Causes of Death Coding in COVID-19 Pandemic

Reporting causes of death is an important function in our society, and involves a number of people in completing each death certificate:

  • Pronouncer of death – may be a physician
  • Certifier of death – usually a physician; assigns cause of death
  • Funeral director – completes the demographic information, next of kin, and burial information portions of the death certificate
  • Local registrar or health department – registers the death certificate, and has long term management responsibility of same

The Office of Vital Statistics performs statistical analysis and reports on the mortality data, which are used in many ways, including surveillance of diseases, tracking of national deaths in emergencies and pandemics, and to justify health spending. Any misinformation along the way will impact not only the individual death certificate, but also all the data that includes that death certificate.

Death certificates are legal records. The physician as certifier of death “determines and accurately records the sequence of medical conditions that resulted in death. When the physician signs the certificate, he or she has legally certified that, to the best of his or her knowledge, the individual died for the reasons listed under the cause of death.” (CDC online course on “Improving Cause of Death Reporting (Web Based),” WB2959)

The Cause of Death (COD) portion of the death certificate entails two main sections. Part Ia is where the immediate cause of death is listed, and subsections Ib, Ic, and Id detail the sequence of events, listed backwards in time, that culminated in the proximate cause of death. Any other diseases or conditions that may have contributed to the person’s demise are listed in Part II.   The COD is the important part of the death certificate as far as vital statistics are concerned. The use of “suspected,” “probable,” or “possible” has been previously discouraged in the listed COD on death certificates. In fact, the above-referenced course currently offered by the CDC does not include such possibilities.

But that has changed with the COVID-19 pandemic. The World Health Organization issued its International Guidelines for Certification and Classification (Coding) of COVID-19 as Cause of Death on 20 April 2020.  They declared, “A death due to COVID-19 is defined for surveillance purposes as a death resulting from a clinically compatible illness . . .” New ICD-10 codes have been developed. For cases in which the virus has been identified, the code is U07.1; and when it has not been identified, but COVID-19 is “probable” or “suspected,” the code is U07.2. (p. 8/14).

The CDC’s National Vital Statistics, likewise, published new “Guidance for Certifying Deaths Due to Coronavirus Disease 2019 (COVID-19)” in April.  They indicated that the Underlying Cause of Death (UCOD) “should be reported on the lowest line used in Part I” of the death certificate. Although the document encourages testing if possible, the completion of a death certificate does not require it:

In cases where a definite diagnosis of COVID–19 cannot be made, but it is suspected or likely (e.g., the circumstances are compelling within a   reasonable degree of certainty), it is acceptable to report COVID–19 on a  death certificate as “probable” or “presumed.”

The advice goes further, to say that if COVID-19 is involved, “it is likely the UCOD and thus, it should be reported on the lowest line used in Part I of the death certificate.”

What are the ramifications of such changes to death certificates?

  •  Possibly inflated COVID-19 death counts
  •  Perhaps (unfairly) increased federal aid to areas with inflated COVID-19 deaths
  •  Under-reporting of other causes of death, and resulting lack of attention to  appropriate health concerns
  •  Loss of veracity in the persons responsible for completing the death certificates       
  •  Loss of trust in a system that has been manipulated

None of these is desirable, and all will cost us in the end.

 

Love in a Time of Pandemic

Last month’s story of Italian priest Don Giuseppe Berardelli giving up his ventilator so a younger patient could use it was an attention-grabber. The truth of the matter was a bit different, but the end result was, somewhat predictably, unchanged. Berardelli did refuse a ventilator, due to medical reasons. At the hospital, sometime in the night of March 15-16, the beloved, jovial, and accessible 72-year-old priest died from the coronavirus. He was one of at least 60 priests who succumbed to the SARS-CoV-2 virus during one month in Italy.

Physicians and dentists in Italy who have lost their lives to the coronavirus are listed here. In a similar vein, Medscape Medical News is maintaining (and adding to) a list, “In Memoriam: Healthcare Workers Who Have Died of COVID-19.” These are not the only victims, however. The frontlines are multitudinous, from people who work as clerks or deliverers of goods, to first responders, to all those caring for the ill (personally or professionally). These are exposed to increased risk of contracting the virus, and possibly dying from it. But these are not the first, nor will they be the last, to incur risk in such a manner.

