Top five words IRBs see as red flags.

In the patient recruitment world, institutional review boards (IRBs) serve as our ethical guides to speaking with patients, and we look to them for feedback and approval each time we create new materials. Over the years, we’ve picked up on some words and phrases that IRBs would consider red flags – that is, terms that overpromise, misconstrue, or coerce. Below are our top five to watch out for when writing for patients.

1. “Can” or “Will”
Phrases like “can help” or “will improve” imply a definite benefit from an investigational product. Instead, use “may” or “might” to soften the language, so as not to overpromise any one benefit to patients.

2. “Free”
Talking about “free medical treatment” can imply that any treatment outside the study-related procedures is provided at no cost. Instead, find out if the sponsor is providing some sort of approved compensation or reimbursement, and speak only to those benefits.

3. “New”
While the clinical trial you’re working on may be a “new option” for patients, it’s unethical to state that the drug, procedure, device, or biologic is “new” without providing the disclaimer that it is also investigational or experimental. When in doubt, be sure to reference to the investigational nature of the product.

4. “Alternative”
Claiming an “alternative” option implies that the trial provides benefits equal to or better than the approved options already on the market. Again, always be clear that the product is investigational and has not yet been proven effective.

5.  “Treatment” or “Cure”
If patients see the words “treatment” and “cure,” they may assume that the investigational product is effective and will provide them with a definite benefit. Because the product is not yet approved, this type of language could be misleading for patients looking to participate in a trial.

When in doubt, err on the side of caution. And if you’re still unsure, we’re here to help.

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