In this world scientists are conducting life sciences research to accelerate better healthcare outcomes. For that, both clinical and basic science researches are done for the development of new treatments. The development of new treatments is necessary for various disorders. To understand the normal psychological or pathophysiological disease processes researchers are using animals for experiments but ethical violations are being noticed. Therefore, in this paper all those ethical violation issues will be discussed that are surrounding the clinical and basic science research. In addition, it will present the importance and need for animal studies over clinical trials that involve humans for experiments.
While underlining the need for the development of new treatments and processes to prevent the possible occurrence of life-threatening episodes in physiological/pathophysiological processes, it is necessary to understand the research ethics. There are many scientists have done clinical researches in which humans were also involved. However, there are many laws that say that clinical research should be based on animal and laboratory experiments only. As pathologyis the field in which disease state is analyzed, and physiology is the process in which biological discipline is described. Therefore, in both further and new treatments are required and for that the best way is to do research from bench to bedside. To complete the clinical trials and proper research, it is necessary that following the research ethics should do experiments. There are specific laws and policies that are applied on researchers to stop using humans for the experimentsand use animals. According to Emanuel (2003) for the development of new treatments for humans the experiments can only be done on humans for the appropriate results. However, Waljee (2014) have presented the contradictory statement in which he mention that animals also have multiple mechanisms and cell types that can provide same results as clinical research on humans could have responded. Research ethics law were further modified considering this theory because of the increasing use of animals in research and types of animals for researches were also included in the research ethics (Waljee 89). Thus, animal studies become bench studies as compared to bedside studies that are clinical trials that involves humans for experiments.
Clinical Research Ethics
There are various events occurred in past that are known for their ethical violations in clinical research. It can be said that there are few major historical events that became a reason for human protection from experiments and promoted laws to be created for the clinical researches that include humans. The reason is that there were some ethical violations recorded. It is a fundamental tenet of ethical research that rights and welfare of the volunteer should be protected. Therefore, a great deal of progress was made some decades ago and those are related to testing of drugs on humans before marketing, testing of cigarette on human lungs and effects of diet-drug on humans and so on. Considering all these researches on humans, the Nuremberg Code was established in 1948. According to this code, participant consent over such researches is necessary, and the benefit of research must outweigh the risks. The other one is Thalidomide that was established in 1950 due to those babies who were born with severe deformities due to the use of those drugs that were not approved for use by the FDA.
Therefore, this act was about the testing of the drugs before marketing. Then, amendments were made in 1962 and Food, Drug and Cosmetic Act were launched. In between year1932 to 1972 some major points were covered in Tuskegee Syphilis Study regarding clinical researches and those were related to the research protocols, research with humans and informed consent. Furthermore, the policies were made in which it was mentioned that risks should not exceed the benefits for human research, and research must be conducted under the consideration of medically qualified individuals. Later in 1974, national research act was established on the basis of Tuskegee Syphilis Study that underlies to conduct the biomedical and behavioral research involving humans as major participants. Then, publication of FDA regulations in 1980, CIOMS Guidelines in 1982, publication of common rules 1991, advisory committee on human radiation experiments 1993-1994, HIPAA privacy rule1996 and in early 20’s OHRP and SACHRP acts were introduced. However, the FDA regulations 1980, advisory committee on human radiation experiments 1993-1994 and HIPAA privacy rule 1996 are those laws that are specifically designed to protect the clinical research participants. However, considering the violation of these rules informed consent rule was amended in which strictness was increased. Herein, it should be noted that the informed consent is the process to obtain before starting a clinical research project that each participant should be given the opportunity to choose what should or should not happen to theminvolving humans or else it will be the ethical violation. The essential components of informed consent depends on three elements information, comprehension and voluntariness.
Therefore, before the publication of any clinical research it is necessary that an oversight committee should approve it. The oversight committee is known as International Review Board IRB. All clinical human subject researchers must receive approval from the IRB. The purpose of this review board is to assure that appropriate steps must be taken to protect the human participants’ rights and welfare as in a research study (Emanuel 321).
Use of Animals in Research
Scientists are using animals for their researches to conduct experiments and research studies to improve human life. Animals are often used in psychological researches and mostly birds, rats, pigeons, and monkeys are used in conducting psychological researches. Considering the increasing use of animals ethical guidelines are defined and scientists are instructed to handle animals with care. However, there are ethical violations are reported several times. For example, the use of dogs for the mental health treatments and use of monkeys in drug trials and many other animals were used for drug testing that was not allowed to use for any researches. Therefore, the laws and regulations for animal welfare act further amended, and it only allowed animals such as rats, mice, and birds bred for research. There are animal testing regulations, and Laboratory Animal Welfare Act exists to protect the laboratory animals.
All institutions that use animals for their laboratory researches must require the approval from Institutional Animal Care and Use Committees (IACUCs). The reason is that IACUCs review research protocols and evaluate the animals care regulations are being followed or not. There are few federal organizations or agencies that are working to perform annual inspections of all facilities involved in animal research those are Public Health Service (PHS) and United States Department of Agriculture (USDA). There are other non-profit organizations as well that are working to oversee the university committee and annual inspections for animal research (Pankevich 16). It is the reason that researches cannot be done without having the approval from the agencies because the use of legal animals and approval are the first and main requirements.
There are many scientists and theorists who believe that animal research save lives of many humans. However, there are some misconceptions regarding the use of animals in research. For example, Gluck, DiPasquale and Orlans mentioned that cigarette or smoke trial on monkeys for its effects on lungs did not affect them as much as it affects human lungs. Similarly, dogs were used to complete the research on the human behavioral changes due to the extreme level of anxiety but the results for this were also different for humans (Gluck, DiPasquale and Orlans). Therefore, it can be said that it is not necessary that the use of animals in research can give accurate results and save lives. However, animal research has various benefits due to which researchers prefer to use animals in their researches.
Many animal rights activists have claimed that the use of a single animal for research more than one time or the degree of pain that sometimes inflicted without anesthetic is wrong and should be stopped. However, the fact is that animal-based research has contributed to a significant improvement in human lives. There are few specific cases in which the use of animal research proved as a vital component of medical progress. Those are cancer, heart stroke and diseases, diabetes, and hepatitis and many others. Therefore, it will not be incorrect to state that for the scientific discovery animal research has played a vital role (Gluck, DiPasquale and Orlans 74).
Concluding the information above, it can be said that animals and humans suffer from almost similar diseases and it is the reason that the use of animals in researches has given significant results. Considering the benefits of these clinical and animal researches there are some rules and regulations issued. Although violation of these rules and regulations is noticed, there are certain rules and amendments are made to promote these researches in a healthy and positive manner.
Works Cited
Emanuel, Ezekiel J. Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. New York: Johns Hopkins University Press, 2003. Print.
Gluck, John P., Tony DiPasquale and F. Barbara Orlans. Applied Ethics in Animal Research: Philosophy, Regulation, and Laboratory Applications. New Jersy: Purdue University Press, 2002. Print.
Pankevich, Diana E. International Animal Research Regulations: Impact on Neuroscience Research: Workshop Summary. New York: National Academies Press, 2012 . Print.
Waljee, Jennifer. Health Services Research and Evidence-Based Medicine in Hand Surgery, An Issue of Hand Clinics. New York: Elsevier Health Sciences, 2014. Print.
