The shell game: how institutional review boards shuffle words

Abstract

Concepts like coercion, vulnerability, and dignitary harm have acquired specialized meanings in the research ethics literature. Institutional Review Boards (IRBs), also called Research Ethics Committees (RECs), sometimes use these concepts in two different ways without acknowledging or even realizing what they are doing. IRBs mislabel any language that encourages subject participation in trials as "coercive," then demand its removal as if it were actually coercive in the sense of a threat of force. An example of language that is treated as coercive is the use of the word "hope" in an educational brochure about clinical trials. The concepts of vulnerability and dignitary harm are similarly misused. The regulations instruct IRBs to protect vulnerable groups; but IRBs sometimes use a group's vulnerability to one threat to protect it against an unrelated and harmless threat, as when homeless people, who are vulnerable to street crime and disease, are protected from the risk of an interview. Finally, the term "dignitary harm" is so vague that IRBs can use it to restrict research that is entirely free of risk, while ignoring the possibility that research might provide the dignitary benefit of contributing to society's health and welfare. Dignitary harm--usually nonphysical "harm" of which the subject is entirely unaware--can be deemed more important than obtaining information that subjects want or actual risk of physical injury. These vague or shifting definitions permit the IRB to play a shell game without either the board or the investigator realizing what is happening.