Protestant perspectives on informed consent (particularly in research involving human participants).

• Author: Childress, James F.

INTRODUCTION

It is virtually impossible to state the Protestant position on any bioethical problem or issue. As a result, interpreters must focus on one Protestant position or, at most, identify a few Protestant positions with respect to a particular bioethical problem. Thus, in addressing my assigned topic, I will focus on selected Protestant perspectives on informed consent/refusal, particularly in the context of research involving human subjects or participants.

Several factors contribute to this limitation, not the least of which is that a couple of hundred denominations in the United States march under the banner of Protestantism. (1) Even if we start with the major Reformation traditions, we discover that the Lutheran and Calvinist (Reformed) traditions have splintered, (2) and that the so-called "radical" Reformation, or "left-wing" of the Reformation, encompasses numerous other groups, including the Anabaptists, a label that also covers different denominations. (3)

An attempt to discern a broad Protestant tradition, in contrast to traditions, would necessarily operate at a very high and largely uninformative level of generality. For example, Paul Tillich identified what he called "the Protestant principle," which represents "the divine and human protest against any absolute claim made for a relative reality, even if this claim is made by a Protestant church." (4) For Tillich, this principle is "the theological expression of the true relation between the unconditional and the conditioned or, religiously speaking, between God and man." (5) It is "the guardian against the attempts of the finite and conditioned to usurp the place of the unconditional in thinking and acting." (6) However important this principle is, it provides little guidance about Protestant beliefs and practices, including bioethics.

Yet another limitation is also worth noting. The assigned topic of informed consent, with particular attention to research involving human subjects or participants, has not received extensive treatment in Protestant denominational statements and guidance. To illustrate, I will draw examples from the valuable Park Ridge Center series on different religious traditions' beliefs and practices regarding health care.

The document on the Lutheran tradition notes that "consistent with their general respect for medicine and informed decision making, [Lutherans] are likely to favor self-determination and informed consent." (7) The document on the Presbyterian tradition (out of the Calvinist or Reformed tradition) notes that, because of the emphasis on freedom of conscience, Presbyterians would emphasize free exchange of information by patient and caregiver and would tend to err on the side of patient autonomy rather than caregiver paternalism. Turning to research involving human subjects, the document notes that the Presbyterian Church (U.S.A.) "generally supports self-determination and informed consent in medical procedures and experimentation. The General Assembly advocates that `human subjects be given the strongest human protections, including full information about the research, and that their consent be obtained without coercion.'" (8)

The Park Ridge Center report on Anabaptist beliefs and practices--including the Mennonites and Amish--notes that no official positions were found on therapeutic or nontherapeutic medical experimentation on various populations or on self-determination and informed consent, but, the report continues, the Anabaptist tradition's theological-ethical beliefs, such as God's creation of persons in his own image and noncoercion in religious matters, tend to support self-determination and informed consent in such settings. (9)

The report on the United Methodist tradition stresses that, for Methodists, personal autonomy and self-determination are highly valued because God has created human beings in his own image. (10) "The right of persons to accept or reject treatment is protected in a just society by norms and procedures that involve the patient as an active participant in medical decisions...." (11) Informed consent requires disclosure to the patient of all information that a reasonable person would find useful in similar circumstances. This information would include the proposed treatment's benefits, harms, and risks, as well as alternatives. This report notes that in medical experimentation and research, which are considered important, "it is imperative that governments and the medical profession enforce prevailing medical research requirements, standards, and controls in testing new technologies and drugs on human subjects. The standard requires that those engaged in research shall use human beings as research subjects only after obtaining full, rational, and uncoerced consent." (12)

These last comments suggest one explanation for the relative dearth of official Protestant statements on and guidance about our topic. There exists an affinity between several Protestant beliefs and practices on the one hand, and requirements of voluntary, informed consent (or refusal) in medicine, health care, and research involving human participants, on the other. Indeed, there is often a convergence or overlap of Protestant religious norms and secular standards of informed consent. This convergence or overlap may result, in part, from historical Protestant influences on social life, including medicine. Sociologists of religion and others have often noted the affinity between major beliefs and practices in Protestantism and individualism, (13) which, when fleshed out, can support voluntary informed consent. As I will stress later, some Protestant beliefs and practices that have supported individualism may have left deposits of norms of conduct that now function independently of their religious origins. Indeed, one interpretation of the process of secularization is that it institutionalizes, in the broader society, values that originated in particular religious traditions--for instance, Talcott Parsons argued that certain Christian values, such as equality, were embedded in the social fabric. (14)

As a result of this historical process, Protestant religious traditions may have little that is materially distinctive to contribute to discussions of voluntary, informed consent. The National Bioethics Advisory Commission ("NBAC"), on which I served from its beginning until its demise from passive euthanasia (non-renewal of its charter) in October 2001, invited scholars of and within particular religious traditions to present testimony on human reproductive cloning and on human embryonic stem cell research. There was great variety on these topics across and within different religious traditions. However, when it prepared its reports on research involving human subjects, NBAC did not specifically invite religious testimony--though, of course, all of NBAC's meetings were open, and anyone could present testimony during the public comment period, from any standpoint, religious or otherwise, and could submit written testimony any time. Nevertheless, I recall no specifically religious views presented to NBAC while it prepared its report and recommendations on Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. (15)

1. SELECTED PROTESTANT BELIEFS

   Which Protestant beliefs lend support to standards of self-determination (autonomy) and voluntary, informed consent/refusal in clinical care and research? Methodologically, Protestants have tended to downplay tradition in favor of direct appeals to scripture, and they have found in, or developed from, scripture several key themes. One major theme from scripture is God's sovereignty, which Protestants state in a variety of ways.

   A second broad theme that Protestants, especially Calvinists, emphasize is that of covenant as represented, for instance, in the sovereign God's covenant with humanity following the flood, with Israel, and in Christ. Sometimes covenant is used as a general category for various relationships with God as creator, provider or orderer, and redeemer, and with other creatures who also image God. (16) One of the most influential Protestant works in modern medical ethics, Paul Ramsey's The Patient as Person, which will receive more attention below, presents covenant faithfulness as the primary category for understanding medicine and its responsibilities in light of the Christian faith. (17) Human covenants, such as medicine, can mirror and reflect God's covenants, and such covenants share several features: they are rooted in events or actions; engender moral community; endure over time; and in contrast to contracts, cannot be completely specified. (18) Those covenants, as David Smith notes about Paul Ramsey's thought, follow a "principle of replication ... as God has committed himself to us, so ought we to commit ourselves to each other. The God-human relationship establishes a standard or norm for person-to-person relationships." (19)

   Third, God's covenantal action begins with his creation of human beings in his own image, and this conviction has profound implications throughout bioethics. According to the biblical account:

   Then God said, `Let us make man in our image, after our likeness; and let them have dominion....' So God created man in his own image, in the image of God he created him, male and female he created them. And God blessed them, and God said to them, `Be fruitful and multiply, and fill the earth and subdue it; and have dominion over ... every living thing that moves upon the earth.' (20) Interpretations of the image of God usually focus on what is distinctive about persons, particularly their use of reason, exercise of will, making decisions, and the like. Thus, the image of God has been viewed as a theological basis for respect for persons. However, it would be a mistake to construe the image of God as equivalent to autonomy in the modern liberal tradition. While respect for persons is...