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Biomedical subjects

M C Lara

Publications and source records attributed to M C Lara.

3 recordsLinked to original sources

On informed consent.

The question of whether patients should influence medical decisions, and if so how much, is not simple. Among other things, it is necessary to decide whether the patient's well-being should take precedence over respect for the patient's autonomy, or vice versa; whether or not the patient has the capacity to exercise true autonomy; what information should be furnished in order to provide the patient with the basis for making a decision about treatment; and how such information should be provided. This article examines these matters, reviews the pros and cons of various methods for obtaining patients' informed consent, presents some broad guidelines for dealing with informed consent issues in a therapeutic setting, and discusses ethical principles that should be applied in obtaining patients' informed consent to participate in clinical research.

Clinical Trials as Topic

[The informed consent].

To what extent can or should a patient influence medical decisions? For a valid decision to be made, it is usually considered essential that the patient be autonomous and competent. If a person is not incapacitated for autonomous action, he can accept or reject a medical intervention on the basis of the information available to him. This raises the question of what the patient is to be told. The answer rests on which value is considered fundamental in medical practice: the patient's well-being or respect for his status as a person. This controversy arises in both the strictly therapeutic and the research contexts. In both cases, information must be explicit and clear. Many printed forms are hard to understand; the patient's signature merely precludes the possibility of legal problems. Depending on the kind of disease and treatment, the patient's consent may at times be almost tacit while at other times it should be based on complete information, especially if his decision seems irrational or contrary to the physician's judgment. In clinical trials, information and consent problems usually relate to the possibility that information given the participant will invalidate the findings. Nevertheless, the patient's rights and well-being should always be considered more important than the research.

Human Experimentation