Respect for Children as Research Subjects

Robert J. Levine

“So act as to treat humanity, whether in thine own person or in that of any other, in every case as an end withal, never as a means only.” The German philosopher Immanuel Kant, writing late in the eighteenth century, provided this formal statement of the ethical principle of respect for persons. Persons are to be regarded as ultimate values in and of themselves; they are not to be used merely as means to another’s goals.

Those who conduct research involving human subjects first define their goals and then identify persons whom they use as means to accomplish these goals. This is not unethical. What is proscribed is the use of persons merely as means— “as means only.” To avoid this, researchers are required both ethically and legally to secure the approval of persons to be used as research subjects through a process called informed consent. If this approval entails acceptance of the researcher’s goals, then the subject is not used merely as a means. Rather, the subject freely chooses to embrace the goals as his or her own and thus remains an end.

This chapter is concerned with informed consent and other issues related to the principle of respect for persons (e.g., privacy and confidentiality) as they relate to the involvement as research subjects of adolescents and children of various ages.

Ethical Principles

The basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1) as those that should underlie the conduct of research involving human subjects are “respect for persons,” “beneficence,” and “justice.” These principles were endorsed subsequently by the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (2) as “basic values” for medical practice as well as for biomedical and behavioral research, calling them by somewhat different names: “respect,” “well being,” and “equity.” According to these authoritative commissions, research involving human subjects should be conducted in accord with norms or rules designed to uphold and embody these basic principles or values. These rules are assembled in federal regulations for the “protection of human research subjects”; most relevant to the present concerns are those of the Department of Health and Human Services (Code of Federal Regulations, Title 45, Part 46; hereafter abbreviated as 45 CFR 46)¹ and the Food and Drug Administration (Code of Federal Regulations, Title 21, Parts 50 and 56; hereafter abbreviated as 21 CFR 50 and 21 CFR 56).

In this chapter there are frequent references to federal regulations. This is not intended to suggest that all ethical considerations are reflected adequately in the law. Rather, the regulations in this field generally represent a broad social consensus about what ought and ought not to be done. Even for research not covered by the regulations, they have come to be regarded as establishing a community standard, departures from which require justification (3). The regulations include both substantive and procedural rules (norms). A substantive rule specifies behaviors that are required (or forbidden) because they are morally right (or wrong). Some procedural rules specify procedures that should be performed to determine the most appropriate behavior when the behavior has not been specified by a substantive rule. Other procedural rules are designed either to assist in the adherence to the requirements of a substantive rule or to provide documentary evidence that
research has been conducted in accord with the relevant substantive rules (3).

An Illustration

The principle of respect for persons requires that human persons must be treated as autonomous agents. The substantive norm that requires informed consent is a specification of one way in which this principle is to be made operational in the conduct of research involving human subjects. The procedural norm that requires review and approval by an institutional review board affords a method for determining what specific bits of information must be divulged to prospective subjects in a particular research protocol. Another procedural norm that requires the signing of a consent form provides documentary evidence that the behavior required by the substantive norm has been accomplished. The form itself assists the investigator’s efforts to comply with the substantive rule.

According to the National Commission:

Respect for persons incorporates at least two basic ethical convictions: First, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy and thus in need of protection are entitled to such protections. An autonomous person is…an individual capable of deliberation about personal goals and of acting under the direction of such deliberation (1).

To show respect for autonomous persons requires that we leave them alone, even to the point of allowing them to choose activities that might be harmful (e.g., hang gliding), unless they agree or consent that we may do otherwise. We are not to touch them or encroach on their private spaces unless such touching or encroachment is in accord with their wishes. Our actions should be designed to affirm their authority and enhance their capacity to be self-determining; we are not to obstruct their actions unless they are clearly detrimental to others. We show disrespect for autonomous persons when we either repudiate their considered judgments or deny them the freedom to act on those judgments in the absence of compelling reasons to do so.

Clearly, not every human being is capable of self-determination. The capacity for self-determination matures during a person’s life; some lose this capacity partially or completely, owing to illness or mental disability or in situations that severely restrict liberty, such as prisons. Respect for the immature or incapacitated may require one to offer protection to them as they mature or while they are incapacitated.

Because the central focus of this chapter is on respect for persons, it is necessary to emphasize that the other two principles are of equal importance in the sense that they have equal moral force. Research involving human subjects can be considered ethically justified if, and only if, it is adequately responsive to each of the three basic ethical principles (3). As we shall see, considerations of justice and beneficence place constraints on, for example, whom we can ask to serve as research subjects and how much risk we may ask them to accept in the interests of research.

Informed Consent

Principle I of the Nuremberg Code (4) provides the definition of consent from which definitions supplied in all subsequent codes and regulations are derived:

The voluntary consent of the human subject is absolutely essential.

This means that the person involved should have 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 constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision [emphasis added].

Thus, consent is recognized as valid if it has each of these four essential attributes: It must be competent (legally), voluntary, informed, and comprehending (or understanding).

It is through informed consent that the investigator and subject enter into a relationship, defining mutual expectations and their limits. This relationship differs from ordinary commercial transactions in which each party is responsible for informing himself or herself of the terms and implications of any of their agreements. Professionals who intervene in the lives of others are held to higher standards. They are obligated to inform the layperson of the consequences of their mutual agreements.

It is worth noticing that the Nuremberg Code defines and requires “voluntary consent.” Since 1957 this term has been replaced by “informed consent,” a term that reflects an idealized vision of the person as a rational, self-determining agent (5).

Federal regulations identify “elements” of information that must be transmitted during the negotiations for informed consent (45 CFR 46.116a); these are:

A statement that the study involves research, an explanation of the purposes of the research, and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures that are experimental
A description of any reasonably foreseeable risks or discomforts to the subject
A description of any benefits to the subject or others that may reasonably be expected from the research
A disclosure of appropriate alternative procedures or courses of treatment, if any, which might be advantageous to the subject
A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they may consist of or where further information may be obtained
An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject
A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled