July 2, 2014, by Brigitte Nerlich
You say regulatory science, I say mandated science; let’s call the whole thing off?
One issue of contention after the Circling the Square conference was the apparent confounding of science with regulatory science. I finally took a bit of time to dig into the history and use of the concept of ‘regulatory science’ and a related concept, ‘mandated science’. I should stress that there are whole courses on ‘regulatory science’ and entire careers can be made in regulatory science; so I am only scratching the surface (and my head!). I am certainly no expert in this field.
I’ll proceed in five steps. First, I’ll point to some current definitions of regulatory science (which anybody can find on the internet). Second, I’ll give an overview of the history of the concept (as far as I can make it out). Third, I’ll provide a glimpse of Sheila Jasanoff‘s work which put regulatory science on the intellectual map (again, as far as I can make things out). Fourth, I will hint at one competing concept. And I’ll end by asking lots of questions! Sorry about the length of this post!
Definitions of regulatory science can be found in Europe, the US, Japan and so on. Most of them seem to indicate that regulatory science, especially with regard to drug and therapeutics development, is seen as “the application of the scientific method to improve the development, review, and oversight of new drugs, biologics, and devices that require regulatory approval prior to dissemination”. In short, it is something like ‘the science of evaluation of regulations’. Regulatory science in this sense seems to be a policy tool used for continued scientific risk/safety/impact assessment. More critically perhaps, one may also see it as a marketing tool. Let us now look at the history of the concept and some important theoretical work.
The concept of regulatory science has a fascinating history with different actors competing for the same conceptual space. The end of the 1980s saw quite a flurry of definitional attempts both in the US and in Japan. In an interview with Sheila Jasanoff about regulatory science, carried out in 2011, a Japanese researcher pointed out that Dr Mitsuru Uchiyama wrote about ‘regulatory science’ in 1987 and then again in 1996 and defined it as “the science of optimizing scientific and technological developments according to objectives geared to human health” (p. 2).
At the same time, three scholars wrote about regulatory science in the US: In 1985 A. Alan Moghissi “established the Institute for Regulatory Science in the Commonwealth of Virginia as a non-profit organization with the objective to perform scientific studies ‘at the interface between science and the regulatory system'” (wikpedia). In 1986 Mark Rushefsky talked about regulatory science in his book Making Cancer Policy. And in 1988 Liora Salter wrote a book on Mandated Science. She herself traces this phrase back to Andrew Thompson, the then director of the Westwater Institute at the University of British Columbia. I shall come back to mandated science at the end of this blog post.
In the interview mentioned above, Sheila Jasanoff told the interviewer that she first pondered on issues related to regulatory science in 1987, but that, at the time, she called it ‘policy-relevant science’ (p. 4). She created the new label in her 1990 book The Fifth Branch: Science advisers as policy makers so as to contrast this type of science with normal research science (p. 4), a contrast set out in a table in chapter 4 (see also here).
Seven years after the publication of her seminal book Alan Irwin and others elaborated Jasanoff’s approach to regulatory science and regulatory science became a staple of Science and Technology Studies.
Why were the 1980s such a fertile ground for reflections on science and policy, science and regulation, scientific advice, science and politics? Perhaps because this was a time of increasing environmental awareness and also a time of burgeoning hopes and fears related to biotechnology, in particular after the 1975 Asilomar Conference on Recombinant DNA (see Hiskes and Hiskes, 1986, p. 127). Both environmental and biotech issues demanded better regulation and oversight. However, more historical work needs to be done on the origins of regulatory science reflections. What seems to be clear is that amongst the competing concepts ‘regulatory science’ as defined by Jasanoff within the framework of STS has become very successful. So I’ll first summarise its most important aspects (as I see them) in the next section.
Regulatory science and STS
In the 2011 interview Jasanoff provides two definitions: “Regulatory science … is that body of scientific and technical knowledge which serves regulatory decision making.” (p. 12) She also defines it as: “Regulatory science is a term that’s used to describe a particular domain of scientific activity: that domain of science which serves regulation in the same way that you can talk about medical science (science that serves medicine) or you can talk about environmental science (science that helps us understand the environment). Regulatory science describes a social zone in which a particular kind of knowledge is produced.” (p. 11) While the analogies may be debatable, the important insight here is that regulatory science is defined as ‘a social zone’ in which scientists and regulators try to provide answers to questions that advance policy-making (see p. 3). STS scholars are interested in investigating what happens in this zone in terms of negotiation and legitimation. Hence, STS becomes part of activities that assess whether regulatory science works well or not. It becomes a ‘science of science advice‘ it seems.
At the beginning of the interview, the interviewer points to “some critical observations” which distinguish STS’s understanding of regulatory science from the focus on its “good points” by Japanese scholars (p. 2). I think these critical observations, relating to facts, bias and scientists, may shed light on some of the reasons why ‘regulatory science’ provoked some critical comments after the Circling the Square conference.