History has much to teach us about staying at one’s post in difficult times. One of the prime examples is Martin Luther, who stayed in Wittenberg in 1527, in the midst of a bubonic plague outbreak. In response to multiple queries, he wrote a tract, “Whether One May Flee from a Deadly Plague.” His conclusion was that, unless someone can accomplish your duties in your absence, your presence is required.

  • Preachers and pastors: “For when people are dying, they most need a spiritual ministry which strengthens and comforts their consciences by word and sacrament and in faith overcomes death.”
  • Mayors and judges: “To abandon an entire community which one has been called to govern and to leave it without official or government, exposed to all kinds of danger such as fires, murder, riots, and every imaginable disaster is a great sin.”
  • Public servants like city physicians and city clerks: These “should not flee unless they furnish capable substitutes who are acceptable to their employer.”

Citing Matthew 7:12, Luther concluded that “we are bound to each other in such a way that no one may forsake the other in his distress but is obliged to assist and help him as he himself would like to be helped.”

Luther did not neglect the complementary side of the issue: prudent care of our bodies. He wrote, “I am of the opinion that all the epidemics, like any plague, are spread among the people by evil spirits who poison the air or exhale a pestilential breath which puts a deadly poison into the flesh.” Therefore, Luther recommended that one keep one’s distance from those ill (if they did not require help), set up hospitals to care for the sick, “help purify the air, administer medicine, and take it.” Luther, like the priests and health care professionals referenced above, provides a strong example of love in a time of pandemic.

Assisting Suicide — for Everyone — in Germany

In what is manifestly a case of legal and verbal gymnastics, the Federal Constitutional Court of Germany has “found” a right to suicide. The Court announced its finding in a press release, dated 26 February: “Criminalisation of assisted suicide services unconstitutional.”  Calling self-killing, or suicide, “an act of autonomous self-determination,” the Court grounded suicide – and assisting suicide – in human dignity. Here is what they proclaimed: “Inalienable human dignity accordingly requires that any human being be unconditionally recognised as an individual with personal autonomy.”

Further, the Court wrote

Maintaining one’s personality in self-determination requires that the             individual can control their life on their own terms and is not forced into     ways of living that are fundamentally irreconcilable with their ideas of self    and personal identity. In terms of human personality, the decision to end      one’s own life is of the most fundamental significance to one’s existence. For  the individual, the purpose of life, and whether and for what reasons they        might consider ending their own life, is subject to highly personal beliefs and  convictions. The decision to commit suicide concerns basic questions of   human existence and bears on the identity and individuality of that person like no other decision. Therefore, the right to a self-determined death is not   limited to the right to refuse, of one’s own free will, life-sustaining          treatments. It also extends to cases where the individual decides to actively   take their own life.

This right to suicide does not depend upon “serious or incurable illness” or stage of life. Indeed, “this right is guaranteed in all stages of a person’s existence.” The right to suicide cannot be denied based on the argument that suicide forfeits one’s dignity. Actually, the Court decided, “the individual knowledge of actually being able to act according to one’s own wishes is in itself a crucial element of asserting one’s identity.” Additionally, “(t)hird parties must also legally be allowed to act in accordance with their willingness to render suicide assistance.”  Finally, the Court opined, “there can never be an obligation, on anyone, to assist in another person’s suicide.”  (See English translation of the Court’s press release here.)

Dies ist eine Dose Würmer! (Translation: This is a can of worms!). A right to suicide gives an incredible bargaining chip to every citizen. Imagine this new power in every relationship. If a teenager does not get his/her way, s(he) can threaten, “Do this, or I will kill myself.” Any spouse or lover could likewise gain the upper hand by such a threat.

There are other concerns as well.  Can a person who has survived a suicide attempt be treated by medical staff in order to repair the damage done to him/herself? Can someone judged to be a possible harm to him/herself be involuntarily committed to a psychiatric institution? Can such a patient even be treated?

Then there are the “assistors.” Who will be “qualified”? Will they need a license?  Although physicians are not required to assist now, will that always be the case? How will the prescriptions be obtained? Will pharmacists eventually be compelled to participate? How much can one charge for assisting suicide?   Since this case was brought before the Court by those who wish to assist suicides, one must wonder about the amounts of money involved and what the flow of it will look like.

