Benefits may accrue during the course of research either to the subject, to his or her community, or to society in general. Benefits may accrue to subjects either as a direct result of the experimental intervention or procedure (e.g., improvement in disease control or alleviation of pain) or indirectly, from being included in the study (e.g., intense evaluation, monitoring, or follow-up). Still other benefits may accrue to society through the development of generalizable scientific knowledge. It is the goal of all research to produce generalizable knowledge, and in most protocols this is the only potential benefit. In cases where benefits may accrue directly to subjects, investigators must be cognizant that subjects often confuse involvement in research protocols with therapy (the therapeutic misconception). To prevent this misconception, investigators must take the time during the consent process to explain the differences.
Defining the potential benefits from participation in research, like defining risks, is a difficult task, and investigators often pay less attention to it than to defining a protocol’s risks. But a proper assessment of the potential benefits is essential if an accurate risk-benefit analysis is to be performed. An investigator’s assessment of the potential benefits from participating in the study also serves as the basis for writing and reviewing the consent form. IRBs have different perspectives on how to weigh the various types of benefits or whether they should enter into the risk-benefit analysis at all. Generally, benefits that accrue directly to subjects as a consequence of participation in a protocol (i.e., as a result of the procedures and interventions of a study) are included in the risk-benefit analysis and listed in the consent document. Indirect benefits that may be experienced by subjects from participation in research may or may not be included. Indirect benefits derived directly and exclusively from the research that would not be available to the subject otherwise, such as an intense “out-of-the-ordinary” evaluation, would be considered a benefit. Other indirect benefits that could be readily obtained by the subject outside of the research setting, such as access to personal cognitive test data, are generally excluded from the risk-benefit analysis, and must not be used to entice subjects to participate. These indirect benefits may be listed in the Economic Considerations section of the consent document. The value of the study to society, from the development of generalizable knowledge, is always included in the risk benefit analysis and is often the only potential benefit. The quantification of potential benefit from participation in a research protocol is both a qualitative and a quantitative exercise in which investigators must use their best judgment.