Lori B. Andrews, J.D.
Distinguished Professor of Law,
Chicago Kent College of Law, Illinois Institute of Technology

The issue of research involving embryos and fetuses has been a matter of serious social concern for the past three decades.  As each new scientific and medical development is introduced that affects embryos and fetuses, new state laws are proposed to deal with them.  In the wake of the 1973 U.S. Supreme Court abortion decision in Roe v. Wade,¹ for example, 24 states passed laws prohibiting research on human conceptuses.² When in vitro fertilization (IVF) was accomplished, at least one state passed a law attempting to discourage the procedure.³  After Dolly the cloned sheep was born, nine states adopted laws restricting human reproductive cloning.⁴  When researchers began creating and using human embryos for stem cell research, states began introducing laws to deal with that technology as well.  In 2002 and 2003, dozens of bills were introduced in state legislatures on cloning and stem cell research.  In total, 38 states considered such bills;⁵ some states considered multiple and conflicting bills.  In all, 133 separate bills were introduced on these subjects.  (See overview in Chart II and specific provisions in Chart III).

Although state legislatures have addressed regulation of research on the unborn for 30 years, the more recent technologies are being debated within a new context.  Pro-life and pro-choice advocates are aligning in unusual ways.  Unlike the clear line of demarcation between the groups on the issue of abortion, some pro-choice advocates oppose all forms of human cloning⁶ and some pro-life advocates support so-called "therapeutic" cloning.⁷  It would seem that these unique alliances might allow more fruitful policy discussions.  However, despite agreement across traditional boundaries on the substance of particular bills, some of the new alliances break down because the sponsors of the bills include preambles that evince either pro-life or pro-biotechnology sentiments that go far beyond the substance of the bills themselves.  This is a new development in the policy considerations related to human conceptuses.  The legislators themselves are acting like lobbyists by including within their bills language espousing a particular position that goes far beyond the bills' actual legal substance.⁸ Some bills seem to be driven more by political posturing than by an attempt to actually get legislation enacted to deal with the issue at hand.

This paper surveys the state law landscape by analyzing 1) existing laws with implications for reproductive cloning, therapeutic cloning and embryo stem cell research, 2) proposed bills addressing those technologies, and 3) potential constitutional challenges to the laws.

I. The Existing Legal Framework

A.  Existing Bans on Cloning

1. The Restrictions

There are eight states that have enacted explicit laws to ban reproductive cloning,⁹ and one state that prohibits only the use of state funds for reproductive cloning.¹⁰  (See Chart I).  Of these eight states, four also ban "therapeutic" cloning.¹¹ Some states also ban shipping, transferring, or receiving for any purpose an embryo produced by human cloning.¹²

Under the existing reproductive cloning bans, some states ban the purchase or sale of an ovum, zygote, embryo, or fetus for the purpose of cloning a human being.¹³ Other states, however, have bans on payment for eggs, embryos, or human tissue that could also cover some of the transactions involved in reproductive or "therapeutic" cloning.¹⁴

California's initial anti-cloning bill, adopted in 1998, created an advisory committee that met frequently over a five year period, heard extensive testimony from scientists and members of the public, and issued a report.¹⁵

2. Exceptions for Certain Research

In some states, the ban on reproductive cloning is accompanied by language supporting other types of research or medical practices.  In Louisiana and Michigan, for example, the cloning bans say that they do not prohibit scientific research on a cell-based therapy.¹⁶  Similarly, some states allow the use of nuclear transfer or other cloning techniques to produce molecules, DNA, cells other than human embryos, tissues, organs, plants, or animals other than humans.¹⁷ The Arkansas and Rhode Island laws also specifically allow in vitro fertilization and fertility enhancing drugs, so long as they are not used in the context of human cloning.¹⁸  The Iowa law more broadly allows in vitro fertilization and the use of fertility drugs.¹⁹

3. Penalties

The penalties for violation of existing cloning bans range widely.  In Louisiana and Michigan, for example, penalties can be up to 10 years imprisonment and fines of $10 million for an entity such as a clinic or corporation and $5 million for an individual.²⁰  In contrast, in Arkansas the penalty is a mere $250,000, but there are also felony criminal penalties.²¹ Moreover, in some states, cloning can result in the permanent revocation of a doctor's license²² and the denial of any other type of license or permit from the state regarding any trade, occupation or profession.²³

B. Existing Bans on Embryo Research

Twelve states' laws apply to in vitro embryos.  In New Hampshire, the regulation of research on embryos prior to implantation is minimal.²⁴  The research must take place before day 14 post-conception,²⁵ and the subject embryo must not be implanted in a woman.²⁶ These stipulations could readily be met by researchers wanting to use IVF embryos as a source of stem cells. 

