Ethics of Research Trials in Developing Countries

Zoheb Rafique

INTRODUCTION:

Asia is the most diverse continent in the world in terms of culture, religion, population size, finance, education, health care, academic research, general population skills, and governmental drug regulations. Each Asian country has its own unique qualities when it comes to attracting industry sponsored clinical trials. Factors that influence selecting location of a study site for a sponsored trial are mainly population size, infrastructure, education levels, quality of health care, cost and drug regulatory platform. Some Asian countries such as Japan, Hong Kong and Singapore have among the longest life-expectancy, lowest infant mortality and highest per capita income worldwide, while others are in the lower end of such rankings. Several, notably China and India, are amid rapid economic development, as the Asian economy is more-or-less becoming the global axis, with the economies of US and Europe slowing. Asia has a population of 3.8 billion, at least ten times more than North America or Europe. As the world’s most populous continent, Asia has by no means reached full capacity in contributing with subjects in testing new medical products in collaboration with the international pharmaceutical industry. This trend will certainly direct more sponsored clinical trials to Asia, but not necessarily benefit all Asian countries. Engaged in 18.1 % of all protocols globally Asia is involved in more sponsored trials than any other region. India, Korea and Taiwan standout as the most active locations for multi-national trials in Asia. When ranking is for cities Seoul is the most active Asia city, followed by Taipei, Hong Kong, Singapore and New Delhi. The globalization process of sponsored clinical trials has provided an opportunity for Asia to attract international companies to the region and also seemingly encourages development of local life-science industries (1). In this paper, I will discuss the responsibilities of researcher/funder when the research trial is conducted in developing countries and especially in our country Pakistan and I will also talk on ethical justifications of doing research trials in Pakistan and other poor and developing countries.

DISCUSSION:

Resource poor countries require a lot of attention from the medical research establishment in order to sustain the quest for treatments and remedies for diseases and other health-threatening conditions. However, the collaboration between rich countries and well-endowed agencies, on one-hand, and economically constrained research communities, on the other, requires a careful assessment of responsibilities and options for researchers and research subjects alike. Major players in international research also include big pharmaceutical companies who seek people living in developing countries as subjects. Safety and standard of care for human volunteers are also major issues. “I had not been exploring Big Pharma of third world ‘volunteers’ as cheap guinea pigs, observes writer John le Carre (2001). “Their role, though they may not ever know this, is to test drugs, not yet approved for testing in the US, which they themselves will never be able to afford even if the tests turn out reasonably safe” (le Carre, 2001). In the US, it costs on average $ 10,000 per patient to conduct a clinical trial, in Russia $ 3,000, and in the poorest parts of the world, much less. This is one of the strong reasons why clinical trials are now a Third World growth industry. In the end, the drugs under trial are for western markets. In its May 2000 edition, Center Watch, a newsletter for the burgeoning clinical trials business, published an exuberant article under the title Latin American Fever in which it said the continent ‘may offer a unique opportunity to reach much larger numbers of study subjects’. Eli Lilly tested 590 patients, in 1994, across Africa, the Middle East and Central and Eastern Europe. In 2001, the company expected to run tests in those regions on 7,309 patients. It is not only the human subjects who are at risk. In the rush to market, poorly constructed, weakly monitored trials are releasing untried and untested drugs for consumption (le Carre, 2001). The Contemporary practice of biomedical research on a global scale has given rise to evolving forms of exploitation. Standards of justice and equality tend to be put in question in the face of research practices that often put heavy burdens on poor people and poor communities in poor countries. There is a need to remain vigilant in the prior review of these activities and the monitoring of their implementation in order to ensure that biomedical research is conducted in accordance with universally acceptable standards. One of the most important requirements for the conduct of research in developing countries is emphasized in the WHO-Council for International Organizations of Medical Sciences’ Guidelines for Biomedical Research Involving Human Subjects: to guarantee that those communities where these new drugs have been tested will be given affordable access to the newly developed and approved drugs. Otherwise, one might rightly argue that people in developing countries have yet again been exploited by Western researchers without benefiting from the positive results their risk-taking has yielded (Del Rio, Kamarulzaman, and Schuklenk, n.d.). Ruth Macklin observes that it is not just individuals who can lose out when big drug companies carry out their tests. When industrialized countries do research in a developing country, the developing country can’t afford the products of that research. The researcher’s pullout and the successful products then become available in the Western industrialized countries and the population in the countries where the research was done get nothing. So that’s truly a question of justice, and we’re beginning to see a movement to rectify that injustice (2000). The wide disparities in resources that are available for biomedical research in developed and developing countries give rise to ethically relevant issues of research prioritization and collaboration. The international research community has to accelerate the shift to an environment where researchers from developing countries are recognized as full and equal partners in biomedical studies; where the technologies of developed and developing countries are integrated and made widely available; and where the benefits of biomedical research for participant communities can be ensured (2). In resource-poor countries like Pakistan and majority of developing countries, the two primary means of protecting participants-IRB review and Informed Consent may be inadequate. IRBs in developing countries may lack training, experience, and resources. IRBs in the United States are unlikely to be familiar with conditions in the host country. Informed Consent may be problematic in a country where people are poorly educated and lack health literacy, and where physicians in clinical practice usually do not tell patients their diagnosis, admit uncertainty, or obtain consent. Participants may not accept Western models of disease. Furthermore, participants might hear rumors and other misinformation about a research study. In several highly publicized cases, researchers from developed countries have been harshly criticized for allegedly conducting inappropriately risk studies in resource poor counties without adequate consent. The other problem is health priority and it would be an imprudent use of limited health care resources in a developing country to conduct human-participants research that does not address a health or public health priority in the host country. Because of scarce resources and logistical constraints, medical interventions that are standard in developed countries may not be available or feasible in resource poor countries where the trial is conducted. This creates an ethical tension between providing a benefit to research participants and obtaining generalizable scientific knowledge. According to the ethical obligation to minimize harm to participants, researchers should provide interventions that are known to be effective and feasible to prevent or treat the condition addressed in the clinical trial. Because participants in a research study help researchers, sponsors, and society at large, they should receive some benefit in return as a matter of reciprocity. Advocates contend that researchers and sponsors must avoid taking unfair advantage of participants and their communities by providing those who bear the risks of research appropriate benefits, in addition to the long-term benefit of generalizable knowledge. Researchers and Sponsors need to consider whether the study intervention will be available in the host country if it is shown to be effective and safe. Some ethics expert point out that providing reasonable access to study interventions after a trial may be an inadequate reciprocation for participation in research. First, it is too limited and weak an obligation. If the study is something other than a pivotal clinical trial (for example, an epidemiological study), no additional benefits will be required. Even if the study is a clinical trial, it might be a negative study. Second, other benefits might be more useful to participants or their communities than the trial drug. For example, they might benefit more from better primary care or better education for host country health care workers. Third, the appropriate target group for benefits may be all persons in the community where the study is carried out, not just trial participants.

