Ethical Issues Concerning Vulnerable Populations in Clinical Trials - Coursework Example

Module Ethical Issues Concerning Vulnerable Populations in Clinical Trials INTRODUCTION The fact that medical research has been central in the creation of drugs that have improved the lives of billions across the globe cannot be disputed. However, medical research has been used as an excuse to infringe on the dignity and lives of research participants. This was a common practice in bygone eras. For instance, African American men were used in an experiment that endangered their lives by subjecting them to an illness that could result in their going mad more than 80 years ago. During the Second World War, Jewish prisoners in concentration camps were forced to undergo the most disturbing experiments; naturally, without their consent. The realities of being participants in these inhuman medical researches would be revealed during the Nuremberg trials which took place after the War had been won by the Allies. Medical research no longer uses helpless victims as unwilling research participants today. However, there are still ways in which research participants can be disadvantaged because they may not know all the facts pertaining to the research before agreeing to participate in it. In the recent past, health research has become increasingly global, and the use of clinical trials has brought to light new ethical issues (Siegfried, Clarke, Volmink, and van der Merwe 6). Today, clinical trials form a huge and expensive enterprise in which companies related to the healthcare sector can invest more than $100 million to test new products for the health sector market. Ethical Issues in Clinical Trials A clinical trial basically describes a research study in which human participants can offer or be engaged to participate by giving answers to particular health questions. Essentially, the simplest and most cost effective way to find new treatments that would help sick people is by carrying out clinical trials. Clinical trials may be used to study different things. For instance, some may be conducted in order to study prevention options, while others may be conducted to test the effects of newly manufactured drugs on sick people (Legerski and Bunnell 440). There are other clinical trials that basically study the effect of newly discovered diagnostic techniques and others that test the veracity of alternative treatments that are suggested for patients with grave medical conditions. In general, clinical trials are usually carried out according to a program known as a protocol which describes what kinds of research participants the study will benefit from. The protocol also carries information about the schedules of procedures, tests, and drug dosages that the participants will be exposed to. Every research participant has to consent to observing the regulations as stated by the protocol. It is normal for clinical trials to include the comparison of new drugs or therapies to others in order to find the best treatment option. For instance, in a blinded study, a research participant may be indiscriminately assigned to be given the test product, or an already existing therapy. In some clinical, research participants can be assigned to be given a placebo, which is a product that has no therapeutic benefit but materially resembles the test product. Using placebos in clinical trials is one of the quickest ways of testing for the therapeutic effectiveness of newly manufactured products (Legerski and Bunnell 441). Moreover, ethical guidelines categorically state that placebos are not used in cases where the research participant who is a patient may have his or her health put at risk, as may happen when the participants suffer from a serious illness. Most of the clinical trials that use placebos mainly compare the effectiveness of new product against the known results of using approved therapies. Research guidelines in such cases advocate that patients should always be told that there will be placebos used. Clinical Trials that involve Drugs Before any newly manufactured drug can be duplicated and distributed within society, it has to be painstakingly vetted. One of the most important stages in this process entails the use of participants in a clinical trial. During the trial, the drug is given to the participating human patients to determine, among other things, what the best dosage should be and in what dosages the drug becomes toxic to the human body. The clinical trial stage is controversial because it is fraught with risk for the participants, and could have legal implications as well (Siegfried, Clarke, Volmink, and van der Merwe 7). Over the years, there have been different lawsuits filed against companies that manufacture medicinal drugs as well as against hospitals that manage clinical trials. Owing to the fact that many times there are unknown variables linked with clinical trials, there are numerous ethical concerns that have been expressed and continue to be expressed in this phase. In spite of the fact that there are numerous safeguards that are put in place to ensure the safety of patients, the majority of clinical trials are still seen as being inherently dangerous because they are conducted with people who are already ill as participants. The people who oversee clinical trials have to be careful in the way that they balance their responsibility so that they may conduct a medically-relevant trial while also ensuring that they do not further injure the health of sick participants. Vulnerable Populations The investment in medical research activities has greatly increased in the recent past. Increased funding naturally means that there will be increased pressure to deliver medically sound results. Out