Ethical Issues on International Research in Developing Countries on HIV Vaccine Trials - Essay Example

Clinical Trials, HIV/AIDS Vaccine and the Vulnerated Introduction Human Immunodeficiency Virus /Acquired Immunodeficiency Syndrome (HIV/AIDS) is the most devastating epidemic that the recent times have encountered. (UNAIDS, 2011, p.15). Thirty years after it has been first announced, it is only in the last decade that the world has taken cognizant of the fact that it is a pandemic that affects countries around the globe, regardless of condition, regardless of location (UNAIDS, 2011). The first two decades following the identification of HIV/AIDS, the global community has taken no vigorous or categorical approach in addressing the pandemic. This circumstance has resulted in a situation wherein low and middle-income countries witnessed not only the increase in the global burden of the disease, but also the increase in the number of their people afflicted with HIV/AIDS (UNAIDS, 2011). This reality does not ignore the fact that, since its identification, there has been urgency in finding the right medicine for the disease, since the number of people affected with the disease rose from one million in 1981 to 27.5 million by the end of 2000 (UNAIDS, 2011). As such, scientific researches regarding HIV/AIDS have been conducted and clinical trials of potential treatments are being undertaken in different countries across the globe. However, as the race for the cure of HIV/AIDS ensued, the design and conduct of clinical trials for HIV/AIDS in developing countries have been mired with ethical issues (Shapiro & Meslin, 2001). Ideally, clinical trials should not exploit human subjects (Shapiro & Meslin, 2001). Ethical standards for clinical trials have been developed following the principles of justice and respect for human dignity and individual autonomy (Shapiro & Meslin, 2001). However, the context of the clinical trials is such that it is between the rich and the poor, the developed country as the funder and the developing country as the site. As such, there is an increasing concern regarding the potential exploitation in the existing relationship between funder and the host country. In this condition, this paper will address two pivotal questions. First, what are the ethical issues surrounding clinical trials of HIV Vaccine in poor, developing countries? Second, how and why the poor people, who are in a vulnerable condition, become a target in the discourse of exploitation in a clinical trial for HIV/AIDS vaccine? The Ethical Issues There are several ethical issues surrounding clinical trials of HIV vaccines. Some of these are the following. First, there is no guarantee and clarity whether the benefits of the clinical trials of HIV/AIDs vaccine will be delivered equally to all who need it, especially the world’s poor (Selemogo, 2008; Shapiro & Meslin, 2001; Singh & Mills, 2005; Vallely et al., 2011). This ethical issue has become apparent in Sub-Saharan Africa. HIV/AIDS is an extremely monumental hurdle that prevents sustainable development in the region (Poku, 2002). This is due to the fact that an “estimated 22.5 million [20.9 million–24.2 million] people living with HIV resided in sub-Saharan Africa in 2009, representing 68% of the global HIV burden” (UNAIDS, 2010). In this context, numerous clinical trials have been conducted in the region, including the controversial studies of the efficacy of ARVs for the prevention of mother-to-child transmission of HIV - PMTCT (Selemego, 2008). However, despite these studies, by 2005, 540 000 children were infected with HIV, with most of the cases happening through mother-to –child transmission (Selemogo, 2008). This happened because only about 9% of HIV-positive pregnant women in SSA are estimated to be receiving ARV prophylaxis for PMTCT (WHO, 2006). This reality attests to the condition that, despite the involvement of people from Africa in finding the cure for AIDS, there are no clear guidelines as to how it will be used and to whom will it be given. From these experiences, it can be deduced that the vaccine is not intended for those people who cannot afford it or simply do not have access to it because of poverty and other extenuating circumstances (Poku, 2002). This is an extremely relevant question pertaining to risk-benefit. People in Africa are risking their lives in the clinical trials, but for whose benefit are they doing it; is it for the world where the reality of inequality in health is predominant or is it only for those people who can afford to purchase the developed vaccine. The second issue that is raised against the clinical trials of HIV vaccine is the process of gaining informed consent. Informed consent is essential not only for the validity of the research, but because the entire research on human subjects, human beings. These are people endowed with the same human dignity and as such, should be respected at all times. However, in most of the poor developing countries where these trails are conducted, most of the participants are illiterate, thus, how can they give their consent to participate on the project on the basis of their understanding of the necessary information regarding what they are going to do. More often, the consent is not given by the individual, but is secured through the community leaders or family heads. As such, the Western strategy of securing the signature of the participant is not enough to get a sufficient knowledge whether the person genuinely understands what he/she is doing. The third ethical issue that have observed is the use of placebo. Helsinki declaration stipulates that if there is an available treatment for the disease, participants of the trial