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Providing benefits only to trial participants will widen health disparities in the resource-poor host country and therefore raise concerns about causing injustice. Thus, providing benefits to the host country should be done in a way that ameliorates rather than worsens health disparities. For these reasons, some writers argue that researchers and sponsors from the developed world should provide fair benefits to the research participants and their communities in reciprocity for what they contribute to the research. Researchers could provide benefits to research participants in a number of ways, such as by providing health education or some basic health services; training local health care workers, researchers, and IRBs; donating equipment at the end of the study; and giving local investigators a key in analyzing data and writing papers. Such contributions ensure that the community where the research is carried out will receive benefits in reciprocity for participating in the research. By building infrastructure, researchers can help provide sustainable improvements that will help to narrow health disparities between rich and poor nations (3). Pakistan is also among the poor and one of developing country and the health care conditions here are same as any South Asian or African country. We will apply the same ethical and moral rules when we talk about research here in Pakistan. Ethical requirements for clinical research do not end when individuals either sign the consent form or are enrolled in research or refuse enrollment. Individuals must continue to be treated with respect from the time they are approached even if they refuse enrollment throughout their participation and even after their participation ends. Respecting potential and enrolled subjects entails at least 5 different activities. First, since substantial information will be collected about enrolled subjects, their privacy must be respected by managing the information in accordance with confidentiality rules. Second, respect includes permitting subjects to change their mind, to decide that the research does not match their interests, and to withdraw without penalty. Third, in the course of clinical research new information about the effect of the intervention may be gained. Respect requires that enrolled subjects be provided with this new information. Fourth, the welfare of subjects should be carefully monitored throughout their research participation. If subjects experience adverse reactions, untoward events, or changes in clinical status, they should be provided with appropriate treatment and, when necessary, removed from the study. Finally, to recognize subject’s contribution to clinical research, there should be some mechanism to inform them of what was learned from the research (4).

CONCLUSION:

The basic disclosure requirement for satisfying the informed consent provision in U.S. research regulations focus on information needed by a potential participant to decide whether or not to participate in a study. Of the eight basic disclosure requirements, one focuses on potential benefits: a description of any benefits to the subject or to others which may reasonably be expected from the research. Traditionally, such a disclosure has been required to ensure that potential participants understand whether there is any possibility that the intervention itself might benefit them while they are enrolled in the study. There is, however, no specific mention of any post-trial benefits. If any case, those who may participate in studies should be informed of the potential benefits, if any, that they might receive by doing so. Because this information is relevant to participants’ decisions to participate in the research, ethics review committees should require investigators to make these disclosures (5). In the end I will conclude by saying that research participants should know each and every thing regarding their participation in the research trial or rejecting it, and it is their right to know all risks and benefits while participating in the research trials and this should be applicable to all countries around the world including all developing countries and also our country Pakistan.

REFERENCES:

1. Johan PE Karlberg. Development of Sponsored Clinical Trials in Asia. Clinical Trial Magnifier. 2008; Vol. 1:5: 77-100.

2. Leonardo D. de Castro Et Al. Bioethics in the Asia-Pacific Region: Issues and Concerns. 2003; 1-108.

3. LO B. Clinical Research in Resource-Poor Countries. Ethical issues in Clinical Research: A practical Guide. 2008; Ch.22:194-210.

4. Ezekiel J. Emanuel Et Al. What Makes Clinical Research Ethical? JAMA. 2000; 283(20): 2701-2711.

5. Ch 3; Voluntary Informed Consent. National Bioethics Advisory Commission. 35-53.