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Shefaly Yogendra, Doctoral Candidate University of Cambridge
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Shirley Nurock's point about relative risk propensities of patients and ethics committees also emerged in my conversations with many patient interest groups during my work on a note on gene therapy for MPs and peers in the UK. I can see two reasons for this difference. Firstly ethics committees must make decisions with a view to the future. An early clinical trial, if successful with a small number of very ill patients, will be replicated for a larger segment of the population, including a control group. This requires that safety must be the most important focus. Ethics committees must also ensure that with nothing to lose, patients do not enter trials with the hope, sometimes false, that there is a lot to gain. Secondly should anything go wrong in a trial approved by an ethics committee, the outcomes would significantly affect not just the ethics committee but the whole institutional framework and its societal context. As Ms Nurock says, a patient has very little to lose. The ethics committee bears a larger responsibility and may have a lot more to lose, including its credibility. Competing interests: Presently I am serving in a Fellowship at the Parliamentary Office of Science and Technology (POST) in the UK. My work relates to gene therapy which gave me access to the regulator and several patient interest groups. |
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