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informed consent is arguably the most critical aspect of any clinical trial in the previous module we reviewed the ethical and regulatory impacts on informed consent as it relates to clinical research now we will explore the specifics of the process and discuss the nine key elements that make up any informed consent document this module will be followed by a brief knowledge check to assess your understanding of the topic lets begin our learning objectives for this module will be to understand the basics of the informed consent process to be able to identify the nine different elements of an informed consent and then to apply those nine basic elements to any given research study icf document now lets get started with a review of the basics informed consent is a standardized process that provides participants with all information necessary in order to make an informed involuntary decision the information in nicf must be comprehensible by the receiving party and free of any exculpatory
