Informed consent to research is not simply the signing of a document, nor verbal or implied acquiescence to participation. Instead, informed consent describes a process by which potential subjects are offered information about the research as it applies to them, followed by a reasoned and voluntary decision to participate.
Whether given verbally or in writing, specific information about each study must be tailored to the level of understanding of each person invited to consent, assent or give permission. Because research subjects come from a variety of backgrounds and educational levels and are frequently under physical and emotional stress, it is important that consent forms are easy to understand. If a medical term is essential, include a lay definition.
Only after providing sufficient opportunity to consider whether or not to participate, and after possibilities for coercion or undue influence are minimized, should prospective subjects be asked for consent.
The informed consent document provides a guide for the researcher and potential subject. The document must describe the research in such a way that the potential subject will understand the information necessary to reach an informed choice about participation.
The principal investigator is responsible for ensuring that informed consent is obtained from each research subject and that the document is signed and dated appropriately. The PI remains responsible even if the obtaining of informed consent has been delegated to other members of the research team. Informed consent must be obtained prior to initiation of any screening procedures that are performed solely for the purpose of determining eligibility for research.
Signed ICFs, and all study data, are to be retained by the principal investigator for a minimum of three years.
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