Expected value of ethical approval?

I’m sure many of you are familiar with the process of seeking ethical approval for a project. In my opinion there is not enough of an explicit link between the potential value of a trial and its likelihood of receiving ethical approval. In recent years a growing contingent of health economists have started pushing for wider use of value of information analysis. I believe that these methods could be used to formalise a link between the value of research and whether it receives ethical approval.

The system of ethics committees and the approval processes exist for good reason; to protect patients. I believe this protection could be valued and captured in monetary terms. One can imagine a study that elicits willingness-to-accept (WTA) values from the general public for various types of trial involvement and studies of various characteristics. We could then use these values, along with expected value of sample information (EVSI), to establish a decision rule for whether or not a project should receive ethical approval. I see the methodology going as follows:

  1. calculate the relevant EVSI for a project – the patient group benefits
  2. assign WTA values for the study type – the patient group costs
  3. calculate the net benefit of the trial to the patient group

This final figure is essentially the net benefit of ethical approval for the research. If this has a value greater than 0 then the study is worthwhile from an ethical perspective. Based on probabilistic WTA values assigned to the proposed patient group we could generate something similar to a cost-effectiveness acceptability curve to show the probability that the study would be ethics-effective at different threshold values (because these will affect the EVSI). Therefore, for a given study type, projects with a high EVSI would be more likely to receive ethical approval than projects with a lower expected value.

Now, clearly very few projects seeking ethical approval will have an EVSI to hand, so this is not something that could quickly become the norm. However, those who do could use it as a means of getting ethics committees ‘on-side’.

Is this methodology flawed? What would need to be done to implement this? Would there be support if it could be done?

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