Biomedical Engineering Reference
In-Depth Information
A
Bioethical
Legal
B
Bioethical
Legal
C
Bioethical
Legal
Figure 5.2 Ethical decisions differ from legal decisions. Legality can be a subset of bioethical decisions (A). An example is
a bioethical researcher's responsibility to abide by copyright and intellectual property laws. In addition, bioethics also includes
extralegal responsibilities, such as maintaining competence in the scientific discipline. Other situations may arise where a
certain amount of legal behavior is, in fact, unethical (B). An example is the paying of bribes or gratuities or conducting
research without appropriate informed consent of the subjects, which in certain cultures may be legal or even mandated by
regulations. On rare occasions, the laws may be completely unethical (C), such as slavery, mandatory abortions, or “ethnic
cleansing” (such as in the Darfur region of the Sudan). Many would argue, that embryonic stem cell and blastocyst research,
cloning, and animal experimentation also fall in this category. Ecoterrorists in a similar but distorted way attempt to rationalize
their extralegal activities, e.g., spiking trees to prevent logging activities or torching facilities that they consider ecologically
immoral.
of persons in experimentation. The resulting Nuremberg Code set standards for medical experimentation
on humans. The first rule of the code states that: “The voluntary consent of the human subject is
absolutely essential.” 4 Thus, bioethics requires that persons knowingly agree, that is, they give their
consent to participate based upon credible information. From Socrates on, ethical norms must always
consider antonomy. The Nuremberg Code's implied informed consent requirement was later formalized
by the World Medical Association in its Declaration of Helsinki, which reiterated the need for voluntary
consent, but added that participants must be fully and completely informed before deciding to participate. 5
In the United States, informed consent has been codified in the Code of Federal Regulations. 6 Integrity
in bioethics was further articulated in the 1979 release of The Belmont Report: Ethical Principles and
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