PT Classroom - A Review of the Ethical Issues in Human Experimentation  ׀ by Puja Panjwani, PT

 

The APTA Vision Statement for Physical Therapy 2020 contains an element which suggests the application and integration of evidence to guide clinical decision making to provide the best practice for the patient/client. In order to obtain this evidence it will be essential to continue to conduct and evolve research but in an ethical manner. In this article I will review the ethical issues in human experimentation.

 

Scientific research requires studies on human subjects or on fluids drawn from human subjects. New drugs or technologies are normally tested on animals first & as the research progresses, products are tested on humans before they could be used by physicians in clinical practice. Since the tests/drugs could cause harm to humans, experimentation on humans poses to be an ethical concern. Another ethical concern in research/experimentation is what it does to the people or subjects of testing. This includes embryos & fetuses which are part of studies & what happens of them is an ethical concern since embryos & fetuses are human life & harming it without sufficient reason is not moral. According to Ethical & Religious Directives (1), “No one should be the subject of medical or genetic experimentation even if it is therapeutic, unless the person or surrogate first has given free and informed consent. In instances of non-therapeutic experimentation, the surrogate can give this consent only if the experiment entails no significant risk to the person’s well-being. Moreover, the greater the person’s incompetence and vulnerability, the greater the reasons must be to perform any medical experimentation, especially non-therapeutic.”

History shows that subjects used for human experimentation were mostly disenfranchised like orphans, mentally retarded, prisoners & charity patients (5). Even the most defenseless are not safe from those researchers who possess no heart. The mentally retarded are easy targets for human experimentation. However it sometimes gets difficult to get human subjects for experimentation especially for those involving high risk or pain. In 1930s researchers found a solution to the shortage of human subjects for experimentation - don’t ask for consent (6).


The recent moral awareness about medical research & laws regulating them has developed as a reaction to ill treatments of human beings in research in the past. History of medical research or experimentation throws light on how it became unethical when desire to achieve medical & scientific progress overshadowed moral sensitivity to the well being of patients involved (1). A look at well known abuses in research is important in understanding the current concerns in ethics in medical research. The Tuskegee Syphilis Study, Cruel Nazi experimentations in German Camps, and the Willowbrook School Hepatitis study are just some examples of atrocities done on humans in experimentation with no regards to morality or ethical consideration.

 

As a result of the international outrage over Nazi Medical experimentation, judges at Nuremburg set forth Principles for Medical Research, the first 10 of its principles are known as the Nuremburg Code (4). This Code was published by the U.S. Government Printing Office in 1949. United States medical researches were to abide by the Code from then onwards but unfortunately sometimes they did not (7).


There was a growing sense of discomfort about this & many other studies which was instrumental in developing standards of research & human experimentation. Henry Beecher, a professor of anesthesia at Harvard Medical School published an article in The New England Journal of Medicine identifying 22 research projects where researchers failed to provide adequate information to their subjects or were successful in obtaining voluntary consent. These studies were funded by various governmental agencies & pharmaceutical companies. Reports of the studies were cited in journals like Journal of American Medical Association, The New England Journal of Medicine, and Journal of Clinical Investigation & Circulation. Beecher also identified many other studies with questionable ethical values. His work made an immediate impact .The government set forth rules & regulations raising the moral values of human experimentation. Later Pappworth & Jay Kartz presented many papers revealing the unethical conduct of experimenter/researchers.

Early Federal Initiatives to regulate guidelines on human experimentation are tracked to the time even before Beecher. In 1966, the Surgeon General issued the STATEMENT OF POLICY on clinical investigations using human subjects requiring approval of research funded by the public Health Services. After Beecher's article was published, the Dept. of Health & Education & Welfare issued the Institutional Guide to DHEW Policy on Protection of Human Subjects (1971) (7)- this emphasized informed consent & institutional review. By now, these committees reviewing research proposals were called Institutional Review Boards.-IRB.

The U.S. Congress passed the National Commission for protection of human subjects of Biomedical & Behavioral Research which was instrumental in developing medical ethics during that decade. The National Commission also adopted the principles of ethics advocated by William Frankena- first being Justice -understood as equality & obligation to treat everyone equally & fairly. The second being beneficence - understood as general good-doing greatest good for greatest number. Autonomy i.e. respect to ability of patient to decide for himself was the other principle. This model of ethics is used to analyze if a moral agent behaves morally well. The second report of the National Commission was the IRB. The IRB's main function is to protect the needs of human subjects in human experimentation.

Along with these directives there were other documents prepared to govern the rights of human experimentation including The Helsinki Declaration and the Belmont Report.

Science has made many fascinating advances. This has all been possible with numerous trials & experimentations. Human experimentation is an essential step to test effectiveness of a chemical or technique to help develop effective treatments for individuals. I believe that experimentation can be done on willing human subjects but with strict rules to ensure just treatment & respect to all human life. Following are a few regulations that may serve as a guideline to guarantee the above:
- There is a possible harm to subjects of human experimentation & we should keep in mind that everyone should be humane in dealing with them.
- Experimenters & physicians should not be tempted to feed their curiosity at the cost of harming someone else. They should follow the code of human experimentation appropriately. They should inform an individual completely about the trial with its consequences. They should take full responsibility to treat them in case of infection or disease.
- Subjects should be allowed to retract at any time they want & be honored the usual treatment option if they want to leave the study at any time.
- An Institution Review Board (in accordance to FDA regulation) should oversee the proceedings of human experimentation to ensure subjects are treated ethically & morally & the experiment is conducted in an ethical manner. An IRB is a board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct continuing review of biomedical research involving human subjects in accordance with FDA regulation.


Ethical issues arise from emergence of new technologies that can be harnessed. It’s true that no amount of experimentation on animals in labs can be completely reliable in predicting outcome of disease or intervention on humans. Doctors have recognized the importance of human experimentation since the days of Hippocrates, though the ancient Greeks used it to benefit individual patients rather than science itself or any profit-driven industry. There is temptation for experimentation to go too far often jeopardizing the quality of human life involved. Curiosity is a powerful human motivation which can lead well-meaning people to actions that are harmful, and even fatal, as a look at the most extreme cases clearly shows (2).The growth of technology only makes vigilance more necessary. As science is growing it is getting more & more difficult to keep a control over it. Scientists have to learn to restrain & inhibit their pulse of curiosity that could cause potential harm to innocent human subjects. Study of ethics in human experimentation helps to understand where a draw a line when it comes to dealing with humans.

References
1) http://www.ascensionhealth.org/ethics/public/issues/human_experiment.asp
2) http://www.pcrm.org/resch/humres/humanexperiments.html
3) http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1816110
4) http://www.rbs2.com/humres.htm
5) http://www.associatedcontent.com/article/203447/when_is_human_experimentation
6) http://www.naturalnews.com/019193.html
7) Practical Decision Making in Health Care Ethics: Cases and Concepts Feb 2000 - Raymond J. Devettere

 

Last revised: July 10, 2009
by Puja Panjwani, PT


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