Federal and State Regulation of Research Involving Human Fetal Tissue

Federal and State Regulation of Research Involving Human Fetal Tissue

Order Code RL31147
CRS Report for Congress
Received through the CRS Web
Federal and State Regulation of Research
Involving Human Fetal Tissue
October 9, 2001
name redacted
Legislative Attorney
American Law Division
Congressional Research Service ˜ The Library of Congress

Federal and State Regulation of Research Involving
Human Fetal Tissue
Summary
This report discusses federal and state regulation of research involving human
fetal tissue. The NIH Revitalization Act of 1993 and the Health Research Extension
Act of 1985 regulate the federal funding of fetal research and fetal tissue
transplantation. The National Organ Transplant Act restricts the receipt or transfer
of fetal organs. Additional fetal research statutes exist at the state level, but have
been subject to challenges in federal courts. In general, the courts have found the
state fetal research statutes to be unconstitutionally vague.

Contents
Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Federal Regulation of Research Involving Fetal Tissue . . . . . . . . . . . . . . . . 3
NIH Revitalization Act of 1993 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Health Research Extension Act of 1985 . . . . . . . . . . . . . . . . . . . . . . . 5
National Organ Transplant Act . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
State Regulation of Research Involving Fetal Tissue . . . . . . . . . . . . . . . . . 5

Federal and State Regulation of Research
Involving Human Fetal Tissue
Research involving human fetal tissue has provided significant medical
developments. Fetal tissue research assisted with the creation of vaccines for polio
and rubella.1 Transplantation studies with human fetal tissue have shown promise in
treating juvenile diabetes and other ailments.2 However, despite these
accomplishments, research involving human fetal tissue remains controversial.
Because human fetal tissue is derived from aborted fetuses, such research is often
entangled with the politics of abortion. Those who believe that a fetus is a human
being consider research involving human fetal tissue to be unethical.3
Opposition to fetal tissue research and transplantation led to a moratorium on
federal funding for fetal tissue transplantation research in 1988. This moratorium
continued until the passage of the NIH Revitalization Act of 1993 (“NIH Act”). This
report will review the federal government’s regulation of fetal tissue research and
transplantation. The report will also discuss state regulation of fetal research and
cases that have considered the legitimacy of such regulation.
Background
The terms “fetal tissue research” and “fetal tissue transplantation research” are
used to describe two distinct types of research involving human fetal tissue. The term
“fetal tissue research” encompasses research with fetal tissue to develop therapies,
evaluate risk factors, and develop cell lines.4 The term “fetal tissue transplantation
research” refers to research involving a procedure in which cells taken from a fetus
are processed and injected into the faulty organs of people suffering from particular
1See James E. Goddard, The NIH Revitalization Act of 1993 Washed Away Many Legal
Problems With Fetal Tissue Transplantation Research But A Stain Remains, 49 SMU L.
Rev. 375 (1996).
2See Jose L. Gonzalez, The Legitimization of Fetal Tissue Transplantation Research Under
Roe v. Wade, 34 Creighton L. Rev. 895 (2001).
3See Goddard, supra note 1, at 376.
4See Gonzalez, supra note 2, at 896. In 1998, investigators at Johns Hopkins University
published the results of their research with stem cells derived from aborted fetuses. The
properties of these stem cells were found to be very similar to those of embryonic stem cells.
For additional information on stem cell research, see (name redacted),
Stem Cell Research,
CRS Report RL31015.

