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Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules
128, NIH provided a more technical definition of research involving human fetal tissue from elective abortions as research involving the study, analysis, or use of primary human fetal tissue, cells, and derivatives, and human fetal primary cell cultures obtained from elective abortions and stated that it includes 1 human fetal primary or secondary cell cultures, whether derived by the investigator or obtained from a vendor; 2 animal models incorporating human fetal tissue from elective abortions, including obtaining such models from a vendor; 3
derivative products from elective abortion tissues or cells such as protein or nucleic acid extracts; and 4 any human extra-embryonic cells and tissue, such as umbilical cord tissue, cord blood, placenta, amniotic fluid, and chorionic villi, if obtained from the process of elective abortion. NIH noted that this definition is consistent with the statutory definition that HHS
proposes to adopt here for purposes of these regulations. To provide further specificity about the issue, NIH
excluded certain types of research from the definition of research involving human fetal tissue from elective abortion, namely 1 human fetal primary or secondary cell cultures, if cells were not derived from an elective abortion; 2 already-established as of June 5, 2019 human fetal cell lines e.g., induced pluripotent stem cell lines from human fetal tissue, immortalized cell lines, differentiated cell lines; 3
derivative products from human fetal tissue or cells e.g., DNA, RNA, protein if not derived from elective abortion; 4
human extra-embryonic cells and tissue, including, but not limited to, umbilical cord tissue, cord blood, placenta, amniotic fluid, and chorionic villi if not derived from elective abortion; 5
human fetal cells present in maternal blood or other maternal sources; 6
embryonic stem cells or embryonic cell lines; and 7 research on transplantation of human fetal tissue from elective abortion for therapeutic purposes because of the statutory provisions addressing such research, i.e., National Institutes of Health Revitalization Act of 1993, Pub. L. 103
43, sec. 113, 107 Stat. 126 June 10, 1993, which generally prohibits the imposition of a policy that precludes HHS from conducting or supporting any research on the transplantation of human fetal tissue for therapeutic purposes.
NIH noted that its definition of research involving human fetal tissue from elective abortions is consistent with the statutory definition. As HHS

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proposes to adopt the statutory definition for these regulations, HHS is of the belief that this proposed definition is consistent with the definition adopted in the NIH notice, for purpose of implementing the enhanced review requirements, including review of such research proposals that fall within a fundable scoring range by ethics advisory boards, pursuant to 42
U.S.C. 289a1. Taking into consideration the different purposes and scope of the proposed regulation which would apply to research involving all human fetal tissue, regardless of whether it was obtained from elective abortion and the NIH notice addressing research involving only human fetal tissue from elective abortion, HHS contemplates adopting the statutory definition with the express clarifications that 1 human fetal tissue includes human fetal primary tissue, cells from such tissue, and primary cell cultures; derivative products including protein or nucleic acid extracts from such tissues/cells; and any human extraembryonic cells and tissues, such as umbilical cord tissue, cord blood, placenta, amniotic fluid, and chorionic villi; and 2 human fetal tissue does not include established human fetal cell lines including immortalized cell lines, induced pluripotent stem cell lines from human fetal tissue, and differentiated cell lines; human fetal cells present in maternal blood or maternal sources; and secondary use of data from human fetal tissue. HHS seeks comment on whether it would be appropriate to incorporate some or all of the specificity of the definition and/or the exclusions from the definition contained in the NIH
notice; if so, which aspects of that definition and/or the exclusions should be incorporated into the definition for the purpose of this proposed rule; and if the contemplated express clarifications noted immediately above strike the right balance.
B. Research Involving Pregnant Women or Fetuses, 46.204
HHS proposes to add paragraph k to 46.204, which governs research involving pregnant women or fetuses.
Section 46.204 currently has two provisions which address abortion.
Section 46.204h states that no inducements, monetary or otherwise, will be offered to terminate a pregnancy. Similarly, 46.204i currently requires that individuals engaged in research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy. Proposed paragraph k would require that the pregnant woman provide informed consent before the
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human fetal tissue obtained from the woman is used in HHS-funded research.
Subpart A of the Common Rule generally requires that, before research is conducted on a human research subject, the human subject must provide informed consent, but not for unidentifiable biospecimens.41 As discussed previously, state law generally requires informed consent for participation in research, as well as informed consent for the donation of tissue for research. In light of the serious ethical and moral considerations presented by the use of fetal tissue for research purposes, as well as to protect the interests of pregnant women and the integrity of science, HHS proposes that the requirement for informed consent for tissue donation should apply to research involving human fetal tissue. Because the fetus cannot provide informed consent, it is appropriate to obtain the informed consent of the woman from whom the fetal tissue would be obtained. Such a requirement was included in the 2016 AMA Code of Ethics Opinion.42 For these reasons, HHS proposes to add these requirements in paragraph k. HHS, however, does not propose to include in proposed paragraph k all statements that should be included in such an informed consent. HHS further proposes that the requirement for such informed consent would apply with respect to donations of fetal tissue by women occurring after the effective date of the final rule.
HHS proposes that paragraph k would also establish specific requirements in order to meet informed consent requirements in this unique context:
The pregnant womans consent must be documented on a written informed consent form that is signed by the pregnant woman and written in plain language that is clear and easily understandable. As explained in Canterbury v. Spence, true consent is the informed exercise of a choice, and that entails an opportunity to evaluate knowledgeably the options available and the risks attendant upon each.43
This cannot occur if the pregnant womans options are presented using complex medical jargon. For this reason, in promulgating its 2017 revisions to the Common Rule, HHS considered a growing body of literature that suggests informed consent forms have grown too lengthy and complex, adversely 41 45

CFR 46.116, 46.117.
Code of Medical Ethics Opinion 7.3.5, available at https www.ama-assn.org/deliveringcare/ethics/research-using-human-fetal-tissue.
43 Canterbury v. Spence, 464 F.2d 772, 780 D.C.
Cir. 1972.
42 AMA

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