Description
Informed consent in clinical research is an ethical and regulatory requirement. A research subject must enter a study voluntarily, be informed about risks and benefits, and understand the difference between investigation and treatment. Subjects must not be coerced into enrolment, nor must they be enticed by exaggerated claims of benefit. Before they can enroll, all potential subjects must agree, in writing, to participate.
In addition to ethical and regulatory imperatives, the potential for litigation by subjects further highlights the importance of rigorous adherence to informed consent principles.
In this module we set out the principles and requirements and provide examples of practical issues confronting healthcare professionals and subjects.
Throughout this module, references to consent by a subject apply either to the subject or to his/her legally acceptable representative.