But these could be understood to be “mere administrative details,” and in a certain sense, they are. The more worrisome – much more worrisome – issue is the fact that others are being co-opted into becoming killers.

Let’s face some inconvenient truths. Suicide has always been an available option, albeit treated differently in law over time. Suicide destroys a person and violates his/her dignity. It doesn’t forfeit one’s dignity – it forfeits one’s life. And it impacts the lives of family members, often for generations. These effects are difficult enough, but the Federal Constitutional Court of Germany has gone much further. They have legalized the assisting of suicides – for all people, for whatever reasons.

Legalizing the assisting of suicides means co-opting others in the act of suicide. Where is the autonomy in that? The act of killing, whether of birds, deer, cows, or human beings, registers effects in the human psyche (soul) of the killer. In the case of killing animals for food, most consider it an “acceptable adjustment.” Yet if we observe someone killing too easily, or with too little regard for the life of the animal being killed, we worry. Particularly do we worry if the killer is young. What is being – or has already been – done to the psyche (soul) of that person? Is the psyche (soul) malformed? Participation in the act of killing a human being is not just about the one being killed, but also about the one being transformed into a killer. One will be dead; the other will have experienced killing. What has happened to his/her human dignity? Does assisting suicide violate the participant’s human dignity, regardless of how compassionate he/she may feel? How could it not?

Justified Quarantine?

The 2019 novel coronavirus (2019-nCoV) is a force to be reckoned with, despite its unclear origins (see here and here).  From Wuhan, China, the virus has spread to all of the Chinese provinces, and, by 31 January, eighteen other countries.  By 30 January, the World Health Organization (WHO) had declared the situation a public health emergency of international concern (PHEIC).  

The Centers for Disease Control and Prevention (CDC) reported on 31 January that four states—Arizona, California, Illinois, and Washington—have a total of six known cases of persons infected with corona virus. In addition, 36 states have patients under investigation for the infection.  Citing the approximately 10,000 confirmed cases of the virus in China, and evidence of person-to-person spread of the infection, the White House announced on 31 January the suspension of entry into the U.S. of persons posing a risk of transmitting the virus. One point of that announcement concerned quarantine: 

Sec. 4.  Orderly Medical Screening and Quarantine.   The Secretary of Homeland Security shall take all necessary and appropriate steps to regulate  the travel of persons and aircraft to the United States to facilitate the orderly  medical screening and, where appropriate, quarantine of persons who enter   the United States and who may have been exposed to the virus.  Such steps may include directing air carriers to restrict and regulate the boarding of     such passengers on flights to the United States.

The U.S. is not the only nation planning or implementing quarantine. China has already moved to at least partially quarantine persons in Wuhan.  According to the BBC, the UK, South Korea, Singapore, and New Zealand will quarantine evacuees from Wuhan for two weeks. Australia will similarly quarantine their evacuees on Christmas Island.  

In light of the evolving situation with 2019-nCoV, it is a good time to review some definitions and recommendations from the public health arena:  

Isolation separates sick people with a contagious disease from people who are not sick.

Quarantine separates and restricts the movement of people who were exposed to a contagious disease to see if they become sick.

The essence of quarantine is the restriction of movement of individuals, imposed by an authority, for some length of time. “Quarantine” has been attributed to the Venetians, who, in their effort to stem the spread of the Black Death, required ships “to lay at anchor for forty days” prior to landing.  In the U.S., the National Quarantine Act was passed in 1878 in an attempt to avert the spread of Yellow Fever. A national quarantine system was enacted by Congress in 1893. Fast-forward to 1983, when Executive Order 12452 was issued by President Reagan:

Section 1. Based upon the recommendation of the National Advisory Health   Council and the Assistant Secretary for Health of the Department of Health and Human Services, and for the purposes of specifying certain communicable diseases for regulations providing for the apprehension, detention, or conditional release of individuals to prevent the introduction, transmission, or spread of communicable diseases, the following named communicable diseases are hereby specified pursuant to Section 264(b) of   Title 42 of the United States Code: Cholera or suspected Cholera, Diphtheria, infectious Tuberculosis, Plague, suspected Smallpox, Yellow Fever, and           suspected Viral Hemorrhagic Fevers (Lassa, Marburg, Ebola, Congo-Crimean,   and others not yet isolated or named).

