Different disciplines, similar challenges
Biomedical vs. social science
Marjorie Speers, PhD
Association for the Accreditation of
Human Research Protection Programs
Dr. Speers reports no financial relationships with companies related to the content in this CE/CME activity.
On the surface, it seems that individuals who oversee biomedical research face challenges that are very different from those encountered by their peers in behavioral and social science research.
This perception is understandable, but not entirely accurate. Granted, there are few similarities in the questions and methodologies used by both disciplines. There also is widespread sentiment on the part of investigators and IRBs that regulations governing human research protections were written primarily with biomedical research in mind and, therefore, are not easily applied to non-biomedical research. Dig a little deeper, however, and these differences seem far less significant than what the two research areas have in common. Take as an example the analysis of risk of harm.
For both biomedical and behavioral/social science research, the range of risks is the same: dignatory, economic, legal, physical, psychological, and social. The responsibility also is the same: to minimize risks, to identify and justify those risks that are unavoidable, and to monitor the research to safeguard participants.
Identifying all applicable types of risk is a challenge in every biomedical research protocol and in every behavioral/social science protocol. The temptation is to focus more on the risks most likely to apply to a particular research discipline, but, in fact, those are the risks least likely to be overlooked.
For example, biomedical investigators typically are aware of the higher probability of physical harm in their studies and, therefore, respond with vigilance. They may be less attuned to the psychological, social, legal, economic, or dignatory risks to research participants and, as a result, may find it more difficult to identify and address them.
Behavioral and social science researchers face similar challenges, albeit regarding different categories of risks. Except in certain types of protocols, physical risks tend to be rare. Psychological or social harms are more common than physical risks but still relatively uncommon. Far more common are dignatory harms, particularly if the research involves sensitive information. Although behavioral and social science researchers must be especially alert to dignatory risk, they are equally accountable for identifying all other risk types.
Legal and economic harms are uncommon in either biomedical or behavioral/social science research. Here again, the low probability of occurrence does not relieve investigators and IRBs of their responsibility. The complete range of risks must be considered in every research study, without exception.
Moreover, investigators should perform the initial assessment, and the results of these assessments should be included in the protocol descriptions that are provided to the IRBs. Such information can be invaluable to IRBs as they identify, analyze, and justify the risks involved in research, particularly in behavioral/science research, where the investigator is often in the best position to recognize potential harms.
Criteria for approval
To comply with federal regulations, the IRB must determine that "risks are minimized" and that "risks are reasonable in relation to the anticipated benefits, if any, to participants and to the importance of the knowledge that may reasonably be expected to result." Both biomedical and behavioral/social science protocols must be evaluated in light of these criteria. (Note: There are other approval criteria, but they are not germane to this discussion.)
Frequently in biomedical research, and even more often in behavioral/social science research, there are no anticipated benefits to participants. In such cases, the IRB evaluation weighs the risks against the importance of the knowledge that is likely to be gained. For each risk, the evaluation must involve both probability and magnitude.
In many research studies, the probability of risk — regardless of severity — is low. Even in the aggregate, very often the overall risk involved in a particular study is deemed to be no more than minimal. Many contend that this is the case for most behavioral/social science research. While that might be true, it doesn’t relieve IRBs or investigators from their responsibility to identify, analyze, and justify each risk.
Once the risks are evaluated, the focus shifts to ensuring that they are minimized. Because this judgment must be based on the use of sound scientific or scholarly methods and procedures — and the IRB’s understanding of these procedures — the composition and expertise of the IRB are important factors. Social scientists often express concern that the IRB does not have the expertise or, even, access to the expertise. This does not exempt the IRB from its obligations under the federal regulations. Instead, the IRB must take whatever steps necessary to acquire the expertise.
Also common to biomedical and behavioral/ social research is the risk that a study presents beyond the research participant: to families, friends, or communities. This risk is not addressed by the federal regulations for protecting human subjects or the Belmont Report, whose ethical principles have guided investigators and IRBs for more than 25 years. Yet, this risk should not be ignored, especially since it could apply to a broad range of studies: on genetics, infectious diseases, caregiving, quality of life, violence and abuse, communication patterns between parents and children, cognitive development in children, divorce, aggression, and myriad other possibilities.
Ignoring risk to others has the potential both to harm individuals and to weaken the research itself, either because of poor research design or inadequate enrollment. Furthermore, if such risks are not considered during the initial review, they may surface as unanticipated problems later in the research process.
It seems a far better strategy — in biomedical and behavioral/social science research — to acknowledge and manage these risks up front, when they are least disruptive to the study and before they can result in unintended harm.