Mandatory Organ Donation: Ethical or Outrageous?

by Theresa Spranger, Bioethics Program Alumna (MSBioethics 2012)

Organ donation is the gift of life. By donating organs after we die we can literally bring someone back from the brink. Pretty awesome right?

So awesome in fact, that it could be argued, and has been, that everyone should want to donate their organs when they die, and consent for donation should be presumed.

What would this mean? Presumed consent for organ donation means that viable organs would be harvested from anyone who dies and consent from the patient or family would be unnecessary. Every person would need to opt-out of the donation program rather than the current “opt-in” plan we have now.

As with everything in life there are pros and cons with an opt-out plan. Let’s start with an obvious pro: with more available organs, more sick patients can get the transplant they need. This is a definite good, but is it worth the cost.

One of the arguments I have heard for mandatory organ donation is: you don’t own your body once you die. The assumption is that once I have died neither I, nor those who love me, have a vested interest in my body and until it is released to my family for funeral arrangements it in essence belongs to the government and my organs can be taken for donation without any ethical issue.

I adamantly disagree with the idea that I have no vested interest in my body once I have died. My interest extends from the values I have lived during my life. Furthermore, ownership and all decisions therein, should belong to my next of kin. This ownership is crucial for many families. For me, the final act I can perform for my loved one is ensuring the safe passage of their remains. It is vital for me to have ownership of this task as part of my grieving process. To remove personhood and its intrinsic value because life has left the body is illogical and disrespectful to the person as well as the loved ones they leave behind.

Another issue with presumed consent is that it expects an educated populous. At this point in our society we need to recognize that this cannot be expected. The vast majority of Americans live very uninformed lives for a variety of reasons. If you don’t believe me watch some of Jimmy Kimmel’s Lie Witness News, they will make you cringe.

Finally, I think that making organ donation mandatory changes the psychology of the act. Right now to donate you organs is altruistic and selfless. If it becomes mandatory it changes the dynamic, instead of an altruistic giving of your organs, you become a renter of those organs until your death. This may sound like a small thing, but changing this changes the way we view donors entirely.

In the end, organ donation saves lives, which is an important and wonderful thing. However, making donation mandatory comes at a cost. Are the lives saved worth possibly violating a person’s body? Or upsetting their family?

Treating everyone with respect and dignity is the most important thing we can do. We should not place one patient at a higher priority while neglecting the other patient or their family.

As you have likely gathered I am strongly against mandatory organ donation. That being said, organ donation is crucial and we should educate all citizens on the great gift they can give at the end of their life. This will be an uphill battle, but if you agree with organ donation tell a friend and tell them to tell a friend. With passionate advocates making the case to individuals we can raise the number of willing organ donors without compromising the donation process.

[This blog entry was originally posted in a slightly edited form on Ms. Spranger’s blog on May 15, 2014. Its contents are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

Whose Business Is It If You Want a Bee To Sting Your Penis? Should IRBs Be Policing Self-Experimentation?

by Michelle Meyer, Bioethics Program Faculty.

You might think that the answer to the titular question is pretty obvious. Obviously, it’s your business, and yours alone if you want to induce a bee to sting your penis? Right? I mean, sure, maybe it would be considerate to discuss the potential ramifications of this activity with your partner. And you might want to consider the welfare of the bee. But other than that, whose business could it possibly be?

Well, it turns out that, depending on who you are and why you want to induce a bee sting to your penis, the answer may be: a committee of your peers. As academics whose research involves other human beings know, what others can do freely, they often require permission to do. When you study humans and your research is funded by the federal government, before you can conduct your study — in fact, before you can even recruit a single subject for it — you must submit all of your research plans to your institution’s Institutional Review Board (IRB) for ethics review. Indeed, you must do this even if your research is not federally funded but you work at a college or university that receives federal research grants and is among the 75-90% of such institutions that has promised the federal government that it will require IRB review of all the human subjects research that its students and faculty conduct.

