REVIEW PAPER
Quality of informed consent in clinical trials
1
Department of Ethics and Medical Law, Medical University of Lublin, Poland
Corresponding author
J Pre Clin Clin Res. 2020;14(1):22-24
KEYWORDS
TOPICS
ABSTRACT
Introduction and objectives:
Obtaining consent prior to any medical intervention is currently a necessity, the omission of which may lead to litigation. Years of analyses have resulted in strict policies as to what should the patient be informed about and who should provide such information. It would seem reasonable to assume that the concept of informed consent does not lead to any more quarries, however within the past few years a new concept pertaining to the quality of informed consent emerged. The aim of the article is to bring this concept closer.
Description of state of knowledge:
Quality of informed consent pertains to the information a patient understood during the consent process and the conditions under, which consent was obtained. Recent publications underline a discrepancy between what the patient knows and what the patient should know under the set requirements of informed consent. Research indicates that many clinical trial participants do not understand the provided information and are unable to enumerate basic items such as risk or benefits of the trial. What is more, the forms they obtain are too elaborate and do not facilitate the decision making process. All this undermines the essence of informed consent and decreases its quality.
Conclusions:
Despite years of working on the process of obtaining informed consent and elaborate forms that should facilitate decision making for patients, the information the patients have prior to entering the clinical trial are frequently insufficient to term the consent they make informed.
Obtaining consent prior to any medical intervention is currently a necessity, the omission of which may lead to litigation. Years of analyses have resulted in strict policies as to what should the patient be informed about and who should provide such information. It would seem reasonable to assume that the concept of informed consent does not lead to any more quarries, however within the past few years a new concept pertaining to the quality of informed consent emerged. The aim of the article is to bring this concept closer.
Description of state of knowledge:
Quality of informed consent pertains to the information a patient understood during the consent process and the conditions under, which consent was obtained. Recent publications underline a discrepancy between what the patient knows and what the patient should know under the set requirements of informed consent. Research indicates that many clinical trial participants do not understand the provided information and are unable to enumerate basic items such as risk or benefits of the trial. What is more, the forms they obtain are too elaborate and do not facilitate the decision making process. All this undermines the essence of informed consent and decreases its quality.
Conclusions:
Despite years of working on the process of obtaining informed consent and elaborate forms that should facilitate decision making for patients, the information the patients have prior to entering the clinical trial are frequently insufficient to term the consent they make informed.
ACKNOWLEDGEMENTS
The author expresses thanks Jakub Pawlikowski for his expert review.
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