Healthcare Ethics for the Use of Informed Consents - Literature review Example

Development of new drug or study of a disease pathophysiology is a complicated process taking an extended period despite the significant understanding of the human body. Efficacy, safety, and affordability are the primary reasons for the prolonged time needed to assure of a safe drug for various diseases. Drug development goes through multiple phases of test and study before it is approved. In average the process of developing new therapies might take 10-14 years and cost about 500 million dollars. The drug discovery process goes through six phases before it is declared safe for human consumption.

The preclinical phase which involves the study of cells and animals is the first phase in drug development. The primary goal of this step is to gather more knowledge on the drug's mode of action, metabolic process, elimination and toxicity. According to Freeman & Dervan, (2011) the preclinical studies can take between 3.5 to 6.5 years. Once the drug developers are convinced that the drug is safe for human testing, they then apply with all the relevant information about the preclinical results to the food and drug administration to test it on human beings. Once the application is approved, then the drug goes through phase one to four. In step one a few healthy volunteers (20-80) are administered with the drug to determine if it is safe (Manager, 2014). Further, the developers identify the absorption and metabolism of the drug. The second phase involves a smaller number of the target patients to determine the efficacy of the medication, dosage, and mode of administration. The third stage includes a large group of patients more than 1000 people. In the phase, the researchers assess the risks of the drug, its effectiveness, and benefits. The drug developers request for approval by the FDA to market their drugs. All the preclinical a human tests results are presented to the agency to make a decision. Finally, through the help of sponsors, FDA monitors medications after they have been approved to ascertain their safety.

It was not until 1906 when regulations on the ethical use of human beings in research. During the time there were no consumer regulations no institution review boards, no standard rule nor the food and drug administration. As a result, many issues arose on the safety of the human participants prompting the federal government to establish institutional review bodies and federal rules and regulations to enhance ethical practices. Several ethical violation during the 20th century, led to the development of international laws. As Joel Sparks, (2002) reports, in the year 1946, the United States military tribunal investigated 23 Germany physicians on war crimes against humanity during the Second World War. The physicians carried out medical experiments on prisoners in concentration camps without their consent. Consequent to the trials, the prisoners died or were crippled permanently. To curb such occurrences, the Nuremberg code was established in 1948 requiring researchers to seek the consent of human participants. At the same time before consenting, the participants should be informed that the benefits outweigh the risks.

In the 1950s there was a widespread use of thalidomide among pregnant women to control nausea and sleep. The FDA did not approve the drug in the United States. However, it was an accepted sedative in Europe. Most patients in the United States did not know that the FDA did not approve the drug nor did they give their consent. Eventually, over 12000 babies were born with severe congenital disabilities because of thalidomide use. In the year 1962 following Senate hearing the "Kefauver amendments" were made to the food drug and cosmetic act to ensure safety and efficacy of drugs. The amendments required manufacturers to prove the safety and effectiveness of drugs to the FDA before marketing.

Between the year 1932 and 1972, the United States public health services conducted a study on low-income African American men on the effects of untreated syphilis in the famous Tuskegee syphilis study (David B. Resnik, n.d.-b). The department provided free medical examination to about 400 men suffering from syphilis for a 40 year period without treating their syphilis despite the availability of penicillin. As a result, most men died due to untreated syphilis. The practice became public in 1972 leading to the establishment of the national research act. The act outlined basic principles to be followed when carrying out behavioral and biomedical research in human beings.

Due to the rising number of the ethical issue, several regulations recommended for the use of informed consents. An informed consent refers to the process of acquiring permission from an individual before disclosing personal information, conducting a medical intervention, or enrolling a person in a clinical trial. The participants can choose on what should be done or not done to them. Informed consent is composed of three elements; information, whereby the person is explained to in details on what they are about to engage. Secondly, the person must be in sound mind to understand what they should experience in the study. Lastly, they have to accept to participate in a study voluntarily. An informed consent might be invalidated if the participant is a minor or insane. Further, it can be invalidated if the researcher did not disclose all the information on the impacts of the study on the participant.

The Institutional Review Board is mandated with the responsibility of reviewing methods of study in institutions to ensure that they era ethical (David B. Resnik, n.d.-a). Thousands of animals including dogs, rabbits, monkeys, and cats suffer in Laborites as they undergo painful trials. Animals have experienced many violations in the past with severe consequences. For instance, dogs were forced to take test substances for five consecutive days at the Charles River laboratories. As a result, they developed difficulty in breathing, elevated heart rate. Eventually, two dogs were euthanized, and one of them died. In another case in the year 2013, Harvard medical school was fined for violating animal rights. Some members of staff failed to check watering devices or forgot to put watering devices in the cage (Bob Grant, 2013). As a result, some of the monkeys had to be euthanized following severe dehydration. The university was fined 24,036 dollars.

Following the extensive violation of the animal’s rights in numerous occasions, the United States resulted in the development of laws to protect the animals. To date, there are two regulation: PHS policy and animal welfare act governing the use of animals in the United States. The animal welfare act covers animal research. The law enacted in 1966 regulates the use and care of animals in transport, exhibition, research, teaching, and testing. However, the law does not cover many animals like the mice, rats, and birds despite the fact that they form 90 percent of the animals in the laboratory. The act also excludes cold-blooded animals like amphibians, reptiles, and fish. It mostly covers dogs, non-human primates like monkeys and chimpanzees and cats. The laws outline the minimum handling, feeding, housing and veterinary care standards. For the chimpanzees, the bill also focuses on the psychological well-being.

The animal welfare act directs all the research institutions to establish and institutional animal care committee (IACUC) to ensure appropriate use of animals in their studies. The boards should: review the facilities used in the animal care, inspect the labs after every six months, approving and disapproving research protocols, reporting shortcomings in animal use and care. In the United States, the use of animals in a study has to be regulated and approved by the regulation committees for legalizations to ensure that the animal’s rights aren’t violated.

There are significant misconceptions concerning animals. The common one is the belief that there is no relevance in research on animals because they are different from people. To the contrary, all animals have a common ancestor and hey work similarly. They have similar internal organs which are controlled by the bloodstream and the central nervous system. The differences are minimal as compared to the similarities. Secondly, most people believe that the studies on animals are not necessary because they suffer from different diseases. Which is not true. In fact, most of the drugs used in the management of animal’s conditions are similar to those used in managing human beings.

Animals have been very beneficial in the medical industry. For instance, as Cox, (2010) reports, the pigeon was useful in understanding the malaria life cycle. Similarly, cats and dogs were essential in realizing the functions of the neurons.