Science-based on medicine is dependent upon human experimentations. The scientists are able to conduct the tests using animals through vitro and biochemical experiments. However, without conducting human tests, it would be hard to establish if the result will improve the health of the patients. It will be hard to establish if the discoveries made will be useful when treating a certain disease. To determine if the medication is essential, human experiments have been conducted in medicine. Some of the tests done on human beings are illegal and unethical. There are laws meant to protect people from being forced into medical experiments.
The unethical human experimentations are mostly performed without the consent or knowledge of the test subjects. In some cases, however, the patients have given their authorization. Most of the experiments are risky and may result in death or related physical disabilities. It requires federal regulations for the institutions to conduct human experiments to make sure that ethics are used, and experiments which harm human beings are not conducted (Barber, 2018). If a hospital is responsible for causing harm to the study subjects, the programs are closed down and worse; they can face legal cases.
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One of the hospitals that fell for unethical human experimentation is Johns Hopkins University’s human medical-research program. It was shut down after a healthy woman died during an asthma study. There are federal departments such as the Department of Health and Human Services, National Science Foundation, Central Intelligence Agency and others are meant to protect human beings from being used as subjects of study. These federal departments adopted a federal policy in 1991 so that they could protect individuals who were subjected to science research (Slate, 2001). A group such as the Food and Drug Administration is guided by its own policy on human subjects’ protection. A human subject is defined as a living person who is used as research by a professional. Data is gained through interaction or intervention with the human subject or through identifiable private information. Some of the surveys and researches are however exempted from federal regulations.
The Institutional Review Boards are involved in overseeing human research as they act as the local review panels. The Institutional Review Boards can be able to provide approval, modification or rejecting of research which is within their jurisdiction. Since Johns Hopkins Hospital is very large, it has several Institutional Review Boards which are in charge of all the science-medicine studies. The members of the Institutional Review Boards are from different fields such as education, law, science, home keeping, and clergy. The members are supposed to make sure that the board is competent in ensuring that ethics are held in the hospital. However, in case of conflicts of interests, the members are expected to vote to ensure that a fair decision is made. Strict documentation is required concerning the Institutional Review Boards for the studies concerning human beings. The health institutions which have plans of carrying out human researches are required to submit a written Assurance. At Johns Hopkins, they had an agreement known as Multiple Project Assurance. The institutions which receive federal funding for human-based research are given for five years.
The Assurance provided by institutions is required to have a statement of principles. Most of the Assurances in America cite the Belmont Report. It is a study that was conducted by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1978. There are three ethical principles found in the report concern using humans as research subjects. The principles are justice, respect, and beneficence. To show respect, an institution is first required to acquire the consent of the human subject and educating them of the possible respects so that they can agree on their own free will to participate in the study. Justice requires fairness and being equitable when selecting the subjects of the study. In most cases, the poor or disadvantaged may be chosen which is unfair since their lives are also essential. Beneficence requires carrying out a risk/benefit analysis to establish if it is worth conducting the tests on the subject or not.
According to the Belmont Report, any inhumane or brutal treatment of the subjects is never justified. Any investigation should be done by medical professionals who are qualified, and the appropriate designs should be used (World Medical Association, 2002). The subjects are allowed to withdraw at any time they feel uncomfortable.
After an investigation on the reasons Johns Hopkins failed in the research, it was established that the risks to the subjects were not minimized. The medical professionals involved in the study had failed to examine the existing studies on the dangers of asthma drugs. The institution had also changed the research designs, and they did not receive approval from the Institutional Review Boards. The Department of Health and Human Survive has provided various regulations that should be used during human experimentations. 45 CFR part 46 established the regulations which institutions should use in protecting the human subjects. The Health Insurance Portability and Accountability Act (HIPAA) regulations found on 45 CFR parts 160 and 164 of HHS indicating about keeping the information of the study subjects privacy (McNeill, 1993). The FDA also has regulation in protecting the human subjects and concerning the reviews that should be carried out. The regulations are supposed to guide the studies to avoid causing any harm to the participants. There are some studies which are known to have resulted in harm not only to the subjects but also related people. The Tuskegee syphilis study, for example, which was carried out by the Public Health Service (PHS) from 1932 to 1972 caused harm to the subjects. The correct measures were not taken when dealing with the untreated black men who had syphilis. When the programs that were assisting eradication of syphilis were introduced, PHS refused the participants to get medical help (Gorski, 2011). As the study ended in 1972, twenty-eight of the 399 men who took part in the research died of syphilis, and one hundred more died due to related complications, forty wives of the participants were infected, and there were nineteen children who were born with congenital syphilis.
In conclusion, science-medicine can be proven if it is successful through the human subjects’ only it all the indicated procedures are followed. An institution should ensure that only the competent and skilled professionals are used for the study. The human participants should also give their consent, and if they want to withdraw, they should be allowed. There are federal regulations that should be followed to ensure the safety of the human subjects and success of the studies.
References
Barber, B. (2018). Research on human subjects: Problems of social control in medical experimentation. Routledge.
Gorski, D. (2011, March 13). Ethics in human experimentation in science-based medicine. Retrieved November 19, 2018, from https://sciencebasedmedicine.org/ethics-in-human-experimentation-in-science-based-medicine/
McNeill, P. M. (1993). The ethics and politics of human experimentation. CUP Archive.
Slate. (2001, July 24). What Are the Rules for Experimenting on Humans? Retrieved November 19, 2018, from https://slate.com/news-and-politics/2001/07/what-are-the-rules-for-experimenting-on-humans.html
World Medical Association. (2002). World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Nursing Ethics, 9(1), 105.