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diseases.5 It is this latter type of research that prompted the moratorium on federal
funding.
In 1988, a group of scientists at the National Institutes of Health ("NIH") sought
approval from the Assistant Secretary of Health and Human Services ("HHS") to use
human fetal tissue for transplantation in a research protocol.6 In response to the
request, the Assistant Secretary issued a temporary moratorium on the federal funding
of fetal tissue transplantation research. The moratorium was intended to last until an
NIH advisory panel could study and report on the ethical, legal, and scientific issues
associated with fetal tissue transplantation research.7 Although the panel eventually
recommended continued funding for fetal tissue transplantation research pursuant to
certain guidelines, the moratorium was extended indefinitely by the Secretary of HHS
in 1989.8 The Secretary maintained that fetal tissue transplantation research would
increase the incidence of induced abortions.9 Legislative attempts to override the
Secretary's decision were either not enacted or were vetoed by President Bush.10
Shortly after assuming office, President Clinton instructed the Secretary of HHS
to lift the ban on federal funding.11 On February 5, 1993, the moratorium was
officially rescinded. In March, 1993, NIH published interim guidelines for research
involving the transplantation of human fetal tissue.12 These guidelines were later
incorporated into the NIH Act.
5See Goddard, supra note 1, at 378. See also Cory Zion, The Legal and Ethical Issues of
Fetal Tissue Research and Transplantation, 75 Or. L. Rev. 1281 (1996).
6Goddard, supra note 1, at 383.
7Goddard, supra note 1, at 383-84. See also Nat’l Bioethics Advisory Commission, Ethical
Issues in Human Stem Cell Research - Volume I (1999).
8Nat’l Bioethics Advisory Commission, supra note 7, at 31.
9Id. Most researchers believe that the success of fetal tissue transplantation research depends
on tissue derived from induced abortions. Fetuses obtained from spontaneous abortions and
ectopic pregnancies often contain genetic abnormalities that make the tissue unusable in
transplantation research.
10See H.R. 2507, 102nd Cong. (1991); H.R. 5495, 102nd Cong. (1992); President's Message
to the House of Representatives Returning Without Approval the National Institutes of Health
Revitalization Amendments of 1992, 28 Weekly Comp. Pres. Doc. 1132 (June 23, 1992)
11See President’s Memorandum for the Secretary of Health and Human Services, 58 Fed. Reg.
7457 (1993).
12Nat’l Bioethics Advisory Commission, supra note 7, at 31.

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Federal Regulation of Research Involving Fetal Tissue
Research involving fetal tissue is regulated primarily by three federal statutes.
The restrictions imposed by these statutes are described in this section.
NIH Revitalization Act of 1993. Under the NIH Act, the Secretary of HHS
may conduct or support research on the transplantation of human fetal tissue for
therapeutic purposes. The Secretary may provide support for research only if the
applicant for financial assistance agrees to conduct the research in accordance with
applicable state law.13 Similarly, the Secretary may conduct research only in
accordance with applicable state and local law.14
Fetal tissue that is used for transplantation research under the NIH Act may be
obtained pursuant to a spontaneous or induced abortion or pursuant to a stillbirth.15
However, before the fetal tissue may be used in research, written statements must be
made by the woman providing the tissue, by the attending physician who obtains the
tissue, and by the principal researcher. Each of these statements requires specific
declarations.
In her written statement, the woman providing the tissue must declare that (1)
she is donating the tissue for use in transplantation research for therapeutic purposes;
(2) the donation is being made without any restriction on the recipient of the tissue;
and (3) she has not been told of the identity of the recipient.16 The physician’s written
statement must declare that (1) the woman’s consent for the abortion was obtained
prior to requesting or obtaining consent for the tissue donation; (2) there was no
alteration of the timing, method, or procedures used to terminate the pregnancy for
the purpose of obtaining the tissue; (3) the abortion was performed in accordance
with applicable state laws; (4) the tissue was donated in accordance with the
requirements set out in the mother’s statement; and (5) the woman has been fully
informed of the physician’s interest, if any, in the research to be conducted and has
been fully informed of any known medical risks or risks to her privacy as a result of
the donation.17
Finally, the individual with the principal responsibility for conducting the research
must declare that (1) he is aware that the tissue is human fetal tissue obtained
pursuant to a spontaneous or induced abortion or pursuant to a stillbirth; (2) the tissue
was donated for research purposes; (3) he has provided information about the tissue
to other individuals involved with the research; (4) he will require, prior to obtaining
consent from a transplantation recipient, written acknowledgment that the recipient
1342 U.S.C. § 289g-1(e)(1).
1442 U.S.C. § 289g-1(e)(2).
15See 42 U.S.C. § 289g-1(a)(2).
1642 U.S.C. § 289g-1(b)(1).
1742 U.S.C. § 289g-1(b)(2).

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is aware of the kind of tissue to be used; and (5) he had no part in determining the
timing, method, or procedures used to terminate the pregnancy.18
In addition to requiring written statements, the NIH Act also prohibits the
knowing acquisition, receipt, or transfer of any human fetal tissue for valuable
consideration if the transfer affects interstate commerce.19 Moreover, the NIH Act
provides:
It shall be unlawful for any person to solicit or knowingly acquire, receive,
or accept a donation of human fetal tissue for the purpose of
transplantation . . . if the donation affects interstate commerce, the tissue
will be or is obtained pursuant to an induced abortion, and –
(1) the donation will be or is made pursuant to a promise to the
donating individual that the donated tissue will be transplanted into a
recipient specified by such individual;
(2) the donated tissue will be transplanted into a relative of the
donating individual; or
(3) the person who solicits or knowingly acquires, receives, or accepts
the donation has provided valuable consideration for the costs
associated with such abortion.20
Persons violating these restrictions shall be subject to fines, imprisonment for not
more than ten years, or both.21 Violations involving the payment of valuable
consideration shall result in fines reflecting not less than twice the amount of the
valuable consideration received.22
Although the NIH Act responded to numerous concerns involving fetal tissue
transplantation research, it also aroused criticism for its ambiguity. For example, it
has been argued that Congress’ failure to define the term “therapeutic purposes”
could result in the transplantation of fetal tissue to enhance the body’s normal
functioning.23 It has also been argued that the Act’s use of the term “valuable
consideration” could result in abuse by those who transport or process human fetal
tissue.24 Uncertainty about what constitutes “reasonable payments” could result in
1842 U.S.C. § 289g-1(c).
1942 U.S.C. § 289g-2(a).
2042 U.S.C. § 289g-2(b).
2142 U.S.C. § 289g-2(c)(1).
2242 U.S.C. § 289g-2(c)(2).
23See Goddard, supra note 1, at 393 (“Currently, researchers have discovered that fetal tissue
injections can accelerate muscle healing in animals. It is foreseeable, then, that fetal injections
could be used to ‘enhance - like steroids - the ability of athletes . . .’”).
24Goddard, supra note 1, at 394. See 42 U.S.C. § 289g-2(d)(3) (The term “valuable
consideration” is defined to exclude “reasonable payments associated with the transportation,
implantation, processing, preservation, quality control, or storage of human fetal tissue.”).

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fetal tissue transporters and processors charging excessive amounts and declaring
such amounts to be “reasonable.”
Health Research Extension Act of 1985. The Health Research Extension
Act of 1985 (“Extension Act”) restricts research or experimentation on nonviable
living human fetuses ex utero and living human fetuses ex utero whose viability has
not been determined.25 Under the Extension Act, the Secretary of HHS may conduct
or support research or experimentation on the specified fetuses in only two situations.
The Secretary may conduct or support research or experimentation that enhances the
well-being of the fetus or enhances the probability of its survival.26 The Secretary may
also conduct or support research or experimentation that is undertaken to develop
important biomedical knowledge that cannot be obtained by other means.27 This type
of research or experimentation must pose no added risk of suffering, injury, or death
to the fetus.28
National Organ Transplant Act. The National Organ Transplant Act
(“NOTA”) makes it unlawful for any person to knowingly acquire, receive, or
otherwise transfer any human organ for valuable consideration if the transfer affects
interstate commerce and the organ is to be used in transplantation.29 The term
“human organ” includes fetal organs.30 Reasonable payments associated with the
removal, transportation, processing, and storage of the organs are excluded from the
definition of “valuable consideration.”31 Violation of NOTA’s prohibition shall result
in fines not to exceed $50,000, imprisonment for not more than five years, or both.
State Regulation of Research Involving Fetal Tissue
Under the NIH Act, federally-funded research on fetal tissue transplantation
must comply with applicable state laws.32 Laws relating to the use of human tissue
exist in all states. The Uniform Anatomical Gift Act, first proposed in 1968, sought
to govern tissue donation from all dead humans and fetuses.33 The Act permits the
use of human tissue for the purpose of education, research, or the advancement of
science.34 However, while the original Act was adopted by all fifty states and the
25See 42 U.S.C. § 289g.
2642 U.S.C. § 289g(a)(1).
2742 U.S.C. § 289g(a)(2).
28Id.
2942 U.S.C. § 274e(a).
3042 U.S.C. § 274e(c)(1).
3142 U.S.C. § 274e(c)(2).
3242 U.S.C. § 289g-1(e)(1).
33See Goddard, supra note 1, at 388.
34Id.

