by Phoebe Friesen, Lisa Kearns, Barbara Redman, and Arthur L. Caplan

Emily Caldes and Jennifer McCormick make several excellent points in their blog post “Rethinking the Belmont Report? Yes!” We appreciate the response to our target article, and generally agree with their comments.

The authors point to an important distinction between the territory covered by the definition of research and the territory covered by research oversight. They rightly observe that, while we tend to conflate the definition of research with where oversight belongs in our article, these two can and perhaps should come apart. As per Caldes and McCormick’s suggestion, we are open to the possibility of retaining the definitions of research and practice offered in the Belmont Report and improving the system of research oversight by other means, although by which other means is a question that remains to be answered. As the authors acknowledge, our primary goal is not a conceptual one, but a pragmatic one: We are pushing for a system of research oversight that aims to maximize knowledge production and benefits to all communities while minimizing harms to research participants.

We do have a disagreement with Caldes and McCormick: that the overarching goal of research ethics ought to be non-exploitation. Although we agree that preventing exploitative research is of central importance to research ethics, we also expressed concern in our article about the harms that have resulted from an exclusive focus on non-exploitation over the past several decades. In the aftermath of the Belmont Report, a document that was primarily intended to prevent harm to vulnerable communities, protectionism has resulted in the exclusion of many groups from research, leaving them with little health data to rely on during medical decision making (e.g. pregnant women, older people). As emphasized above, we see the goals of knowledge production, benefits to all communities, and minimizing harms to participants as equally central to research ethics, and hope to augment the focus on non-exploitation with its historical result of exclusion with a new emphasis on inclusion in research.