Informed Consent combines two different processes: one, the researcher informing the potential or participating subject, and two, the individual consenting or not. Both processes may be thought to extend from the moment of first contact until the research is concluded, which in some cases may be several years after last contact.
The researcher has a continuous and undiminished responsibility to keep the human subject informed about the purposes and risks of the the research. The subject has the right to disengage from the research at any time without any personal consequences. Consenting is a valid process only when the informing is appropriate.
Researchers must bear in mind that, although they may have hypotheses about what will happen in the course of research, the very nature of research includes the concept of surprise results. For this reason the principle of continuous informing exists in all human subjects research, and it must be anticipated and provided for.
In the following pages the specific elements of the informing process are covered.
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