Does quarantine constitute “an unwarranted diminution of personal liberty”? Ross Upshur, M.D., M.A., M.Sc, who is also a Hastings Center Fellow, deals with this question and more in a 2003 article in the AMA Journal of Ethics.  He cites two goals achieved by quarantine: stopping the chain of transmission of infection, and allowing “individuals under surveillance to be identified and directed toward appropriate care if they become symptomatic.”  Additionally, Upshur describes four principles that must be met for quarantine (or other autonomy-limiting steps) to be considered:

  1. The general principle of preventing harm: particularly, this would include prevention of person-to-person spread of the infection
  2. The “proportionality, or least-restrictive-means principle”: quarantine should          be voluntary “before mandatory orders or surveillance devices, home cameras, bracelets, or incarceration are contemplated”
  3. Reciprocity: if persons are quarantined, they should be provided with “adequate food and shelter and psychological support . . . They should suffer no penalty on account of discharging their obligations to society.”
  4. Transparency: “(P)ublic health authorities have an obligation to communicate clearly the justification for their actions and allow for a process of appeal. (See full article here.)

If all of these criteria can be met—no small order—Upshur writes that quarantine is justified.

2020, or 20/20?

Near the end of 2018, He Jiankui was on the world’s stage announcing that he had edited the genome of twin girls, in the hope of making them resistant to HIV. On Tuesday, December 31, 2019, the Wall Street Journal (WSJ) printed a report that Dr. He and two others have been convicted of “illegally practicing medicine related to carrying out human-embryo gene-editing intended for reproduction.” (online version here).

A court in Shenzhen concluded that the defendants had acted for “fame and profit,” when they “deliberately violated the relevant national regulations, and crossed the bottom lines of scientific and medical ethics.” For the crime committed, He received the most severe sentence. In addition to the three-year prison sentence, He is banned for life from “working in the field of reproductive life sciences and from applying for related research grants, “ according to the WSJ.

The Xinhua News Agency also noted that a third genome-edited baby had been born, and that this child, along with the previously born twins, “would be monitored by government health departments.” The WSJ did not state for how long the monitoring would continue. Not only were the children experimental subjects as embryos, but they continue to be subjects as well. Further, these genome effects will affect their progeny, potentially into perpetuity. Additionally, the Smithsonian Magazine reports that in the summer of 2019, He met with “investors to discuss a potential commercial genetic modification clinic in Hainan, which aims to become a ‘world-class medical tourism hub’.”  One might reasonably call this “a crime against humanity,” even if it does not include genocide of humans already born. (For further reading, see David Luban, “A Theory of Crimes Against Humanity”)

In the print edition of the WSJ, alongside the article on He is an article about Pastor Wang Yi of the Early Rain Covenant Church. Pastor Wang was sentenced on 30 December to nine years in prison. His crime was “incitement of subversion of state power and illegal business operations” (online article here).

Consider that a pastor receives a nine-year sentence for an offense against the State; and a scientist, a sentence of three years for a crime against multiple generations, and indeed, humanity. In the year 2020, we could use a check of our understanding of what is important in the life of the world. Would that our vision were 20/20 also.

Experimental Subjects for Life?

More than a year after the birth announcement of genome-edited babies in China, we are only slightly more informed of He Jiankui’s experimentation, the results of which are named “Lulu” and “Nana.” Although apparently approached, neither Nature nor the Journal of the American Medical Association (JAMA) chose to publish He’s work. Antonio Regalado reported on an unpublished manuscript in “China’s CRISPR babies: Read exclusive excerpts from the unseen original research” in Technology Review on 3 December 2019. The Technology Review article includes not only excerpts of the manuscript from He, but also reactions from Stanford law professor Hank Greely; University of California—Berkeley’s gene-editing scientist Fyodor Urnov; the scientific director of Eugin assisted reproduction clinics, Rita Vassena; and reproductive endocrinologist Jeanne O’Brien, from Shady Grove Fertility.

