Quality’s Role in Biomedical Morals and Ethics

For answers to some troubling life-science questions, ask a quality professional

Mike Richman

November 13, 2018

The future is the ultimate abstraction; anyone who has ever attempted to discern the nature of tomorrow by looking at the yesterdays leading up to today knows that prediction is a fool’s errand. That’s the unfortunate reality for weather forecasters, stockbrokers, sports bookmakers, political pundits, and writers of science fiction. Yet people keep trying to project trend lines and read tea leaves, maybe because we like to wonder about the moral and ethical choices that some future state will force us into. Or maybe these kinds of stories just make good copy. Either way, with this article you can add another fool—yours truly—to the list.

The changes to come in most industrial sectors are fascinating to ponder and debate, but in truth few will force us to confront and come to grips with the most essential aspects of our humanity. Sure, self-driving cars, super composites and alloys, molecular computing, and similar breakthroughs are already changing the world, and will continue to do so in the next decade and beyond. Yet few if any of these changes will also change us in any substantive way.

In the broad, wild, and already weird world of the life sciences, however, it’s another story. In that sector, the challenges of innovation offer a bounty of benefits that we can scarcely imagine, and perhaps may only dream of. But the line between a dream and a nightmare can be gauzy and thin. Navigating the perilous path between the two will require wisdom and vision, a certain procedural discipline, and a plan-based approach.

Sounds like a job for quality professionals to me.

A definition of terms

Let’s start by clarifying just what morals and ethics are, because although they’re closely related, they have at least one key distinction. Morals involve one’s principles, which are developed over time in any number of ways and are general in scope. Ethics, on the other hand, tend to be rules of conduct (dos and don’ts) that govern very specific activities—in a professional society, for example. In short, morals are internal in nature, and ethics are external.

It’s important to think in terms of both morals and ethics, because managing humanity’s coming challenges in the realm of life sciences will require the development of firm moral convictions and strong ethical controls. In a sense, we’ll need the character to tell the difference between right and wrong, and the discipline to pay attention to the rules when confronted with unintended consequences.

What happens if morals and ethics come into conflict? It can happen, usually in the case of unjust laws that deserve to be broken. But who determines what “unjust” really means? Should an individual’s sense of morality take precedence over an entire society’s ethics, or must rules and laws contain character-driven actions?

These are not arbitrary or merely academic questions in today’s world—and as technology grows increasingly complex, these concerns will only grow in prevalence. Nowhere will that complexity cause more consternation than in life sciences.

Issues and concerns

Artificial life. Designer babies. Genetic hacking. Diseases—and cures—developed specifically for individuals.

All this and much more was covered in the article titled, “Biotech CEO: Genomics World to Get ‘A Lot Weirder,’” which initially ran on the Laboratory Equipment blog on Oct. 9, 2018. QD editor in chief Dirk Dusharme and I discussed the piece on our Quality Digest Live web TV show a few days later.

The takeaway here is that companies operating in the life sciences industry, specifically within its genomics sector, offer humankind a treasure trove of incredible benefits, if only the considerable risks can be appropriately identified and managed.

Let’s take just one example. The subject-matter expert quoted in the piece mentioned above, biomed entrepreneur Andrew Hessel, CEO of Humane Genomics, posits that we could soon see the advent of a kind of “app store” for customizable DNA, enabling consumers to potentially pick and choose specific genetic traits for themselves and their offspring. Of course, bad guys could also take advantage of such a platform to design new plagues, or viruses targeted to a specific individual.

As quality professionals, we should all stop here, take a breath, and remind ourselves of the lean wisdom of poke yoke, which quite literally means “mistake avoidance.” Some would translate it as “mistake-proofing” or the pejorative “idiot-proofing,” but this rose by any name would still sweetly nip quality problems in the bud. Essentially, poke yoke means that you design the solution into your system, so that a given anticipated problem simple can’t occur.

How might this work with a DNA app store of the future? Bearing in mind that I’m no geneticist, consider a piece of genomic code that might, say, provide the ability to give one’s unborn child a unique eye color. Perhaps part of that code contains a protein that can be “switched on” to allow for heterochromia, but that also could (in combination with another protein) increase the likelihood of Down syndrome. A bad actor could potentially exploit this backdoor vulnerability and thereby threaten to hack the embryo’s DNA unless some large cryptocurrency payment was made.

But now, in the spirit of poke yoke, consider that this particular “app” was modified so that this specific combination of proteins could not be sequenced, or that such sequencing might somehow be concealed. Could the bad guys still find a vulnerability? Sure, but the good guys would, hopefully, stay one step ahead through a reliance on our essential sense of morality as well as an ethical framework of rules, regulations, processes, and procedures.

How quality can help

A structure such as the one described above can help ensure the best possible outcomes for the greatest number of people—criminals excepted. If things like a DNA app store, or bio-engineered micro-bot medical devices, or organ transplants cultured from the patient’s own stem cells will be popular “products” in the future (as indeed they will), then strong consumer demand will require equally strong protections. Developing the system to achieve this goal will be the responsibility of the quality professionals of tomorrow.

How do I know this? Because that’s what quality professionals of today do already.

Regulatory, compliance, certification, and auditing frameworks such as those from the Food and Drug Administration (FDA) or the International Organization of Standardization (ISO) provide guidance and enforcement of the rules pertaining to good manufacturing practices and quality practices for a host of industrial sectors, not the least of which are within life sciences. Quality professionals make sure that rules are followed and that their organizations can pass audits to prove this fact to regulators, suppliers, and customers alike. Failure to do so can result in the loss of valid registration to standards such as ISO 13485—“Medical devices—Quality management systems—Requirements for regulatory purposes,” which could mean financial disaster for the organization. The risks are even higher for organizations if and when FDA regulators come knocking at the door, badges in hand. But all of that is nothing compared to the dangers that faulty practices might pose to the customers of life science products.

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In the future, as the opportunities and challenges found within the life science industry increase both exponentially and in tandem, systems thinking must be brought to bear. In this sector, innovation focused on “defense” (i.e., creatively exploring unintended consequences and the nightmares represented by the worst of humanity) will have to take precedence over the more standard innovation based on “offense” (creative destruction and new product or service development).

Ethical frameworks like those from the FDA and ISO are critically important to maintaining healthy innovation of both types, but without a certain moral regard the ethical rules will only be so many fingers in so many dikes. A rules-based approach has limits, but when there is cultural agreement on what constitutes moral action, the regulations are undergirded with a layer of human-centric poka yoke. In other words, although a set of ethical laws may say “don’t,” only moral codes make humans think, “can’t.”

It’s not too grandiose to say that quality is a noble profession. When considering the inevitability and importance as well as the risks and rewards found in forthcoming developments within the life sciences, it’s also not overstating things to note that quality professionals will play a major role in allowing us all to both enjoy the fruits of what’s sure to be startling innovations while also remaining safe. Checking boxes and passing audits is only the barest minimum of what society needs from those working in life-science quality today, and especially tomorrow. The higher allegiance is to a moral code that expresses itself through systemic, repeatable action to ensure that we control—and are not controlled by—the technological changes to come.

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Mike Richman