Rights of conscience and the distinction between needed and desired treatment

Rights of conscience, the moral concept that physicians or other medical providers should be able to choose not to provide or participate in medical treatments which they believe to be morally wrong, continues to be widely debated in our society. A recent article in Vox titled “He needed a gender-affirming procedure. The hospital said no.” Expresses some things that I think are misunderstandings of what this debate is about.

Although it mentions other faith-based institutions, the article is primarily about the types of procedures which Roman Catholic hospitals in the United States do not provide under the Ethical and Religious Directives for Catholic Health Care Services. Throughout the article it is stated that Roman Catholic hospitals have refused needed care to persons seeking care in those hospitals. It also raises the concern that people may die because they are not provided necessary emergency care and care from another hospital willing to provide the care may be too far away. My main concern with this article is that there appears to be a misunderstanding about the distinction between needed and desired treatment. Among the things listed as needed care are “fertility treatment, gender-affirming care, or tubal ligations.” The article begins with the case in which a Roman Catholic hospital would not provide an elective hysterectomy to a biologically female person who identified as being male. The hospital’s reason for not providing this elective surgery was not because it was desired as a part of the person’s gender transition. They chose not to provide the surgery because of their belief that removing a healthy uterus impairs fertility in a way that should not be done.

There is a difference between desired elective treatments that people may choose to do even though there is no medical reason why they need to be done and treatment that is either life-saving or needed for other medical reasons. Such things as fertility treatments, gender affirming surgeries, tubal ligations, and abortions are elective treatments that an individual may choose to do but are not medically necessary. There is an appropriate difference between the obligation of a physician or hospital to provide medically necessary and life-saving care and the presumed obligation to provide elective medical treatments that are desired but not medically necessary.

I am not Roman Catholic, but I practiced in a Roman Catholic hospital for about 30 years. I served on the ethics committee at that hospital as well. I became very familiar with the ethical and religious directives and the type of things they direct Catholic hospitals not to do. These things are elective treatments or procedures that a person may desire, but which are not medically necessary. I also became familiar with the important role that Roman Catholic hospitals play in providing care for the poor and marginalized, many times providing care for people that other hospitals and physicians would not. Those who think that our society would be better without Roman Catholic and other faith-based hospitals are quite mistaken. If those hospitals are forced out of our society by those who would require them to do anything that anyone requests even when they believe that those things are wrong, the poor and marginalized in our society will suffer greatly.

Screening that benefits the screener

I teach it course on human diseases for students in a public health program. One of the things that we talk about is asymptomatic disease. If a disease has no symptoms the only way that we can detect it is by screening. For screening to be beneficial it needs to be able to detect asymptomatic diseases accurately and there needs to be something which can be done that will help those in whom the asymptomatic disease is diagnosed. Many times, a screening test will only be accurate if the test is used to screen a selected population which is at risk. Sometimes there are asymptomatic diseases which we can detect accurately, but the people diagnosed do not benefit because there is not something we can do to make their life better than it would be if the asymptomatic disease had not been diagnosed. Since the purpose of screening is to help people, there is no reason to do it if the people being screened will not be helped. That idea is based on the principle of beneficence. Everything that we do in medicine should be done for the benefit of the person being treated.

Some people do not follow that moral principle. There have always been some who have used the practice of medicine to benefit themselves more than those they were treating. That is why the Hippocratic physicians had to put a statement about beneficence in their oath. One of the ways that the principle of beneficence can be violated is for some people to encourage other people to do screening that will not benefit those being screened but will benefit the one doing the screening. One of the examples I see most often is supposedly low cost ultrasound screening for such things as carotid stenosis. Those doing the screening can make a significant amount of money by screening everyone who will accept their pitch but the people being screened do not benefit. It is currently not recommended to screen for asymptomatic carotid stenosis because there is no evidence that intervention is beneficial for those who are diagnosed and some evidence that intervention may cause more harm than good.

As new technology is developed it is subject to being used in a way that violates the principle of beneficence. One of the new ways to do that is with genetic screening. A recent article in the health news section of Reuters.com describes the fraudulent promotion of genetic screening to older adults in the US. Again, this is screening being done to benefit screeners who have collected huge sums from Medicare while providing no benefit to those being screened.

These abuses do not mean that we should not do screening. It simply means that screening should be done the right way. We should choose which screening tests we use and which people we screen with those tests based on how the screening will benefit those who are being screened. We should not do it to benefit those who are doing the screening.

Stem Cell Rx No Longer For Sale on Google

Perhaps once a week, I will be asked by a patient about the potential benefits of stem cells for reversing the normal affects of age, particularly with respect to arthritis of the knee joints, hip joints or the degenerative discs in the lumbar spine. I believe one of the reasons for this interest has come from increasing advertisements by various clinics in my region of East Tennessee claiming stem cells are the answer for these problems. My region is not unique. A simple Google search on “stem cells for knee pain” yields ads for clinics offering such treatment.

Stem cells are cells that have potential to become any type of cell in the human body such as a new blood cell, nerve cell or bone/cartilage cell. Scientists are rapidly learning how to find or create stem cells, as well as how to safely use them to replace old or missing cells, thus restoring function in worn out, damaged or diseased areas of the body. In fact, stem cells are presently used to replace the bone marrow for some individuals with certain cancers and disorders of the blood and immune system, and in many of these cases, the results are lifesaving.

The problem is that stem cell treatment remains yet unproven in all other medical conditions, including the age-related arthritis conditions which I treat. This lack of efficacy has not stopped clinics from offering and patients from receiving stem cell injections with the hope of achieving improved function or cure. I am willing to grant that many offer these treatments with the sincere hope and belief that they are acting in their patient’s best interest, though I suspect not all have the patient’s best interest in mind. Unfortunately, there have been severe adverse events. Examples include blindness following an injection of stem cells into the eye, and loss of function with development of a spinal cord tumor following stem cell injection into the spine.

The FDA is trying to educate the public and prevent stem cells from being offered for unproven treatments. The FDA has the authority in the US to stop these unproven treatments and take punitive action if needed. This is not to suggest that the FDA is in the business of preventing legitimate investigation into the potential benefits of stem cells, such as this Mayo Clinic Phase 1 study looking at the risks of injecting stem cells in to the cerebrospinal fluid of patients following a spinal cord injury to see if this particular stem cell technique causes harm (with future studies needed to determine benefit).

The FDA is recently getting some help from Google. On September 6th, Google announced it would stop accepting ads for unproven medical treatments, including stem cell therapies. It is early in the effort and the initial link above still has four ads for non-bone marrow stem cell treatments returned with the Google search. Maybe by the time you read this blog entry, the stem cell ads for unproven treatments will be gone.

I am hopeful that stem cells will eventually provide patients with safe therapies that repair injury and return patients to normal health. Offering that promise without the studies that prove such benefit is unethical and potentially harmful. It is good to see Google favoring human welfare over financial profit.

Much going on about heritable genome editing

The first meeting of the International Commission on the Clinical Use of Human Germline Genome Editing was held in Washington, DC on August 13.  This is a US/UK commission convened by the UK Royal Society, the US National Academy of Medicine, and the US National Academy of the Sciences.  Space for in-person attendance at these meetings appears limited, but information is freely accessible on the internet.  For example, the meeting materials and videos from the August 13 can be accessed here, and one can register to be on the Commission’s mailing list at this link. 

It is challenging for anyone with a “day job” whose work is not dedicated to the field of gene editing to try to keep up with developments, so the open access to information is welcome.  The August 13 meeting included numerous basic science discussions as well as some from biotechnology companies seeking to develop gene editing approaches.  As discussed often on this blog and elsewhere, so-called “somatic” gene editing—that is, gene therapy of fully-formed individuals by editing an undesirable gene such as one known to cause disease–appears generally to fall within the existing regime of human research ethics and regulation and pose relatively few unique ethical issues.   The day included industry presentations regarding somatic gene editing, either “in vivo”—involving injecting the gene editor into a person—or “ex vivo”—involving removing cells from a person, editing the cells in the medical lab, then re-injecting the gene-edited cells into the person’s body as a form of treatment.  In neither case is the editing inherited across generations, avoiding the larger issues of manipulating human beings more fundamentally, and, as your present correspondent has consistently argued, unacceptably.

Even for somatic gene editing, however, “getting it right” in the form of editing the genes intended, and only those, and developing approaches to assess and control for longer-term or unintended risks is still a substantial set of tasks, as was described in a presentation by an official from the FDA.

The day also included a presentation from the separate World Health Organization multidisciplinary advisory panel, which held its first meeting in March 2019 with another one having been due this week in Geneva, Switzerland.  At the March meeting, the WHO panel adopted three main recommendations for developing oversight of human genome editing:

  • Establish a structured mechanism for collecting and curating details about proposed and ongoing research;
  • “it would be irresponsible at this time for anyone to proceed with clinical applications [they mean trying to establish a pregnancy or birth] of human germline genome editing”
  • Establish approaches to obtain input from the “broadest possible range of stakeholders” and “explore opportunities for an open, online mechanism for seeking input.”

All that said, the Salk Institute in San Diego is working on a new technique of editing, called SATI (short for intercellular linearized Single homology Arm donor mediated intron-Targeting Integration [say THAT three times fast!], which is expected to be more versatile than the current “preferred” technique called CRISPR-Cas9.  Biologic details between the two differ, but the ethical issues mainly apply to applications, and are therefore the same for both.  But don’t be surprised if you hear about “SATI” for 5-10 minutes in the news sometime.

And scientists at Cornell Medical Center in New York City are trying to gene-edit human sperm to alter the characteristics of children conceived using them.  Pressing ahead with getting ready for the WHO panel’s “clinical applications.”

Mildred Solomon of the Hastings Center has recently added her voice to those pointing out that whether heritable human genome editing should ever be done is not just a matter of weighing benefits vs risks, but involves much more momentous possibilities that should give us pause.  The key graphs:

“Even as [the WHO and US/UK commissions] regroup to produce clearer guidance, however, I sense a shift in the debate. For a very long time, the scientific and bioethical consensus was that we must not do human germ-line modifications—that we should not change gametes and embryos in ways that would be permanent, affecting all future generations. In contrast, somatic modifications, which affect only the person in whom the edits are made, have been mainly uncontroversial.

But that border between germ-line and somatic genome modification is blurring; the zeitgeist feels different. There is a growing sense of inevitability that we will eventually do human germ-line modification and that our only obligation is to wait until it is safe. When that day comes, we may want to make permanent heritable changes to the human species to eradicate otherwise intractable diseases. We should, however, enter this discussion with eyes wide open, considering each application on its own merits and anticipating a wide range of issues that go well beyond safety. Many of these issues are explored in Human Flourishing in an Age of Gene Editing, which will be published by Oxford University Press on August 28, 2019.”

I’m willing to forgive the plug for a book from people at Dr. Solomon’s institution, which is where the editors of the book in question work.  It looks worth checking out.  In the meantime, the US/UK commission has called for “expert evidence” to assist them in the task “to develop a framework for considering technical, scientific, medical, regulatory, and ethical requirements for human germline genome editing, should society conclude such applications are acceptable.”  Follow this link to have a look at their questions.

Promoting vaccination with a not-too-heavy hand

This week’s Nature has a worthwhile read, “Mandate Vaccination with Care.”    The recent rise in the number of cases of measles is well-documented in the general press, and there is a strong argument that it is a social good that sufficient numbers of children be vaccinated for a range of infectious diseases.  Your correspondent considers it unfortunate, to put it mildly, that there is a persistent belief that vaccines for the standard childhood diseases are harmful.  Although some cases of vaccine harm occur, they are rare—rarer than many in the general public believe—and the cost of under-vaccination is great.  I, for one, never want to see an infant with pertussis (whooping cough) again, and, although I recall having had measles and chicken pox when I was a kid, it’s best to prevent them.  Some can even be eradicated (see: smallpox—which we should fervently hope is never purposely re-introduced, now that we don’t routinely vaccinate for it). 

In brief, the authors in this case argue for promoting vaccination in the public with such steps as ensuring supply and access, providing information and allowing public forums, monitoring safety carefully, and tracking vaccination rates.  They argue, reasonably, that mandatory vaccination that carries the wrong kind of penalties—such as, fines or even jail sentences imposed in some countries—for non-compliance actually can harm poorer, medically underserved people, and as such be counterproductive and, frankly, unfair.  They comment that harsh mandates can unnecessarily prompt a backlash, with increased resistance.

They say, further, that if mandates are deemed “politically appropriate,” then the procedures should be just, with constraints on choice as limited as possible; any penalties must be proportionate; those who do suffer complications should be adequately compensated.   They speak favorably of creating administrative hurdles to getting exemptions from mandates.  They also argue against governments mandating only some vaccines while excluding others.  They claim that making some vaccines only “recommended” can limit the uptake of all. 

This last point may be the most questionable of all in this article.  It is easier to justify mandating vaccination for highly contagious diseases that can have devastating effect (e.g. measles, rubella, diptheria, and others), than, for example, vaccination for human papilloma virus (HPV), infection with which predisposes to certain kinds of cancer but transmission of which is through sexual activity.  In this last case, the argument for a mandate is substantially weaker; vaccination at a fairly young age might be wise, but one might still reasonably accept, for oneself or one’s child, the less certain and more remote risks of the consequences of infection, and therefore reasonably object to mandated vaccination.

Again, a worthwhile read. >

Should Abortion be a Trivial Event?

A recent NEJM Perspective by Drs. Jane Henney and Helene Gayle is calling for reduction in the current restrictions on Mifepristone, previously better known as RU-486. Mifepristone, a progesterone blocker, which effectively opens the cervix of the uterus, when combined with misoprostol, which promotes contractions of the uterus, forms the two-pill combination marketed as Plan C – an effective, safe, self-administered home medical abortion. Arguing that the drug has been shown to be far safer than originally thought, and because many US women are accessing foreign internet sources of potentially suspect quality Mifepristone, Drs. Henney and Gayle are encouraging the FDA to make the drug available from regular US pharmacies rather than at special medical/surgical clinics from a restricted set of doctors as it is presently distributed.

At the time of its initial FDA approval in 2000, it was unknown whether mifepristone would have a high risk of excessive bleeding or incomplete abortions so it was approved under FDA Subsection H, which required that the drug be dispensed directly from a physician (rather than a pharmacy) who can provide blood transfusion or surgical abortion. Drs. Henney and Gayle argue that numerous studies since 2000 support that this level of restriction is unnecessary. This is not to say that the risks of Mifepristone are zero but rather, as one of their arguments goes, there are many other medications available from a pharmacy via prescription that have higher risks so why single out Mifepristone? They are not specifically calling for the medication to become “over-the-counter” (meaning available without prescription) but they list other countries where this is the case.

Their concern about the ease of obtaining Mifepristone (or Plan C) over the Internet is not exaggerated. A quick search of the Internet shows one advocate website called plancpills.org providing a report card where their own secret shoppers grade various Internet sites offering Mifepristone for sale. Another popular site called AidAccess.org offers an informative video, telemedicine consultation as well as foreign sourced Mifepristone and this site is presently one of the least expensive sources of the drug.

One of the statistics offered in support of abortion, especially medication-based abortion such as Plan C, is that these processes are safer for women from a morbidity and mortality standpoint than actually being pregnant, particularly the labor and delivery of birthing a baby. Of course, it (always) goes without saying that the same processes are nearly universally fatal for the baby. But, for arguments where the morbidity and mortality of the child are excluded, abortion, particularly medication-based abortion, has become a relatively safe process.

I have no doubt that the present restrictions by the FDA on access to Mifepristone will be reduced for the reasons Drs. Henney and Gayle have provided, perhaps eventually to point of making Plan C available over the counter.

