Additional elements of Informed Consent:

(1)     A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable;

(2)     Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s or the legally authorized representative’s consent;

(3)     Any additional costs to the subject that may result from participation in the research;

(4)     The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject;

(5)     A statement that significant new findings developed during the course of the research that may relate to the subject’s willingness to continue participation will be provided to the subject;

(6)     The approximate number of subjects involved in the study;

(7)     A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;

(8)     A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and

(9)     For research involving biospecimens, whether the research will (if known), or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen.