Unethical medical research projects are those in which the experiments performed are without the prior consent or knowledge of the subject. Medicine requires tests and experimentation and as such animals and humans have been used for experimentation and for study. However, testing of human subjects without their will or experimentation on human subjects against their wishes is considered unethical.
Many such projects have been uncovered in the past and some even continue to the present day. During the second world war, Nazi scientists performed horrendous experiments on human subjects and were brought to trial following the war. The Nuremberg trials resulted in the conviction and sentencing of the accused and as a result the Nuremberg code was established. The Nuremberg code is a set of rules that defines what constitutes an ethical medical research project and several countries, including the United States, have adopted the standards. Let us look at the Nuremberg code briefly which are summarized in ten points:
1. Consent of the human subject should be voluntary and informed. Voluntary consent is defined as the willingness of the subject without any means of force, coercion, fraud or deceit. Informed means advising the subject on any kind of hazards they may face or any inconvenience they might experience. Furthermore, any risk to the health of the subject should be disclosed and the subject should be well-informed about the nature of the project or experiment and what it constitutes.
2. The experiment should result in results that are fruitful and for the good of society as a whole. The results should not be obtained by any other methods or means of research. The nature of the experiment should be necessary and not random.
3. Experimentation of animals should precede the experiment, and results of animal experimentation should form the basis of the design of the experiment. The results of the experiment should justify the performance.
4. Any kind of physical or mental suffering to the subject should be avoided.
5. If there is reason to believe that the experiment will cause a disabling injury or death to the subject, the experiment should not be performed. The only exception to this is if the physician conducting the experiment is himself or herself the test subject.
6. The risk factor should never exceed the humanitarian importance of the problem.
7. Preparations and facilities should be adequate and proper so as to avoid even the remote possibility of harm, injury or death to the subject.
8. Only those who are scientifically qualified must perform the experiment. Further, it is required to maintain the highest degree of skill and utmost care should be taken throughout every stage of the experiment by the qualified.
9. If the subject decides to terminate the experiment at any point or stage due to physical or mental exhaustion or not being able to continue any further, then the experiment should be terminated.
10. The scientist in charge of the experiment should be prepared to terminate the experiment at any point or stage, using the highest degree of skill and utmost care to make a sound judgment, if he or she believes the experiment will cause harm, injury, disability or death to the subject.
This code lays the foundation and the groundwork for all medical research projects. Any violation of any of these principles is direct violation of medical ethics and the project is considered to be unethical. Further, the federal or national and state guidelines issued by the government concerning ethical medical research should be followed. Any violations of any of these rules constitutes an unethical medical research project.