The Impact of the Study on the Trials Team
I interviewed the Chair of the Ethics Committee, a data coordinator and a principal investigator on the study to explore the impact of the study on them. The Ethics Committee used their standard evaluation criteria for evaluating randomized clinical trials. The major ethical issue was the blinding of the participants to the intervention within the study which could also require risk management. The data coordinator was concerned that she didn’t receive all of the information she would have desired about the study and found it difficult to respond to the detailed questions participants asked. She didn’t have any objection to blinded or randomized studies as such, but was reacting to her perception of the need to blind the study team. The principal investigator, an atheist, was excited at being a part of the design and analysis of a “creative” study. However, as she became aware of the controversy surrounding other such studies and the personal discussions with investigators in related fields she became concerned about her involvement compromising her future career and declined the responsibility of authorship. Knowing the impact of a study on those involved informs the approach to future studies.
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