In the Wall Street Journal article entitled, “The Ethics of Experimenting on Yourself” published online on October 24, 2014, staff reporter Amy Dockser Marcus explores the emerging concept of “citizen ethicists.”
Almost all clinical research performed in the United States today goes through a regulatory and ethical review by institutional review boards (IRBs). This review is required for all federally-funded research, and for research that will be submitted to the Food and Drug Administration (FDA) in support of an application to market a new drug. When research doesn’t fall into either of those categories, the institutions at which the researchers are based, the sponsors of the research, or the medical journals in which the researchers hope to get their work published usually have internal policies that require IRB review.
However, more clinical research studies are emerging that are patient-driven, not based within healthcare institutions, and not subject to the regulations or institutional policies that require IRB review. Almost all research ethicists would agree that the independent review of proposed research is essential – not because researchers will attempt intentionally unethical behavior, but because their perspective may prohibit them from seeing issues that are of concern to others, and harm can be done in their attempts to do good.
Research organizers have begun to explore alternative methods for ensuring that proposed research is ethical. One such proposal includes the use of citizen ethicists. In theory, citizen ethicists provide an ethical assessment of the proposed research and their opinions are posted online or otherwise made available to participants who are considering the research study. It’s possible that different ethicists may disagree on aspects of the review, or disagree with the researchers; in those cases, the disparate opinions would be made available for potential participants to read and consider before making their decision about whether to join the study.
The idea of the citizen ethicist and allowing the participant to consider the ethical assessment of the protocol themselves can be seen as respect for individual autonomy and decision-making, and a movement away from the “paternalism” of a Board which allows or disallows research, therefore deciding what studies a participant may or may not have available to them. However, there are aspects of this new framework where caution is required:
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- The ethicists would perform in an advisory capacity; they have no regulatory authority, and no ability to halt proposed research, even if their review discovers significant areas of concern.
- Making the research reviews available and transparent is a good step. However, the burden of reading, considering, weighing, and comparing different opinions on the ethics of a protocol would now fall on the potential subject, who likely has little or no ethics or scientific training. This is a particularly large burden to place on someone who is ill, stressed and perhaps overwhelmed with a recent diagnosis.
- IRBs review more than just the ethics of a protocol. Within the regulatory criteria they consider is an assessment of the science behind the research plan, whether the risks to potential participants have been minimized as much as possible, and if the risks of the research are reasonable in proportion to the benefits. For studies in which participants may come from different geographical areas, the IRB is also required to consider regional, state and local laws. For example, the age at which someone can consent to participate in research is not the same in all states. Citizen ethicists may not be familiar with these concepts or requirements.
The intention of an IRB is not to protect patients from themselves. As authors Emanuel, Wendler and Grady stated in their seminal 2000 Journal of the American Medical Association (JAMA) paper, entitled, “What Makes Clinical Research Ethical?,”“… diverse interests can generate conflict that may distort the judgment of even the most well-intentioned investigators regarding the design, conduct and analysis of research…Clinical research imposes risks on subjects for the benefit of society. Independent review…assures members of a society that people who enroll in trials will be treated ethically and that some segments of society will not benefit from the misuse of other human beings.” While there may be disagreement about how much paternalism or autonomy is appropriate in making sure that research participants are protected, the ethical treatment of those who volunteer to participate in research is surely something we can all agree on.