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Industry-sponsored study? Be careful about recommending changes to the consent’s injury and costs sections

New submissions may be reviewed by several other offices before they ever reach the IRB. One of these reviews is done in the Research Support Center, where staff negotiates with industry sponsors about, among other items, who will cover which costs associated with the study. Part of this negotiation includes nailing down the injury and cost statements in the consent form. This language lets the subject know who will be responsible for paying for treatment for any study-related injuries, and also describes which of the study costs will be covered by the sponsor and which may be billed to subjects or their insurance companies. Because these are negotiated, legally binding statements, they cannot easily be changed after they are finalized. You may suggest contingencies to change these statements if you notice something in them pertaining to the criteria for approval of research or other significant human subject protection issues. However, the IRB should not suggest changing specifics of the language or the addition of items such as tables indicating what will be covered and what won’t. While this was routinely done in the past, the RSC review, combined with the IRB review requirements, now helps ensure the contract language and consent form language are clear and consistent.