Informed consent is an essential part of the design of every research project involving human subjects. Researchers who involve human subjects in their research have both an ethical and legal obligation to secure the informed consent of the potential research subjects prior to initiation of the research. The basic elements of effective informed consent are: A. the full disclosure of the nature of the research, any risks and benefits, and a description of what the subjects will experience; B. adequate information for the potential subjects to make an informed choice about participating in the research; C. disclosure of measures to protect privacy and confidentiality; D. affirmation of the subject’s voluntary choice to participate.

Designing ICF

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