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Relevant Research

Introduction

It is increasingly common for researchers from developed countries to go abroad to conduct research in developing countries. However, many of these researchers wish to study diseases or drugs that impact developed countries, instead of focusing on the diseases that inflict the areas where they are conducting research. Due to this discrepancy, it is important that researchers conduct research that is relevant to the communities in which they are working. Researchers should also avoid conducting research solely because it is line with their personal interests or for career development.

Research Should Benefit the Community

It is essential that research studies benefit the communities where the research occurs. Research studies should be in tune with the communities’ needs and wants, and the results should be made available to them.  “International research projects must ensure that their work serves the needs of the community where the research is to occur. Often, projects are developed without the input of local partners. Rightly, this has been referred to as a form of neo-colonialism.” (1)

Unfortunately, professional researchers and students researchers alike often do not pursue locally relevant research studies, especially with regards to research that takes place in developing countries. In 2005, it was estimated that of the 50,000 international clinical trials conducted globally, more than 40% took place in poor countries. However, none of these trials have focused on diseases that preferentially affect the poor or the countries where the trials take place. “The proportionally small number of investigations conducted by multinational companies with the aim of producing medicines to meet the particular needs of poorer countries, for example drugs to treat malaria, Chagas disease or schistosomiasis, give further reasons for concern.” (2) The fact that most (90%) of the world’s expenditure on health research and development is devoted to problems that primarily affect the richest 10% of the world’s population is called the 10/90 gap and illustrates the increasing need for research to be relevant to developing countries.(3) It is critical that research studies, especially those that take place in poor countries, develop “therapeutic, preventive or diagnostic methods targeting health problems that are a priority for the populations of the host countries.”(4)

However, it is also important that research and clinical trials on issues relevant to the U.S. be studied in Western countries. In 2008, according to the inspector general of the Department of Health and Human Services, 6,485 clinical trials were being conducted in foreign countries on drugs intended for American use.(5)  Though many drugs intended for use in the U.S. are still tested abroad, “medical researchers question whether the results of clinical trials conducted in certain other countries are relevant to Americans in the first place. They point out that people in impoverished parts of the world, for a variety of reasons, may metabolize drugs differently from the way Americans do. They note that the prevailing diseases in other countries, such as malaria and tuberculosis, can skew the outcome of clinical trials.”(6) Thus, it is not only important that developing countries host research studies that benefit their own communities, but also that research on treatments or drugs that are intended for use in developed countries be conducted in those countries.

Research Should Not be For Personal Benefit

Consider the following scenario: “Chris is a medical student applying for an international research grant. He wants to study HIV. Chris’s advisor approves his proposal and puts him in touch with his colleague Dr. K, who runs a clinic in Vietnam. Dr. K tells Chris that patients have become wary of Westerners studying HIV, and some have complained that only HIV-positive patients benefit from research. Dr. K suggests that Chris develop a project focused on heart disease, which is an increasing concern in the community. Chris is reluctant to start over on his research proposal and feels that his HIV project is more desirable for his own professional development.” (7)

Chris’s scenario is increasingly common as students go abroad to conduct short term research projects. Though Chris would prefer to study HIV, it is critical that he listen to the local doctor and put aside his personal interests and desire for professional development. Moreover, it is also important to consider Chris’s motivations to conduct work abroad in the first place. “Although there is some evidence that these experiences positively contribute to the professional development of medical students, there is no evidence that the patients involved in research by these trainees derive any benefit from these programs. Sending students to developing countries for short-term research experiences brings additional layers of complexity to an already ethically fraught situation.” (8)

It is also important to recognize that sending student and professional researchers abroad may place a burden on the host country’s medical institutions and physicians.  “Already overburdened local staff may be forced to expend significant amounts of time and energy to orient student researchers and assist them with these problems rather than focusing on serving their patients.”(9) Therefore, before conducting research abroad, “students from the United States and their medical schools have the ethical responsibility to critically assess whether a research project may cause harm by necessitating the diversion of material or human support from the host institution.” (10) In addition, the medical schools must ensure that research studies will benefit the community and are in line with the community’s needs and wants.

Ethical Considerations

It is necessary to consider the consequences of conducting research that is not relevant in developing countries. Many researchers and drug companies choose to conduct trials in developing countries because they have fewer regulations. In addition, their study participants are often illiterate, poor, and may not understand that they are taking part in a study and instead may believe that they are receiving proper or preferential treatment for a condition. In New Delhi, for instance, clinical trials were conducted with blood pressure drugs on children. “The blood-pressure drugs had never before been given to anyone under 18. The editor of an Indian medical journal said it was obvious that the trials were intended to extend patent life in Western countries with no consequence or benefit for India, using Indian children as guinea pigs.” Unfortunately, in this 30-month clinical trial, 49 babies died. This example illustrates the unethical and exploitative nature of research which is not relevant. (11)

