Informed consent checklists, just like the informed consent, are more than just a document, but rather can be a process. To begin, what is an informed consent checklist and how do you use one?
According to 21 CFR 50.20, an investigator must obtain
The regulations go on to list the required elements of the informed consent, 21 CFR 50.25 (a) and additional elements of the informed consent, 21 CFR 50.25 (b), which may be applicable depending on the type of study.
This is where an informed consent checklist can be helpful. A checklist can be developed and used by the sponsor or investigator to ensure compliance with the federal regulations (21 CFR 812.40 and 21 CFR 812.100 respectfully) as they relate to 21 CFR 50, Protection of Human Subjects. Reviewing members of an IRB may choose to utilize a checklist to ensure compliance with 21 CFR 56.109 (b), requiring that information given to subjects as part of the informed consent is in accordance with 21 CFR 50.25. A checklist can list all of the required and additional elements of the informed consent and all requirements of HIPAA according to 45 CFR 160 Part 160 and Subparts A and E of Part 164.
But, is just completing a checklist ensuring that the subject is being presented with all of the risks, benefits, and all other important information to know related to participating in research enough? We don’t think so- read on for helpful ICF checklist hints.
1) Don’t just check the list, read the consent! If the informed consent checklist is developed solely based on the required/additional elements as noted in the regulations, details related to the protocol may be missed, such as:
- Protocol specific procedures
- Expected timelines and commitments of participating in a particular trial
- Number of sites or participants as noted in the protocol
- Expected adverse events
Simply checking a box to confirm that the statements or elements are present does not allow the reviewer to have a holistic review of the content of the informed consent.
2) Review prior to submission to the IRB! Typically, it is the sponsor that is performing the review of the informed consent documents provided by the site. Once the site receives the template and adds institution specific language, the informed consent is again reviewed by the sponsor prior to IRB approval. This is an ideal time for the sponsor to complete the IRB checklist. If the sponsor waits until after the site has IRB approval and missing elements are noted, additional submissions and review will be required by the IRB, extending the time to study start-up.
4) When the informed consent changes-check again! When there is an amendment to the protocol or a change to significant information presented to the subject, the version of the informed consent is updated. There are often several versions circulated between the sponsor, site, and IRB. A required element of the informed consent may be inadvertently removed or amended incorrectly. A review of the informed consent checklist when the version changes
These are just a few helpful hints when utilizing an informed consent checklist. Can you think of more? Have you used an informed consent checklist in the past? Do you find them helpful? Please share your thoughts below.