Abortion is becoming a trivial event.

Abortion kills a human being.

Killing a human being should not become a trivial event.

Parental responsibility in childhood immunizations

Last week I wrote about the issue of parental responsibility and medical decision-making for children. We have good reasons for having parents be the primary decision makers for children who are not capable of making their own medical decisions. However, as I discussed in the last post, there are some situations in which parents make decisions that are not in the best interest of their child. When those decisions reach the point at which the child’s life is in danger, society clearly has a moral obligation to intervene to save the life of the child.

Parental refusal of recommended immunizations for their children raises similar issues but is more complex. We can clearly demonstrate that it is in a child’s best interest to receive at least most of the commonly recommended immunizations for children. Those immunizations help to prevent a child being affected by diseases that can be serious and have a very low risk for serious adverse effects. However, the chance of an individual child being affected by many of these diseases is relatively small and the situation is quite different from a child whose life is in immediate danger due to a parental refusal of treatment. Since the risk to an individual child is relatively small and there is some possible risk to the child from receiving the immunization, it is not clear that a parent who refuses immunizations for a child is being negligent in the same way as a parent who refuses treatment for a life-threatening illness. It can be argued that the best way to deal with this type of situation is education. Many times, parents refuse immunizations for their children because of misconceptions about the risks and a lack of understanding of the benefits of doing the immunizations. It can be difficult to counter widespread misconceptions, but physicians have the responsibility of trying to do that the best that we can. However, this is not the only issue involved in determining whether society has an obligation to intervene and mandate childhood immunizations when parents refuse.

Immunizations are unique in the way that they work. They help protect the individual who is immunized, but they also help protect the community as a whole when we can achieve sufficient levels of immunity to halt the spread of an infectious disease within the community. This is sometimes called herd immunity. We have an excellent example of how this works with the current measles outbreak in the United States. Measles happens to be one of the most easily transmittable infectious diseases that we know of. It also can be deadly in a small percentage of the people who acquire the disease. It is also primarily a disease of children and is transmitted by children. When about 97% of children have been immunized in a community the disease will not be transmitted through that community and those who have not been immunized or cannot be immunized are protected from acquiring the disease. This level of immunity was accomplished in the United States about 20 years ago and for some time the only cases of measles that were seen in the United States were cases that originated elsewhere. However, because of parents refusing to have their children immunized for measles in significant numbers in some parts of the country, herd immunity is no longer present and we are having outbreaks of measles this year that are more than we have seen in 20 years.

That raises a different question. Should we mandate immunization of children for diseases such as measles and override parental decision-making not solely for the benefit of the children whose parents refuse to have them immunized but for the common good of the community? There are some children and other individuals who cannot be immunized or for whom immunizations would not be effective who are put at increased risk when herd immunity is not achieved in the community. This makes the decision about whether to immunize a child not just a decision about what is best for that child but also a decision about what is best for the community. For Christian parent it makes the decision about whether to immunize a child a decision about love of neighbor. Immunizing one’s own child helps to protect the child, but it also helps to protect the most vulnerable in the community. If we truly love our neighbor, we should do that even if there is a small risk to our own child. The final question is whether we as a society should require children to be immunized for these diseases when a parent is not willing to authorize it out of either concern for the best interest of the child or concern for those who are vulnerable in the community.

Parental responsibility in medical decisions for children

The 2 posts on this blog this week by Neil Skjoldal and Mark McQuain raise issues related to parental decision-making for the medical treatment of their children. Neil raised this issue related to parental refusal of life-saving treatment for acute leukemia and Mark raised it related to parental decisions not to have their children immunized for measles. There are some similarities in these situations and some differences. An obvious similarity is that in both of these situations parents are making a decision to refuse treatment for their children that is the recommended standard of care. Both situations raise issues about who should make decisions about the medical care that children receive and how those decisions should be made.

