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Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules affecting their ability to effectively convey the information needed for prospective participants to make an informed decision about participating in research. 44 For the pregnant womans consent to be informed, the consequences of her decision must be written in plain language that is clear and easily understandable. Moreover, the pregnant womans consent should be documented in writing. Requiring such documentation would also minimize costs by reducing uncertainty and the risk of subsequent disputes or litigation.
The form documenting the informed consent must include a statement that there have been and will be no enticements, benefits, or financial incentives to incentivize the donation or acquisition of human fetal tissue, or the abortion if any from which such tissue is obtained. This would require participants to document that they are following federal and state law. The Public Health Service Act already makes it unlawful for any person to knowingly acquire, receive, or otherwise transfer any human fetal tissue for valuable consideration if the transfer affects interstate commerce. See 42 U.S.C.
289g2. Many states also forbid persons from providing enticements, benefits, or financial incentives to donate human fetal tissue.45 HHS proposes that the statement also indicate that no enticement, benefit or financial incentive was provided to incentivize the abortionas a mechanism to ensure that persons do not evade the statutory prohibition on providing valuable consideration for human fetal tissue by providing incentives for the abortion.
Furthermore, after conducting its review, HHS has determined that it is unlikely that persons involved in human fetal tissue research would provide enticements, benefits, or financial incentives to incentivize an abortion, without also seeking to incentivize the human fetal tissue donation.
44 82

FR 7211.
e.g., CA HLTH & S 125320 A person may not knowingly, for valuable consideration, purchase or sell embryonic or cadaveric fetal tissue for research purposes pursuant to this chapter.;
CO ST 252111.5 No physician or institution that performs procedures for the induced termination of pregnancy shall transfer such tissue for valuable consideration to any organization or person that conducts research using fetal tissue.;
IN ST 354651.5 making it a Level 5 felony to intentionally acquire, receive, sell, or transfer fetal tissue; MO ST 188.036 No person shall offer any inducement, monetary or otherwise, to the mother or father of an unborn child for the purpose of procuring an abortion for the medical, scientific, experimental or therapeutic use of the fetal organs or tissue..
45 See,
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The form documenting the informed consent must permit the pregnant woman to choose to donate fetal tissue for research or to decline to donate fetal tissue for research. In order for informed consent for the donation of human fetal tissue to be truly voluntary, the donor has to understand that the donation decision is truly voluntary and that she can choose to donate the fetal tissue or can choose to decline to donate the fetal tissue. HHS proposes to require including both options on the form; it believes that this would help to ensure that the informed consent is truly voluntary.
The form documenting the informed consent must be signed by both the pregnant woman and the individual obtaining the informed consent for the donation, with both individuals attesting to the truth of the statements in the form. Given the serious moral and ethical considerations involved in human fetal tissue donation, it is appropriate to propose to require written documentation that the donor has provided informed consent and that the individual obtaining the informed consent has acted properly. Requiring both individuals signatures would reduce costs by reducing the risks of litigation or other disputesand assist HHS and the research grant recipient ensure compliance with the statutory and regulatory requirements.
These provisions would be applicable to all donations of human fetal tissue, regardless of whether the tissue was obtained from an elective abortion. This requirement is based on principals of informed consent or on a statute with respect to human fetal tissue, both of which are independent of the methods by which the fetal tissue is obtained.
Where the human fetal tissue is to be obtained from an elective abortion, HHS
further proposes that the informed consent include several additional provisions:
The pregnant womans informed consent must be obtained after the decision to have an abortion has been conclusively made and informed consent for the abortion has been obtained. This proposed requirement would be consistent with Congressional intent and the views of the medical community. Congress required that research on the transplantation of human fetal tissue that is funded or conducted by HHS can only occur if the attending physician who obtains the tissue declares that the consent of the woman for the abortion was obtained prior to requesting or obtaining consent for the donation of the tissue for use in research. 42 U.S.C. 289gb2Ai.

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Likewise, the 2016 AMA Code of Ethics Opinion states that physicians involved in research that uses human fetal tissue should ensure that the womans decision to terminate the pregnancy is made prior to, and independent of, any discussion of using the fetal tissue for research purposes. Congress and the AMA recognize that a woman may not be truly providing informed consent to a human fetal tissue donation if the decision to donate is intermingled with the decision about whether to have an abortion.
The pregnant womans informed consent must be obtained by an individual other than the individual who obtained the informed consent for the pregnant womans abortion. This proposed requirement would help ensure that the decision whether to donate human fetal tissue is independent of the decision whether to have an abortion.
The pregnant woman must be at or over the age of majority in the jurisdiction in which the pregnant womans donation is made. American law has long recognized that important decisions about medical procedures should generally be made by adults.46
That is all the more so in this unique context that raises serious moral and ethical concerns. Accordingly, HHS
proposes to impose this requirement with respect to the donation of human fetal tissue.
The form documenting the informed consent must include a statement that the decision to have an abortion and the method of abortion have not been affected by the decision whether to donate human fetal tissue.
This would require documentation that the requirement concerning the order in which the informed consents are obtained, above, has been met. It would also ensure that the pregnant womans consent to the human fetal tissue donation is informed and independent, since the method of abortion would not be affected by the decision whether to donate human fetal tissue.
HHS proposes to provide, in an appendix to the preamble, sample informed consent form provisions, as guidance to regulated entities on the type of informed consent form 46 See Moore, 793 P.2d at 483 A person of adult years and in sound mind has the right, in the exercise of control over his own body, to determine whether or not to submit to lawful medical treatment. quoting Cobbs v. Grant, 8 Cal. 3d 229, 242 1972; Canterbury, 464 F.2d at 780 The root premise is the concept, fundamental in American jurisprudence, that every human being of adult years and sound mind has a right to determine what shall be done with his own body. quoting Schloendorff v. Socy of N.Y. Hosp., 105 NE 92, 93
N.Y. 1914.

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