I believe that it is the responsibility of the manufacturer to notifying the user of any side effects or risks with the drug being administered. A study can be shutdown for several reasons, one being cross contamination. A recent article I read discusses the risk severity of cross contamination when manufacturing medical product for patient use. By FDA, a study can be shut down if cross contamination is found. All participants within the study should be informed about the findings because the FDA’s main purpose is to uphold the safety and efficacy of the users of medical products. All documentation should be updated to include any risks discovered later in the study. The modification in documentation must be approved by the IRB.