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District of Columbia, fewer states adopted a revised 1987 version of the Act. Instead,
many states enacted alternate legislation to specifically regulate fetal research.35
At least nineteen states restrict fetal research.36 For example, North Dakota law
provides: “A person may not use a fetus or fetal organs or tissue resulting from an
induced abortion in animal or human research, experimentation, or study, or for
animal or human transplantation except for diagnostic or remedial procedures.”37 The
validity of state laws that restrict fetal research has been considered in four federal
circuits.38 In general, the courts have concluded that the language of the state fetal
research statutes is unconstitutionally vague.39 These courts have found that the
statutes’ use of the terms “experiment,” “experimentation,” or “investigation” fail to
provide adequate guidance on the conduct that is prohibited.
In Forbes v. Napolitano, the U.S. Court of Appeals for the Ninth Circuit found
Arizona’s fetal research statute unconstitutionally vague under the due process clause
of the Fourteenth Amendment.40 The court indicated that the statute “provides no
guidance as to where the state should draw the line between experiment and treatment
and gives doctors no constructive notice.”41 Moreover, the statute failed to give
police, prosecutors, and judges any standards to “focus the statute’s reach.”42
35See Gonzalez, supra note 2, at 905.
36Ariz. Rev. Stat. Ann. § 36-2302 (1993); Ark. Code Ann. § 20-17-802 (2000); Cal. Health
& Safety Code § 123440 (1996); Fla. Stat. Ann. § 390.0111 (1998); 720 Ill. Comp. Stat.
Ann. 510/12.1 (1993); Ky. Rev. Stat. Ann. § 436.026 (1999); La. Rev. Stat. Ann. §
40:1299.35.13 (2001); Me. Rev. Stat. Ann. tit. 22, § 1593 (1992); Mass. Gen. Laws Ann.
ch. 112, § 12J (1996); Minn. Stat. Ann. § 145.422 (1998); Mo. Ann. Stat. § 188.036 (1996);
N.D. Cent. Code §§ 14-02.2-01, 14-02.2-02 (1997); Ohio Rev. Code Ann. § 2919.14 (1999);
Okla. Stat. Ann. tit. 63, § 1-735 (1997); R.I. Gen. Laws § 11-54-1 (2000); S.D. Codified
Laws § 34-23A-17 (1994); Tenn. Code Ann. § 39-15-208 (1997); Utah Code Ann. § 76-7-
310 (1999); Wyo. Stat. Ann. § 35-6-115 (2001). See note 38 (The Arizona, Illinois,
Louisiana, and Utah statutes have been found unconstitutional.).
37N.D. Cent. Code § 14-02.2-02.2.
38See Margaret S. v. Edwards, 794 F.2d 994 (5th Cir. 1986); Lifchez v. Hartigan, 735
F.Supp. 1361 (N.D. Ill. 1990), aff’d mem., 914 F.2d 260 (7th Cir. 1990); Forbes v.
Napolitano, 236 F.3d 1009 (9th Cir. 2000); Jane L. v. Bangerter, 61 F.3d 1493 (10th Cir.
1995), Rev’d and remanded on other grounds sub. nom., Levitt v. Jane L., 518 U.S. 137
(1996).
39See Forbes, 236 F.3d at 1011 (“The due process clause of the Fourteenth Amendment
guarantees individuals the right to fair notice of whether their conduct is prohibited by law .
. . Although only constructive rather than actual notice is required, individuals must be given
a reasonable opportunity to discern whether their conduct is proscribed so they can choose
whether or not to comply with the law.”).
40236 F.3d 1009 (9th Cir. 2000).
41Forbes, 236 F.3d at 1013.
42Id.

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Despite the invalidation of various state fetal research statutes, opponents of fetal
tissue research and transplantation maintain that the vagueness problems identified by
the courts can be overcome.43 If such statutes were to withstand constitutional
challenge, it would appear that federally-supported fetal tissue transplantation
research could be restricted in states with fetal research laws.
43See AG Finds Fetal Tissue Research May Be Banned By State If Law Properly Drafted,
9 Health L. Rep. (BNA) No. 10, at 338 (March 9, 2000).

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