Series: Helpful Information from BRANY’s Quality Assurance Team Introduction and Informed Consent Process
Introduction
BRANY’s Quality Assurance team conducts Quality Assurance Reviews of clinical trials across all indications. The purpose of these reviews is to assess compliance with applicable regulations, IRB determinations, and the study protocol. These reviews are also an opportunity for study personnel to see areas where they need to improve research conduct and areas where they are doing well. Are there areas where your study team could improve the quality of research you are conducting? Find out by following along with the QA team’s upcoming series of posts on the BRANY LinkedIn page. The QA team will summarize common findings based on Quality Assurance Reviews and provide helpful tools that can be used to assess compliance at your site. They will explore four topics of common findings: informed consent process, eligibility criteria, protocol deviations, and regulatory document including study personnel documentation.
Informed Consent Process
Welcome to the first topic in the BRANY QA team’s series discussion of common findings from our Quality Assurance Reviews. Part of the Quality Assurance Review is to review the informed consent process. There are several common noncompliance issues related to the informed consent process that the BRANY QA team finds during our reviews. When reviewing the signed consent form, we often find missing signatures, printed names, dates, or initials as required on the consent form. We will also confirm that the correct, IRB-approved consent form was used to obtain informed consent. A common finding is that, when obtaining informed consent, sites use an outdated version of the consent form or use the correct version without an IRB-approval stamp on the consent form. We will then confirm that the person obtaining informed consent is appropriately delegated to do so as we often find that personnel are not delegated on the Delegation of Authority log to obtain informed consent. Next, we will review the informed consent process note if one is available. A common finding is that there is no documentation of the informed consent process, including documentation of any re-consents. We review the note to confirm that, at the very least, the participant’s questions were answered, informed consent was obtained prior to any study procedures, and that the participant received a signed copy of the informed consent form.
BRANY has tools focused on the informed consent process that can be helpful. BRANY’s Informed Consent Process Guidance Checklist can be a useful tool for your site to assess compliance. BRANY’s enrollment note template can be used as a starting point to document the informed consent process. To download the checklist and enrollment note, please visit https://www.brany.com/research-auditing-and-monitoring/
Any questions? Please reach out to QA@brany.com