Nine states ban research on in vitro embryos altogether,²⁷ and two states ban destructive embryo research.²⁸ In Louisiana, an in vitro fertilized ovum may not be farmed or cultured for research purposes;²⁹ the sole purpose for which an IVF embryo may be used is for human in utero implantations.³⁰

In the other states, embryo research is banned as part of the broader ban on all research involving live conceptuses.  These laws ban embryo stem cell research.  The penalties are high -- in some states, the punishment includes imprisonment.³¹

In some instances, the woman or couple who donate an embryo or fetus for research purposes also face liability.  Laws in Maine, Michigan, North Dakota, and Rhode Island prohibit the transfer, distribution, or giving away of any live embryo for research purposes.³²  In Maine, a person who does so is subject to a fine of up to $5,000 and up to five years' imprisonment.³³

A California law declares that research shall be permitted on human embryonic or adult stem cells from any source, including somatic cell nuclear transfer.³⁴  Such research must be reviewed by an approved institutional review board and such research may not be undertaken without written informed consent of the embryo donor.  Interestingly, the law does not say consent of the "donors," plural.  So it would appear that the female patient of infertility services (and not the woman and her husband) is the sole source of consent.  California also enacted a law urging Congress to ban reproductive cloning, while permitting therapeutic cloning and embryo stem cell research.³⁵

II. Proposed Bills³⁶

Legislators are currently considering bills that govern the technologies of cloning or embryo stem cell research. But even when the provisions of those bills are narrowly tailored to deal with those specific technologies, lawmakers include extensive preambles that include sweeping pro-life or pro-biotechnology language.  None of the bills include a pro-choice preamble. 

A Kentucky bill attempts to fuel a biotechnology sector in the state.  Its preamble mentions the "great potential" of nuclear transplantation to treat "diseases and disorders, including but not limited to Lou Gehrig's disease, Parkinson's disease, Alzheimer's disease, spinal-cord injury, cancer cardiovascular diseases, diabetes, rheumatoid arthritis, and many others."³⁷  Its provisions would require anyone engaging in therapeutic cloning to register with the health department and pay a $50 fee.  The bill also implores public colleges in Kentucky to protect "the interest of the Commonwealth or the institution relating to all intellectual property and other rights to any research, experiments, or other activity related to human nuclear transplantation. . . ."³⁸

On the other hand, some bills' preambles are designed to cast aspersions on the technologies.  The preamble of a Virginia Senate resolution contains a hodge-podge of historical facts (from slavery in Virginia 1619 to 1865 to Advanced Cell Technologies cloning of an embryo), Presidential statements (from President Reagan through President George W. Bush), and concerns about eugenics and commodification of humans.³⁹  The resolution would establish a legislative task force, but its agenda is directed in a one-sided way.  It is supposed to "examine the medical, ethical and scientific policy implications of prohibiting the creation of embryos in vitro for any purpose other than bringing them to birth, and the criminalizing of the transfer of compensation, in cash or in-kind, to induce any person to donate sperm or eggs for any purpose other than procreation. The joint subcommittee shall also examine the efficacy of research using adult stem cells rather than embryonic stem cells."⁴⁰

Some bills assert scientific or medical facts that are not necessarily accurate.  For example, Louisiana's resolution says, "stem cells derived from adult or placental tissues may hold greater promise than embryonic stem cells for human medicine, due to a lesser danger of immune reactivity against a recipient."⁴¹

1. The Restrictions

In 2002 and 2003, 27 states introduced bills that would ban reproductive cloning.⁴² One bill details a specific enforcement mechanism for the human cloning ban.  A New Jersey bill provides that the Commissioner of Health and Senior Services may issue a cease and desist order, with a subsequent administrative hearing within 20 days, with judicial review available.⁴³ 

Many of these proposed laws suffer from drafting infirmities.  For example, some of the states' proposals create a loophole by only prohibiting the reproduction of a "genetically identical" individual through cloning.⁴⁴  Since the current cloning technique uses a donated egg to create a clone, the resulting individual will have some additional mitochondrial DNA from the enucleated egg, so he or she will not be genetically identical to the original individual.⁴⁵  In contrast, other states' bills prohibit the reproduction of a "virtually genetically identical" individual through human cloning using a human or non-human egg,⁴⁶ which would apply even if a donated egg, containing additional mitochondria were used.

