45 CFR 46.116 (a)(5)(i) (Revised) adds a requirement,
Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.
45 CFR 46.116 (b)(9) (Revised) adds a new required element of informed consent:
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
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.
45 CFR 46.116 (c)(7), (c)(8) and (c)(9) are additional elements of consent required only when appropriate given the nature of the research at hand:
- 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;
- A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and
- 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).
Added informed consent document requirements under the 2018 regulations will apply to:
- Studies initially approved on or after the Effective Date
- Studies initially approved before Effective Date, ONLY if ALL of the following apply
- Current or pending funding from a federal department or agency applying the Common Rule
- Future study activity after Effective Date includes
- Ongoing consent process (new enrollment or anticipated occasions warranting re-consent), and
- greater than minimal risk to subjects
In the interest of transparency, although it is not yet a regulatory requirement, IRBMED consent template revisions as of spring 2018 incorporate additional required statements about the re-use of information or biospecimens, and about the potential for profit to researchers, companies, or others.