Abstract
It is now typical for human subjects research to be regulated by review by an independent research ethics committee in most jurisdictions. However it is common for countries to opt to only compulsorily regulate medical research while leaving some or all non-medical research either unregulated or only regulated on a voluntary basis. In this paper I will argue, using regulation in the UK as an example, that it is difficult to justify this sharp distinction in practices. While I won’t come to any definitive conclusions in this paper as to whether research ought to be regulated compulsorily I will suggest that we would be better to regulate all research, albeit perhaps with a lighter touch than the present UK system if we want to prevent some highly risky research avoiding appropriate regulation. I will examine several arguments to defend making such a distinction; that medical professionals have special moral duties, that medical research has a higher magnitude/frequency of risks and that regulating non-medical research constitutes the inappropriate imposition of the medical model onto non-medical research. Having critiqued these objections I will then discuss the advantages of harmonizing the regulation of research and conclude that there is not a good reason to treat medical and non-medical research as fundamentally different in kind.
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Notes
These committees are known by different names in different jurisdictions, Institutional Review Boards (IRB) in the US, Research Ethics Boards (REB) in Canada, Research Ethics Committees (REC) in the UK—I will stick with REC since I am using the UK as my example.
I'm intentionally being vague about what counts as medical versus non-medical research because there doesn't seem to be any commonly agreed definition of medical research internationally with several countries relying on something like this distinction but interpreting it significantly differently. Given that I am focusing on the UK for the sake of the argument I will use the distinction used there—effectively medical research is clinical trials and research involving NHS patients.
It is uncontroversial that the US research ethics system has been the most influential, spawning even the UK research ethics system and being largely responsible for the rise of research ethics review internationally. Nonetheless at its heart the US system is institutionally and funding focused as opposed to being based on a distinction between types of research, perhaps because of the special difficulties regulation faces in regards to legitimacy in the US.
While there is more agreement about the notion of “minimal risk” there is little or no consensus about a definition of high risk research, and even the notion of minimal risk changes depending on context and jurisdiction (Rid and Wendler 2011). Hence I will not attempt to define these terms (since that would be a paper in itself) but instead rely on commonsense understandings of the terms.
I don't want here to endorse the moral scandal account of the development of medical ethics, as Adam Hedgecoe persuasively argues in ‘“A Form of Practical Machinery”: The Origins of Research Ethics Committees in the UK, 1967–1972’ (Hedgecoe 2009) self regulation was also an important driver, but it is understandable that the focus was on medical research ethics rather than research ethics more generally.
In this article I will refer to a number of ethically controversial cases of non-medical research. I don't want to imply that this research is necessarily unethical nor that the researchers were ethically wrong to carry out the research, merely that these cases are ethically controversial, and the research or some version of it might be morally problematic.
I use the term subjects intentionally here since this is broader than participants and includes those involved in research without their knowledge, who could not be plausibly described as participating in research.
Reference removed to maintain anonymity.
Note risk here is being used as a broad term, not merely referring to physical harms, but also social, psychological, financial and other harms as well as other outcomes that might be thought of as wrong or regrettable without being harmful.
Largely because I believe it is difficult to tell the level of risk involved and thus the correct amount of scrutiny without the review of something very much like a well constituted REC (Hunter 2007).
There are alternative proposals in various jurisdictions to have either a two stage lighter touch ethical review process or to exclude research from review if it is of minimal risk. While I am a skeptic about such proposals because of the epistemic difficulties in identifying research that is minimally risky reliably (Hunter 2007).
There is of course more to research ethics than just research ethics committees, such as governance and ethical standards—however I am focusing on committees in this paper.
Although NHS committees are not the only committees that are legally approved to review some sorts of research—there were some independent Research Ethics Committees (REC) which were approved, as are the Ministry of Defence (MOD) RECs.
In the last two cases this legislation also only applies in some parts of the United Kingdom and different legislation or no legislation regulates the same activities in Scotland and Northern Ireland due to devolution.
Here I mean no disrespect to university RECs many of which are rigorous and arguably appropriately independent, nonetheless given the variation among university RECs it would be foolish to regard the sector as a whole as being so (Hunter 2008).
Although the muscle biopsies involve human tissue research involving human tissue only has to seek an approved REC's approval if the institution carrying out the research isn't licensed by the Human Tissue Authority or the research is being carried out without the consent of the subjects (Human Tissue Act 2004).
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Hunter, D. Can significant differences in regulating medical and non-medical research be justified?. Monash Bioeth. Rev. 32, 254–267 (2014). https://doi.org/10.1007/s40592-015-0022-2
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DOI: https://doi.org/10.1007/s40592-015-0022-2