Informed consent documents should describe any compensation or medical treatments that will be provided if injury occurs. If specific statements cannot be made (., each case is likely to require a different response), the subjects should be informed where further information may be obtained. The consent should also indicate whether subjects will be billed for the cost of such medical treatments. When costs will be billed, statements such as "will be billed to you or your insurer in the ordinary manner," "the sponsor has set some funds aside for medical costs related to.... Here's how to apply for reimbursement if you think you might be eligible" or "no funds have been set aside..." are preferred. Statements such as: "will be the responsibility of you or your insurance company" or "compensation is not available," could appear to relieve the sponsor or investigator of liability for negligence, see 21 CFR .
1 Appelbaum PS. Assessment of patient’s competence to consent to treatment. New England Journal of Medicine. 2007; 357: 1834-1840. [ back to article ]
Top | Additional Readings | Related Websites C ases: Case 1 | Case 2 Core clerkship material for: Internal Medicine | Psychiatry | Rehabilitation Medicine | Urology | Anesthesiology | Family Medicine | Surgery Jessica De Bord, DDS, MSD, MA (Bioethics)