of desperation, there are researchers that have begun to use incentives in order to get ready volunteers. As a result, it has become evident that it is the most vulnerable populations that bear the burden of being research participants in clinical trials. Monetary incentives cause an ethical dilemma Owing to the existence of uncertainties’ regarding the question of payment amount, morality, and vulnerability of participants. According to Rid, Emanuel, and Wendler different researches conducted on this subject have indicated that in many cases, financial motivation is the foremost reason why people will volunteer for medical researches (Rid, Emanuel, and Wendler 1475). Medical organizations have emphasized that in such cases, there is mutual benefit as the participants are given some much needed financial rewards, while the company conducting the trial also observes the effect of drugs on different populations. There are many medical scientists, though, who have categorically stated that using monetary incentives to attract participants is coercive in nature (Rid, Emanuel, and Wendler 1473). Ethics in Clinical Trials It is a recognized fact that clinical trials should be only carried out after a suitable ethics review committee has come to the conclusion that several ethical concerns have been satisfactorily addressed. The basic issues have to do with ensuring that voluntary informed consent will be petitioned, that the risks can be classified as being reasonable when compared to the potential benefits, and that there is proof of a fair distribution of the burdens as well as benefits of the research (Munro, Holmes, and Ward 1023). Where vulnerable participants are concerned, the main issue of contention is whether the potential participants have the mental capacity to understand what they are being asked and then give consent. Some of the populations that are considered as being vulnerable participants in any research are pregnant women, children, prisoners, mentally impaired individuals, students, illiterate people, people from nations with dictatorial governments or undeveloped infrastructures, and employees. Owing to the fact that clinical trials, by their very nature, require the use of physically or mentally compromised or sick people, it can be safely assumed that clinical trials always use participants from vulnerable populations in their studies (Rid, Emanuel, and Wendler 1474). Naturally, this has resulted in various forms of human rights abuses. In developed nations such as the United States ordinary citizens sometimes volunteer, when they fall ill, to be used as research participants. There have been cases where the true effects of drugs being tested are not revealed to the participants. Their consumption of the research drugs thus results in serious medical conditions. The citizens in developed nations, though, have the option of suing the companies that subject them to such drugs. By and large, it is the participants who are sourced from third world nations or developing nations whose lives are most negatively affected by unscrupulous researchers conducting clinical trials. Ethical Issues concerning the use of Third-World Participants in Clinical Researches In the course of the past three decades, drug manufacturers have increasingly turned to developing nations for participants in clinical trials for medicine that will only benefit the American market. This is because it is cheaper and easier to source for trial patients in third world nations and there is not as much stringent supervision of all the processes being conducted by the researchers. This means that researchers can give their subjects almost lethal cocktails of drugs without incurring an outcry. While this process is very profitable because the participants in developing nations may not be paid as much as those in developed nations, it can result in extremely negative consequences for the participants taking part in such trials. According to Munro, Holmes, and Ward it is a known fact that pharmaceutical companies view Third World clinical trial recruits as being the best option for the trials because they are “drug-naïve”- meaning that they are most likely not to be taking any other medicine for any illnesses that they may have (Munro, Holmes, and Ward 1024). Such patients, whose bodies have not been chemically altered in any way by other prescriptions, are almost sure to produce better test outcomes than participants in developed nations who might be on a cocktail of drugs depending on the illnesses or even skin conditions they may be dealing with. Patients in developing nations also tend to be more uninformed than their companions in the developed world. In addition, they may not have access to information about the effects of the drugs that they may voluntarily be choosing to take. There are many cases where researchers intentionally choose to conduct clinical trials among the uneducated populations in developing nations where the participants do not comprehend research jargon and are not aware of what ‘placebos’ are or of what informed consent is, or even what experimental studies may include. Such participants may simply indicate their consent by making a thumb print on the consent form or writing an ‘X’ (Munro, Holmes, and Ward 1023). In developing nations, it is also quite easy for unscrupulous researchers to bribe the local governments to remain silent about the effects of clinical trials on specific parts of the population. Even in cases where the companies do not succeed in bribing local governments, in many cases, they have more financial clout than them and are able to restrict the possibilities of their actions being leaked to the international press. There have, however, been reports