should be given the care they need and not placebo. For example, a short- term trial to compare zidovudine for PMTM with placebo. In this trial, the use of placebo is considered as unethical because zidovudine is known effective in reducing perinatal transmission (Angell, 1997; Connor et al., 1994; Lurie & Wolfe, 1997). The Vulnerated People are in a vulnerated condition when they are in the actual state of deprivation, when their chances in attaining quality life is dramatically diminished and when there are limited opportunities with which they can reach the flourishing of life (Kottow, 2004). In other words, people are vulnerated when they are in the actual process of destitution. It should be noted that vulnerability is different from vulnerated. There is a long history of philosophical discourse clarifying vulnerability, but they look at it as the universal human condition. Thus, vulnerability is deemed as an essential, abstracted human condition while being vulnerated is in the concrete circumstance of being deprived, experiencing disease, poverty and other forms of human suffering. Using this concept and connecting it with the HIV clinical trials in poor citizens of developing countries are in vulnerated condition because they are already subject to definitive instances of suffering - poverty, disease, war, destitution and other material hardships that reduce their quality of life. In the context of being vulnerated, people become more susceptible to harm, they become easy targets (Kottow, 2004). There are factors that contribute to the vulnerated condition of the poor, these are First, there are no strong social structures that can protect and assert their human dignity and integrity. The people are already in a particular state of deprivation, as such, the trials can give hope or an opportunity of addressing a deprivation that, in their current predicament, they cannot address. Second, an important dimension in clinical trials of HIV vaccines is the reality that it does not create the platform that can change the status of women in the countries where it the trials are conducted. The status of women in poor developing country is more often that of a second-class citizen. By second –class citizen, it means that they are valued as an object of sex and are subject to the guidance of men or the community. They are not their own persons. This reality is often overlooked in the clinical trials through slow response in developing contraceptives for women that can help protect them from AIDS. On the other hand, condoms have been freely given to men who do not use them. Likewise, the clinical trials offer a paradigm wherein women can momentarily escape from their oppression and assert their empowerment, but after the trial, they go back to the reality of their own society – oppressive to women. For this reason, one of the main concerns in the conduct of clinical trials is the lack of post trial counseling given to the participants (Shapiro & Meslin, 2001) It is crucial to understand that the issue of clinical trials of HIV vaccine is being framed as female-friendly issue by some activities grouped (Singh & Mills, 2005). Lange (2005) stipulates that “the increasing feminization of the HIV/AIDS epidemic, reflects the vulnerable position of women in many societies, HIV is a virus, but inequity is at the roots of most of its spread" (p. 833). Women are not given the option. In some of these countries, they are susceptible to violence, harassments, abuse and other dehumanizing activities, thus, limiting their choices. In this regard, women, their inferior status, poverty and diseases create a double burden with their already vulnerated condition, thus making them more susceptible to harm and abuse. The third reason why the poor becomes a target of abuse in clinical trials is the fact that there is the presence of structural injustices in the society. In the United States, there are strong IRBs that can advocate and campaign for the rights of the human participants, but in poor developing countries, there is a possibility that there are no existing IRBs and if there is one, it is comprised of members, which are not that well proficient in the functions of IRB. These factors combined plus the reality that the poor people in a developing country are not just vulnerable but are already in a vulnerated condition- a state of existing deprivation, destitution, poverty, disease and suffering – then, they become more liable to more harm and danger as others take advantage of their vulnerated condition. Conclusion Clinical trials of HIV vaccines to poor developing countries have been packed with controversies and ethical issues. It becomes critical not only because of the fact that HIV/AIDS is the most severe epidemic of the modern period, but also because of the fact that people who are vulnerable are already in substantial vulnerated condition of destitution, poverty, disease and suffering. The search for treatment should not be made at the expense of people who are already vulnerated. REFERENCES Angell, M. (1997). The ethics of clinical research in Third World. N Engl J Med, 337, 847 – 849. Connor, E.M., Sperling, R.S., Gelber, R et al. (1994). Reduction of maternal-infant transmission of human immunodeficiency virus in developing country. N Engl J Med, 331, 1173 - 1180. Ditmore, M. (2010). How ethical is your clinical trial? Int J Clin Pract, 64(9), 1179–1182. Kottow M.H.L. (2004). Vulnerability: What kind of principle it is? Medicine, Health Care and Philosophy, 7, 281 – 287. Lange, J. (2005). We Must Not Let Protestors Derail Trials of Pre-Exposure Prophylaxis for HIV. PLos Medicine, 2(9), e248. 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