The Ethics Of The Pediatric Clinical Trial Of Very Early Antiretroviral ( Vet ) For Hiv Children

The justification is weak at best, Angell says, with researchers claiming that the placebo-group would not be receiving the necessary treatment anyway, so they are simply observing the natural manifestation of the infection in the mother and infant that would occur regardless of the study. Yet, if there is a shift in ethical reasoning from what is “best” to what is “local”, vulnerable populations will be open to further exploitation by researchers and the practice is ultimately a direct violation of the guidelines set forth by the various public and global health organizations which all require equal protection to that received in the sponsoring nation (848). The context of the study,

The Willowbrook research also contributed to the public debate over research ethics and the impetus for regulation” (NAP, 2004). This research does not downplay the egregious acts of the research or coercing family members or guardians to consent to the research study through allowing entry into the school via the experiment venue. The residents of the school suffered while being exposed to a live hepatitis virus and while living in severely unsanitary conditions with undertrained and unsupervised staff that performed acts of violence on residents of the school. “Children were sitting on the floor, some nude covered in feces, rocking back and forth making pitiful sounds. Willowbrook was a state school, yet there was very little education happening. This was simply a dumping ground for the city’s unwanted children. The staff, overwhelmed and under-supervised, resorted to prison-style control tactics: disruptive residents were confined in solitary ‘‘pits’’ and left for hours or were beaten with keys and sticks” (Starogannis & Hill, 2008, p. 89). Evidently the research setting was not the optimal setting; the research was performed during a time when guidelines were nonexistent. Protection of the residents was put aside to reach for a vaccine that would aid many more than were affected which places into question the ethical behaviors of the determining entities.

Vaccination was first introduced globally for small pox and later on extended to other communicable diseases which are now known as vaccine preventable disease. Vaccination is beneficial both for individuals and community. This bring us to the ethical dilemma - Vaccination of a healthy child with the intention of protecting both the individual child and the community at the same time exposing the child to the theoretical risk of exposure to disease products whether live, attenuated or killed. There was a time when people never questioned the government or their physicians. Now because of more public awareness and accessibility to medical information, they are questioning the safety aspects of vaccines.

Another issue involving the Orphan Drug Act that has caused great conflict and controversy is the market exclusivity it provides as an incentive. In 1989 Amgen’s drug erythropoietin was approved by the FDA to treat anemia. Amgen was given exclusive marketing rights for seven years and erythropoietin became one of the most successful drugs in history. In these types of instances, the issue is that these companies have essentially created a monopoly where they have complete control. [6][7] Since there is no competition, companies have the opportunity to drive up the prices forcing people to be left with the ultimatum of either paying high out of pocket prices or leaving their condition untreated. The reduction in competition also severely limits the access to treatments for patients with rare diseases. [6]

Part I: The legal considerations would be to inform the participants that there would be no harm or risk to the participants. Since the participants are adolescents the researcher needs to obtain a secure informed consent from the parent or guardian before they participate. The researcher’s ethics are to provide full disclosure to the participants. The researcher should be open and honest to the participants regarding the study. The researcher’s ethical consideration is to protect the privacy of each participant. This can be accomplished by ensuring confidentiality and by having the data stored securely. Also, the researcher should

In current times, children are not getting infected with diseases in order to find curative vaccines, but they are being made part of clinical trials for studies of genetic screening, the enrollment of healthy children in studies of sibling bone marrow donation, and the use of hypothermia for neonates with asphyxia (Laventhal, Tarini & Lantos, 2012). These trial studies have become ethical dilemmas in pediatrics for various reasons, people believe that there are not strong enough regulations for these trials and also that children are not given the opportunity to make their own decisions, most of the time, because children are underage, parents are the ones who make the decision of making their children part of these studies. Current regulations for pediatric clinical trials only require the consent of one parent, unless they are high level risk trials, in which case both parents needs to give approval and the child must also assent. The issue of children given assent for high risk trials is controversial because how do we know that the children really understand the risks that are associated with the trials, do they fully understand that they could possibly get hurt and sometimes their lives can be in danger.

