain cases, knowing how a treatment works is just as important for the patient as knowing whether it does. In this paper, we explore how and why giving patients mechanistic information can be an important factor in obtaining informed consent for medical treatment, focusing on the example case of hormonal contraceptives.     

DNA sampling and informed consent.

Standard consent forms for blood and tissue sampling are inadequate for DNA sampling. However, creating new and separate forms for each type of activity associated with DNA analysis (banking, linkage analysis and genetic diagnosis) tends to dissociate the participant from what is essentially a medical continuum. Furthermore, DNA sampling involves the sharing of samples and data among centres. To ensure patient control throughout this multifaceted process, we have developed an integrated approach to obtaining consent for DNA sampling at each level of participation. Movement from one level to another is reflected in the choices offered to participants. This inclusive approach is based on the underlying principle of informed consent, namely the respect for individuality, confidentiality and freedom of choice. This approach should help practitioners of medical genetics recognize the medical context of DNA sampling.     

Module two: informed consent

The objective of this module is to familiarise you with the concept of informed consent, its ethical basis, its elements, and typical problems that are encountered even by the most well intentioned researchers when trying to achieve genuine informed consent.     

How informed is signed consent?

The assurance that patients fully understand the information given to them before they sign the consent form for operation has never been validated in this country. One hundred patients were interviewed by an independent medical observer in one surgical unit in a teaching hospital between two and five days after their operation. Although all the patients interviewed were fully aware that they had had an operation, 27 did not know which organ was operated on and 44 were unaware of the exact nature of the surgical procedure. A significantly higher age group was observed in the group of patients who were unaware of the basic facts relating to their operation, and the problem was encountered most commonly in patients over the age of 60. Because of the medical and legal importance the findings of this pilot study warrant further large scale investigations.     

Physicians and the minefield surrounding informed consent.

Most of the legal cases that follow the informed-consent standard set in recent court cases have involved surgical procedures. However, issues concerning a pregnant British Columbia mother who contracted chicken pox and whose child was subsequently born with severe medical complications demonstrate the complexity of medical decision making and the inadequacy of established legal requirements, especially when consent has dimensions beyond technical considerations usually associated with medical procedures. The problem physicians face, says lawyer Karen Capen, is to find a way to balance a range of professional responsibilities and the overriding fiduciary obligation to patients in matters associated with informed decision making and consent.     

Medical experimentation, informed consent and using people

In this paper we argue that the standard focus on problems of informed consent in debates about the ethics of human experimentation is inadequate because it fails to capture a more fundamental way in which such experiments may be wrong. Taking clinical trials as our case in point, we suggest that it is the moral offence of using people as mere means which better characterizes what is wrong with violations of personal autonomy in certain kinds of clinical trials. This account also helps bring out another important way in which the autonomy of the participants in clinical trials my be violated, even in cases where they have given informed consent to their involvement. Where relevant information about the trial is framed in such a way as to induce a patient's participation by appeal to their nonrational preferences, this is also a violation of their autonomy, and one which is distinct from a failure of informed consent. The underlying wrongness of both kinds of violations, we argue, is plausibly captured by the moral offence of using people as mere means.