Clinical Research Ethics Between 1932 and 1972, a clinical trial sponsored by the U. S. Department of Health, welcomed 400 African Americans to join a trial. The perception of trial was very different from the participants and the researchers (sponsors). Participants thought they were getting treatment for “bad blood”, which means a minor illness. In exchange for participation, the participants received free medical exams, meals and burial insurance. Participants were not informed it was an experiment. The true purpose of the experiment was to study the effects of untreated syphilis among the 400 African American participants.
Throughout the study, researchers refrained from treatment. Though they know penicillin was widely available, which could cure syphilis in the early stages. The experiment continued for 40 years, within the 40 years they continued to withhold treatment. The results killed many of the participants, 28 men died directly of syphilis, 100 men died of related complications, 40 of their wives had been infected and 19 of their children had been born with congenital syphilis (U. S. Public Health Service Syphilis Study at Tuskegee, 2016).
As years passed and lives were lost, conflicts and questioning arose. The clinical trial was called The Tuskegee Syphilis Study. The Tuskegee Syphilis Study shows the importance of informing participants about the purpose of a study. Although the participants freely agreed to testing, they were not informed it was a study. The code of ethics and Belmont principles states the importance of the safety of a participant. The researchers who were authorities in the Tuskegee Syphilis Study violated the The Declaration of Helsinki as well as the Belmont Report that were both later ritten.
Another experiment that demonstrates the violation of the The Declaration of Helsinki and Belmont principles, The hepatitis experiment at Willowbrook state school. Lead researchers Saul Krugman and Joan Giles conducted a hepatitis experiment on mentally disabled children at The Willowbrook State School. (CITE). The experiment took place in 1956 and ended in 1980 with settlements. In the experiment, researchers purposely infected subjects with the disease and observed its natural progression. The experiments were approved by the New York Department of Health.
Due to the mishaps and unfortunate tragedies due to human experimentation, laws and policies were created. Example of two, the Declaration of Helsinki and Belmont Principle. The declaration of Helsinki was initially created in 1964 in Helskini, Finland. The declaration includes a set of ethical principles toward human experimentation. The set of ethical principles were developed for the medical community by the World Medical Association (WMA). \Since created, the declaration has gone through seven revisions and clarifications.
The declaration is seen and regarded as the keystone document on human research ethics. Next, the Belmont Principle, the principles were created through a process. Due to the results of the Tuskegee syphilis study, the national research act was passed in 1974. The national research act created the national commission for the protection of human subjects of biomedical and behavioral research. (CITE POWERPOINT). The purpose of the commission charge was to recognize the basic ethical principles that should be a followed when conducting biomedical and behavioral research that involves human volunteers.
When researchers conduct a trial they must be in conformity with principles. Thus the commission created the Belmont Principles. It is a guideline to resolve possible ethical problems that could arise among research with human participants. There are three core principles, respect for persons, beneficence, and justice. The two experiments above share a common similarity, researches violated the Declaration of Helsinki and the Belmont Report principles. Researchers who conducted the experiments did not share full information of studies they were conducting.
Researchers used their authority to keep information from participants. Participants were unaware of what was really happening as trials were being conducted. It is ethical for participants to know the purpose and the actions of researchers. The actions of researchers were only to benefit themselves, which violates beneficence according to the Belmont principles. Researchers compromised their research for the lives of the participants. Many participants suffered greatly, a number of participants even died. The safety of a participants should mean more than a break through for researchers.
They failed to recognize the safety issue and respect for persons. However, today as laws and policies are being reevaluated, such unacceptable behaviors from researchers are slowly decreasing. Before a clinical trial it is important participants are informed about the research they are partaking in (What is informed consent? ) Through the informed consent process, the purpose of the research is explained to the potential participants. If they are willing and understand the purpose of the clinical trial, they need to provide their voluntary consent.
It is important to obtain prior to starting a clinical research project involving humans because, if a participant does not agree or feel comfortable with certain steps throughout the study, they can decide and remove themselves from the study. It is also important for the researchers to have proof of voluntary consent. If they do not, issues arise. For example, if they do not get consent and further a potential harmful study. They are violating all ethics and principles created to protect human subjects. Informed consent is viewed a corner stone of clinical research to protect human subjects.
