Obtaining Informed Consent for Research Studies

Obtaining Informed Consent for Research Studies
Book Chapter
Lynne M. Bianchi
Research during Medical Residency, 2022 [Taylor & Francis]
Abstract
This chapter describes how to communicate the information included in our institutional review board-approved consent form in an effective and appropriate manner to optimize comprehension and minimize undue influence and coercion. Effective communication involves more than simply reading the form to someone. Informed consent requires that potential participants are given the required information and sufficient time to decide whether they wish to join a study. The informed consent document and conversations include discussion of the voluntary nature of participation, the study purpose, methods, duration, risks, benefits, confidentiality of records, contact information for questions or concerns. Whether investigator- or participant-initiated withdrawal, if there are treatments, protocols, or follow-up appointments required to protect the well-being of the participant upon study withdrawal, those are explained in the consent form and reviewed during informed consent conversations. A parent or legally authorized representative grants the consent for the individual to participate.

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