Regalado summarizes some of the problems with Chinese experiment as follows:

 . . . key claims that He and his team made are not supported by the data; the      babies’ parents may have been under pressure to agree to join the experiment; the supposed medical benefits are dubious at best; and the researchers moved forward with creating living human beings before they fully understood the effects of the edits they had made.

Greely points out the lack of “independent evidence” of the claims made in the paper. Urnov labels the paper’s claim of reproducing the usual CCR5 variant “a deliberate falsehood,” and calls the statement about the possibility of millions being helped through embryo editing “equal parts delusional and outrageous.” O’Brien’s concerns include the possibility of coercion of the couples involved, and, noting the social stigma of HIV-positivity in China, she poses the question of whether this was a genetic fix for a social problem. Certainly, the Chinese experiment raises many questions, including how a culture views children. Are children gifts to be received or projects to be completed? Is it appropriate to subject children to experimental research because we can? One of the quotes from the paper reads, “we have made a follow-on plan to monitor the health of the twins for 18 years and hope to then reconsent for continued monitoring through adulthood.”

We would be remiss if we thought that China alone plans to remake humanity. Vassena is quoted regarding He’s study:

Unfortunately, it reads more like an experiment in search of a purpose, an    attempt to find a defensible reason to use CRISPR/Cas9 technology in human embryos at all costs, rather than a conscientious, carefully thought through, stepwise approach to editing the human genome for generations to come.  As the current scientific consensus indicates, the use of CRISPR/Cas9 in human embryos destined to give rise to a pregnancy is, at this stage, unjustified and unnecessary, and should not be pursued.

Vassena, who directs a fertility enterprise, it should be noted, appears comfortable with impacting the human genome for generations to come:  It just needs to be a “reflective” and “mindful” approach. That is chilling. Would she, or the study’s authors, or Greely, or Urnov, or O’Brien sign up to be a science experiment for the rest of their lives? I would not consent—not for myself nor for my children—no matter how “reflective” or “mindful” the researcher happened to be.

Finally, “Lulu” and “Nana” should be known as more than the results of someone’s laboratory experiment. They are human beings, not laboratory rats or cells under a microscope to be studied at the will and convenience of the experimenters.

Regulating New Technologies

History’s lessons applied to Artificial Intelligence (AI) regulation is the subject of a recent Brookings article by Tom Wheeler.  He writes

Societies impose government oversight for the protection of old principles in a time of new technology. Foremost among those principles is each individual’s right to a future; and it comes in multiple manifestations. In the educational realm, it means adequate training to be meaningfully employed. Economically, it means maintaining the benefits of capitalism through checks on its inherent incentive to excess.

Most importantly, the right to a future begins with the belief that there is a future, and that national leaders care about whether individuals affected by new technologies participate in that future.

Although the author has AI in mind, it is interesting to consider his words in relationship to the regulation of human gene editing. Now is certainly “a time of new technology,” particularly regarding human germline gene editing.  The “old principles” of experimentation on human research subjects ethically done and informed consent, along with the restrictions/bans in many countries heretofore prohibiting human germline modification, come to mind.  Additionally and importantly, in Greely’s extensive review of how “CRISPR’d babies” came to be, he includes a welcome overview of the state of affairs regarding regulation (or not) of human germline genome editing, in the October 2019 Journal of Law and the Biosciences. 

An upcoming meeting (London, November 14-5) of the International Commission on the Clinical Use of Human Germline Genome Editing is slated to discuss more than governance of the technology. Their agenda is available here.  In addition to a discussion of issues and perspectives relayed by various parties in their evidence submitted to the Commission, there is a planned discussion of “how the rights of future people have been considered and established in other medical and nonmedical scenarios, and how consenting to any necessary or preferred long term follow up on behalf of future generations could be established.”

Exactly how does one generation prescribe the “necessary or preferred long term follow up” of succeeding generations? How does one generation assure consent of future generations? When Wheeler penned the Brookings article about AI regulation (quoted above), he wrote about the right to a future, which rests in part on the fact that “national leaders care about whether individuals affected by new technologies participate in that future.” It certainly seems reasonable that those who are affected by a project be allowed to participate in it – as something more than research subjects. If such is true for AI, how much truer should it be for those whose very selves are affected by the research! There has to date been no compelling reason to go forward with human germline genome editing, and there are many reasons not to proceed. The most appropriate regulation is a ban.        

