The Duke University Health System (DUHS) Institutional Review Board (IRB) interprets responsibility for the costs of treatment for a study-related injury as a risk of study participation, and the potential subject must be fully apprised of this risk before making an informed decision on study participation (45 CFR 46.116(a)(2) and if applicable, 21 CFR 50.25(a)(2)). The IRB, ORC, and the study team must work together to ensure that the wording in the IRB-approved consent form is consistent with the relevant wording in the fully executed research contract with the sponsor.