Table.

Summary of New Consent Form Additional Elements

When the research involvesInclude in the consent form
the collection of identifiable information or identifiable biospecimensa statement indicating whether identifiers may be removed and if the deidentified information or biospecimens may or may not be used or shared for future research
use of biospecimensa statement indicating whether biospecimens may be used for commercial profit and if the subject will share in that profit
clinically relevant resultsa statement indicating whether clinical results, including individual research results, will be returned to the subject and if so, under what conditions
whole genome sequencinga statement indicating that the research will/will not/might involve whole genome sequencing