“Please clarify what questions can be asked to determine possible eligibility for screening a subject, prior to them signing consent.”
—Independent Research Center
I can’t answer questions on any specific protocols, for confidentiality reasons, but I can tell you the general perspective about pre-screening activities. Per the regulations, informed consent needs to occur before any study procedures are performed.
There are many studies and organizations (for example, commercial phase 1 units that run lots of studies) that ask general health and medical history questions to help people assess whether they might be eligible for open studies. If someone is voluntarily answering questions about their health and medical history with no tests or study-specific procedures, that’s generally considered okay before consent. Although the pre-screening questions are often submitted to the IRB anyway, just to be safe.
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