All consent forms must now have one of the following two statements, whichever is appropriate:
o A statement that identifiers might be removed from identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; OR
o A statement that the subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies
Please note: If you include the first statement above, it means that you (or other investigators) may decide to use the de-identified information or biospecimens in future secondary research studies approved by the IRB. This is consistent with IRB policies and practices that were already in place prior to the recent revisions to federal guidelines; the statement that is now required simply makes this practice explicit for potential research participants. If you include the second statement, identifiable information or biospecimens collected for your study cannot be used in any future secondary research studies, without exception. Researchers applying for approval of secondary research studies will now need to provide confirmation for the IRB that the first statement above was included on the consent form at the time the data was initially collected (this applies only to data collected for primary research studies on or after January 21, 2019).