Failing the Grade in Transplant Ethics

On 3 October, ProPublica published “‘It’s Very Unethical’: Audio Shows Hospital Kept Vegetative Patient on Life Support to Boost Survival Rates,” an article detailing aspects of the organ transplantation program at Newark Beth Israel Medical Center in New Jersey. Specifically, the article revealed portions of an April 2019 audio recording from a weekly meeting of transplant physicians, nurses, social workers, and transplant coordinators. One patient discussed was a 61-year-old man named Darryl Young, who had received a heart transplant on 21 September 2018. Mr. Young had never awakened after surgery, but the director of the heart and lung transplant program, Dr. Mark Zucker, expressed the “need to keep him alive until June 30 at a minimum.” Another transplant surgeon hoped that the transplant program would progress to the point of not having to “think about this ethical dilemma of keeping somebody alive for the sake of the program.”

At issue—at least in the transplant realm—is the “need” of hospitals to keep patients alive for at least one year after organ transplantation.   Why? The Center for Medicare & Medicaid Services (CMS) dictates the rules for transplant centers to exist and to receive funding. Two measures CMS uses for this are the 12-month survival of patients and the functioning of the transplanted organs at 12 months (see page 6/84 of linked article).  The penalty for not meeting the desired CMS algorithms is high. CMS can launch an audit of the transplant program and/or revoke Medicare funding, which pays for the transplants. When programs are not funded, they cease to exist.

There are other issues in this story as well: ethical issues that deserve our best thinking. One glaring problem is that of treating people as means to an end, cogs in a wheel.   The case of Mr. Young is sadly exemplary, but he surely is not the only one. Pressure to maintain the transplant program will be felt by all of the participants in one way or another. Everyone is responsible for his or her actions, certainly, but each person downstream of a decision may well be used as a cog in a wheel. The penalties for non-compliance at different levels may be varied, but are no less real. Additionally, can patients, or their family members/surrogate decision makers, refuse any procedures once they are in the transplant system?

The current CMS rules were instituted on 28 June 2007. This 2006 article from the Los Angeles Times presents some of the backdrop for such rules:

  • Medicare, which funds most of the nation’s transplant centers, requires programs to perform a minimum number of transplants and to achieve a specific survival rate to be certified for funding. The benchmarks vary by organ, and there are none for kidney transplants.
  • Three dozen heart transplant programs didn’t meet federal standards for survival or volume. They accounted for 43 more deaths than expected.
  • Altogether, the programs examined by The Times had 71 more patients die than expected within a year of transplant.

It appears the 2007 rules represent a pendulum swing from 2006. A golden mean is desired and preferable. It is time to look for one.

Whose Body?

In 1923, Dorothy L. Sayers published her first mystery featuring Lord Peter Wimsey, entitled Whose Body?  The concern was that an adult body, wearing only a pince-nez, had been found in someone’s bathtub. Whose body was this? Was it the body of a well-known financier, who had recently disappeared? Or was it the body of someone else? Whose deceased body was this?

Slightly less than one hundred years later, the nation that Sayers called home has answered that question. As of Spring, 2020, in England, and a few months later in Scotland, deceased adult bodies are the State’s for purposes of organ procurement – unless they are in an “excluded group” or have registered an “opt out” decision.  The public is currently being assured that organ procurement will not apply to all who die, but only to those whose organs would be in a “usable condition”—primarily those dying in intensive care units or accident and emergency departments.

The law of “deemed consent” applies to all but these excluded groups:

  • Those under the age of 18
  • People who lack the mental capacity to understand the new arrangements and take the necessary action
  • Visitors to England, and those not living here voluntarily
  • People who have lived in England for less than 12 months before their death

The language of “deemed consent” is the iron fist in a velvet glove. According to the National Health Services’ FAQ page:

 If you have not recorded a decision either way and you are not in an      excluded group, your family will be approached and asked if they have any information about your organ donation decision. If no information is available, it will be considered that you consent to donate your organs and your family would be expected to support this.

Although the language of donation is used, gifts are what is “given.” To call what is “taken” or “coerced” a gift is to contort language into misrepresentation.