Certain states' bills would prohibit the transferring of a human cell into a human egg cell.⁴⁷  But, in January 1998, scientists at the University of Wisconsin revealed that cow eggs could serve as incubators for nucleic DNA of other mammalian species.⁴⁸  Thus, the proposed laws could be evaded by making a human clone via somatic cell DNA transfer into an enucleated cow egg.  Other states' bills prohibit human reproductive cloning using a human or non-human egg.⁴⁹ 

A New Jersey bill has the opposite problem.  Rather than being too narrow, it is too broad, using vague language in places and even potentially banning the creation of children through sexual intercourse.⁵⁰ The focus of the bill is to ban human cloning and germline genetic engineering.  But it defines human cloning as the replication of one or more human beings, through "sexual or asexual reproduction."  When two people create a child sexually are they replicating themselves?  The key word, "replication," is not defined. 

The bill prohibits the destruction of human or non-human embryos "for the purpose of human cloning."⁵¹  There is a certain vagueness to that provision.  If a researcher working on primate cloning generates data that might be useful to cloning human beings could he or she be prosecuted?

Six states' bills would prohibit the use of public funds and facilities to participate in cloning or attempted cloning.⁵²

3.  Other Means to Discourage Cloning

Some states' bills attempt to discourage reproductive cloning by prohibiting either the sale or purchase⁵³ or the shipment or receival of an ovum, zygote, embryo, or fetus to clone a human.⁵⁴  Some states' laws attempt to discourage cloning through liability provisions.  A Florida bill would create vast liabilities as another means to discourage cloning.⁵⁵ Participants in human reproductive cloning would be liable to "the individual, the individual's spouse, dependents, and blood relatives, and to any woman impregnated with the individual, her spouse, and dependents, for damages for all physical, emotional, economic, or other injuries suffered by such persons at any time as a result of the use of human cloning to produce the individual."  Even more dramatically, participants in human reproductive cloning would be liable to the cloned individual and his or her legal guardian for support until the age of majority (or longer, if the clone has "any congenital defects or other disability" related to the cloning).

4. Exceptions

Eighteen states' bills have an exception allowing cloning to create DNA, tissues, and organs.⁵⁶ Eleven states' bills would not restrict the use of in vitro fertilization or fertility enhancing drugs.⁵⁷

C.  Proposed Bills on Therapeutic Cloning

There are 26 states that have bills about therapeutic cloning.⁵⁸  Two states have at least one bill that would ban therapeutic cloning and at least one that would allow therapeutic cloning.⁵⁹

1.  Ban Therapeutic Cloning

Twenty-six states have bills that would prohibit all human cloning including therapeutic cloning.⁶⁰ Some states prohibit therapeutic cloning through a general cloning ban that defines human cloning as the creation of any human organism through somatic cell nuclear transfer.⁶¹ Others prohibit therapeutic cloning by banning not only the creation of the cloned embryo, but also the "derivation of any product from human cloning."⁶²

2.  Allow Therapeutic Cloning

Two states have bills that specifically allow therapeutic cloning.⁶³  In addition, twelve other states allow for the use of stem cells from any source, including those derived from somatic cell nuclear transplantation.⁶⁴

One state bill would encourage researchers to do stem cell research using only human adult or placental tissues obtained with informed consent, and would discourage research involving human embryonic or fetal tissue.⁶⁵  One state's bill urges state universities to refrain from embryonic stem cell research.⁶⁶

Five states have bills that would prohibit acts where a human fetus or embryo is destroyed or subject to injury.⁶⁷  New Jersey has these provisions in a cloning bill, while Wisconsin has them in an artificial insemination/in vitro fertilization bill.⁶⁸ The others (Kansas, Michigan, and Virginia) have these provisions in stem cell research bills.⁶⁹ One state's bill would make all contracts for payment for the extraction or use of embryonic stem cells against public policy, void, and unenforceable.⁷⁰  In addition, a Michigan bill, in its preamble, opposes the White House decision to allow certain embryonic stem cell research.⁷¹ The substance of the bill is a provision urging the state's public universities to refrain from embryonic stem cell research.⁷²

2.  Allow Embryo Stem Cell Research, Including Therapeutic Cloning

Twelve states have bills that would allow embryo stem cell research from any source.⁷³  While the bills literally say "from any source," some also have a list saying this includes human embryonic stem cells, human embryonic germ cells, and human adult stem cells, from any source, including somatic cell nuclear transplantation.⁷⁴ In the states where proposed bills would permit embryonic stem cell research, there are often provisions regarding how the research should be conducted.  In eleven states, for example, physicians undertaking in vitro fertilization on patients must discuss options for the disposition of frozen embryos, including donation to research, and written informed consent for such donation would have to be obtained.⁷⁵  In at least one state, the proposed research must be assessed by a state department,⁷⁶ and in eleven states the research must be assessed by an institutional review board.⁷⁷  A Kentucky bill requires that individuals engaged in therapeutic cloning must register their name, address, and phone number, which information shall be public record.⁷⁸  Under one proposed California bill, the State Department of Health Services would have the responsibility to develop guidelines regarding the derivation or use of human embryonic stem cells.⁷⁹

