Institutional review boards (IRBs) help us communicate with patients in the most ethical way possible. Each time trial recruitment begins, all the content we create must be reviewed and approved by an IRB, which means we’ve learned a lot over the last 14 years about how to make the review process as smooth as possible. Here are just a few of the big takeaways we’ve picked up along the way.
- Avoid using the phrase “can help” in your content. These medications, treatments, and devices are investigational, so you can’t imply any definite benefits of trying them. Instead, use phrases like “may help” or “might be an option.” This subtle difference can determine whether your content passes review.
- IRBs like when “clinical research” or “medical research” is used in headlines for advertising materials, as they want the language to be as upfront, clear, and straightforward as possible.
- Avoid coercive, over-promising language, such as, “Cure your [fill in the condition]” or “Relieve your [fill in the symptom] with this new treatment.” When in doubt, just remember that the effectiveness of the medication, treatment, or device is not yet proven, so if the language insinuates otherwise, it likely won’t pass review.
- Gift giving during a retention program can be touchy. Any items given to patients should have an obvious connection to the study, like branded journals, writing utensils, etc.
- Avoid using the word “alternative.” You do not want to make any claims that the trial medication, treatment, or device is equal to or better than approved options. The medications, for example, are investigational and should not be compared with rescue medications or other drugs proven to help with a condition.
- Don’t use language that promises quick, definitive results, like “Get better today.” Trial participation usually requires a fairly significant time commitment, so a patient should understand that the trial can take time, and there may be different outcomes for each person.
- Finally, do not mislead potential participants or purposefully leave out details. Be open and truthful about study requirements so the patient does not encounter any surprises after enrollment.