Human Fetal Tissue — Considerations

The NIH Human Fetal Tissue Research Ethics Advisory Board met on 31 July 2020 to “make recommendations regarding the ethics of research involving human fetal tissue (HFT) proposed in NIH grant and cooperative agreement applications and R&D contract proposals, as set forth in the NIH Guide Notice NOT-OD-19-128.” The meeting agenda included a brief time set aside for public comment. Additionally, written comment could be submitted within a prescribed time frame prior to the meeting.

It is my hope that the advisory board seriously considered the following comment penned by this writer, on behalf of the educational non-profit Tennessee Center for Bioethics & Culture:

All human beings belong to one another.  Whatever our genetic constitution, our ethnicity, our color, our femaleness or maleness, our geographic location, or stage of life:  we are part of the human family.   That membership is not bounded by a cradle-to-grave timeline.  As human mammals, our beginnings begin before the exodus from our mothers’ wombs.  From the fertilization of the egg by the sperm, a new human being arises (and sometimes, multiples).  How we treat that human zygote, embryo, fetus, newborn, baby, toddler, preschooler, child, adolescent, adult, and elder, has effects on that human being – as well as on ourselves.  How we treat other human beings, especially vulnerable ones, tells future generations and civilizations about what kind of people we are.

In 1993, President Bill Clinton signed into law the NIH Revitalization Act.  That Act charged the NIH to conduct or support research that reduced the number of animals used in research, and that produced less pain and distress in those animals (https://grants.nih.gov/grants/olaw/pl103-43.pdf). Those are laudable goals.  That same 1993 NIH Revitalization Act authorized the use of human fetuses for research, including fetuses from induced abortion (www.hhs.gov/ohrp/regulations-and-policy/guidance/public-law-103-43/index.html).  The same law that sought to reduce pain and suffering in animals opened the door wider to using nascent human beings as research subjects.  Utilizing tissue that becomes available by virtue of spontaneous abortion (miscarriage) does not actively convert living beings into research subjects/objects.  It is not a planned procedure that can be scheduled around tissue procurement firms.  That is not the case, however, with the use of fetal tissue from induced abortion.  The willful taking of tiny, live human beings from their mothers’ wombs, followed by the use of them in whole or in part, as research subjects/objects, sets up a human market.  Abortionists and abortion facilities are paid to render a living being into products or parts.  Then they are paid again to yield up these beings or parts to research.  Money is exchanged for parts or labor, even if said payment is labeled “handling charges.” This is a market, and it is a market in human flesh:  a stain upon our culture and our civilization.

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.)