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Bioethics analyzes social, ethical, moral, and policy issues in biomedicine. The multidisciplinary field encompasses various topics, from research ethics to health policy, patient privacy to genomic policy, and more. Bioethics is all around us, even if it’s difficult to define. It’s such a broad topic that it evades quick definitions. Although you may not realize it, pathologists and laboratory professionals encounter complex bioethical dilemmas every day. One common example: What do you do if a specimen comes into the laboratory that doesn’t meet your quality standards? That’s a bioethical question.

Despite the significance of these decisions, many individuals are not acquainted with the ethical framework that governs them. Improving the medical community’s understanding of bioethics can facilitate more comprehensive discussions and the development of more informative policies in laboratory science.

Critical Values spoke with Kamran Mirza, MD, PhD, associate professor and vice chair of education at Loyola University Chicago Stritch School of Medicine, and Cullen Lilley, MS, MA, MB(ASCP), MDxT(AAB), MD at Loyola University Chicago Stritch School of Medicine and incoming PGY1 at UCLA for pathology. Dr. Mirza and Dr. Lilley discussed in length what bioethics in the laboratory entails and how distilling it into five categories can help the medical community better understand how it interplays in almost every facet of a pathologist's or laboratory professional’s work.

Breaking down bioethics

“Bioethics encompasses many, many different fields,” Dr. Lilley explains. It’s tricky to define, in part because medical ethics topics tend to traditionally be patient-facing, while laboratory bioethics happen behind the scenes.

“When the medical community thinks of clinical bioethics, they don’t think of the behind-the-scenes patient care that the laboratory does,” Dr. Mirza shares. “But any time you face a question that doesn’t have a perfect yes or no answer, that’s a time you have to use your bioethical decision-making.”

For example, consider a patient nearing the end of their life and needing palliative care. How do you balance laboratory testing with quality of life?

“It’s impossible in bioethical inquiry for one person to fully understand the whole picture,” Dr. Lilley notes. “As pathologists, we have a very different perspective on patient care than a laboratory professional or those in management positions. Having those different perspectives is a huge part of bioethics.”

According to Dr. Mirza and Dr. Lilley, laboratory bioethics can be broken down into five categories to better understand what it entails for those starting to explore this topic. These categories include:

• handling of patient data
• social and ethical implications of laboratory testing
• interventions in clinical trials
• staffing and supervision in the laboratory and
• special populations

Here’s a closer look at each.

Ethical handling of patient data

The ethical handling of patient data encompasses questions of confidentiality, privacy, and informed consent. And it can get a lot more complicated than you might think.

First, there’s the simple concept of transmitting data from one machine to another, Dr. Lilley explains. You can’t discuss a patient’s data in a hallway—this is a basic tenet of modern clinical ethics. However, when different electronic systems talk to each other, there are critical bioethical considerations in data security to maintain the highest level of patient confidentiality, especially with sensitive laboratory results. Beyond this, there are even more complex questions involving informed consent with testing.

“Let’s say a patient has a tube of blood drawn and has consented to laboratory procedures that are supposed to help diagnose leukemia,” Dr. Mirza says. “The patient has given us a whole specimen that includes their DNA. So where is the informed consent line? We could study the genetic makeup, protein makeup, the enzymatic makeup … Is our testing limited based on what is ordered or consented?”

It can get even more complicated the deeper you dive into the topic.

“There are times when the pathologist considers something necessary for the diagnosis and/or prognosis of a disease—such as a defining cytogenetic abnormality in tumor tissue—and will order additional testing which, by and large, the patient-facing physicians will be OK with,” Dr. Mirza explains. “But the patient may not be aware this all happened in the background. And while it was for their benefit, there might be an element that they may not understand or have wanted.”

Molecular testing brings up numerous ethical debates. Dr. Lilley uses the example of sequencing 18 samples for a new molecular test, only to discover that one was a carrier for cystic fibrosis. What do you do next?

Dr. Lilley concludes, “informed consent for molecular tests is a bit more nuanced, and we’re starting to realize that, but it’s a process.”

Social and ethical implications of laboratory testing

Social and ethical implications of laboratory testing encompass topics of social justice, such as who has access to laboratory testing. For example, some patients may be unable to have tests that medical laboratory scientists feel are important simply because they’re too costly.

“Certain tests are very expensive,” Dr. Mirza explains. “Access to testing is different based on patients’ resources, insurance, etc. In the laboratory, let’s say somebody gets a diagnosis of leukemia and they don’t have insurance. A bioethical conundrum is deciding how far we’re going to take the testing. It can cost a couple hundred dollars to give a preliminary answer, and maybe tens of thousands of dollars to complete the genetic testing. But genetic testing might change the course of treatment for the patient. Not all patients have equal access to [that level of] testing, so it becomes a justice issue.”

There are also considerations involving situations like reportable diseases and how the testing interplays with other societal factors.

“Do some people decide to forego certain tests if they are for reportable diseases, like HIV or syphilis?” Dr. Lilley asks. “The interaction between the lab and society is not fully explored.” He cites an article in the AMA Journal of Ethics that explores the concept in more detail.¹

Involvement of pathology and laboratory medicine in clinical research and trials

The laboratory is deeply intertwined with clinical trials, from providing the data that determines if a patient can enroll to monitoring the data throughout the trial. Each step involves ethical decision-making, Dr. Mirza explains.

