Do you sign consent documents even when someone else actually carried out the informed consent process? As a result of the Bureau's research quality assurance program the Scientific Committee has become aware that some principal investigators sign consent forms after someone else – usually a resident or junior member of the research team – has carried out the informed consent process, when the PI was not actually present to witness the interaction.

The signed consent document attests that the consent process -- the verbal exchange between investigator and potential subject -- was carried out appropriately and completely. You cannot attest to that fact if you were not there for the entire informed consent process.

When a PI signs a document for a consent process he/she did not witness, the document itself can be called into question. If a signature suggesting that the PI witnessed the interaction is misleading, then what else may not be true?

It is completely appropriate, of course, for a PI to review the signed documents to insure that all the blanks have been filled correctly. A signature attesting that all the blanks have been filled is more than a little redundant, however, and a signature that suggests that the PI has overseen more than the paper work can undermine the whole rationale for documenting informed consent.