Abstract
Ethical requirements of informed consent stipulate that patients approached to participate in a clinical trial be provided with written information that must cover key aspects of the trial. For consent to be deemed “informed”, potential participants should be provided with a range of information about the trials (e.g., the trial aims, the anticipated benefits and potential risks of the trial, and their right to withdraw consent at any time). However, it is well documented that simple provision of this information does not ensure that participants make truly informed decisions. Decision aids, tools that have been shown in a treatment and screening context to support better-quality decisions, are emerging as a possible vehicle to support decision making about trial participation. However, information on how they should best be developed and evaluated in a clinical trial context is lacking. Therefore, this article, drawing on theoretical and empirical insights, outlines a framework for the development and evaluation of decision aids for people considering taking part in a clinical trial.
Highlights
The requirement for informed consent to be sought from potential participants when they are deciding whether to enter a clinical trial is enshrined in the Declaration of Helsinki and several other international and national regulations [1,2,3]
We reviewed a range of possible candidate frameworks and identified the Ottawa Decision Support Framework (ODSF) as being a highly relevant theoretical framework to use for development of trial participation decision aids
To determine what the content requirements of any trial participation decision aid would be, we first conducted a concept-mapping exercise. This concept-mapping process brought together the evidence we identified from the literature relating to factors that influence an individual’s decision about whether to participate in a clinical trial, the regulatory guidance on what information participants have to and should be told when considering trial participation, and the International Patient Decision Aid Standards (IPDAS) content items [27]
Summary
The requirement for informed consent to be sought from potential participants when they are deciding whether to enter a clinical trial is enshrined in the Declaration of Helsinki and several other international and national regulations [1,2,3]. Providing ways for people to be able to compare options, facilitating the ability to make trade-offs between options, and allowing people to weigh up potential outcomes of decisions and assess how different outcomes matter to them have all been shown to promote “good” decisions [8]. These items, and others, are often included in socalled “decision aids”, formal tools which help people to participate in treatment (or screening) decisions that involve weighing up associated benefits and harms in the face of clinical uncertainty [8, 9].
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