IRBs are designed to provide a neutral, third-party review of research in large part in order to counteract the built-in conflict of interest that researchers have. The IRB system has lots of flaws, but the basic idea is sound. Researchers have lots of reasons for studying other humans, among them scientific curiosity, financial rewards, the pressures and prospects of tenure and promotion, and the desire for fame (or what passes for fame in the small pond of academe, anyway). In pursuing these benefits for society and for themselves, however, they usually impose risks and costs on their subjects (or participants, as they are now most frequently called). Investigators have lots of reasons to proceed with a study, and to characterize it as not-very-risky to people that the investigator needs to agree to participate.

But only academic researchers (and drug and device manufacturers) are subject to IRB review, and ironically, only when their motive in engaging in an activity is to learn something useful and generalizable. And so journalists, for instance, can ask potentially traumatizing questions to children without having to ask whether the risk to children of interviewing them is justified by the expected knowledge to be gained; academics, by contrast, have to get permission from their institution’s IRB first (and often that permission never comes).

So, too, it turns out, with potentially traumatizing yourself — at least if you’re an academic who’s trying to induce a bee to sting your penis in order to produce generalizable knowledge, rather than for some, um, other purpose.

Yesterday, science writer Ed Yong reported a fascinating self-experiment conducted by Michael Smith, a Cornell graduate student in the Department of Neurobiology and Behavior who studies the behavior and evolution of honeybees. As Ed explains, when, while doing his other research, a honeybee flew up Smith’s shorts and stung his testicles, Smith was surprised to find that it didn’t hurt as much as he expected. He began to wonder which body parts would really smart if they were stung by a bee and was again surprised to learn that this was a gap in the literature. So he decided to conduct an experiment on himself. (In addition to writing about the science of bee stings to the human penis, Ed is also your go-to guy for bat fellatio and cunnilingus, the spiky penises of beetles and spiders, and coral orgies.)

As Ed notes, Smith explains in his recently published paper reporting the results of his experiment, Honey bee sting pain index by body location, that

Cornell University’s Human Research Protection Program does not have a policy regarding researcher self-experimentation, so this research was not subject to review from their offices. The methods do not conflict with the Helsinki Declaration of 1975, revised in 1983. The author was the only person stung, was aware of all associated risks therein, gave his consent, and is aware that these results will be made public.

As Ed says, Smith’s paper is “deadpan gold.” But on this point, it’s also wrong.

Most obviously, were Cornell to lack a specific policy about self-experimentation, that would not mean that it possesses a policy exempting self-experimentation from IRB review. As Cornell’s Office of Research Integrity and Assurance correctly notes, although

[f]ederal regulations are silent on the matter of researchers who want to participate in their own studies. . . . , the regulations do not distinguish between self-experimentation and research on people who are recruited for a specific project.

And in fact Cornell, like many other institutions (including Johns Hopkins, the University of Wisconsin-Madison, and Georgia Tech), does have a policy (last updated in October of 2013) requiring researchers to obtain IRB approval before experimenting on themselves:

As part of its commitment to the protection of the rights and welfare of individuals participating in research, Cornell’s Human Research Protection Program requires investigators who wish to act as participants in their own studies to submit for review and approval following standard procedures outline in the IRB policies.

Though investigator self-experimentation may not raise the conventional ethical concerns outlined in the Belmont Report, all human research projects should undergo ethical review to assure the safety of people involved and the integrity of the research at the university. While researchers may be aware of the risks of self-experimentation, they may also be more willing to accept risks that are ill-advised. Application for review with the IRB office allows a neutral third party to raise concerns and/or propose measures to promote the welfare of researchers.

According to his paper, Smith’s research “is based on work supported by a United States National Science Foundation (NSF) Graduate Research Fellowship.” But even if it weren’t federally funded, it wouldn’t matter. Cornell filed a FederalWide Assurance (FWA) with DHHS’s Office for Human Research Protections (OHRP) promising to apply the same federal regulations to all human subjects research, regardless of funding (see #5 here).