Facts: Jasanoff points out that she was the first to think about regulatory science “from a sociology of knowledge perspective” and that in this field the focus is on “how a fact is made and produced in this domain of scientific activity that serves public policy” (p. 5). Bias: In a section of the interview dealing with the question as to whether science is or can be independent from policy-making, Jasanoff says: “The STS theoretical position is that there is no science that is not biased. The moment an experimental scientist decides that he or she is going to undertake an experiment, there is bias. There is bias because a path has been chosen which the scientists wishes to follow. They wouldn’t be following this particular path if they didn’t have a desire to follow it or if the didn’t have a commitment to reaching particular kinds of results.” (8) Scientists: Jasanoff stresses that (regulatory) scientists and policy makers share the responsibility of providing the ‘best answers’ to difficult questions (see p. 4), what she also calls achieving ‘serviceable truth’ (p. 9) or science that is “good enough for decisions” (p. 10). Achieving such aims can be compromised however by scientists becoming an “interested party” (p. 11)… In such a situation the values that always steer decision making in regulatory science seem to become a special problem, if I understand things correctly.
Mandated science – a competing concept
In her 1988 book on ‘mandated science’, Liora Salter defines mandated science as science which is “either produced and/or interpreted for the purposes of public policy”. As one of the scientists interviewed for Salter’s study said, mandated science is “not science, but ‘screening’” (p. 187, bold added). This seems to me quite a neat way of putting things. Although this concept was not as successful as the concept of ‘regulatory science’, it has been taken up in some discussions about issues related to scientists working at the science/policy interface.
In 2001 Ed Levy, who had been involved in Salter’s work, defines mandated science as “the activities of scientists in situations where they have been given a mandate by government to make recommendations or decisions that have a large scientific component”. Or: “Put more broadly, the central issue is to help elucidate the best ways for science to play an effective and honest role in public life.” Honesty appears to be an important part of mandated science.
Levy talks the reader through a particular case. “The aggregations that take place can be either implicit or explicit. DODAC [Dermatologic and Ophthalmic Drug Advisory Committee] is an excellent example of the latter. It is also a paradigmatic case of what several of us called ‘mandated science’. Each of the scientists on the panel is in effect asked not merely to focus on her own discipline, but also to take account of the overall picture in voting on the much broader questions about the safety and efficacy of the drug. What we have in this and most other cases of mandated science is a kind of institutional arrangement by which to achieve what is not accomplished by standard (applied) disciplinary science. That is, although many of the multifarious elements that contribute to the overall decision are testable within standard scientific disciplines, such as toxicology, pharmacokinetics and so on, the determinations of safety and efficacy are essentially meta-discliplinary.”
In 2004 Darrin Belousek wrote an interesting article in which he points out that “‘[m]andated science’ is science done for public policy-making purposes and takes two forms: original investigations commissioned by government officials or regulators, and reviews (either by an individual or by a consensus committee) of peer-reviewed science done originally for ‘academic’ purposes (Salter 1988). Mandated science relies upon the ideal image of normal science as objective knowledge. Indeed, the very turn to science by government officials and agencies concerning public policy matters that bear on competing private interests is based upon the assumption that science can be a ‘neutral arbiter’ (or, at least, an ‘honest broker’) between those interests.” Belousek goes on to explore the challenging tensions between mandatory and normal science around a specific case study.
In 2012 Tobias Bach and Marian Döhler looked into mandated science in Germany (although there is no German word for it), where it happens against a backdrop of “a consensus … to regard the ‘science system’ as a separate domain in which the rules of politics or economics are not allowed to dominate scientific standards” (p. 10). In this context Government Research Agencies engage in mandated science, in the sense of “’preparation, support or implementation of political decisions’ which means that they are ‘inextricably linked with assuming public functions’ (Bundesregierung 2007: 3)” (p. 2).
Are regulatory science and mandated science synonyms, that is, words with largely overlapping meanings, or not? Is regulatory science an antonym to normal (research) (academic) (fundamental) science? Is regulatory science, as some contend, an oxymoron? And what about mandated science? How does it work semantically and theoretically? What about the philosophical foundations of the two concepts? Are there conceptions of regulatory science that fit within a realist rather than constructivist philosophy of science? Is it right to say, as John Abraham did, that regulatory science “is heavily influenced by social and political factors, but contrary to fashionable constructivist philosophy/sociology of science, this does not imply that regulatory science is simply politics by another name.” Does work on mandated science address and deal with the messiness of the social activities that go into what Jasanoff calls regulatory science? And what’s the link between regulatory science, mandated science, translational science and responsible research and innovation? But most of all, what really is the relation between the ‘science system’ and the policy system and are regulatory or mandated science the right labels for this relation? I would love to get some comments on this….
PS A most enlightening overview of the history and development of the concept of regulatory science has just (08/11/2018) been published in Science, please read it here!
Image: Le bon conseil (good advice) by J. B. Madou, Wikimedia Commons
[I would like to thank Sheila Jasanoff for giving me a chance to discuss this topic with her. She really made me think. But of course, there is much more thinking to do!]