“Shrinking” IRBs and Cutting-Edge Bioethics

A recent conversation from my IRB work—for several reasons, I must limit the details of the case:

An IRB had received, for review and approval, a research protocol for gene editing of human embryos obtained from an IVF clinic.  The embryos would be at about the 150-cell stage—an early stage at which some (incorrectly, as I understand the science) believe a fertilized, dividing-and-differentiating zygote has not yet attained sufficient maturity to be called an embryo.  These embryos would have been “donated,” in compliance with current law and regulation, including informed consent from the relevant party or parties.  Further, the embryos would have been found to have a “life-threatening” mutation by preimplantation genetic diagnosis (PGD).

The first impression of the IRB’s primary reviewer (a scientific member for you readers familiar with regulations about the makeup of an IRB) was that the study was approvable on an expedited basis—that is, without a discussion at a full IRB meeting.  Current regulations identify nine categories of research eligible for expedited review.  The study in question arguably fits criterion #3:  “Prospective collection of biological specimens for research purposes by noninvasive means.”

Under current law and regulation, this is a reasonable view.  The Code of Federal Regulations (45 CFR 46.204) includes requirements for the protection of live human fetuses who are subjects of research.  The regulations define “fetus” as “the product of conception from implantation until delivery.”  Research involving dead fetuses, in whole or in part, including those obtained as a result of elective abortion, is to “be conducted only in accord with any applicable federal, state, or local laws and regulations regarding such activities.”  As the Congressional Research Service points out in a general reader-friendly FAQ document (go to https://www.fas.org/sgp/crs/misc/R44129.pdf), any research involving human subjects must be approved by an IRB in advance, but the dead fetus is not considered to be a human subject.

It’s logical to apply the same considerations to embryos used in research, and PGD, and, to be sure, IVF itself.  Of course, these embryos are usually destroyed in the process, and all the related issues of embryo or fetal tissue donation are raised in the process.  In the present case, were the research to be done on embryos intended for implantation and bearing in pregnancy, the embryos would be human subjects as well, and all the related issues—consent and others—that I and others have discussed on this blog in the past would apply as well.  It’s arguable that, to be sure all regulations are met, an IRB should send research like the proposal in this case to full review. (One question I would have is how strict is the definition of “life threatening” mutation.)

For those who, like me, argue that human life begins at conception and might like to see the current regulations changed, that probably would require a new statute—a law passed by Congress and signed by the president.

But none of those thoughts is my main concern here.  Rather, I think of the recent discussions of whether it is wise to edit the genes of human embryos or germline cells (eggs or sperm).  Scientists meeting in Washington DC recently issued a statement that it would be “irresponsible” to proceed with such editing in embryos intended for pregnancy.  There appeared to be at least a cautious embrace of basic research on editing genes in these cases, however, implying support for proposals like the one crudely outlined here.  But some leading scientists in the gene editing field disagree, arguing for a broader societal discussion first.

And, in that light, consider the shrinking role of the IRB.  I think the standard understanding of the IRB’s jurisdiction, in the early 21st century, is narrow—it is empowered only to address whether current regulations are being met.  Whatever the individual members of an IRB may think about the broader questions of the wisdom of forging ahead with human embryo or germline gene editing, I bet most IRBs would not think that it is not their business to weigh in on whether studies like the one described here should be done at all.  In other words, whatever societal discussion of these ethical issues is needed, the IRB is walled off from it.  Am I the only one who finds it ironic that IRBs, which had their genesis in the effort to prevent mistreatment of human research subjects, and whose members are required to have varying backgrounds, are considered unqualified to weigh in on matters like this?

A Tale of Two Friends

I am thinking of two friends from church with advanced cancer, both men about my age, 60-ish.

One has a high-grade brain tumor, persistent after standard therapy and more than one experimental new treatment.  He’s a fighter, looking for something new to try.  He’s an ex-Marine, famously fit at baseline, willing and able to tolerate some toxicity.  He also tells me that he is trusting Christ more than ever, and his devotional life is stronger than ever.  Although he’s pretty stoic, his tears up easily, in part because of the effects of his disease on his emotional processing, in part because having the illness seems to have brought him low.  In his younger days, he published some papers on bioethics—on end-of-life issues.

The other one has colon cancer, metastatic to his liver.  After the disease grew despite multiple tries at chemotherapy that, frankly, just made him sicker, he stopped active treatment of his tumor and started home hospice with the best current palliative care available.  On that, his condition has improved, and he’s done well for the better part of a year.  But he is in pain, some days worse than others.  He’s candid but reserved about his experience, also stoic.  He tells me to “keep working on miracles.”  (I work in clinical development of experimental drugs for cancer.)  I tell him there is only One miracle worker.  And, to his and my shock and outrage, some people have actually gone to him and asked him whether he would consider assisted suicide.

By the way, both of their wives are stalwarts, even heroic, IMHO.

Of course, none of knows how many more Christmases we will see, how many more times we will turn the calendar.  But the question is more acute for these two men.

