Costs to Subjects for Research Participation and the Informed Consent Process: Regulatory and Ethical Considerations

Abstract

T he role of money in biomedical research is a frequent point of controversy. Concern focuses on the extent to which money offered to prospective subjects may unduly influence them to participate in a study and on investigator/institutional financial conflicts of interest.' Additional concerns that have received considerably less attention involve the permissibility of charging subjects for participating in research and the extent to which investigators should disclose these costs to prospective subjects. Costs associated with research participation generally fall into two categories: health system related expenses paid directly to entities that provide health services, such as hospitals, labs, clinics, and pharmacies; and non-health system related expenses such as fees to public transit or taxi companies, gas stations, and parking garages. Some health system related expenses are expected costs (e.g., tests or services that will not or will likely not be covered by third party payers) whereas others are not (e.g., injury-related costs). This paper focuses on the former, which are both knowable and quantifiable in advance. Although most research studies do not impose anticipated health system related costs on subjects, some do, and the Food and Drug Administration (FDA) explicitly permits the practice in some cases.3 Federal regulations governing human subjects research stipulate that, when appropriate, prospective subjects should be informed of any additional costs to the subject that may result from participation in the research.4 Yet, the regulations do not state whether the costs must be itemized or what level of detail must be provided. Institutional Review Boards (IRBs) vary in how they interpret this regulatory requirement.s Some have explicit policies requiring detailed disclosure of costs, but others do not.6 Because the Office for Human Research Protections (OHRP) and the FDA have offered little guidance on how they expect the regulations to be interpreted, there is both an opportunity and an obligation to consider the issues from an ethical perspective.7