Office of Research & Sponsored Programs

IRB Manual Risks and Benefits

Assessing Risks and Benefits for Participants in Research

 

Most investigators are able to readily identify the potential benefits of their proposed research to the knowledge base in their discipline as well as to society, since those are often the underlying motivations for undertaking the research.  Identifying the potential benefits and risks to participants can be a little more challenging, and it is not uncommon for our judgment as researchers to become clouded by a strong desire to realize those benefits to society.  It is also helpful to recognize the personal advancement that is the intended product of most research endeavors in an academic setting.  With that in mind, it is particularly important to carefully consider the possible participant benefits and risks to ensure appropriate procedures and protections are established.  All research can be said to carry some risk, including inconvenience at the very least, but much of the research done has little direct personal benefit to participants.  Payments or incentives provided to participants who consent to the research are not considered benefits to the research – they are considered compensation for efforts.   We seek their involvement primarily as volunteers in the hope that their contributions will lead to the broader benefits to society.

Benefits are only likely to accrue directly to participants if something beneficial is being provided to them as an aspect of the research.  Experimental medical treatments may be of benefit to patients who are ill, as may new counseling services to those who are in need of psychological care.  Children may likewise benefit from involvement in an experimental new approach to education.  But some research does not involve experiments with new services or interventions, but instead are designed to simply examine outcomes of existing programs or methods. There may therefore be no benefits to participating in the research at all.  However, if the risks from the research activities are likewise low, nonexistent, or sufficiently mitigated, the study can still be approved.

Risks of potential harm to participants can sometimes be subtle, and should involve an assessment of both the magnitude (severity) and likelihood (risk) of the potential harms.  Death would be a very serious harm, for example, but the risk of its occurrence in relation to a given research project may be extremely low or nonexistent.  More common are potential psychological or privacy harms that actually do have a reasonable chance of occurring as a result of research participation.  Discussion of sensitive topics may cause emotional or psychological concerns, particularly in individuals with particular vulnerabilities.  Employability or reputational harms could result from individuals sharing negative opinions or private information, and they could actually have a reasonable risk of occurrence if the data were to become known, unless the PI takes precautions to mitigate the risk of a potential breach of confidentiality.  Mitigation of risks does not render potential harms nonexistent or less harmful; it merely reduces the likelihood they may occur.  In almost all studies, participants run the risk that they will be inconvenienced and their valuable time used profitably or wasted, making it all the more important that the PI develop a sound design that has a reasonable chance of at least benefiting society through an increase in knowledge.

 

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