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 Applications proposing HFT research that do not include this assurance will be administratively withdrawn and not reviewed.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.)

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