The Ethics of Clinical Research in the Third World by Marcia Angell

Due to the lack of money but the high demand of need of specific regimens in developing countries, researchers from developed countries are allowed to conduct trials on those citizens. In this article, Baruch Brody argues against moral criticisms given towards clinical trials in developing countries. His three arguments are the subjects weren’t treated unjustly (following an appropriate standard of justice), the subjects weren’t coerced (in terms of any plausible interpretation of the word), and the subjects weren’t being exploited (if they themselves gain access to the treatment after the study).

A 35-year-old man named Paul, who has a supportive wife and two adventurous kids, has been diagnosed with a very severe case of bone cancer for 1 year now. Since this type of cancer is so severe, chemotherapy is starting to not work as well. Paul’s oncologist unfortunately had to suggest a final option for Paul to try which was a clinical research trial. Clinical research trials are experimental studies that deem whether or not a medical drug, treatment, surgery, or device is safe and beneficial for humans to use ("National Heart, Lung, and Blood Institute"). As explained in Marcia Angell’s Article, “The Ethics of Clinical Research in the Third World”, the Declaration of Helsinki of the World Health Organization (WHO) provides a guideline

I have chosen to discuss the case of Terri Shiavo which was a very big ethical case back in 2005. She had been left on a ventilator for 15 years. So let’s start from the beginning. On February 25, 1990 Terri Schiavo had a cardiac arrest that was causes by extreme hypokalemia (low potassium) brought on by an eating disorder (Quill, 2005). As a result of this cardiac arrest Terri developed severe hypoxic – ischemic encephalopathy which is another way of saying lack of oxygen to the brain (Quill, 2005). During this period she exhibited no evidence of brain function and eventually scans of her brain showed severe atrophy of her cerebral hemispheres (Quill, 2005). Her electroencephalograms were fat, indicating no functional activity of the

In addition to not properly policing unethical research, the CDC also knowingly funds questionable studies. . It is important to note that the money the CDC puts towards controversial experimentation comes from American tax dollars. Marcia Angell M.D, the first woman to serve as editor-in-chief of the New England Journal of Medicine, describes an example of a CDC sponsored experiment that is very similar to the Tuskegee Experiment in her editorial, “The Ethics of Clinical Research in the Third World”. In 1997, the CDC sponsored a placebo test in third world countries to study HIV positive pregnant women. At the time, the drug zidovudine was known to be a successful means of preventing vertical transmission of HIV from infected mothers to their babies. However, the majority of the women in the study were denied antiretroviral treatment (Angell). Denying these pregnant women harms both the women and their babies. According to U.S. Sen. Carol Moseley Braun, because of this

Even though the parents gave consent for the blood to be taken, the consent was only given to screen for diseases not anything else. Furthermore, it is not fair to use the blood in other ways all because the parents originally gave consent for one thing. Even with the strict oversight and approval process for research with human subjects the gap of complete informed consent allowed for these situations to occur. With the Indians, they were not fully aware of what they were consenting to. No one helped them understand it was more then just the diabetes research in which their blood will be used for. With the infants, the parents gave consent for the blood to be taken for the screening, but they were not informed that the blood would be kept and used for other researches. They took advantage of the parents wanting to make sure their baby was healthy in order to use the blood for

Describe the ethical implications of the researchers’ actions and the lack of medical treatment given to research participants in both studies

Human beings were utilized as test subjects, enduring extreme suffering, merely serving as means to an end. The ethical misconduct was obvious; inclusion in clinical trials was associated with enormous risk and nominal benefits.2 As scientific research has evolved, more subtle manners of exploitation have become prevalent, and the direct or indirect exclusion of subjects places the same vulnerable populations at risk. Although the explicative methods are opposing, the outcome is the same. Vulnerable populations do not receive equal medical treatment. They are not given equal opportunities to experience the potential health benefits associated with research and therapy, placing them at higher medical