Although, informed consent can be invalid when a potential participant does not have the capacity to make a decision. The name of the committee that approves and oversees research involving humans at universities is the Institutional Review Board (IRB). The purpose of the IRB is to review all proposed research that includes human subjects, human subjects must be treated ethically and their rights and welfare are rightfully protected (What is informed consent? ) Use of Animals in Research Examples of ethical violations involving use of animals, immobilizing using restraints devices and burning.
It is important that animal subjects are not harmed or in any discomfort. There are some individuals who believe that animals should not be used for medical research. In history, the attempt to bring back dead animals, decapitating animal body parts, placing two heads on an animals etc, have lead to the questions of what is really ethical among animal research? History has shown ethical violations from researchers in the past, mainly in early and mid 1900s. The outcome of violations produced laws and principles to protect animal subjects, for example the Public Health Services Policy (PHS) on Humane Care and use of laboratory animals.
In order for researchers to gain government funding for their research, vertebrate animals be included in their study. Also, they must follow the PHS policy. The policy depends upon all-inclusive animal care and welfare program that abides by the Guide for Care and Use of Laboratory Animals (Guiding Ethical Principles) The policy is implemented among rats, mice, bird and cold blooded vertebrate like fish and reptiles. If an institution does not grant exceptional care their animals, funding will discontinue.
A handbook called Guide for the Care and Use of Laboratory Animals presents advice on how to care for research animals. Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC), International which was founded by veterinarians and scientist who had the desire to provide affirmation that laboratory animal research was controlled professionally and humanely (Guiding Ethical Principles). The committee that is responsible for the approval and oversight of research involving any animal at universities is called the Institutional Animal Care and Use of
Committee (IACUC). Both are in accordance with all government regulations, including the Animal Welfare Fact and the Public Health Service Policy on Humane Care and Use of Laboratory Animals (Why do some people say animal research is wrong? ) Lastly, the Animal Welfare Act (AWA) controls the care of warmblooded vertebrates which includes guinea pigs, hamsters, rabbits and non human primates (Why do some people say animal research is wrong? ) Institutions that reserve the list of animals for research must adhere by the AWA regulations.
They must arrange them exceptional food, shelter and veterinarian care. The U. S Department of Agriculture enforces the AWA through regular inspections of research labs and animal suppliers (Why do some people say animal research is wrong? ). Some misconception’s regarding the use of animals in research are that animals are constantly harmed. However, research’s have the duty and obligation to minimize the suffering of animals in their institutions.
Through laws and observations, researchers have the duty to treat animals humanely (Why do some people say animal research is wrong? Due to the continuous regulated research involving animals, a tremendous amount of lives and improved the quality of life for many people and animals. It is important for researchers to study animals, they are able to learn more about how living organisms work and how certain disease affect the human body. The biological processes are alike in humans and in animals, in certain ways. Researcher study simple organisms that help them understand why animals are prone to diseases like human diseases. Due to the similarities, researchers can study the roots of cause, prevention and treatment.
Two examples of animal discoveries among animal rodents, first a controlled spinal cord contusion for the rhesus macaque monkey. The study was a controlled spinal confusion model that produces severity dependent functional and historical deflects in non human primates. . (Ma et al, 2016) The use of human primates in the study are reliable large animal models. The development of a clinically relevant contusive Spinal Cord Injury (SCI) model that produces severity dependent anatomical functions deflect in non human primate.
A model like the controlled spinal confusions, has the potential to advance the translation of novel SCI repair strategies to the clinic. Next, the discovery of sarolaner. In study included Isxozoline ectoparasitcide and sarolaner. Both were identified during a lead optimization program, as an orally active compound with efficacy against fleas and ticks on dogs. As a results for the exploratory investigations, saraonlara was progressed for development as an oral monthly dose for treatment and control of fleas and ticks on dogs (McTier et al, 2016)