Die Entwicklung des Konzepts der Einwilligung nach Aufklärung in der psychiatrischen Forschung View Full Text


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Article Info

DATE

2019-07-18

AUTHORS

Hanfried Helmchen

ABSTRACT

ProblemThe juridical concept of informed consent is based on respect for the right of self-determination. It has evolved since the end of the 19th century, has gained considerable significance through the rapid expansion of clinical research since the middle of the 20th century with the Declaration of Helsinki and particularly in the USA since 1972, and since then also in clinical practice. Clinical research in psychiatry soon encountered the basic problem that mental disorders may impair or even destroy the capacity to consent, the prerequisite for any participation in research.ProcedureAttempts to solve this ethical and legal problem during the past 30 years, from early questions provoked by the concept through the development of procedures for assessing the capacity to consent up to current proposals of research or proband advance directives and research permissions, will be outlined in the context of societal resonance as well as our own experience.AimThis review aims to elucidate the increasing differentiation of the concept; differentiation follows disputes about problems that result from the clinical implementation and efficacy of the concept in preserving the autonomy of research participants.Conclusions(1) The juridical concept of informed consent only then became serviceable with the development of clinical criteria for the establishment of consent capacity. In the context of research the determination of consent capacity is absolutely essential because the validity of the consent depends on it. (2) A gradual change can be recognized from the fulfillment of a legal obligation by the psychiatrist performing the research to ask the patient, after presenting information, for his/her consent now to a stronger patient orientation that acknowledges the right of self-determination and strives by the process of informing the patient to optimize his/her capacity to decide about research participation in a self-determined manner. Within this process the capacity to consent according to clinical criteria becomes determinable. (3) It is doubtful whether the latest legislative attempts are suited for ensuring research with individual self-determination without potential individual benefit with probands lacking consent capacity because it is questionable whether the preliminary but in principle only non-specific possible information along with a decision taken later by a specifically informed patient representative can be realized in a practically adequate manner. Ethically this controversial limitation of self-determination involves at least the risk that the relationship of individual well-being and community well-being would be decided to the disadvantage of the individual. In that way the concept based on consent after being informed as a basis for the right of self-determination could be placed in question. More... »

PAGES

207-220

References to SciGraph publications

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