Beyond the ethics deflection: Why patient burden is a scientific review question, not just an IRB concern.

Patient advocates increasingly serve as voting members of Scientific Review Committees (SRCs) charged with evaluating the scientific merit and feasibility of clinical trial protocols. In principle, this gives advocates a seat at the table when the scientific architecture of a trial is most malleable. In practice, a recurring pattern undermines that promise. When advocates raise concerns about visit frequency, procedural invasiveness, or restrictive eligibility criteria, those concerns are often deflected on the grounds that they are ethical rather than scientific, and therefore properly the province of the Institutional Review Board. This Comment names that pattern jurisdictional dismissal and argues that it rests on a category error. Patient burden is a primary determinant of accrual, retention, data completeness, and generalizability. These are scientific concerns by any reasonable definition. When SRCs decline to engage with them, they let an unsuccessful trial proceed to ethics review with a fixed design that the IRB cannot meaningfully alter. I describe how jurisdictional dismissal operates, distinguish the scientific feasibility question that belongs to the SRC from the ethical acceptability question that belongs to the IRB, and propose four concrete changes to SRC practice that recognize feasibility as a scientific criterion in its own right.