Of course, to come within the IRB’s jurisdiction, an activity not only has to involve human subjects; it also has to constitute “research” — “a systematic investigation . . . designed to develop or contribute to generalizable knowledge.” Did Smith’s bee sting adventure fit the bill? Here’s Ed again:

Smith was methodical. He collected bees by grabbing their wings “haphazardly with forceps” and pressing them against the body part of choice. He left the stinger there for a full minute before removing it, and then rated his pain on a scale of 1 to 10. . . . He administered five stings a day, always between 9 and 10am, and always starting and ending with “test stings” on his forearm to calibrate the ratings. He kept this up for 38 days, stinging himself three times each on 25 different body parts.

Sounds systematic to me. What about “designed to contribute to generalized knowledge”? Ed again:

Now, clearly, these data are very subjective, and they all come from one person. Smith is clear that his anatomy of pain can’t be generalised to everyone else. “If someone else did this, they’d probably have different locations that they felt were worst”, he says, although from talking to his colleagues, he feels that the rough shape of the map would be similar. “I didn’t see a lot of merit in repeating this with more subjects,” he says.

But Smith’s pain map being identical to everyone else’s is hardly the only way that his experiment could lead to generalizable knowledge. And anyway, “generalizable knowledge” is a notoriously fuzzy concept in IRB review. In determining whether an activity will contribute to generalizable knowledge, Cornell’s IRB, like many, uses the proxy of asking whether it will “be used in a publication, presentation, or achievement of a degree.” Smith’s study pretty clearly passes that test.

My point in noting Smith’s error about his institution’s IRB policy is not to cause trouble for him or to impugn his character. To the contrary, I think requiring IRB review for all self-experimentation is absurd. And it’s worth highlighting absurd laws and policies.

But maybe Cornell has a point when it notes that researchers “may . . . be more willing to accept risks that are ill-advised.” In discussing the list of body parts that he tested, Smith told Ed that he “had originally had the eye on the list, but when I talked to [my advisor], he was concerned that I go blind. I wanted to keep my eyes.”

But it’s not surprising that researchers might pose undue risks to themselves or make other unwise decisions. All of us have the potential to do that. And there are a variety of mechanisms for trying to reduce the chances that people will take bad risks. A faculty advisor who pressures a graduate student to engage in risky self-experimentation might be disincentivized from doing so by faculty guidelines or disciplinary procedures, for instance.

The question isn’t whether or not to try to deter unduly risky behavior by scientists who self-experiment; it’s whether this goal requires subjecting every instance of self-experimentation, no matter how risky, to mandatory, prospective review by a committee. It’s one thing to require a neutral third party to examine a protocol when there are information asymmetries between investigator and subject, and when the protocol’s risks are externalized onto subjects who may not share much or any of the expected benefits. Mandatory review of self-experimentation takes IRB paternalism to a whole other level.

What do you think?

(Incidentally, the penis shaft turns out not to be the most painful place in which one can be stung (and as suggested above, the testicle wasn’t even close). Check out Smith’s paper or Ed’s post on it to see which two body parts won that particular contest.)

[This blog posting originally appeared in edited form on The Faculty Lounge on April 3, 2014. The contents of this blog are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

Reasonable Accommodation to Objections to a Brain Death Determination: Religious Principle Versus Disputed Diagnosis

This guest post is part of The Bioethics Program’s Online Symposium on the Munoz and McMath cases. To see all symposium contributions, click here.

by James Zisfein, M.D.
Chief, Division of Neurology, and Chair, Ethics Committee, Lincoln Medical Center

Is the objection to determination of brain death by Jahi McMath’s parents based on religious principle, disputed diagnosis, or both? Media reports go in all directions. And does it matter? Should it matter?

In New York (considered as a transfer destination for Jahi), it matters. New York Department of Health regulations require hospitals to provide “reasonable accommodation” (as defined by each hospital) when there is an objection to a brain death determination on a religious or moral basis:

Hospitals must establish written procedures for the reasonable accommodation of the individual’s religious or moral objections to use of the brain death standard to determine death when such an objection has been expressed by the patient prior to the loss of decision-making capacity, or by the Surrogate Decision-maker. Policies may include specific accommodations, such as the continuation of artificial respiration under certain circumstances, as well as guidance on limits to the duration of the accommodation.