The authors Van Rooyen, Frood, & Ricks, (2012) stipulated that AIDS is a disease that affects not only the individual but also the entire family. They embarked on a journey to convey the experiences of AIDS orphans living in a township, situated in the Eastern Cape of Africa. The title is substantiated because only the orphans have the experience.

The ethical issues involved in this topic include age limits, medical ethics, informed consent, and autonomy. It is unethical and immoral to allow adolescents to make their own medical decisions, because the judgment and capacity to make coherent decisions is unstable. However, adolescents should be involved and have a voice in the process of decision making, nonetheless I believe that the concluding medical decision should be made by the guardian and the doctor. An adolescent is between the ages of thirteen and nineteen. Society permits the legal determination of decision making for health care at the age of eighteen years. It is very important to consider developmental issues which will influence both reasoning and information processing, the brain not being fully developed causes a sense of a lost identity, and low self esteem challenges adolescents to develop a logical decision. An adolescent brain is not yet fully developed, the lack of grey matter and an

Through research, I have determined that this audience would enjoy the issue at hand and consider the piece’s content. As my audience contains educated individuals, they will do any research possible to prevent any harm being done to their child.

Throughout history there has been many ethical dilemmas that have resulted in change, and many that have still not been resolve. These dilemmas often result in controversial issues arising, and both sides of the spectrum arguing as to which proposed idea is the morally correct one. Today, there is an enormous controversy in the ethical dilemma involving child care. This issue revolves around whether the views of the parents should be upheld when their child is in danger medically. To further assess the impact of this ethical dilemmas, a case study involving the treatment implemented on a child by a physician while opposing the views and wishes held by the parents will be analyzed in terms of the ethics of the situation, the stakeholders, values,

It is very important for healthcare providers to be educated on the safety concern of vaccination. Proper protocols must be taken through evidence-based research on the issue of vaccination and the risk factors that can allow stakeholders better implementation on laws that can be beneficial to parents. The stakeholder’s in the healthcare field such as patients, healthcare providers, insurance companies, organizations, and those who enforce policy main concern are the safety of these patients. The decisions most of these stakeholders make can either benefit patients or affect them. For example, the consequences parents have if their child is not vaccinated. The mandatory law of children who are not vaccinated cannot enrolled in school is unfair to parents. I believe parents should not be penalized or forced for their child to be vaccinated. If all stakeholders can reunite through evidence based research on the topic of vaccinations risk concern it can cause a positive impact on parents and alternative ways children can prevent the side

Clinical research has a storied, often very dark, history regarding the use of children as test subjects during clinical trials. While it is necessary that children be the subject for certain clinical trials, since there are certain diseases or disorders that affect children in particular, performing these trials is a proverbial ethical “slippery slope”. Children are extremely vulnerable populations and this can be further compounded by parents of the children involved. Often, the children involved in a clinical trial are already diagnosed with a disease or have an illness. This can compromise the judgement of the parents as well, since they are both seeking to treat their child and protect them. Tremendous care and time needs

The HIV and AIDS pandemic remains one the most serious development crises in the world (WHO, 2006). Women and children bear a disproportionate share of the burden, and in many settings continue to experience high rates of new HIV infections and of HIV-related illness and death. In 2005 alone, an estimated 540 000 children were newly infected with HIV, with about

Thousands of people voluntarily enroll in clinical drug trials every year. They are putting their health and safety at risk by participating in a drug trial. One would think they would be doing this to promote medical advancement, but in all actuality, it is for the high dollar amounts they receive for compensation. People that frequently enroll in drug trials are often called “guinea pigs.” The monetary amount people are paid can go as high seventy-five hundred dollars. The more invasive the procedure is the higher the compensation. These “Guinea pigs” are required to pay taxes on the money they do make. (Elliott, 2008)

The “Unite for Children, Unite Against AIDS Campaign” is dedicated to reversing the HIV and AIDS epidemic by 2015. Its work is complimentary to the Millennium Development Goal 6, which is ending HIV, Malaria and Tuberculosis.