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Informed Consent
A person's voluntary agreement, based upon
adequate knowledge and understanding of relevant information, to participate in
research or to undergo a diagnostic, therapeutic, or preventive procedure. In
giving informed consent, subjects may not waive or appear to waive any of their
legal rights, or release or appear to release the investigator, the sponsor, the
institution or agents thereof from liability for negligence.
Informed consent is a process, not just a
form. Information must be presented to enable persons to voluntarily decide
whether or not to participate as a research subject. It is a fundamental
mechanism to ensure respect for persons through provision of thoughtful consent
for a voluntary act. The procedures used in obtaining informed consent should be
designed to educate the subject population in terms that they can understand.
Therefore, informed consent language and its documentation (especially
explanation of the study's purpose, duration, experimental procedures,
alternatives, risks, and benefits) must be written in "lay language", (i.e.
understandable to the people being asked to participate). The written
presentation of information is used to document the basis for consent and for
the subjects' future reference. The consent document should be revised when
deficiencies are noted or when additional information will improve the consent
process.
Use of the first person (e.g., "I understand
that ...") can be interpreted as suggestive, may be relied upon as a substitute
for sufficient factual information, and can constitute coercive influence over a
subject. Use of scientific jargon and legalese is not appropriate. Think of the
document primarily as a teaching tool not as a legal instrument.
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