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Research-Related Injury: Problems and Solutions

Published online by Cambridge University Press:  01 January 2021

Larry D. Scott
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Extract

The highly publicized deaths of research participants Ellen Roche and Jesse Gelsinger are stark reminders that risk is inherent in medical research and while untoward outcomes are infrequent when compared to individual and societal benefits, injury and even death will happen. Who is responsible for the welfare of research subjects and what are they owed? Why were they put at risk to begin with? Are obligations, if any, to research subjects dependent on the type of study in which they participate, in recognition that there may be personal benefit from participation in some studies?

The issue of injury resulting from participation in research and answers to questions such as those just posed were last considered in depth nearly 20 years ago by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research.

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Article
Information
Journal of Law, Medicine & Ethics , Volume 31 , Issue 3 , Fall 2003 , pp. 419 - 428
Copyright
Copyright © American Society of Law, Medicine and Ethics 2003

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References

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A universal health-care system in which all participate has appeal in the research setting because it fulfills the criterion of responding to medical need, regardless of the setting in which injury was incurred. Moreover, it would eliminate the conflict for the uninsured created when the individual's primary motivation for participation in research may be access, not otherwise available, to the health-care system. It would also signal a new era in health-care justice in the United States, one that would likely encompass sharing in the burdens as well as the benefits of clinical research. It would not, however, address economic losses, should they occur.Google Scholar
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An example is a clinical trial involving surgery in which the control group receives a sham operation. But is the IRB justified in raising the standard for research protocols like this? Federal regulations set minimum standards and do not specifically authorize IRBs to raise them. Nonetheless, there are no limits or restrictions set on the role of IRBs in assuring participant safety and welfare. As a result, the level of protection necessarily increases as risk increases and more so if there is no offsetting benefit. Respect for individuals and beneficence, two of the three guiding principles of the Belmont Report, obligate the research community to assure that these protections are in place when circumstances require them.Google Scholar
Given the burden of responsibility and work already shouldered by IRBs, it could easily be argued that expecting them to develop expertise in options for injury compensation is unrealistic. Risk assessment, however, is already an IRB function. For studies in which there is concern regarding risk and injury, resources could be developed that would be generally accessible not only to IRBs, but investigators as well. An example might be guidance material developed by Office for Human Research Protections, which provides this information and contains examples of studies for which injury compensation should be considered and available options appropriate for that study.Google Scholar
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