One thing we should be clear about is that this is not a conflict between the principle of respect for autonomy and the principle of beneficence. Respect for autonomy says that a person should be able to make decisions about what happens to his or her own body. It says that it shows disrespect to an individual as a person to insist a person receive recommended medical care when that person has the capability of making his or her own decisions and does not consent to the recommended care. This principle does not apply to decisions about the medical care of young children. Young children are not capable of making decisions about their own care and the parents are not the ones receiving medical treatment, so respect for autonomy does not apply to these situations.

What is involved is our understanding of parental responsibility for making medical decisions for their children. Because young children do not have the ability to make their own medical decisions, someone needs to serve as a decision-maker for them. We generally understand that parents ought to be the ones making those decisions. We have good reasons for that. Decisions about the medical care of young children should be made based on what is in the best interest of those children. God has created us as human beings to be dependent during the early part of our lives. He has put us in families with parents who have the responsibility for providing for the needs of their dependent children. Parents should love their children unconditionally as a precious gift and make decisions for their children based on what is best for each child. This usually makes parents the people who care the most about doing what is best for a child and makes them the best medical decision makers for their child.

However, sometimes parents do not fulfill their parental responsibilities as well as they should. None of us are perfect, but there are times when it is clear that the decision being made by a parent is not what is best for a child. When the potential consequences for the child are serious enough it can become the responsibility of the rest of us to intervene for the benefit of the child. We should not violate parental responsibility lightly, and it needs to be done in a controlled and orderly way, but when the child’s life is in danger, we have a responsibility as a society to intervene to protect a child. We should do this in any type of severe neglect or abuse.  We should do it when parents refuse medical treatment for a child who is likely to die if without treatment and the treatment has a good chance of saving the child’s life.

That appears to be the case in the situation in Neil’s post. The concern about parents refusing immunizations for their children has some similarities, but is more complex. It will take another post to address that.

Measles: When does Screening, Quarantining and/or Vaccination become Mandatory?

As this linked PBS NewsHour interview between Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, and Judy Woodruff reports, the number of new cases of measles in the US has reached nearly 700, which is the highest number of new cases since measles was supposedly eliminated in 2000. The video is short and provides a quick review of the current causes of the outbreak and suggested steps one can take to mitigate future personal and family risks of contracting the disease. The reason for this being the subject of this bioethics blog is to touch on the ethical tensions between personal autonomy and utilitarian public health calculations regarding the recent measles outbreak.

So what is the problem with getting measles in the first place? Measles is a highly contagious viral respiratory disease. Simply being in the same room with someone with the disease can lead to becoming infected. In its milder form, the disease results in fever, runny nose, ear infection and a classic spotted red skin rash. In its more severe form, it can cause a severe pneumonia requiring hospitalization, deafness, lifelong brain damage and even death. Children under 5 years of age are at particular risk. A common two-stage vaccine called MMR is available that successfully immunizes 97% of those that receive it. It is given at age one and again around age 5.

The benefits of the immunization are two-fold. The first is direct personal protection against contracting the disease if you receive the vaccination and are one of the 97% of individuals who gain future immunity against the measles virus. The second is something called herd immunity. If enough people are immunized (experts estimate “enough” to be between 95-97% of the population), then even people who cannot be immunized, such as infants less than one year of age or individuals whose immune systems are compromised, are still somewhat protected from contracting the disease. This is because new measles cases from “outside the herd” are severely limited in their ability to spread to the small number of non-immunized people within the largely immunized herd. The immunized people effectively act as a physical barrier to protect the non-immunized people. Problem solved, right?

To quote my favorite ESPN College Gameday commentator coach Lee Corso: “Not so fast, my friend”. The measles vaccine is not completely risk-free. Minor side effects include fever, rash and local injection site infections. Much less common but more severe reactions include seizures and rare deaths from severe allergic reactions. In the late 1990s, the British medical journal Lancet published a study by Andrew Wakefield positing a link between the MMR vaccine and autism. This study was later proven to be a completely falsified claim and Wakefield was completely discredited, though some parents still use the original study to argue against vaccinating their children.

