Creating an Informed Consent Process
Informed consent is not a single event or just a form to be signed — rather it is an educational process that takes place between the researcher(s) and the prospective participant. 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 greater the potential risks - whether physical in nature or not - the greater the need for a deliberately outlined process.
The investigator should create a process specific
to that protocol, or develop standard operating procedures for all the research
being conducted under their lead. The documentation of a process helps researchers
understand what their responsibilities are regarding informed consent. The
written process contains the details of how the information will be presented
to participants - in addition to the complete execution of the informed consent
document.