Before a clinical trial can begin, its protocol must be reviewed by an independent ethics committee, whose mandate is to protect human research subjects and ensure that the trial offers a favorable harm/benefit balance.
A core component of the ethics committee’s responsibility is to evaluate the scientific merit of the trial. That is, the committee is supposed to examine the details of the trial’s proposed design, as well as its surrounding scientific context (e.g., other similar trials), to ensure that (1) if the trial is completed, it will produce valid results, (2) there is a real clinical or social need for the trial, and (3) the scientific assumptions underpinning the design reflects an up-to-date understanding of the evidence.
Thus, for ethics committees to discharge their duties, they essentially need to have a landscape analysis or systematic evidence review in hand, which they can use to inform their judgments of scientific merit. Unfortunately, this is rarely (if ever) the case. Ethics committees do not typically receive this information from study sponsors or investigators and they are not given the time or resources necessary to conduct a landscape analysis or systematic review themselves.
In this publication in Ethics & Human Research, our co-founder Spencer Hey and his colleague, Ariella Binik (a professor at McMaster University), describe how this lack of decision-making support for ethics committees’ scientific merit assessments is a serious failing of our system of research oversight. An ethics committee’s sign-off on a protocol is supposed to mean that the trial has sufficient scientific merit to balance out the risks and harms for research subjects. But if ethics committees are not truly evaluating the scientific merit, then they are not actually protecting research subjects, who will be exposed to risks and harms for no good reason.
We are proud to say that Prism is now working to fix this problem. Building directly on the conceptual work that Hey and Binik did in their paper (which they called the “Value-Validity Framework”), Prism is partnering with researchers at the University of California, Davis to create a rapid landscape analysis tool that ethics committees could use to inform their judgments of scientific merit. Funded by a grant from Arnold Ventures, the goal is to leverage Prism’s expertise in producing living evidence landscapes toward this new use case—giving ethics committees the context and insight that they need to protect human research subjects and uphold the integrity of the research enterprise as a whole.
Binik, A. and Hey, S.P. (2019), A Framework for Assessing Scientific Merit in Ethical Review of Clinical Research. Ethics & Human Research, 41: 2-13. https://doi.org/10.1002/eahr.500007