- Controversial Issues in the History of Dutch Research Ethics Governance
A society in stable equilibrium is—by definition—one that has no history and wants no historians.—Henry Adams
Research with human subjects is a sensitive matter. Every now and then, cases in which research subjects are seriously harmed meet the eye of the public, which then calls for more governance of research. The result is that research with humans today is governed by an extensive and complex set of regulations.
The history of this regulatory system in the Netherlands is usually told as a story of a free, licentious medical profession that had to be put under control by externally enforced public regulations. The Central Committee on Research Involving Human Beings (CCMO), which supervises accredited medical research ethics committees (MRECs), highlights the establishment of the first MREC in 1976 and the Dutch Law on Research involving Humans (WMO), which was established in 1999.1 Before then, the CCMO suggests, many informal ethical review committees were doing their job but lacked central control and uniform criteria. Only the 1999 law, which established the CCMO, solved such problems.
The CCMO's 2003 self-evaluation report presents the law as necessary, if not always popular: "The Law didn't have any transitional arrangements and the field was hardly enthusiastic about the law and the central committee," it notes. "Moreover, there were a lot of uncertainties: it was unknown how many local research ethics committees were active, and how many of these committees wanted to be eligible for accreditation. Also, a national register for research with human beings was lacking."2 Henk Visser, the CCMO's chairman, paints a more positive picture, but his statement also implies [End Page 74] a radical improvement since legislation was established. He stated in the CCMO's first annual report: "In our country since the early nineteen eighties procedures of medical research with human subjects—as well as ethics review—in practice was in general adequately arranged. When the WMO came into force on December 1, 1999, an integral regulation and review system was established."3
This historical account of the development of research regulation in the Netherlands shows a particular deterministic style. A common presumption or methodological premise in such determinist histories is that events in the historical sphere have a chain of causation with an inner logic, which is considered characteristic for the course of events.4 Generally, all events in a chain ought to be explainable by specific laws. Typically, these laws only mention characteristics or variables in terms of which the chain is specified, which suggest completeness. Also, the explanations of events exclude everything outside this logic, which suggest the state of closure.5 Determinism in this sense can also be found in the historiography of Dutch governance of ethical issues in research with human subjects. It suggests that strict and formal regulation offers the solution to all obstacles that might be encountered. Subsequently, historical events are defined and explained in this framework and seem to form a progressive path to the future. Such a narrow historical view might prohibit a thorough understanding and evaluation of current ethical review practice. It also seriously narrows the scope of potential alternatives, since formal regulations are regarded as the best and only logical way of governing research ethics.
In this article, I try to provide a more balanced history of ethics governance of human-subjects research. By taking seriously the controversies about governance issues, it argues that, instead of resulting from inevitable historical logic, things could have been otherwise, and regulation was not the only possible solution to governance dilemmas. It describes changes in Dutch governance of ethics in research with human subjects by exploring three controversial issues in the development of research governance. First, it will focus on the debate about internal and external control regarding the medical profession to show that different stakeholders held different views on how to govern ethics of research with human subjects. Second, it will describe discussions about centralized versus decentralized governance. This topic was especially relevant in the constitution of formal ethical review practices in the late twentieth century. Third, it will investigate the homogeneity versus...