The Need for Ethical Structure in Biomedical Research

Academic biomedical scientists don’t really need formal ethical guidelines because they’ve already committed themselves to working for the public good. After all, academics would be in a different (more lucrative?) line of work if they were seeking self enrichment rather than creating knowledge to benefit the world, so we don’t expect ethical violations from them. I doubt it. There are plenty of reasons that even the most well-intentioned end up drawing ethical eyebrow raises.

Most academic biomedical scientists don’t even think about ethics, not because they believe they’re above the law but because they don’t think what they’re doing has any substantive ethical implications. This attitude has deeply routed philosophical traditions that espouse there is no way to get from what is (i.e., science) to what ought to be (i.e., right and wrong), and since these two concepts are conceptually divorced there’s not much need for scientists to think deeply about ethics, so the thinking goes. (This often goes by the “can’t get ought from is” tagline courtesy of David Hume.) But this way of thinking misses the practical point. Scientists need to be concerned about ethics not because they will inadvertently create new ethical rules but because what they do with their work may, in fact, change something about society through ideas or technology, and we need to know if it’s a change we want. (And if a scientist doesn’t think anything they will ever do will change society in any way, they had better take a look at what they’re up to and whose paying for their enterprise.)

This leads to the biomedical scientists’ second perceived reason to ignore ethics: my project is so small (or incremental, or esoteric, or technical, or insignificant) that it would never have a societal effect large enough to merit ethical scrutiny. Trainees might feel this most acutely, since they often don’t get the purview to direct grand scientific visions, but rather organize small parts of studies or even just execute protocols given from on high. But this is a mistake of the “my vote is too small to matter paradox” variety. In the end, it is individual voters that elect a leader however seemingly insignificant each individual vote, and so too it is the individual efforts and studies that in aggregate form the arc of science. Scrupulous ethics at every stage helps ensure a broader process of integrity.

Having an ethical structure to biomedical research helps create a broader discipline of integrity that promotes the public health, whether the participating individuals are psychologically inclined to think about ethics regularly or not. Such a structure also short circuits other ethical pitfalls. For example, if one’s professional pedigree runs through a lab culture that doesn’t have its ethical compass pointed North it can be hard to notice potential violations from inside the group, and a codified external ethical structure is a touchpoint that can help engender that outside perspective.

Aside: I’m using “ethics” here to refer to norms and rules designed to uphold the mission and values of the biomedical enterprise, at the level of behavioral goals. I am not referring to anything metaphysical about an abstract morality that stands above human activity to delineate objective right from wrong (e.g., moral realism).

The Biomedical Engineering Society Code of Ethics

Fortunately, the US national society for biomedical engineers (BMES) has provided us with the outline of such an ethical structure in their Code of Ethics. (Full disclosure: I authored it.) The point of the document is to provide guidance to biomedical researchers on how to protect the integrity of the field and help ensure that the field’s progress is of benefit to society, “thereby honoring the public trust placed in [biomedical researchers] to work honestly to advance the public health” (quoting from the preamble). The code covers (well, perhaps “raises” is more accurate) topics from law to technology to human value to professional culture.

One could use the code straightforwardly as a way to evaluate if their own perceptions and behavior conform to the society’s consensus views or as a roadmap for introducing trainees to the types of ethical issues they’re sure to face working in the profession. No code of ethics is ever really complete – it is a living document that needs feedback to stay relevant and useful – so reach out to the BMES Ethics Subcommittee with feedback and/or leave it here.

The top two levels of the code are organized into general topics and the third level enumerates behavioral goals. The author group decided that the most reasonable way convey the ethical norms was through high-level aspirations of conduct rather than specific courses of action, thereby accepting that the implementation and action planning is beyond its scope. For example, the code lists the goal of “due diligence” in biomedical R&D but does not list how often one must review the current literature to stay up to date or what credentials one should have to undertake a project. In large measure, this decision was made to both keep the code brief enough that it isn’t overwhelming with minutiae (only three pages!), but also in recognition that there is substantial and healthy disagreement on how to achieve the goals, with best practices changing frequently. For most goals the code gives a parenthetical list of examples to either help make the abstract ideal more concrete or to give context for what common strategies there are for conforming to the behavioral goal.

This profession is rife with ethical implications. Everyone’s conduct matters to the integrity of the profession, whether one sees their own behavior as implicated in societal or interpersonal ethics or not. We all can benefit from a shared set of norms as a way to ground our thinking on these difficult topics.

Biomedical Engineering Society. (2021). 2021 BMES code of ethics.

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