Writing an Informed Consent Document

Drafting a good IC document is not as easy as it may look. Although a well-developed IC template with imbedded instructions and examples is useful, it does not guarantee an adequate document. Mentoring in the preparation of an IC document can be quite helpful. Although the IRB is in a sense the PI's partner in research, it must maintain its distance to be objective. The IRB must be retrospective and independent - and therefore is unable to directly collaborate with the PI in design or implementation of any part of a research study.

A poorly written IC document can be confusing and even opaque to the participant. If unnecessarily long and complicated, the IC document can either intimidate a participant into consenting without full understanding (embarrassment at lack of comprehension; de facto delegation of decision to RTM on the assumption that the topic is beyond the participant's ability to understand), or scare off an appropriate candidate. Neither outcome serves the participant or the research project well. An IC comment should be only long enough to convey all needed information succinctly and clearly.