Please note that “reasonable accommodation” does not give the family veto power over the determination of death nor the performance of tests necessary to make that determination. It does, however, allow continuation of ventilator support and routine nursing care after a brain death determination, thereby preserving for the family the illusion of life until the heart stops. Other medical supports are discontinued, e.g., ICU care, physiologic monitoring, blood and radiologic testing, CPR status, medications, and nutrition and hydration support.

Continue reading

The Munoz Tragedy: A First Step in the Right Direction

This guest post is part of The Bioethics Program‘s Online Symposium on the Munoz and McMath cases. To see all symposium contributions, click here.

by Alexander M. Capron
University Professor and Scott H. Bice Chair in Healthcare Law, Policy and Ethics, University of Southern California

On November 26, 2013, Erick Munoz of Haltom City, Texas, found his wife Marlise unconscious on the floor of their kitchen; she had apparently suffered a pulmonary embolism. Mr. Munoz, a paramedic, succeeded in resuscitating his wife, who was rushed by ambulance to John Peter Smith (JPS) Hospital in nearby Fort Worth. Two days later, physicians concluded that Ms. Munoz met the criteria to be determined dead on neurological grounds.  Mr. Munoz requested that the medical interventions that had been used in the attempt to save his wife’s life be withdrawn, but the hospital refused on the ground that the Texas Advanced Directives Act (TADA) forbids the withdrawal of “life-sustaining treatment” when the patient is pregnant, and Ms. Munoz was carrying a fetus of 14 weeks gestation.

Mr. Munoz—along with Marlise’s parents, who supported his decision—pleaded with the hospital for more than a month, to no avail.  Finally, on January 14, 2014, his attorneys filed a petition asking the district court in Tarrant County to declare that the TADA does not apply to dead bodies or, if it does so apply, to rule that the statute’s prohibition on ceasing treatment during pregnancy constitutes an unconstitutional deprivation of equal protection or denial of privacy rights.  Ten days later, Presiding Judge R.H. Wallace ruled that the statute does not apply to Marlise Munoz and ordered the hospital to pronounce her dead and “remove the ventilator and all other ‘life-sustaining’ treatment” from her body no later than 5:00 pm on January 27th.

As an ethical matter, this is certainly a good outcome. It must have been painful not only for Ms. Munoz’s loved ones but for many of the healthcare professionals who continued to apply medical interventions against her wishes and past the point when they could provide any benefit for her. Now, the family can be allowed to grieve over and to bury her body, and to turn their attention to the needs of the Munoz’s young son, who has been cared for by his grandparents while his father was absorbed with the tragedy at JPS Hospital.

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JPS Hospital’s Statutory Interpretation Argument on Appeal

This guest post is part of The Bioethics Program‘s Online Symposium on the Munoz and McMath cases. To see all symposium contributions, click here.

by Thaddeus Mason Pope
Director of the Health Law Institute, Hamline University

Marlise Munoz is dead.  Yet, despite her husband’s instructions, John Peter Smith Hospital has refused to withdraw intensive care interventions sustaining Munoz’s body.  The hospital explained both in the media and in court that it was bound by Texas Advance Directives Act, section 166.049.  That statute provides:  “A person may not withdraw or withhold life-sustaining treatment under this subchapter from a pregnant patient.”

But as I and others have argued, this statute has no possible application to Munoz.  The Texas Advance Directives Act defines “life-sustaining treatment” as that which “sustains the life of a patient and without which the patient will die.”  Because Munoz has already died, cardiopulmonary or any other form of support is not, and cannot for her be, “life-sustaining.”  In short, the unambiguous language of the law requires only that a living pregnant woman be kept alive.

On January 24th, the Tarrant County, Texas District Court agreed.  It held: “the provisions of § 166.049 . . . do not apply to Marlise Munoz because, applying the standards used in determining death set forth in § 671.001 . . ., Mrs. Munoz is dead.”

But the court stayed its order until Monday evening.  By then, the hospital may appeal.  And despite the seeming open-and-shut nature of the legal issue here, such an appeal might not be frivolous.  That is because there is more than one way to interpret a statute.