In Illinois, care was taken in the proposed bill favoring embryonic stem cell research not to create barriers for the research due to contract or tort liability.  Consequently, the proposed Illinois bill states that "procuring, furnishing, donating, processing, distributing, or using embryonic or cadaveric fetal tissue for research purposes pursuant to this Act is declared for the purposes of liability in tort or contract to be the rendition of a service by every person, firm, or corporation participating therein, whether or not remuneration is paid, and is declared not to be a sale of any such items and no warranties of any kind or description nor strict tort liability shall be applicable thereto."⁸⁰

3.  Address Embryo Donation

Twelve states' bills would expressly allow a person to donate human embryos for research.⁸¹ Twelve states' bills would also prohibit the sale of embryonic or cadaveric fetal tissue for research purposes.⁸²

4. Review Committees

Six states' bills would establish a subcommittee or task force to review and/or study issues related to stem cell research.⁸³ Some of these states have a bill that only establishes a task force.⁸⁴ Some states establish this task force, subcommittee, or review board within a bill relating to stem cell research.⁸⁵  Maryland has one of each.⁸⁶

It has often been true in the bioethical area that when controversial new technologies are introduced, states propose commissions to address the issue.⁸⁷ Often, the creation of the commission is a stalling tactic to avoid having to confront the issue head on or to postpone having to limit a technology, or to facilitate a moratorium on the technology (while the Commission evaluates the technology).  Sometimes, though, state commissions have admirably overseen a technology's development, application and evaluation.  Such was the case in the 1970's and 1980's with Maryland's newborn screening commission.  So it is no surprise that of the bills proposing a state task force or commission, the Maryland bill provides the best guidance about what the commission would do.  The Maryland task force would:

5. Public Funding or Tax Credits for Stem Cell Research

States have also proposed bills allowing for or prohibiting the granting of state funds for stem cell research.  California's proposed "Biomedical Research and Development Act of 2004" would award grants or loans to public or private institutions conducting research in stem cell biology.⁸⁹ To be eligible for funding, all research projects must be reviewed and approved by an institutional review board.

The states of Indiana, Michigan, Mississippi, and Nebraska have gone the opposite direction and introduced bills specifically prohibiting the use of state money or tax credits for stem cell research.⁹⁰ The Indiana bill proposes an amendment to the state tax code denying tax exemptions and credits for research involving human cloning or stem cell research with embryonic tissue.

A Mississippi House Bill and a Mississippi Senate Bill provide that no public funds shall be used to assist in or to provide facilities for stem cell research that uses cells from human embryos and human cloning. 

Finally, although not establishing public funds for embryonic stem cell research, six Florida bills seek to establish a center for "Universal Research to Eradicate Disease" which will facilitate funding opportunities for stem cell research.⁹¹

E.  Proposed Bills on Health Care Providers' Right of Conscience

In addition to proposing bills on the prohibition of or allowance of embryonic stem cell research and cloning, a number of states have proposed bills protecting a health care provider, payer, or institution's right to refuse certain services based on moral or ethical convictions.  Kansas, Louisiana, and Rhode Island have all introduced bills entitled "Health Care Providers Rights of Conscience." ⁹²

The Kansas bill introduced on January 28, 2002, specifically allows all persons to refuse to participate in the provision of, or pay for, a health care service related to human cloning and embryonic stem cell and fetal experimentation.  The Louisiana bill and the identical Rhode Island House and Senate bills allow all health care providers, institutions and payers to decline to counsel, advise, pay for, provide, perform, assist, or participate in providing or performing health care services that violate their consciences, including, human cloning and embryonic stem cell research. 

