Since the issues of deciding what to do with the data from withdrawn participants was not defined when developing research protocols, the investigator does not feel obliged to develop a new policy after the fact.

These are some possible outcomes:

Although a pre/post test comparison of intervention and control cases cannot be conducted with the participants who have withdrawn, data from the baseline survey can still provide an informative profile of characteristics from the patients at these sites.

Co-principal investigator expresses reservations about using data but eventually agrees to this.

Co-principal investigator contacts IRB committee chairperson to discuss the issue.