Informed Consent Changes in the Revised Common Rule

Many of the revised Common Rule’s changes aim to make informed consent more meaningful, so that research subjects have the necessary information to make informed decisions. In practice, this means changes to ICF requirements.

If your research must comply with the revised Common Rule, you’ll need to update the way you write ICFs to meet the new requirements. And even if you don’t conduct research subject to the Common Rule, it’s important to be aware of these new requirements, as it’s likely you’ll soon encounter ICFs that incorporate these requirements. (If you’re not sure if your research is subject to the Common Rule, this blog may be helpful.) Read on for an overview of the revised Common Rule’s new ICF requirements.

Key Information

Key information about the study must be provided at the beginning of the ICF. The presentation must be concise and focused, and the information should be provided in sufficient detail, organized and presented in a way that helps subjects think about why they might or might not want to participate.

The standard is to provide the information that a reasonable person would want to have in order to make an informed decision about whether to participate.

Consider the following questions when writing your key information:

• What are the main reasons a subject will want to join this study?
• What are the main reasons a subject will not want to join this study?
• What is the research question the study is trying to answer? Why is it relevant to the subject?
• What aspects of research participation in this particular study are likely to be unfamiliar to a prospective subject, diverge from a subject’s expectations, or require special attention?
• What information about the subject is being collected as part of this research?
• What are the types of activities that subjects will do in the research?
• What impact will participation in this research have on the subject outside of the research? For example, will it reduce options for standard treatments?
• How will the subject’s experience in this study differ from treatment outside of the study?
• In what ways is this research novel?

Note that if information included in the key information section also satisfies the basic elements or additional elements of informed consent (under 45 CFR 46.116[b] and [c]), this information does not need to be repeated later in the ICF.

New Basic Consent Element

For research that involves the collection of identifiable private information or identifiable biospecimens, the ICF must now include a notice about whether information and biospecimens collected as part of the current research might be stripped of identifiers and used for future research. Include 1 of the following statements as appropriate:

• That identifiers might be removed from the identifiable private information or identifiable biospecimens and could then 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.

OR

• 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.

We suggest using caution when implementing the second statement in your ICF, as it can be very challenging to keep subjects’ information or biospecimens from being used for future research. This is not to say the second statement should not be used; researchers will just need to be extra vigilant to make sure the information/biospecimens are used and not used in accordance with the ICF.

3 New Additional Consent Elements (Include if Applicable)

Include the following information in the ICF only when appropriate:

• Commercial profit – A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subjects will or will not share in this profit.
• Clinically relevant results – A statement whether clinically relevant research results, including individual research results, will be disclosed to subject and, if so, under what conditions.
• Genome sequencing – 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).

Some IRB professionals have opined that these ICF changes could be the hardest part of implementing the revised Common Rule. That may well be true; the ICF is already a rather complicated document. But any kind of change comes with some degree of difficulty. With plenty of communication and patience, we’ll make it through this transition—and improve the research experience for study subjects while we’re at it.

Need more information on complying with the revised Common Rule? View our webinar Making a List, Checking It Twice… The Revised Common Rule Is Coming to Town!

For assistance in implementing these requirements for a new study submission, contact Business Development.

Back to Resources