Table.

Summary of New Consent Form Additional Elements

When the research involves	Include in the consent form
the collection of identifiable information or identifiable biospecimens	a 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 biospecimens	a statement indicating whether biospecimens may be used for commercial profit and if the subject will share in that profit
clinically relevant results	a statement indicating whether clinical results, including individual research results, will be returned to the subject and if so, under what conditions
whole genome sequencing	a statement indicating that the research will/will not/might involve whole genome sequencing