You are working on a project for a hospital emergency depart…

Yоu аre wоrking оn а project for а hospital emergency department to develop evidence-based guidelines for the treatment of skin and soft tissue infections in patients who do not have homes.  As you review studies for your project, you notice that very few studies actually include this patient population. This is surprising to you as other sources you have found indicate that this population has a very high risk of complications related to these infections. Which one of the criteria below is the most likely to be a barrier for IRB approval of this type of study?