Frequently, by the time a monitor or CRO is brought into a clinical research study, the protocol, case report forms, and informed consent template have been finalized. As noted in 21 CRF Part 812.42, the sponsor is required to have all study documents approved by the participating institution’s IRB. As the sponsor is working to create their informed consent document, they likely reference 21 CFR Part 50, specifically incorporating 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, but may be required by the sponsor of the clinical study, or by the IRBs for the specific investigative sites.
Many sponsors may not realize that since monitors are also well-versed in the applicable clinical federal regulations, we could assist them by providing a “second set of eyes” to review their informed consent template prior to its distribution to all site IRBs. We 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.
In addition, we see many different informed consent templates from a variety of sponsors and sites. For this reason, we may be able to provide valuable insight to the sponsor, if provided the opportunity to review the informed consent prior to its distribution to sites and subsequent IRB approvals. For example, a sponsor may not want to include a line for subject initials on each page of the informed consent, as monitors can confirm that we commonly see pages missed or resulting documentation errors.
During our review of the sponsor’s informed consent template, we may also confirm with the sponsor that they do not plan to include one or more of the additional elements on informed consent in 21 CFR 50.25(b). There have been times when this has been noted after the fact, and the sponsor has acknowledged that they would like to revise the informed consent document to include these missing elements. In addition, the monitor may catch an oversight, such as an error in the requirements of the protocol, including testing and follow-up visit schedules that are not noted or are noted incorrectly, as the informed consent template was likely used from a previous study or phase of the study.
Bottom line- monitors are trained to be meticulous in their reviews and have a strong knowledge of the applicable Federal Regulations concerning informed consent. Part of our job is to help facilitate the clinical study for our sponsors, and this would be one way to double-check that any potential informed consent template errors are identified and rectified quickly and efficiently.
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