Kind of like finishing the Indy 500 on a yellow flag – with the government shut down and no one available to postpone the changes, it appears the new Common Rule revisions will go into effect January 21st.
After the 21st, the IRB will ask you to update your study forms. Below is a summary of the changes
that will now be required for all studies regulated under 45 CFR 46. Some studies regulated under 21 CFR 56 may be asked to be updated as well.
Informed Consent Forms (ICFs) need to be updated as follows:
Consent forms will now require a concise summary of study activities, risks, and
benefits presented to research participants in advance of the body of the
consent document.
In addition, the following elements need to be added to your consent:
New Basic Element at 45 CFR 46.116(b)(9)
One of the following statements about any research that involves the
collection of identifiable private information or identifiable
biospecimens:
- A statement that identifiers might be removed from the 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
- (ii) 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.
New Additional Elements at 45 CFR 46.116(c)(7) – (9)
46.116(c)(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;
46.116(c)(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
46.116(c)(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).
Protocols will also need to be updated it any of the above are added to your ICF.
For more information on the changes, please refer to our comprehensive guide and FAQs to the 2019 Final Rule or contact us directly at info@pearlirb.com.