Biomedical Engineering Reference
In-Depth Information
The design and performance of each experimental procedure involving human subjects
should be clearly formulated in an experimental protocol, which should be transmitted
to a specially appointed independent committee for consideration, comment, and
guidance.
Biomedical research involving human subjects should be conducted only by scientifically
qualified persons and under the supervision of a clinically competent medical person. The
responsibility for the human subject must always rest with a medically qualified person
and never rest on the subject of the research, even though the subject has given his or her
consent.
Biomedical research involving human subjects cannot legitimately be carried out unless
the importance of the objective is in proportion to the inherent risk to the subject.
Every biomedical research project involving human subjects should be preceded by
careful assessment of predictable risks in comparison with foreseeable benefits to the
subject or to others. Concern for the interests of the subject must always prevail over
the interests of science and society.
The right of the research subject to safeguard his or her integrity must always be
respected. Every precaution should be taken to respect the privacy of the subject and
to minimize the impact of the study on the subject's physical and mental integrity and
on the personality of the subject.
Doctors should abstain from engaging in research projects involving human subjects
unless they are satisfied that the hazards involved are believed to be predictable. Doctors
should cease any investigation if the hazards are found to outweigh the potential
benefits.
In publication of the results of his or her research, the doctor is obliged to preserve the
accuracy of the results. Reports of experimentation not in accordance with the principles
laid down in this Declaration should not be accepted for publication.
In any research on human beings, each potential subject must be adequately informed
of the aims, methods, anticipated benefits and potential hazards of the study and the
discomfort it may entail. He or she should be informed that he or she is at liberty to
abstain from participation in the study and that he or she is free to withdraw his or
her consent to participation at any time. The doctor should then obtain the subject's
freely-given informed consent, preferably in writing.
When obtaining informed consent for the research project, the doctor should be
particularly cautious if the subject is in a dependent relationship to him or her or
may consent under duress. In that case, the informed consent should be obtained by
a doctor who is not engaged in the investigation and who is completely independent
of this official relationship.
In the case of legal incompetence, informed consent should be obtained from the
legal guardian in accordance with national legislation. Where physical or mental
incapacity makes it impossible to obtain informed consent, or when the subject is
a minor, permission from the responsible relative replaces that of the subject in
accordance with national legislation.
The research protocol should always contain a statement of the ethical considerations
involved and should indicate that the principles enunciated in the present Declaration
are complied with.