It is a conundrum the government is trying to solve. Every day, some people needing organ transplants die. Every day, some people with potentially transplantable organs die. Inviting people to decide whether or not they want to be organ donors, and register that decision, seems a reasonable step. But deciding that the government has the right to take organs upon death is overreach. Human organs are not property. We do not “own” our organs. Whether one views human beings as ensouled bodies or embodied souls, human organs are integral to those bodies.  The government did not give the people organs; it is an injustice – to the language and the people – to take human organs and call such “donations.”

Decrying Human Fetal Tissue Research Justification

The National Institutes of Health (NIH) released on 26 July “Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research.”  A new bullet point is required for “Human Fetal Tissue Research Approach.”   The applicant for funds is obliged to justify the use of human fetal tissue (HFT) in proposed research:

  • Why the research goals cannot be accomplished using an alternative to HFT?

  • What methods were used (e.g. literature review, preliminary data) to determine that alternatives could not be used?

  • Results from a literature review used to provide justifications

  • Plans for the treatment of HFT and the disposal of HFT when research is complete

  • Description of planned written, voluntary, informed consent process for cell/tissue donation, or description and documentation of process if cells/tissue were already obtained. Include a sample of the IRB approved consent form with the application or during the JIT process. The informed consent for use of HFT from elective abortion requires language that acknowledges informed consent for donation of HFT was obtained by someone other than the person who obtained the informed consent for abortion, occurred after the informed consent for abortion, and will not affect the method of abortion; no enticements, benefits, or financial incentives were used at any level of the process to incentivize abortion or the donation of HFT; and to be signed by both the woman and the person who obtains the informed consent. Include an assurance letter

  • Information must be submitted by the applicant Institution in a letter assuring the HFT donating organization or clinic adheres to the requirements of the informed consent process and documentation that HFT was not obtained or acquired for valuable consideration. . . . Applications proposing HFT research that do not include this assurance will be administratively withdrawn and not reviewed.

Journalist Nick Hazelrigg decried this as “Another Setback to Fetal Tissue Research Under Trump.”  Hazelrigg called the recently announced requirements for grant applications “the newest in a number of barriers . . . for fetal tissue researchers.” His first stated concern is that the applicant would have to “in a detailed manner, explain why no alternative methods could be used to accomplish the research.”  Secondly, Hazelrigg complains that both graduate and postdoctoral students who are supported by NIH training funds will be banned from using HFT in research.

Interestingly, on the same day the NIH released the new requirements regarding HFT research, the NIH Office of Laboratory Animal Welfare updated the “Vertebrate Animals Section” portion of their website.  Not only do grant applicants have to tell what kinds of procedures they plan for animals –inter alia, behavioral tests, blood draws, surgeries, and substance administration— but also justification for the use of animals is required.  Specifically:

Investigators must justify the use of animals in the proposed research. U.S. Government Principles require grantees to consider mathematical models, computer simulation, and in vitro biological systems. The justification should:

  • Indicate why the research goals cannot be accomplished using an alternative model (e.g., computational, human, invertebrate, in vitro).
  • Provide rationale for the choice of species (e.g., advantages of the species chosen and why alternative species are not appropriate).
  • Discuss why less highly evolved or simpler animal models are not appropriate. For example, the use of non-human primates, dogs, or cats should be thoroughly justified.

The justification for the number of animals, sex, ages, and other biological variables should be described in the Research Strategy.

We need to consider that the justification of use of resources is a common theme in human existence. Family members are accountable to one another for resources held in common. Business partners are also. When seeking a loan at a bank, the applicant has to justify the amount requested. These are true when only money is involved. When animal life is affected, the higher level of justification is rightly required. And when human life is involved, the highest level of justification should be demanded.

Restricting the use of human fetal tissue in research furnishes us all with the opportunity to consider our ways. In the words of Paul Ramsey, it gives us, the people,

final authority within constitutional limits in determining how in future we mean to be healed—when the means is human experimentation. The technical expertise of the medical research community cannot be the sole or chief arbiter in this matter, which is a question of morality and public policy.

(Ramsey, Paul. ”Introduction.” In The Ethics of Fetal Research, xxi. New Haven: Yale University Press, 1975.)