Raising the standard of abortion informed consent: lessons to be learned from the ethical and legal requirements for consent to medical experimentation.

• Author: Seo, Jennifer Y.

INTRODUCTION

In the aftermath of Planned Parenthood of Southeastern Pennsylvania v. Casey, (1) state legislatures have restricted access to abortions by regulating the informed consent process. Taking as an invitation the Court's holding that a state is permitted "to further its legitimate goal of protecting the life of the unborn by enacting legislation aimed at ensuring a decision that is mature and informed, even when in so doing the State expresses a preference for childbirth over abortion," (2) states began to legally mandate specific required disclosures, language, or procedures for obtaining informed consent to abortions. While all states require informed consent before medical procedures either by statute or by case law, the details of the process have traditionally been self-regulated by the medical profession through medical ethics. (3) Currently, thirty-four states have abortion-specific informed consent statutes. (4) However, these statutes mandate disclosures of information that not only go beyond what is required for other medical procedures, but also include information that is inaccurate, incomplete, or irrelevant to the particular abortion procedure to be performed. Thus, states, under the shield of the Casey decision, have used abortion informed consent statutes to express their preference for childbirth over abortion in a way that serves to unduly influence a woman's choice, in violation of the ethical boundaries of medical informed consent.

Under general informed consent principles, abortion providers must disclose information typically required for other medical procedures: the nature and type of the abortion procedure, the risks and consequences of the abortion procedure, alternatives to abortion, and the risks and consequences of not having the procedure, i.e. continuing the pregnancy. (5) The rationale behind these disclosures is to "protect autonomous choice," that is, to ensure the patient's self-determination of whether to undergo a particular medical procedure. (6) However, despite the growing number of state-required disclosures on the risks of the abortion procedure, only twenty-eight states explicitly require physicians to disclose the risks of continuing the pregnancy. (7) This suggests that states are stating their preference for childbirth over abortion but not ensuring that women make a fully informed decision.

Indeed, twenty-four of the thirty-four states with abortion-specific informed consent requirements mandate disclosures of information that go beyond what would be required by medical ethics and general medical informed consent laws and thus do not aid the informed consent process. (8) Despite these additional requirements for abortion informed consent, equal protection challenges brought by providers on the grounds that the abortion procedure is being treated unequally, as compared with other medical procedures, have generally been unsuccessful. (9) Further, under Casey, a state's regulation of the abortion informed consent procedure by requiring disclosures of certain information is permissible if the information is "truthful and not misleading." (10) However, these more detailed abortion informed consent statutes require providers to disclose information about risks of abortion that is inaccurate, incomplete, or irrelevant to the particular abortion procedure that the patient will undergo-for example, mandated disclosures that abortion will increase the woman's risk of depression and suicide, or disclosures about fetal anatomy and pain beyond the gestational stage of the woman's own pregnancy. (11)

These disclosures violate patient autonomy through what bioethicists Tom Beauchamp and James Childress call "informational manipulation." (12) Informational manipulation is a "deliberate act of managing information that nonpersuasively alters a person's understanding of a situation and motivates him or her to do what the agent of influence intends." (13) Beauchamp and Childress assert that "many forms of informational manipulation are incompatible with autonomous decisionmaking," listing as examples, "withholding information and misleading exaggeration with the intent to lead persons to believe what is false." (14) Thus, while supposedly required in order to ensure informed consent, many of the abortion disclosure requirements in fact block informed consent by preventing autonomous decision-making.

Perhaps the broadest development of codified guidelines and regulations to prevent such information manipulation of informed consent has occurred in the area of medical experimentation. The informed consent requirements for medical experimentation arose as a reaction to the abuses of the Nazi doctors who conducted medical experiments on concentration camp victims, as well as to abuses by public health officials and investigators in this country during the Tuskegee syphilis study, in which treatment was withheld from African American men with syphilis who were misled into believing they were in fact receiving treatment. (15) As Berg et al. characterize the development, "informed consent was seen as a protection from abuse by untrustworthy professionals." (16)

From the inception of medical ethics with the post-Nazi trial Nuremberg Code, the principles of informed consent have been reiterated in numerous federal statutes and regulations, as well as in international professional codes and human rights instruments. Broadly, they require an autonomous decision without coercion or manipulation. (17) To that end, they require disclosures of possible risks of the experiment. Indeed, consent in research Was originally premised on the "very notion that makes research distinct, namely the risk of the unknown." (18) These uncertainties include, for example, whether a particular treatment will be proven efficacious, whether the experiment will actually benefit science and society, and whether there may be unforeseen risks to the subject. Furthermore, the requirements seek to protect the individual's interests from the competing interests of the state, science, and society. (19)

The circumstances surrounding abortion are similar to those of medical experimentation. Abortion also includes uncertainties that go beyond the philosophical question of whether the fetus is a human being. Due to the challenge of finding proper control groups against which to compare abortion patients, there is a dearth of methodologically sound studies that confirm the actual risks of abortion. In addition, and equally important, is that both medical experimentation and abortion involve interests that compete against the patient's interests in autonomy, the self-determination of her well-being, and bodily integrity. In medical experimentation, there exist the interests of investigators in contributing to scientific knowledge, as well as the interests of the state and society in gaining not only new knowledge, but also new medical treatments. In abortion, as noted in Casey, the state has a competing interest in "protecting the life of the unborn." (20) Given abortion's similarities to medical experimentation, including the danger of informational manipulation, it follows that, as with medical experimentation, heightened protection of the abortion patient from the state's competing interests through and during the informed consent process is necessary.

Based on that premise, this Article argues that when viewed under the ethical and legal requirements for medical experimentation informed consent, the current abortion informed consent case law fails to adequately protect the patient seeking an abortion. Part I will provide an overview of the ethical and legal requirements for medical experimentation informed consent. Part II will discuss the development of the legal requirements for abortion informed consent in the United States and show how current abortion informed consent case law fails to meet the ethical standards of informed consent, based on the ethical requirements for medical experimentation informed consent. Finally, Part III will discuss how current state requirements for abortion informed consent violate ethical informed consent requirements due to the case law's failure to adequately protect the abortion patient from undue state interference.

1. Ethical and Legal Requirements for Informed Consent to Medical Experimentation

   1. Professional Ethical Codes

      1. The Nuremberg Code

         The Nuremberg Code (Nuremberg) is often considered the founding document of the development of international and national codes on the ethics of human experimentation. (21) Enumerated as part of the judgment against the Nazi doctors in 1947, (22) it was the first international code to establish ethical standards for human experimentation. (23) Nuremberg laid out ten principles, including that subjects give voluntary consent, that the experiment "yield fruitful results for the good of society, unprocurable by other methods," that the experiment "be so conducted as to avoid all unnecessary physical and mental suffering and injury," and that the "degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment." (24) These requirements were based on the ethical principle of the subject's autonomy and self-determination. (25)

         It is of little surprise, then, that the first and most detailed principle enumerated in Nuremberg is that of voluntary consent. Nuremberg defines "voluntary consent" as such:

         The voluntary consent of the human subject is absolutely essential. This means that the person involved should have the legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him...