Economic Considerations

This section of the consent form should address the kind and amount of payment to subjects as well as any additional costs that may be incurred by the subject or his or her insurance as a result of participation in the research study. Also, if monetary awards will be prorated for early termination or ineligibility for certain parts of the study, this information should be noted in this section. Though parents may be reimbursed for their time and effort, such as payment for travel or food expenses incurred on study days, monetary awards should not be given to parents for permitting their child to participate in research. Children may be given something that does not represent undue inducement, such as a gift certificate to a bookstore, toy store, or video/music store. Information about the amounts and totals of payments or reimbursements in the consent form should match that in the protocol. It is generally agreed that subjects are not entitled to monetary or other benefits incurred from commercial products developed from biological specimens. This ineligibility to share in the profit of a marketable product should be expressly stated in this section of the consent form. In research dealing with the evaluation of products, interventions, or medications, the consent form should state whether the product or drug will be made available to the subject after his or her participation is completed and whether he or she will be expected to pay for the product.