However, the lack of regulatory guidance regarding content and length has been problematic. Results: The key information section is intended to be a concise and focused presentation at the beginning of the informed consent document that facilitates potential participants’ comprehension of the research. Methods: We review the history of informed consent as a legal and regulatory concept and the intended impact of the new key information section, a requirement that was introduced in the 2017 revisions to the Common Rule. ![]() Yet the process of informed consent used in clinical research and the lengthy consent documents that are difficult to comprehend have been criticized. Background: The concept of informed consent has evolved significantly with regard to both the practice of medicine and research conducted with human volunteers.
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