If you have an IRB-related question, others probably do too! This column is an opportunity to answer your questions. Check in each month to see the answers to some of the most common questions asked by the research community. To find more questions from previous months, click here to search the archive.
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Q. We have a study in which we propose having the physicians and clinic staff at participating Boston HealthNet Community Health Centers distribute either flyers or anonymous surveys to eligible potential subjects. However, we want to try to keep the study Exempt where the Health Center staff would not be engaged in research. Can you provide any guidelines we should be aware of?
A: A person handing out a survey, even if anonymous, is engaged in human subject research; and per our policy, must be included on the IRB application so that their required training can be confirmed. This is true even for exempt human subjects research – which this would likely be.
On the other hand, if there were a flyer handed out by a person in the clinic (or simply displayed in the waiting area) informing patients about the existence of the study and directing them to a location to pick up and fill out the survey, then the person handing out the information about the study would not be engaged – provided they only handed out the IRB-approved flyer and nothing more. Any research activity taking place within the Boston HealthNet Community Health Centers requires approval of their research committee – even if it is Exempt by the IRB rules.