Although the solution to this problem might seem obvious, why would the proper officials not exhaust every alternative they have in combatting what the WHO considers to be a “public health emergency”? The answer is much more complex, with a multitude of ethical questions that linger. A few good points asked by ethicist are, “who would be the first in liune to get short-in-supply medications? “Who will make that decision”? “How do you communicate the risks of an experimental drug to a poorly educated inhabitant of a rural village”? And “would the money for these drugs be better spent on quarantine supplies and public education, to help prevent disease transmission”? All these questions bring into light and give a better perspective as to the possible consequences to administering such a drug could pose to the public. Considering the fact that those who have tried the drug have shown signs of recovery, have they really? With such a small sample (2 people) and not observing them over an adequate period of time, “the problem is you have no idea whether the medication worked or did not work” as mentioned by Dr. Ezekiel Emanuel, chair of the department of medical ethics and health policy at the University of Pennsylvania’s School of Medicine. A critical factor to consider also is that the people of African countries’ bodies will react differently than those living in the U.S their whole life. The small sample observed is simply not generalizable across a population and is low in external

In conclusion, the purpose of the Code is to guide institutions and researchers in responsible research practice. The Code also promotes integrity in research and explains what is expected of researchers by the community. Therapists have ethical obligation to care for all patients with utmost care. The use of placebo has long been controversial, and the ethics of placebos have been debated frequently in history. When Hope used placebo group, it will only accumulate ethical concerns in her therapy and research procedures. Her placebo group will never get optimal treatment for their treatment is psychological and without actual effects on the condition being treated.

Doctors without borders has had a positive effect on the world despite the negative things said about them. Or the bad things happening to them Doctors without borders continue to work and nothing stops them unless in extreme danger. The good thing about doctor without borders is that “In many places, Doctors Without Borders/Médecins Sans Frontières (MSF) is able to have an impact beyond its immediate activities, reaching populations or pioneering the use of practices in ways that have far-reaching and lasting consequences. The following case studies, which document instances in which MSF's medical work did indeed have an impact beyond the moment”. The impact MSF leaves isn't a temporary one they help many people that

Placebos have been used throughout many studies when testing experimental drugs for certain medical conditions. A placebo is a form of treatment that, in a sense, has nothing in it. Patients in clinical drug trials are often enrolled in the trial because many other treatment options have been tried and have failed. For terminal patients these trials are often their last hope of recovering from their diseases. According to Millum et al. (2013), “To be ethical, clinical research requires balancing rigorous science with the protection of human subjects”. It is common for placebos to only be effective in pain- related cases since pain is a mental state and placebos work on the mind. In other cases, patients are administered a placebo when the real medication is unavailable and deceived into thinking they have a chance at getting better. Many nursing professionals do not agree with placebos since often they are the ones administering and interacting with the patients they hope to help. Placebos are only justified in pain related trials, unethical to be used on terminally ill patients, and can potentially cause negative health effects.

Poor and/or inconclusive science: Many studies are being conducted and articles are also published in major medical journals every month regarding the evidence in order to provide patients with best available treatments, but none of them provide with useful and valuable clinical data, instead it gives misleading or wrong information which raises problems due to improper study design selection during research. Randomized, double-blind, placebo-controlled studies are considered as the “gold standard” of evidence for determining the cause and effect, whereas observational or epidemiologic studies, case series and reports provide the natural history of design. Although some of the well implemented studies may provide the conclusion only from one side of

Initially, extended research on the development of diagnostics and treatment should be prioritised, alongside the funding of scientific laboratories by domestic and international initiatives. Furthermore, national and international organisations ought to cooperate, so as to strengthen the health system of the affected states and provide urgent financial and material support in territories, which seek immediate attention. In addition, it is vital that men and women, the most and least privileged people and vulnerable groups have equal access to primary health care. Basic education on disease prevention, especially in developing and underdeveloped countries should also be enhanced. Only with the united action of all states around the world could we maintain lives of dignity, even when social integrity is

Children with Human Immunodeficiency Virus (HIV) represent a notable number in this epidemic. Accounted for 400 everyday children became newly infected by HIV.1 Currently, almost 2 million children are affected by this virus. 1 This fact ignites scientists’ attention to do clinical trial to treat this population. In some literature, this research is even named with ‘cure research’.2,3 It may represent an optimism to the ultimate goals of the paediatric clinical trial where not only bring individual benefit but also societal benefit to the epidemic. Involving children in clinical trial has been claimed as children right and lead to benefits which are one of principal ethical called “beneficial’. Yet, the potential harm and risk are also being pointed out. This harm and risk will also violate children right to access the benefit research and their right to life, survival, development and health.

Nuremberg Code is a set of 10 sophisticate principles regarding ethical clinical research on human being (Grodin, 1994). It is mainly for protection of subjects’ human right (Shuster, 1997), such as compulsory of informed consent and the equal authority of subjects as the physician-researcher to end the experiment.