Considerations For Informed Consent In Clinical Trials Involving Neurologic Disorders
By Linda Reuter
Informed consent is a cornerstone of ethical clinical research. As stated in the Belmont Report, a foundational research ethics document, true informed consent must have three components: information, comprehension and voluntariness.
Delivering information is the most straightforward part of informed consent. In addition to the informed consent document, research teams, sponsors, CROs and/or study monitors can provide other written documents, verbal explanations and supplementary materials about the clinical trial.
However, in clinical trials involving participants with neurological disorders, the participants’ ability to comprehend the information provided as part of the informed consent process is where ethical challenges can arise. Participants must receive and understand the information, which requires clear communication and opportunities to ask questions. Without genuine comprehension, voluntariness is at risk, as individuals may not be able to make a truly informed choice about participation in a study. Therefore, it is essential to consider the appropriate ethical considerations when developing informed consent documents and related processes to ensure participants grasp the implications of their decision and are free from coercion or undue influence.
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