If the vaccine were completely risk-free, there would be no logical or ethical reason not to receive the vaccination. If everyone who could take the vaccine did so, herd immunity from a public health standpoint would be at its maximum, protecting the remainder of individuals unable to receive or benefit from the vaccine. The current measles outbreak argues that either we are not properly screening or quarantining new cases of measles at the point of entry to the US or our herd immunity may be breaking down (or some combination of the above).

So, at your next social function, after you have debated your usual political concerns or dismay at your favorite NFL football team’s shocking choice in the recent NFL draft, settle in to a potentially more meaningful discussion around the ethics of personal autonomy versus public health policy regarding mandatory measles screening, quarantining and vaccination. Suggested sub-topics might include:

• Is it fair for those who are able to vaccinate but choose not to vaccinate to freely rely on the herd immunity of those that do vaccinate?
• How public should one’s vaccination or immunity status be to avoid quarantine?
• What reasons are reasonable to choose not to immunize?
• Would it be fair to deny public (or private) insurance coverage for treating the measles if one chose not to take the vaccine?

Are AI Ethics Unique to AI?

A recent article in Forbes.com by Cansu Canca entitled “A New Model for AI Ethics in R&D” has me wondering whether the ethics needed for the field of Artificial Intelligence (AI) requires some new method or model of thinking about the bioethics related to that discipline. The author, a principal in the consulting company AI Ethics Lab, implies that there might be. She believes that the traditional “Ethics Oversight and Compliance Review Boards”, which emerged as a response to the biomedical scandals of World War II and continue in her view to emphasize a heavy-handed, top-down, authoritative control over ethical decisions in biomedical research, leave AI researchers effectively out-of-the-ethical-decision-making loop.

In support of her argument, she cites the recent working document of AI Ethics Guidelines by the European Commission’s High-Level Expert Group on Artificial Intelligence (AI HLEG). AI HLEG essentially distilled their AI ethical guidelines down to the familiar: Respect for Autonomy, Beneficence, Non-Maleficence, and Justice, as well as one new principle: Explicability. She downplays Explicability as simply the means to realize the other four principles. I think the demand for Explicability is interesting in its own right and will comment on that below.

Canca sees the AI HLEG guidelines as simply a rehash of the same principles of bioethics available to current bioethics review boards, which, in her view, are limited in that they provide no guidance for such a board when one principle conflicts with another. She is also frustrated that the ethical path researchers are permitted continues to be determined by an external governing board, implying that “researchers cannot be trusted and…focuses solely on blocking what the boards consider to be unethical.” She wants a more collaborative interaction between researchers and ethicists (and presumably a review board) and outlines how her company would go about achieving that end.

Faulting the “Principles of Biomedical Ethics” for failing to be determinant on how to resolve conflicts between the four principles is certainly not a problem unique to AI. In fact, Beauchamp and Childress repeatedly explicitly pointed out that the principles cannot be independently determinant on these types of inter-principle conflicts. This applies to every field in biomedical ethics.

Having an authoritative, separate ethical review board was indeed developed, at least in part, because at least some individual biomedical researchers in the past were untrustworthy. Some still are. We have no further to look than the recent Chinese researcher He Jiankui, who allegedly created and brought to term the first genetically edited twins. Even top-down, authoritative oversight failed here.

I do think Canca is correct in trying to educate both the researchers and their companies about bioethics in general and any specific bioethical issues involved in a particular research effort. Any effort to openly identify bioethical issues and frankly discuss potential bioethical conflicts at the outset should be encouraged.

Finally, the issue of Explicability related to AI has come up in this blog previously. Using the example of programming a driverless car, we want to know, explicitly, how the AI controlling that car is going to make decisions, particularly if it must decide how to steer the car in a no-win situation that will result in the death of either occupants inside the car or bystanders on the street. What we are really asking is: “What ethical parameters/decisions/guidelines were used by the programmers to decide who lives and who dies?” I imagine we want this spelled-out explicitly in AI because, by their nature, AI systems are so complex that the man on the Clapham omnibus (as well as the bioethicist sitting next to him) has no ability to determine these insights independently.

Come to think about it, Explicability should also be demanded in non-AI bioethical decision-making for much the same reason.