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Describing your test article in a consent form

If your study involves a test article (drug or device), then you’ll need to let subjects know during the consent process about the test article’s approval status. Please note that the IRB will want the approval status stated very clearly. We’ve seen, for example, long lists of all the countries in which a particular test article is approved, but the list makes no mention of whether it’s approved in the United States. Or a consent form will say the drug is approved for the treatment of the following conditions in the following populations, but will be silent regarding whether it’s approved for the condition/population in the current study. We’ll send back a contingency asking for clarification if we don’t think the approval status is clear enough.

Also, many consent forms describes drugs or devices as “investigational,” a word which doesn’t tell the lay reader much about a item’s approval status. The IRB routinely sends back contingencies asking that “(experimental)” be added after “investigational.” That’s a small improvement at best; that’s still not super clear regarding whether a drug/device is approved. It simplifies things for everybody if your consent form specifically states whether your test article is approved for use for the condition and in the population being studied.