that in the past, there have been drug trial deaths that resulted from clinical trials conducted in third world nations. One reason why there should be more exposure on this is that populations in the developed world will be harmed if it is not revealed. If a group of clinical trial participants are killed by the lethal effects of a drug being tested and this result is covered up, when the drug is released into the Western markets which are the only ones that can afford it, there will be untold thousands of European as well as American patients who are harmed or killed by the drugs whose endorsement was dependent on questionable trials conducted in Third World nations. According to Legerski and Bunnell there was a study that revealed that 174 clinical trials for the effects of drugs against communicable diseases were conducted developing nations (Legerski and Bunnell 432). Drugs to examine the effects of new drugs on allergies, heart disorders, and arthritis medications were also conducted in places such as India (Legerski and Bunnell 431). There have been past cases documented long after they happened where participants in clinical trials that were carried out in third world nations actually dies. According to Isaakidis and Ioannidis in 1996, the pharmaceutical giant, Pfizer carried out controversial clinical trials in Kano with Nigerian children as the participants (Isaakidis and Ioannidis 925). As the children could not give their consent, it is their parents who did so- after being persuaded that there was nothing lethal in the drugs. Some of the parents were illiterate, and so merely trusted what the researchers were saying. It is also likely that some amount of money was paid to local authorities as well as parents for the use of their children. In the clinical trial, which was conducted in the Infectious Diseases Hospital, the children were given the unregistered antibiotic drug known as Trovan. According to Kano officials, approximately 50 children died of the lethal effects of the drug soon after (Isaakidis and Ioannidis 925). Other children soon developed severe physical and mental deformities. At the same time that this experiment was being carried out, there was a meningitis epidemic. The clinical trial had been timed to happen at the same time as the outbreak so that Pfizer could insinuate that it is the ravages of the disease that had outdone the effects of ‘Trovan’ in the dead and deformed children. This case was not investigated because it was assumed that Meningitis had caused the deaths of the children, as well as the deformities. There were Nigerian medics who might have questioned the fact of the deformities as Meningitis does not cause those. However, it is more likely that these medics were paid off or warned by government officials who had been paid off to remain quiet about what they had observed. African and Asian nations have been particularly susceptible to misuse by foreign medics. According to Isaakidis and Ioannidis, in the late 70s and 80s, a foreign medic, Dr. Aubrey Levin was in charge of a project that required gay and lesbian army military personnel in the South African army to be subjected to sex change operations (Isaakidis, and Ioannidis 924). The apartheid government that was then in authority sanctioned the use of chemical castration, electroshock therapy, and other assorted barbaric medical experiments which were conducted in military hospitals. During the 1970s in Zimbabwe, a population control experiment used the drug Depo-Provera in the guise of a conducting a program for ‘family planning possibilities without informing the participants about just how far-reaching or long lasting the effects of the drug would be (Ashcroft 11). Protecting Vulnerable Populations Clinical trials that are carried out in developing nations have to deal with unique issues such as explaining medical processes to a population with few public healthcare services and high illiteracy rates. It might be necessary to create rules that are unique for clinical researches that use these kinds of populations. CONCLUSION As the world of medical research grows more globalized, there is a need for clinical trials to be made both culturally valid as well as methodologically valid. Carrying out medical research among oppressed populations goes against the existing rules of medical ethics and breaches international law. There are unique ethical dilemmas that emerge with every new diverse setting. The existing principals were not meant to function as inflexible pillars, but as signposts for medical researchers to adapt accordingly to the challenge of carrying out clinical trials whenever they were dealing with new populations from ethnically diverse backgrounds. Works Cited Ashcroft, Richard. “Individual freedom versus collective responsibility: An ethicist’s perspective.” Emerging Themes in Epidemiology 3(2006): 11. Isaakidis, Petros, and John Ioannidis. “Evaluation of cluster randomized controlled trials in sub Saharan Africa.” Am J Epi 158 (2003):921-926. Legerski, John-Paul, and Sarah Bunnell. “The Risks, Benefits, and Ethics of Trauma-Focused Research Participation.” Ethics & Behavior 20(2010):429-442. Munro, Emily, Lisa Holmes, and Harriet Ward. “Researching vulnerable groups: Ethical issues and the effective conduct of research in local authorities.” British Journal of Social Work 35 (2005): 1023-1024. Rid, Annette, Ezekiel Emanuel, and David Wendler. “Evaluating the risks of clinical research.” JAMA 304 (2010): 1472–9. Siegfried, Nancy, Michael Clarke, Jimmy Volmink, and Lize van der Merwe. “African HIV/AIDS Trials Are More Likely to Report Adequate Allocation Concealment and Random Generation than North American Trials.” PLoS ONE 3.1 (2008): 1-11. Read More