Not all regulations affecting research are constitutional.  Laws restricting research on conceptuses may be struck down as too vague or as violating the right to privacy to make reproductive decisions.  Such a challenge was successful in a federal district court case, Lifchez v. Hartigan,⁹³ which held that a ban on research on conceptuses was unconstitutional because it was too vague in that it failed to define the terms "experimentation" and "therapeutic."⁹⁴  The court pointed out that there are multiple meanings of the term "experimentation."⁹⁵ It could mean pure research, with no direct benefit to the subject.  It could mean a procedure that is not sufficiently tested so that the outcome is predictable, or a procedure that departs from present-day practice.  It could mean a procedure performed by a practitioner or clinic for the first time.  Or it could mean routine treatment on a new patient.  Since the statute did not define the term, it was unconstitutionally vague.  It violated researchers' and clinicians' due process rights under the fifth amendment since it forced them to guess whether their conduct was unlawful.⁹⁶

A similar result was reached by a federal appellate court assessing the constitutionality of a Louisiana law prohibiting nontherapeutic experimentation on fetuses in Margaret S. v. Edwards.⁹⁷ The appeals court declared the law unconstitutional because the term "experimentation" was so vague it did not give researchers adequate notice about what type of conduct was banned.⁹⁸The court said that the term "experimentation" was impermissibly vague⁹⁹ since physicians do not and cannot distinguish clearly between medical experimentation and medical tests.¹⁰⁰ The court noted that "even medical treatment can be reasonably described as both a test and an experiment."¹⁰¹ This is the case, for example, "whenever the results of the treatment are observed, recorded, and introduced into the data base that one or more physicians use in seeking better therapeutic methods."¹⁰²

A third case struck down as vague the Utah statute that provided that "live unborn children may not be used for experimentation, but when advisable, in the best medical judgment of the physician, may be tested for genetic defects."¹⁰³ The Tenth Circuit held "[b]ecause there are several competing and equally viable definitions, the term 'experimentation' does not place health care providers on adequate notice of the legality of their conduct."¹⁰⁴

In a fourth case, Forbes v. Napolitano,¹⁰⁵ a number of plaintiffs¹⁰⁶ challenged the constitutionality of an Arizona statute that criminalized medical experimentation or investigation involving fetal tissue from induced abortions.¹⁰⁷  The statute at issue in that litigation, A.R.S. § 36-2302(A), provides: A person shall not knowingly use any human fetus or embryo, living or dead, or any parts, organs, or fluids of any such fetus or embryo resulting from an induced abortion in any manner for any medical experimentation or scientific or medical investigation purposes except as is strictly necessary to diagnose a disease or condition in the mother of the fetus or embryo and only if the abortion was performed because of such disease or condition.¹⁰⁸

An exception to this is found in A.R.S. § 36-2302(C), which reads:

The penalty for violation of A.R.S. § 36-2302, a class 5 felony, is one and a half years in prison and fines up to $150,000.¹¹⁰

Plaintiffs argued that the statute prevented fetal tissue transplantation treatment of Parkinson's disease, certain fertility treatments, and development of treatments for illness.¹¹¹  The court ultimately affirmed the decision of the lower court¹¹² in holding that the statute was unconstitutionally vague.¹¹³  Specifically, the "distinction between experiment and treatment in the use of fetal tissue is indeterminate, regardless of whether the tissue is obtained after an induced abortion."¹¹⁴  Furthermore, the court determined that a criminal statute that serves to prohibit medical experimentation but provides no guidance as to where to draw the line between experiment and treatment does not provide doctors with constructive notice, nor does it provide police, prosecutors, juries, and judges with standards for application.¹¹⁵

Specific bans on embryo stem cell research are unlikely to raise the same constitutional concerns.  Part of the constitutional deficiency in the Arizona, Illinois, Louisiana, and Utah cases was that physicians offering health care services for their patients (such as embryo donation from an infertile woman, preimplantation genetic screening on an embryo, or treatment of a pregnant woman for diabetes) would not know if the activity would be considered by prosecutors to be experimental with respect to the embryo or fetus.  Moreover, the female patient's reproductive freedom was implicated in the previous cases, providing another reason for overturning the statute.  Stem cell researchers do not have those potential legal arguments.  There is a slight possibility, however, a reproductive liberty challenge could be raised against a law banning reproductive cloning.¹¹⁶

Conclusion

Bills on cloning and stem cell research are the subjects of vast media attention and public debate.  As technologies develop that focus increasingly on the human embryo, lawmakers are having difficulty coming to agreement on legislative policy in the absence of societal accord about the moral and legal status of the embryo.

[PLEASE SEE THE ACCOMPANYING CHARTS DETAILING STATE LAWS AND BILLS RELEVANT TO THIS AREA.  ADDITIONAL INFORMATION IS AVAILABLE ON THE COUNCIL'S WEBSITE AT WWW.BIOETHICS.GOV IN THE ELECTRONIC VERSION OF THIS REPORT AS WELL AS IN THE TRANSCRIPTS OF THE AUTHOR'S PRESENTATION TO THE COUNCIL AT ITS JULY 24, 2003 MEETING.]