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Marlise Munoz and Medical Decisions After Death

This guest post is part of The Bioethics Program‘s Online Symposium on the Munoz and McMath cases. To see all symposium contributions, click here.

by David Orentlicher, MD, JD
Samuel R. Rosen Professor and Co-Director, Hall Center for Law and Health, Indiana University Robert H. McKinney School of Law

While the Texas state court probably rendered the right decision in the case of Marlise Munoz, the court and the hospital viewed the case through the wrong legal lens. As Thomas Mayo and others have argued, it did not make sense to invoke the Texas Advance Directives Act to impose treatment on Ms. Munoz for the benefit of her fetus. Nevertheless, other principles of law might justify treatment of some pregnant women—even after they are legally dead—for the benefit of their fetuses.

Ms. Munoz was 14 weeks pregnant when she collapsed at home. Subsequently, she was diagnosed as meeting the legal definition of death because of severe injury to her brain. As with some cases involving death from brain injury, intensive care could maintain Ms. Munoz’s heartbeat and her ability to gestate a fetus. The hospital believed it had a legal obligation to maintain Ms. Munoz’s cardiac function until her fetus was viable and could be delivered.

How should we analyze cases like that of Ms. Munoz? Continue reading

Introducing an Online Symposium on the Munoz and McMath Cases

by Michelle N. Meyer, J.D., Ph.D.
Assistant Professor of Bioethics and Director of Bioethics Policy, Union Graduate College–Icahn School of Medicine at Mount Sinai Bioethics Program

Two high-profile, rapidly evolving cases involving death by neurological criteria — better known as “brain death” — raise vexing and sometimes novel legal, ethical, and medical questions at the edges of life and death. The Bioethics Program is pleased to host this online symposium on these cases and the issues they raise. What follows is a brief overview of these cases and an explanation of the impetus for the symposium. You can view all symposium contributions in reverse chronological order here.

The Impetus for the Symposium

As Stanford Law professor Hank Greely observed, the Munoz and McMath cases have lead to an “unprecedented” amount of discussion by scholars and practitioners on a closed bioethics listserve run by Art Derse, of the Medical College of Wisconsin’s Center for Bioethics and Medical Humanities. In order to open up some of our often-spirited discussion to a broader readership, several members of the listserve have decided to recreate portions of it here. We hope you’ll help us continue the conversation in the comments.

Participants include:

  • Ryan Abbott, M.D., J.D., M.T.O.M.
    Associate Professor of Law, Southwestern Law School, and Visiting Assistant Professor of Medicine, David Geffen School of Medicine at UCLA
  • Alexander M. Capron, LL.B.
    University Professor, Scott H. Bice Chair in Healthcare Law, Policy and Ethics, Professor of Law and Medicine, Keck School of Medicine, Co-Director, Pacific Center for Health Policy and Ethics
  • Pablo de Lora, Ph.D.
    School of Law, Universidad Autónoma de Madrid
  • Michelle Meyer, J.D., Ph.D.
    Assistant Professor of Bioethics and Director of Bioethics Policy, Union Graduate College–Icahn School of Medicine at Mount Sinai Bioethics Program
  • David Orentlicher, M.D., J.D.
    Samuel R. Rosen Professor and Co-Director, Hall Center for Law and Health, Indiana University Robert H. McKinney School of Law
  • Thaddeus Mason Pope, J.D., Ph.D.
    Director, Health Law Institute, and Associate Professor of Law, Hamline University School of Law
  • Katherine Taylor, J.D., Ph.D.
    College of Nursing and Health Professions, Drexel University
  • Alan Jay Weisbard, J.D.
    Professor Emeritus, University of Wisconsin, and Executive Director, New Jersey Bioethics Commission (1987-90)
  • James Zisfein, M.D.
    Chief, Division of Neurology, and Chair, Ethics Committee, Lincoln Medical Center

Contributions will be posted on a rolling basis, and other participants may join later, so check this space for updates. To see all symposium entries, click here. Below the fold, some background on the Marlise Munoz and Jahi McMath cases. Continue reading