forms of nonfinancial payment might include services that investigators offer to parents or children to make research participation more attractive or less burdensome (e.g., additional health information or medical monitoring or tours of a research laboratory). One rationale for using movie coupons, gift certificates, or other noncash tokens of appreciation in certain studies, for example, studies involving adolescents at risk for illegal drug use, is to prevent them from using the cash for purposes that might be harmful to their health (e.g., to buy drugs).

In general, the committee believed that it is appropriate and fair to permit investigators to provide payments to parents and children for expenses related to a child’s participation in research that they would not otherwise incur. Parents and children, especially if they are economically disadvantaged, should not be asked to bear costs that result solely from research participation.

As discussed below, payments may be determined in different ways, but no payment should be so large or be timed in such a way as to unduly influence parents’ or children’s decisions about research participation. For example, providing a small payment at the end of the study may encourage completion, but making the entire payment contingent on completing a study could distort a parent’s or a child’s decision about continued participation in a study. Payments should not influence parents’ or children’s decisions to participate in research when such participation is not in a child’s best interest.

ETHICAL PRINCIPLES AND REGULATORY POLICIES

Ethical Concerns About Payments to Children and Parents

As discussed in Chapter 5, ethical standards for participation in research require that the agreement to participate be freely given, that is, be neither coerced nor unduly influenced by psychological, financial, or other pressure. The major concern about financial incentives—as defined above—is that they may distort decisions about research participation, especially for economically disadvantaged individuals or families. Because parents have the authority to permit a child’s participation in research, safeguards against coercion or undue influence on parents are important to ensure that the child’s best interests are protected. This chapter focuses on payments, but undue influence on decisions about research participation can come in other forms, including psychological pressure from personal physicians who are also investigators with a stake in the research.

In the words of the Belmont Report, undue influence occurs “through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance” (National Commission,



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