As noted in our previous blog, in most cases when a monitor or CRO is brought into a clinical research study, the protocol, case report forms, and informed consent template have already been finalized. Moreover, some or all investigative sites may have already received IRB approval of their protocol and informed consent document. As noted in 21 CRF Part 812.42, the sponsor is required to have all study documents approved by the participating institution’s IRB. The IRB, on the other hand, is required to review clinical research activities, as noted in 21 CFR 56.109.
Prior to distribution of the study documents to the participating clinical sites, the sponsor has undoubtedly referenced 21 CFR Part 50 to incorporate all of the required elements of informed consent into their template. Although many of these elements are required, per the Federal Regulations in 21 CFR 50.25(a), there are also additional elements of informed consent noted in 21 CFR 50.25(b). These are not required by the Federal Regulations, or the sponsor of the clinical study, but many IRBs for the specific investigative sites choose to include many of these, such as number of subjects who may be involved in the study, etc.
Once an IRB reviews and approves the informed consent document, the sponsor may not see the benefit of having the monitors also review this form. Even so, IMARC monitors routinely perform a thorough review of all informed consent documents as standard practice in our site management duties; after visiting a site for the first time, or even prior to a site initiation visit, we complete a checklist to ensure that all required information is included in that informed consent document. It is important for monitors working on a study to be familiar with the IRB requirements for each of their sites, and performing a review of the IRB-approved informed consent document is one of the tools we use to ensure we understand any IRB-specific requirements (i.e. including an impartial witness for every subject consent, etc.)
It may be surprising how often our review of the IRB-approved informed consent results in a revision to the document, either driven by the sponsor or the site. Several examples include:
- Incorrect or missing IRB approval dates
- Informed consent version date not updated
- Missing one or more required elements of informed consent
- Missing required HIPAA language
Furthermore, there have been occasions when sponsors realize that they would like to include one or more of the additional elements on informed consent in 21 CFR 50.25(b), after the informed consent has received IRB approval at one or more sites. Once changes to the IRB-approved informed consent are deemed necessary, it may be a complicated and lengthy process to revise the document; additionally, the sponsor or IRB may then require that previously enrolled subjects are re-consented. Having the monitor review informed consents early in the approval process may help alleviate this potential issue.
Do you agree that there are benefits to a monitor reviewing the informed consent documents, even after they have been IRB-approved?
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