Bioethics and Informed Consent in Human Subjects Research

Introduction to Research Ethics and Bioethics

One of the elements of research that has an impact on how research is conducted and how it is then applied is the ethics of the research design. Any research design is required to follow certain ethical requirements — notably those involving informed consent, but also others related to how participants are chosen, what they are told about the research, how the research is analyzed, how the findings are presented, and how those findings are used to implement action afterward. Certain types of research raise more ethical issues than others, and ethical concepts have been articulated more explicitly for some types of research than for others. How well these requirements are followed has a direct impact on public health, future research, legislation, and public welfare.

Bioethics has become a wide-ranging field because there is a need for an ethical framework governing experimentation on drugs and medical procedures using human beings. In addition, science can now accomplish things once left entirely to human biology, including procedures ranging from genetic manipulation to cloning. Every step forward raises concerns that the next step might go in the wrong direction, and bioethics is a method for deciding which steps to take and which to avoid.

Some believe there is a natural law that must be followed in making ethical decisions and that we must remain true to nature in that process. Others see a different imperative at work:

Natural Law vs. Global Morality in Bioethical Decision-Making

"There is nothing in terms of natural laws or patterns that we should emulate. Our morality is not concerned with obeying laws of nature. Instead it is concerned with facing facts as they relate to a larger plan or vision. Our limited biological morality — which may be partially encoded in genes — concerns rules and behavior relative to our immediate fellow humans" (Heinrich, 1994, p. 42).

What we need, says Heinrich, is a larger morality, one that is global rather than local:

"Our natural morality once sufficed to keep us moral. Now, however, when we drink a cup of coffee we are affecting rain forests in Colombia. . . Such linkage is a new fact of present reality, and the choices we need to make are not just 'natural' biological choices. They are moral ones" (Heinrich, 1994, p. 43).

However, even such a global morality does not answer all the questions raised by new developments in medicine and biology. More and more often, the issue is specifically whether the mere ability to do something means we should do it:

Perspectives on Scientific Objectivity and Ethical Frameworks

"At their best, these new technologies extend life. But often the quality of that life is questionable and the cost of treatment phenomenal, as in the case of a woman tethered to an artificial-nutrition IV in a Washington, D.C. hospital. The woman lingered through 38 years in a persistent vegetative state. At issue here is a conflict between medicine's duty to preserve life and its duty to preserve it without undue suffering" (Phalon, 1992, p. 134).

We may agree that the preservation of life is the highest good. At the same time, more and more people today are asking about the quality of that life as a determining factor, usually in relation to the degree to which the wishes of the individual should be considered.

Informed Consent: Requirements and Principles

The classical point of view is offered by researchers in "basic" natural science — meaning the study of nature without an immediate practical goal. These researchers tend to think of themselves as an autonomous intellectual community following agendas developed from the internal history of science itself, adhering to principles of pluralism, openness, and competition thought to assure "objectivity." On the other hand, the "radical science" movement argues that this vision of scientists as an autonomous group producing objective knowledge is illusory, and that this apparent autonomy derives from the congruence of scientists' career interests and the economic interests of dominant social sectors. The institutional frameworks of science — such as academia, engineering firms, and drug companies — involve class, race, and gender hierarchies, and only those near the top can even claim to function autonomously (Holtzman, 1986, p. 86). Developing any ethical structure may depend on where on the continuum between these two extremes one begins to analyze the issue.

The ethical guidelines for research — and especially for biomedical research — begin with the requirement for informed consent. This means that all participants must understand that they are being assigned to one treatment or method and that they are willing to participate. The choice must be explained to them and they must understand its implications — which, in a comparative treatment study, would include the possibility that one treatment may be more effective than the other. Participants must be informed about the purpose of the research, how long it will last, and the procedures to be followed. They must know that they have the right to decline participation and that they may withdraw once the research has begun if they believe doing so would benefit them. The possible consequences of being assigned to one group or another must also be explained.

Other ethical considerations must be followed as well: research should be conducted by qualified scientists only, plans must be in place to protect subjects from harm, and the experiment must be discontinued if it is shown to be harmful. Knowing when an experiment may be causing harm is itself a test of researcher competence, and this aspect should not receive any less attention than any other element of the research design. Federal regulations also govern this type of research and should be followed carefully; however, such regulations do not go as far as researchers themselves should go in protecting the rights and health of participants.