Research on Human and Animal Health

 

Physicians and scientists make use of medical research results in their clinical practice. To maintain their competence, physicians mustkeep up with the current research in their area of practice through Continuing Medical Education. The most common method of research for practicing physicians is the clinical trial. Ahead of a new drug approval by government mandated regulatory authorities, it must undergo extensive testing for safety and efficacy. The process starts with laboratory studies preceded by testing on animals. Before development of a new drug experiments are done on animals to test the safety of the other product. Many of these trials cause pain to animals and might reduce the quality of line in other ways to the animal involved. Two positions on animal experiments are clearly stated; experiment on animals is acceptable if(and only) suffering is minimized in all experiments, human benefits are gained which could not be obtained by using other methods. If the drug passes the animal test it is then tested on a small group of patients before large scale clinical trials

The following phase are undergone before the drug is allowed to be administered to patients: Phase one, research is usually conducted on a relatively small number of healthy volunteers, who are often paid for their participation, to determine what dosage of the drug is needed to produce a response in the human body, how the body responds to the drug, and whether the drug produces toxic or harmful effects. Phasetwo, research is conducted on a group of patients who have the disease that the drug is intended to treat. Its goals are to determine if the drug has any beneficial effect on thedisease and if has any harmful side effects.

, Phase three research is the clinical trial, in which the drug is administered to a large number of patients and compared to another drug, if there is one for the condition in question, and/or to a placebo. Where possible, such trials are ‘double-blinded’, i.e., neither research subjects nor their physicians know who is receiving which drug or placebo. Phase four researches takes place after the drug is licensed and marketed. For the first few years, a new drug is monitored for side effects that did not show up in the earlier phases. Additionally, the pharmaceutical company is usually interested in how well the drug is being received by physicians who prescribe it and patients who take it.

According to (Ogungbure, 2011)There are established ethical principles to protect human participants in biomedical research from undue exploitation by researchers. However, in the 19th and 20th centuries many prominent medical researchers conducted experiments on patients without their consent and with little if any concern for the patients’ well-being.Although there were some statements of research ethics dating from the early 20th century, they did not prevent physicians inNazi Germany and elsewhere from performing research on subjects that clearly violated fundamental human rights.

After the Nuremberg war crimes, legal representatives soughtto expose the full extent of the systematic acts of cruelty, brutality, torture,enslavement,starvation and mass murder perpetrated by the members and associates of the Nazi regime. The evidence produced by the legal representatives led to a separate trial in 1944 with 23 leading scientists and physicians being charged with war crimes. It was suggested by some of the accused that the warrant of the experimentation was the pursuit of scientific knowledge, advancement of medical practice which would assist  in understanding and helping in the development of standardized procedures and cures. Other organization which emerged after 2nd world war which hadinternational influence and published substantial material on the appropriate treatment of humans are the united nations organizationcharter, which was formerly signed by 50 nations in 1945; the universal declaration of human rights approved by UN assembly in 1948.; the council of Europe founded in 149 under London treaty which published the convention for human rights and fundamental freedoms.The World Medical Association was established in 1947, the same year that the Nuremberg Code was set forth.

Conscious of the violations of medical ethics before and during 2nd World War, the founders of the WMA immediately took steps to ensure that physicians would at least be aware of their ethical obligations. In 1954, after several years of study, the WMA adopted a set of Principles for Those in Research and Experimentation.The basis of the above judgmentis known as the Nuremberg Code, which has served as one of the Nuremberg code is a set of research ethics principles for human experimentation set as a result of subsequent Nuremberg trials at the end of the second world war while Belmont report addresses the ethical principles and guidelines to be followed on research involving human objects; respect for human beings, beneficence and justice, whose major areas of application werestated and include; informed decision, assessment of risks , benefits and selection of subjects.

The above principles were violated by researchers in the Tuskegee syphilis study done from 1932 to 1972 Tuskegee, Alabama, as the participants were not given clear information about  their condition, about the treatment  they were receiving and were treated based on the race, gender and economic class.The men that were used in the research, most of them uneducated sharecroppers were left untreated with syphilis, and suffered tremendously in the hands ofmedical practitioners from the US Public Health Service. As (Vonderlehr) observe, “SuchIndividualsappeared to provide strange opportunity to examine the untreated syphilitic patientsfrom the onset of the disease to the death of the affected person”. The researchers alsosought to compare the syphilitic process uninfluenced by modern treatment with the resultsobtained when treatment had been given. In response to public outcry following an expose on the US public health service syphilis study at Tuskegee, 93rdUnited States congress enacted the national research act in 1974.which created the first national bioethics  commission , the national commission for human subjects of biomedical and behavioral research which was charged with identifying ‘the ethical principles which guidedthe conduct of biomedical and behavioral researcher with human subjects and developing guidelines to be followed in during research conduct. Members of the commission held a closed meeting at Belmont conference center, Feb 13-16, 1976.with the help of advisors and collection of scholarly essays on the role of and nature of moral principles for research, the commission came up with the report known as Belmont report.

 

 

 

 

 

 

 

 

References

Ogungbure, A. A. (2011, December). The Tuskegee syphilis Study: Some Ethical Reflection. A journal of Philosophical Asssociation Of Kenya(PAK), Vol 3, pp 75-92.

Vonderlehr, R. (n.d.). Untreated syphilis in the Male Negro (Vol. No.189).