I expect that both of them, when they leave this earth, will enter into the eternal joy of the Lord Jesus Christ.  I am sure that each of them holds fast to that assurance.  Still, I can see in their faces and hear in their voices real trepidation at the prospect of passing “through the veil.”  I think of a third friend from church, who has endured multiple myeloma for 14 years and counting, saying that he does not fear death but he is not looking forward to the point of dying.  I think of Woody Allen’s quip, “I’m not afraid of death.  I just don’t want to be there when it happens.”  I think of Christian, in The Pilgrim’s Progress,, fearful that he will not endure the passage through the river to the Celestial City, and his fellow traveler telling him that “Jesus Christ will make you whole.”

It’s one thing for an amateur bioethicist like me to press confidently my arguments about what should or should not be our actions, our perspective, in the end stages of life.  And, of course, whether one believes in the prospect of a happy afterlife must drive one’s view of the end of this one.  I am watching these two men as carefully as I can for lessons on how I should behave, at the time, if my latter days afford some advance warning about the end.  They are models of dignity.  I am reminded that, in my time, my ethical convictions may be tested.

And so, yet without irresolution, I am humbled in this season, when Christians like me celebrate the advent of Life Abundant and Eternal, Who, in His sacrifice and resurrection, defeated death and secured everlasting hope for His people.

Bioethics and Donald Trump

Sometimes people say things in public that just need a response. Donald Trump did that recently when he said that the US should deny entry into the country for all Muslims due to the risks to the US from radical Islamic jihadists. Just about everyone has responded with statements of why this is utterly wrong including Republicans, Democrats, Jews, Muslims and Christians. Permit me to respond from the viewpoint of Christian bioethics.

Christian bioethics is grounded in an understanding of who we are as human beings. We believe that every human being has an inherent dignity because we are one of the family of beings that God has created in his image. We believe that every human being should be treated with respect because of that inherent dignity. That dignity does not depend on what an individual has or can accomplish or even what that individual believes. A human being has dignity and deserves our respect even if he or she denies the grounds we have for granting that respect.

We also believe in religious freedom and that does not mean that only those who agree with what we believe to be true about God and what he has revealed to us about how we should live should have freedom. Religious freedom means that we support people being able to live in accordance with their best understanding of ultimate truth even if what they believe turns out to be false. Religious freedom is a part of how we treat human beings because of their inherent dignity.

Religious freedom does not mean that a person should be allowed to do anything in the name of religion. Killing innocent people is wrong because of that same understanding of the value and dignity of human life. Radical Islamic jihadists who kill innocent people should be stopped, but that does not mean we should deny religious freedom to anyone who follows Islam. As a nation we have a responsibility to the protect safety of all people within our borders and should properly screen both visitors to our country and those desiring to come as immigrants to weed out those who threaten that safety. Denying entrance to all Muslims would not accomplish that goal and violates our understanding of religious freedom.


With regard to immigrants we should remember that many of the victims of the violence of radical Islamic jihadists such as ISIS are Muslims. We should be open to caring for them just as we would care for any other victims of injustice. One of the strengths of Christian bioethics is our concern for those who are the weakest and at the fringes of society, including the unborn, the disabled and the dying. We must not forget to include all victims of violence and injustice no matter what religion they profess.

Refusing to Acknowledge the Human Dignity of Refugees

One useful method to try to deny the fact that someone possesses basic human dignity is to cultivate an “us vs. them” mindset. To do this we must ignore the individual in front of us and instead see only the class of people they represent to us. This helps us to forget that the other person possesses the same human dignity that we have, and allows us to place the other person in a category of “bad people” who are inferior to and opposed to us “good people.”

I made a friend several years back, a Syrian man who was in the States for some higher education. He used to tell me over lunch about the glories of Damascus, and he looked forward to going back there. After he finished his education he did return to Damascus, where he set up his own business. We maintained a regular e-mail correspondence.

Then the Syrian civil war broke out. I became worried for my friend and expressed as much to him, but he reassured me that he wasn’t in much danger. He was apolitical and kept a low profile. But one day he stopped answering my e-mails. I wrote several times with no response. I assumed the worst.

However, about a year and a half later, I heard from him again. He had been arrested for doing business with “the wrong kind of people,” and thrown into a jail. There he had been tortured, seen people killed in front of him, and experienced horrors that he refused to write to me about. Somehow he had gotten out, and he is now establishing a new life in Europe, learning a new language and finding new work.

My friend is a refugee, fleeing monstrous evil. There are some politicians and government leaders, even in this country, who would lump my friend in with his persecutors, placing him in the category of “doesn’t deserve our help.” In so doing they would categorically deny the human dignity that he inherently possesses. They would do this by relegating my friend and all other Syrian refugees to the “them bad guys” category — those people, who are fundamentally different from and pose a danger to “us.” Unlike someone with full human dignity status, they are not worthy of our help.

I don’t know much about public policy. There may be perfectly sound reasons to keep out Syrian refugees which don’t involve the outright denial of their full human dignity. If so, I haven’t heard any yet. And to practice this blatant denial of an individual’s human dignity harms not only those whom we would keep out; even more, it damages the character and soul of the people who practice it.