We didn’t hear about this title when it was first released in early 2020 (we, and the entire rest of the planet, had some other stuff going on around that time), but then the folks at PRIM&R posted a review of Regulating Human Research by Sarah Babb, PhD, on their blog, and we got intrigued. Per the review, the book covers the growth of the human subject research oversight field into what Babb calls a “compliance bureaucracy,” in what she describes as a system where professional IRB staff “interpret, apply, and oversee adherence to government rules,” rather than relying solely on an IRB committee comprising faculty volunteers. She is careful to point out that she does not use the term “bureaucracy” in a negative sense, “with its inherently negative connotations of red tape and ineptitude. Rather, I wish to invoke the term as it was used by the German sociologist Max Weber, who thought that bureaucracy was a uniquely effective way of organizing work on a large scale. A bureaucratic system was based on written rules and records as well as a clear division of labor” (from the book’s introduction). The book describes the evolution of human subject research oversight in a field staffed by trained professionals. She argues that “human research protection bureaucracies supplanted amateur IRBs both because they could make sense of the rules and because they were better equipped to manage the demands of auditable compliance.”
Update from July 16, 2021 — Well, we’ve gotten our copy, and we love the book. Babb describes the evolution of the IRB oversight system. In the early days, boards comprised mainly volunteer faculty members with minimal administrative support. This meant board meetings could stretch to hours as reviewers parsed minor details in submissions. It has since evolved into a professional field with boards now supported by full-time IRB administrators who handle much of the preliminary work, allowing IRB reviewers to focus on ethical issues. The author also describes how social/behavioral research has been affected by the evolving oversight structure, and addresses the rise of independent IRBs. Throughout, she indicates how trends and expectations in the larger human subject protection field have driven much of this evolution. Babb’s book is well-written, in an engaging and comprehensible tone. The book is highly recommended for anyone interested in better understanding the entire IRB review system. It really resonates with the IRB office staff — her description of the evolution of IRB offices really resonates with those of us who have worked in human subject protections at UAMS for a while.