By Laura Stark
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Extra resources for Behind closed doors : IRBs and the making of ethical research
The discussion also shows the beginning of a consensus built around Nancy’s opinion that the investigator should not be allowed to do the stress intervention as planned. The ethicist who agreed with Nancy here went on to explain that, having recently become a father, he seconded Nancy’s view. Eventually all of the board members came to side with Nancy’s recommendation, based on her private experiences, rather than the view of the investigator, based on his clinical experience. Nancy’s opinion helped to shift the research design of this study.
17 In the end, all but one chair reported that they could envision a scenario in which the board would allow an investigator to conduct this study if he made certain changes and concessions. However, the chairs diverged on whether they turned to the “rule book” or drew on a resonant past experience. They also diverged in their interpretations of the problems with the study and the modifications that they requested. Because of their unique caseloads prior to my interview, IRB chairs had different views about what risks the standard protocol entailed, who would be at risk, and what the severity of the risk would be.
Knowledge experts considered insights drawn from experiences beyond their professional lives to be relevant for evaluating research protocols. And since IRBs are oriented toward mitigating worst-case scenarios, rather than managing “typical,” “average,” or “common” scenarios, anomalous but vividly or passionately relayed stories were taken to be, if not persuasive, at least difficult to argue against. In this case, the board did not merely require that the investigator change his measures or report abuse; instead, impassioned personal testimony like that of Edward encouraged members to seek a higher level of scrutiny for the project.
Behind closed doors : IRBs and the making of ethical research by Laura Stark