Creating an Informed Consent Process
Informed consent is not a single event or just a form to be signed. It is a description of the procedures that are in place to ensure that informed consent occurs for every participant. Some research, for example, a simple survey, might not require an exhaustive process, however more complicated research would benefit from a very specific written set of procedures.
The investigator should create an informed
consent process that is protocol specific or develop standard operating procedures
for the research group/department. The written process contains details of
how information will be presented to participants, in addition to the execution
of the informed consent document. Creating an informed
consent process assists researchers in understanding their role and responsibilities.