360. Benefits

Updated July 1, 2021

A benefit is a valued or desired outcome, or an advantage. In research, benefits generally fall into two categories: benefits to the individual participants in the research and benefits to science or society. Direct benefits to participants can take the form of therapy, education, information, resources, or empowerment.

When research is diagnostic or therapeutic and involves participants with a specific illness or abnormal condition, individual benefits may include improved health or enhanced understanding of the individual's condition. Individual benefits of education research may include improvements in a student's learning or study skills. Benefits of social research may include increased access to resources for a participant.

Benefits to science/society include the knowledge researchers expect to gain from conducting the study. Scientific/societal benefits may include improved safety; technological advances; or enhanced understanding of a behavior, disorder, or condition.

The Belmont Report proposes that in human research, the concept of benefits implies an obligation for researchers to maximize benefits. This requires forethought and careful planning to ensure the research design has scientific or scholarly validity. Identification of research benefits also requires objective consideration of the presuppositions of the research.

• Research benefits can only be anticipated. If benefits were certain, there would be no reason to conduct the research.
• Research benefits must be consistent with the research purpose and study design and procedures.
• Research benefits must be distinguished from the good that may result from therapies or interventions that would be performed even if the research was not taking place.
• Research benefits must be limited to outcomes/advantages that result from the specific research study; not the possible benefits that may result from future changes to policy or programs.

When inviting and enrolling prospective participants into a research study, investigators must not overstate or use language that implies the benefits will result. Research benefits can never be guaranteed. During informed consent, investigators must make it clear that the stated benefits are what the investigators hope will happen.

When appropriate, investigators have an obligation to provide participants with reasonable alternatives to the research, especially when a known alternative intervention is available that is equally likely to result in the same benefits as the research. In the latter case, the risk of the alternative would be known whereas the risk of participation in the research can only be surmised.

Although participation in research may be a personally rewarding activity or a humanitarian contribution, these subjective benefits should not enter the investigator's justification for the research or the IRB's analysis of benefits and risks.

The benefits of a study do not alter the risk classification. The risk/benefit assessment only refers to the acceptability of the risk, not the level of the risk. A study deemed greater than minimal risk cannot be classified as minimal risk because the potential benefits are great, but it could be approved for that reason (whereas the same greater than minimal risk study may not be approvable if the benefits are lacking). An IRB reviewer should disapprove research in which the risks are judged to be unreasonable in relation to the anticipated benefits.