“There are the ethical considerations of when to shut down a trial, when to continue a trial, and when the trial is actually successful,” Dr. Mirza explains. “From a bioethical lens, we’re thinking about how all the data we find about how patients are responding to clinical trials can influence patient outcome.”

Laboratory professionals might also see that patterns with certain diseases can lead to differences in patient outcomes.

“Technically, you could just say ‘these types of histologic patterns usually portend worse outcomes,’ but you could also explore it more and let the rest of the medical community know about it (through published research),” Dr. Lilley notes. “Is it our ethical responsibility to continue to ask those questions to continue to improve our understanding of disease? That’s where we get into the question of whether research is an ethical responsibility or not.”

Staffing and supervision in the laboratory

When it comes to staffing shortages in the laboratory, the bioethics framework looks at questions of competency, qualifications, and testing oversight, among other things. “ASCP has data on the laboratory workforce shortage and is working toward fixing it,” Dr. Mirza explains. “But laboratories right now are incredibly understaffed. Specimen testing requires human oversight, and laboratory professionals have to be certified by specific authorities and have particular types of training. Those qualifications are incredibly important. But nationally and even internationally, we’re at a loss for people to appropriately run laboratories.”

This leads to an overlap with bioethics questions involving patient data and social implications.

“Every hospital will have a lab, but how much the lab does is variable,” Dr. Lilley explains. “Let’s say we’re trying to bring on a new genetic test. You’d need people to validate that system at the hospital level, and you’d need time and expertise on that. So smaller hospitals probably won’t have that, and those patients won’t have the availability of that test.”

Dr. Lilley adds that laboratory professionals also have an ethical responsibility to help with recruiting more people into the field. Their assistance can help reduce laboratory shortages, allowing for an even higher quality of care every day.

“It’s our responsibility to go out there and start to drum up some interest,” he says. “We’re starting to figure out that people are just finding out about the field too late. You really need to find out about it in high school or earlier.”

Dr. Lilley elaborates on this ethical responsibility. “Laboratory professionals and medical doctors train each other in a long linear procession starting all the way back at Hippocrates. From the Hippocratic Oath: ‘I will impart a knowledge of the art to my own sons, and those of my teachers, and to students bound by this contract and having sworn this Oath to the law of medicine, but to no others,’” he shares. “It is our ethical responsibility to train those who come after us, but when the pipeline of students runs dry, we need to help get people interested. It’s our responsibility as a profession to make sure the general public knows what we do, but it’s also important to make sure there will be a profession for the future of medicine. Modern medicine would cease to exist without the lab. We are performing patient care by making sure the student in Idaho is able to pursue their dream of becoming an MLS, so they can serve as an MLS in a hospital that needs them.”

"The challenging part about bioethics is that the answers are not black and white. As laboratory professionals, we’re very used to finding the answer. This can be a very uncomfortable field for people to dive into."

Patients with unique reference ranges

This final category encompasses bioethics considerations involving test result reporting for transgender patients, pediatric patients, or geriatric patients.

For transgender patients, ethical issues begin with the electronic records themselves.

“There are many EMRs that don’t have the ability to translate the fact that a patient is transgender,” Dr. Mirza explains. “They might still have the patient’s birth gender in the system, but all of their testing is incongruent to the gender the laboratory scientist is assuming.”

Another population that falls in this category is transplant patients. The results of their lab work can sometimes determine if they’re eligible for transplant lists or not.

One stark example involving bioethics of the laboratory was patients waiting for kidney transplantation and their eGFR values. USA Today reported² that this out-of-date test had erroneously overestimated how well certain Black patients’ kidneys were functioning. The Organ Procurement and Transplantation Network board recently decided to prohibit the use of that test.

“Results from laboratories are powerful indicators for patient eligibility for transplantation or other procedures and it is something we take very seriously,” Dr. Mirza explains.

There is always more to learn about laboratory bioethics

With all those layers, bioethics is certainly complicated.

“Bioethics is often about the approach to a dilemma,” Dr. Mirza explains. “It isn’t necessarily about finding a perfect solution but approaching a problem with intentionality and care.”

And these discussions aren’t always easy.

“The challenging part about bioethics is that the answers are not black and white,” Dr. Lilley adds. “As laboratory professionals, we’re very used to finding the answer. This can be a very uncomfortable field for people to dive into.”

Uncomfortable, but necessary, if the laboratory wants to stay a leader in delivering high-quality care. A good starting point for these conversations is simply talking with your colleagues.

“If you’re interested in bioethics, continue to have those discourses,” Dr. Lilley says. “That’s the boots-on-theground work that needs to be done.”

References

1. Lin L, Liang BA. HIV and health law: Striking the balance between legal mandates and medical ethics. AMA Journal of Ethics. October 2005. Accessed May 10, 2023. https://journalofethics.ama-assn.org/article/ hiv-and-health-law-striking-balance-between-legalmandates- and-medical-ethics/2005-10
2. Hassanein N. Widely used test kept Black people from getting kidney transplants sooner. Now that’s changing. USAToday. January 23, 2023. Accessed May 10, 2023. https://www.usatoday.com/story/news/ health/2023/01/23/black-patients-kidney-transplantlists- policy-change/11002476002/