Though testing drugs intended for use in the U.S. in developing countries is clearly controversial, there are additional ethical dilemmas that arise when conducting research on treatments to be used in developing countries.  One of the main questions is whether studies should use the “best” available drugs or treatments instead of the most practical and available ones. It is important to realize that conducting relevant research in developing countries might not imply the use of the best and most effective treatments available in Western countries. Realistically, such treatments will not be readily available or will be too expensive for the majority of people in developing countries. “The testing of less effective treatments for use in poor countries is justly controversial and deeply troublesome. At the same time, the failure to do so would be even more problematic, essentially barring doctors in poor countries from conducting locally relevant research that might save or improve their patients’ lives.” (12) Thus, “studies need to reflect the reality of local care in order to produce locally relevant results.” (13)  Dr Elijah Kagwa from Kampala, Uganda explains, “somehow the ethics and the conduct of research is driven by the standards of the West…My opinion is that we should use the standard of care here. Because it makes more sense if you are investigating whether something is useful, you should compare it with what is being done here rather than what is being done in the US.”(14) Hilda Mulondo, a senior faculty member at Makerere University in Uganda, explained how she has been pressured by international collaborators to use the standard of care employed in their home countries, rather than in Uganda. She brought up the point that many research studies, even the ones involving basic tests, may involve tests and treatments that are not commonly available to patients in Uganda. This practice has become very common for HIV studies where “the need to produce data that are compatible with the expectations of peer-reviewed scientific journals and funding bodies based in wealthy countries requires quantitative measure of disease progression based on CD4 (T-cell) and viral load testing- diagnostic technologies that are far from universally available to doctors and patients throughout much of the country.” (15) Therefore, when conducting research and clinical trials, it is important for researchers to consider what treatments will be available in the country of interest and realize that the treatment that is considered “best” in developed countries may not actually be the most beneficial to a poorer country. There are frequently comparable treatments in developing countries which yield equally excellent patient outcomes.

Ensuring Relevant Research

In order to ensure that research is relevant and does not place a tremendous burden on the host country, it is important to involve local doctors and community members in the study and design. In 2000, the National Institute of General Medical Sciences recommended that researchers obtain community input in all phases of research, respect communities as partners, and establish appropriate community review procedures.(16) It is important to involve community members because “it has been shown that cross-cultural research methods that involve greater community collaboration and participation are more likely to provide long-term benefits to the community.”(17) In addition, community participation is imperative to ensure that communities are not exploited. Community partners should be involved in identifying health problems, assessing the value of the research, and planning and overseeing the research. The development of partnerships among researchers, policy makers and the community is essential to ensuring an equitable relationship.(18)

Conclusion

As medical research is becoming an increasingly global endeavor, research studies have become less relevant to the communities where they occur. However, there is a drastic need for relevant research, which can be ensured through close consultations and partnerships with local communities and local professionals. It is critical for the partner health professionals, for example, to lead and direct the study plan.

Footnotes

(1) Provenzano, A., et. al. “Short-Term Global Health Research Projects by US Medical Students: Ethical Challenges for Partnerships.” Am. J. Trop. Med. Hyg. 83.2 (2010): 211-214. Accessed on 16 December 2010.

(2) Garrafa, V., Solbakk, J., Vidal, S., and Lorenzo, C. “Research Ethics. Between the needy and the greedy: the quest for a just and fair ethics of clinical research.” J Med Ethics. 36. (2010):500-504. Accessed on 16 December 2010.

(3) Simon, C., Mosavel, M., van Stade, D. “Ethical challenges in the design and conduct of locally relevant international health research.” Social Science and Medicine. 64 (2007): 1960-1969. Accessed on 17 December 2010.

(4) Garrafa, V., Solbakk, J., Vidal, S., and Lorenzo, C. “Research Ethics. Between the needy and the greedy: the quest for a just and fair ethics of clinical research.” J Med Ethics. 36. (2010):500-504. Accessed on 16 December 2010.

(5) Barlett, D., and Steele, J. “Deadly Medicine.” Vanity Fair. Accessed on 20 December 2010.

(6) Ibid.

(7) Provenzano, A., et. al. “Short-Term Global Health Research Projects by US Medical Students: Ethical Challenges for Partnerships.” Am. J. Trop. Med. Hyg. 83.2 (2010): 211-214. Accessed on 16 December 2010.

(8) Ibid.

(9) Ibid.

(10) Ibid.

(11) Barlett, D., and Steele, J. “Deadly Medicine.” Vanity Fair. Accessed on 20 December 2010.

(12) Crane, J. “Adverse events and placebo effects: African scientists, HIV, and ethics in the ‘global health sciences’.”  Social Studies of Science. (2010). Accessed on 16 December 2010.

(13) Ibid.

(14) Ibid.

(15) Ibid.

(16) Reddy, P. “The role of community advisory boards in health research: Divergent views in the South African experience.” Journal of Social Aspects of HIV/AIDs. 7.3 (2010).  Accessed on 16 December 2010.

(17) Provenzano, A., et. al. “Short-Term Global Health Research Projects by US Medical Students: Ethical Challenges for Partnerships.” Am. J. Trop. Med. Hyg. 83.2 (2010): 211-214. Accessed on 16 December 2010.

(18) Reddy, P. “The role of community advisory boards in health research: Divergent views in the South African experience.” Journal of Social Aspects of HIV/AIDs. 7.3 (2010).  Accessed on 16 December 2010.