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 legally effective informed consent of a subject or the subject’s legally authorized representative and provide the subject with sufficient opportunity to consider participation without coercion or influence. This consent must be in a language that the subject can understand and contain no language which waives or appears to waive the subject’s legal rights or releases the investigator, sponsor, or institution from liability for negligence.
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 maybe missed , such as:
- Protocol specific procudures
- 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.
3) A second set of eyes never hurts! A second set of eyes may mean a second level of review by the sponsor or the investigational site may want to have their own checklist in their review process. The investigational site may go a step further and include IRB specific requirements in the checklist to ensure compliance to IRB policies and procedures.
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 demonstrates good practice in ensuring compliance to 21 CFR 50.25 (a) (b).
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.
Photo Credit:KristinNador
A checklist is a must for a Sponsor working with clinical sites as they all use different consent templates.They more often than not contain all the elements, either in a different section or worded differently compared to the model/sample IC.
A checklist is a must for a Sponsor working with clinical sites as they all use different consent templates.They more often than not contain all the elements, either in a different section or worded differently compared to the model/sample IC.
2) I would keep the HIPAA checklist separate
3) Don't forget a checklist for children.
Erica
2) I would keep the HIPAA checklist separate
3) Don't forget a checklist for children.
Erica
Your article is very interesting and useful. It is very true that ICFs usually lack information about the study protocol schedule! As a translator, I would also recommend that the whole text be reviewed after an update is done, since some parts may be inadvertently deleted (and not tracked) in the process, and that a lay person reads the final translation to ensure that it is simple and clear :)
Your article is very interesting and useful. It is very true that ICFs usually lack information about the study protocol schedule! As a translator, I would also recommend that the whole text be reviewed after an update is done, since some parts may be inadvertently deleted (and not tracked) in the process, and that a lay person reads the final translation to ensure that it is simple and clear :)