Search term Gene therapy The general approach of gene therapy is nothing more than an extension of the technique for clone selection by functional complementation Chapter
Previous Section Next Section Introduction The practice of informed consent has roots in multiple disciplines, including the health professions, the law, and moral philosophy. In this article, we first explore the ethical and moral basis, the legal grounding, and the limitations of informed consent to treatment.
We then consider informed consent in the research setting. Informed Consent for Medical Treatment The discourse of informed consent has been framed primarily through the languages of law and of moral philosophy [ 1 ]. The legal doctrine of informed consent to treatment has evolved largely through the medium of case law [ 1 ].
Because of the retrospective and adversarial nature of the legal system, the notion of informed consent to treatment has taken on a defensive flavor. This plays out, for example, through heightened attention to disclosure of risks.
While the risk-management aspects of informed consent cannot be ignored, informed consent has had fundamental and positive practical and moral consequences for the practice of medicine.
Bioethicists view informed consent as the practical embodiment of respect for persons and for individual autonomy. Autonomy includes notions of self-governance, liberty rights, and privacy [ 2 ]. Informed consent can be seen through at least two lenses [ 2 ]. The first relates to the concept of autonomous authorization of a medical intervention.
This notion of informed consent is exemplified in Mohr v. Williams [ 25 ].
In this context, the patient consents if she intentionally authorizes a professional to perform a procedure, after expressing understanding and in the absence of control by others [ 2 ].
An alternative conception mandates that a legally valid consent be obtained prior to a medical procedure, thereby locating informed consent in the realm of social rules and institutional contexts [ 2 ].
This definition deals with the institutional rules of consents and does not necessarily insist on consent as an autonomous act.
The consent is valid if it occurs within the rules that govern specific institutional practices [ 2 ]. Valid informed consent incorporates five elements: In practice, we assume that adults are capable of making decisions unless there is strong evidence to the contrary [ 3 ].
The stringency of the standard varies according to the significance, complexity, and consequences of the decision [ 10 ].
For example, a 17 year old may have the capacity to make decisions for him- or herself, but not be competent from a legal point of view.
Disclosure involves providing the patient with the information needed to understand a procedure [ 23 ]. This information includes the nature and purpose of the treatment, as well as its risks, potential benefits, and available alternatives [ 23 ].
Information should be disclosed using simple explanations [ 3 ]. Common complications, irrespective of severity, should be described, as should less frequent but potentially serious or irreversible risks [ 134 ]. Understanding requires that the patient comprehend the information given and appreciate its relevance to her individual situation [ 23 ].
There is little consensus in either law or ethics about what constitutes sufficient understanding [ 12 ]. The courts have not generally held that failure of understanding invalidates informed consent [ 4 ]. Instead, they have relied on evidence of disclosure when determining if a patient was adequately informed [ 34 ].
Consent forms facilitate and document this authorization but should be seen as secondary to the process through which the patient and the physician discuss and negotiate the proposed treatment [ 3 ].
Limitations of Informed Consent Although informed consent is intimately linked to the deontological notion of respect for persons, it also plays an important and positive instrumental role within medical care.
However, it is possible to overstate the benefits of informed consent [ 4 ]. Two limitations of the informed consent paradigm bear mention.
First, although informed consent facilitates communication and decision making between physicians and patients, it cannot create opportunities for autonomous choices when such choices are absent in reality.
Second, informed consent has developed within a particular cultural context.Personalized medicine or precision medicine, is a medical model that separates people into different groups—with medical decisions, practices, interventions and/or products being tailored to the individual patient based on their predicted response or .
The impact of fetal gene therapy for the medical profession, however, has gained much less attention, even though the prospect of gene therapy in the womb promises to change the practice of prenatal medical treatment fundamentally.
Jul 19, · Researchers at University of Massachusetts Medical School and Auburn University College of Veterinary Medicine are nearing human clinical trials on a genetic therapy 3/5(5).
That Medicine is a science is the popular belief, and this has been reinforced by the advent of ′evidence-based medicine. However, the view of science implied is a narrow one, foreign both to pure scientists and to artists and the art of medicine is devalued by this approach.
Above all, discussions on controlling recombinant DNA technology (which forms the basis for human gene therapy) are at the interface of medical treatment and clinical research.
In both the United States and Japan, public discourse on the self-regulation of recombinant DNA technology in the s was associated with the formation of the field of bioethics (Krimsky ; Nagai et al. ). The general approach of gene therapy is nothing more than an extension of the technique for clone selection by functional complementation (Chapter 12).