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Respect for the individual is a fundamental ethical principle of human subjects research. While informed consent is an essential component of clinical research, it remains unclear how to ensure that consent for study participation is truly informed. Many studies have reported poor comprehension about research information among patients following informed consent discussions. The ethics of informed consent are even more complex in paediatric clinical research, where parents must make proxy informed consent decisions for their children.
Informed consent forms supplement informed consent discussions as an additional source of information for patients who are considering research participation. An informed consent form should contain sufficient and accurate information to ensure potential participants (or their proxies) are equipped to make a valid decision about a given research study. However, these documents have become progressively longer over time,1 largely in response to increasing regulatory requirements. As a result, key study information can be hard to find, and current informed consent forms often fail to achieve their primary purpose: to inform.
Many proposed interventions to improve informed consent forms have focused on either increasing or condensing the information presented. To date, these strategies have been largely unsuccessful at enhancing participant understanding. While multiple studies have demonstrated that shorter informed consent forms are as effective as longer forms for participant understanding, …
Funding Eunice Kennedy Shriver National Institute of Child Health and Human Development (K23HD084727).
Competing interests None declared.
Provenance and peer review Commissioned; internally peer reviewed.