Term Paper on "Bioethical Research"

Term Paper 5 pages (1693 words) Sources: 5 Style: APA

[EXCERPT] . . . .

Bioethical Research

One of the elements of research that has an impact on how the 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 others related to how people are chosen, what they are told of the research, how the research is analyzed, how the findings are presented, and how any findings are used to implement action after that. Certain types of research raise more ethical issues than others, and ethical concepts have been set forth more directly for some types of research than for others. How well these requirements are followed has an 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 for experimentation on drugs and medical procedures using human beings. In addition, science can now do things which were once left only to human biology, including procedures 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 step to take and which step to avoid.

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

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
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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, and more and more often, the issue is specifically whether because we can do something means we should:

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 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 related to the degree to which the wishes of the individual in the matter should be considered.

The classical point-of-view is offered by researchers in "basic" natural science, meaning the study of nature without an immediate practical goal, and they like to think of themselves as an autonomous intellectual community following agendas developed by the internal history of science itself and adhering to principles of pluralism, openness, and competition thought to assure "objectivity." On the other hand, the "radical science" movement emphasizes this vision of scientists as an autonomous group producing objective "knowledge" is illusory and that this apparent autonomy derives from the congruence of the career interests of scientists 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 this type of research, begin with the requirement for informed consent. This means that all of the participants have to understand that they are being diverted to one or the other of these methods of treatment and that they are willing to do so. This means that the choice has been explained to them and that they understand the implications, which in this case would be that one treatment may be more effective than the other. This means that participants must be informed about the purpose of the research, how long it is to last, and the procedures to be followed. They have to know that they have the right to decline to participate and that they may indeed withdraw once the research begins if they feel that this would benefit them. The possible consequences of being in one group or the other need to be explained, which in this case means explaining the hypothesis that one of these methods is more effective than the other.

Other ethical considerations must be followed as well, such as that the research should be conducted by qualified scientists only, that plans are in place to protect the subjects from harm, that the experiment will be discontinued if it is shown to be harmful, and so on. Knowing when an experiment may be causing harm is itself a test of the competence of the researchers, and this aspect should not be given less importance than any other aspect of the research design. Federal regulations also cover this type of research and should be followed carefully, but such regulations do not go as far as the researcher should to protect the rights and health of the participants.

In recent years there has been increasing concern in the literature regarding the protection of the rights and welfare of human subjects in biomedical, behavioral, and social science research. The initial concern seems to have developed with reference to biomedical research, perhaps because potential damage to the subjects is more clear-cut. The issue was raised after World War II at the Nuremberg trials because of Nazi experimentation on human subjects. The Hippocratic Oath requires first that physicians do no harm, but there is ample evidence that medical doctors have carried out risky and at times fatal research on human subjects without their consent or even their awareness in settings more normal than the Nazi concentration camps (Katz, 1972, pp. 281-291). It was outrage at the Nazi experiments, however, experiments performed on defenseless political and war prisoners, that led to the Nuremberg trials and that made explicit for the first time in the Nuremberg Code the ethical principles for biomedical research on human beings. This code also formed the basis for the Declaration of Helsinki adopted by the World Medical Association in 1964 and the "Ethical Guidelines for Clinical Investigation" adopted by the American Medical Association in 1966 (Bower & de Gasparis 1978, p. 3).

The research professions have made a particular point of requiring informed consent after these early lapses, aided by the Health, Education, and Welfare Grants Administrative Manual after 1971, providing specific and detailed requirements for informed consent. The guidelines further require all procedures to be documented fully with three forms of documentation, two of which require the signature of the subject or the subject's authorized representative, with the third allowing for modification of the two "primary procedures" with the warning that this imposes additional responsibilities on the review committee and the institution to demonstrate that the risk to any subject is minimal (Bower & de Gasparis, 1978, pp. 5-6). For… READ MORE

Quoted Instructions for "Bioethical Research" Assignment:

Presentation of issues and evidence stemming from ethical research designs and bioethics. *****

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