Abstract
Informed consent is an essential part of an ethical clinical trial; to this end, researchers have developed several interventions to promote participants’ full understanding of trials and thereby improve the consent process. However, few empirical studies have examined how patients make the decision of whether to give consent. The objective of this study, therefore, is to analyze patients’ decision-making process when participating in clinical trials. We conduct an internet survey (n = 2,045) and interview data analysis (n = 40) with patients and categorize respondents into three types of participants: active, passive, and non-participation. Our results show that patients often make informal and quick decisions before medical staff provide them with relevant information during the informed consent process. For example, 55.9% of patients received initial information on clinical trials from an online article or web advertising, and 54.5% consulted no one about whether to participate in the clinical trial before making a decision. Only 20.7% of respondents subjectively spent time making the decision whether to participate; 43.0% of patients who said that they “spent time” coming to a decision took four or more days to reach a decision, while 8.3% of people who “did not spend time” making a decision took this among of time. Based on these results, we were able to break patients’ decision-making process into four steps: first contact, informal decision making, relevant information, and formal decision making. Our results show that patients are most likely to make a decision based on the first information they receive on the clinical trial, whatever the source. To this end, having a list of questions for potential participants to ask researchers would be useful in helping better collecting information of clinical trials. In addition, research teams should give patients more than four days to decide between providing them with relevant information and obtaining written consent, even if the patient seems to make a quick decision.
Highlights
Clinical trials have social value, producing scientific knowledge that can lead to improvements in public health and medical care
The value of audio-visual interventions in helping enhance the informed consent process for potential clinical trial participants remains largely unclear [4] and there is insufficient evidence of whether decision aids are more effective in decision-making than standard information [5]
Current informed consent documents do not encourage good-quality decision-making among clinical trial participants [6,7]
Summary
Clinical trials have social value, producing scientific knowledge that can lead to improvements in public health and medical care. The Declaration of Helsinki dictates current guidance and regulations for patient treatment [1]: patients must be given the opportunity to provide informed consent based on a “respect for persons.” This means that in order to give consent, individuals must be accurately informed of the purpose, methods, risks, benefits, and alternatives to the research; understand this information and its bearing on their own clinical situation; and make a voluntary and uncoerced decision on whether to participates [2]. To this end, investigators must provide potential participants with all relevant information before they enroll in a clinical trial. Current informed consent documents do not encourage good-quality decision-making among clinical trial participants [6,7]
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