Biomedical Engineering Reference
In-Depth Information
2.8.2 Medical Research Combined with Professional Care
In the treatment of the sick person, the doctor must be free to use a new diagnostic and
therapeutic measure if in his or her judgment it offers hope of saving life, reestablishing
health, or alleviating suffering.
The potential benefits, hazards, and discomfort of a new method should be weighed
against the advantages of the best current diagnostic and therapeutic methods.
In any medical study, every patient—including those of a control group, if any— should
be assured of the best-proven diagnostic and therapeutic method.
The refusal of the patient to participate in a study must never interfere with the doctor-
patient relationship.
If the doctor considers it essential not to obtain informed consent, the specific reasons
for this proposal should be stated in the experimental protocol for transmission to the
independent committee.
The doctor can combine medical research with professional care, the objective being
the acquisition of new medical knowledge, only to the extent that medical research is
justified by its potential diagnostic or therapeutic value for the patient.
2.8.3 Nontherapeutic Biomedical Research Involving Human Subjects
In the purely scientific application of medical research carried out on a human being, it is
the duty of the doctor to remain the protector of the life and health of that person on
whom biomedical research is being carried out.
The subjects should be volunteers—that is, either healthy persons or patients for whom
the experimental design is not related to the patient's illness.
The investigator or the investigating team should discontinue the research if in his/her
or their judgment it may, if continued, be harmful to the individual.
In research on humans, the interest of science and society should never take precedence
over considerations related to the well-being of the subject.
These guidelines generally converge on six basic requirements for ethically sound
human experimentation. First, research on humans must be based upon prior laboratory
research and research on animals, as well as upon established scientific fact, so the point
under inquiry is well focused and has been advanced as far as possible by nonhuman
means. Second, research on humans should use tests and means of observation that are
reasonably believed to be able to provide the information being sought by the research.
Methods that are not suited for providing the knowledge sought are pointless and rob
the research of its scientific value. Third, research should be conducted only by persons
with the relevant scientific expertise. Fourth, all foreseeable risks and reasonably probable
benefits, to the subject of the investigation and to science, or more broadly to society, must
be carefully assessed, and the comparison of those projected risks and benefits must indi-
cate that the latter clearly outweighs the former. Moreover, the probable benefits must
not be obtainable through other less risky means. Fifth, participation in research should
be based on informed and voluntary consent. Sixth, participation by a subject in an experi-
ment should be halted immediately if the subject finds continued participation undesirable
or a prudent investigator has cause to believe that the experiment is likely to result in
