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Ethical Issues of Clinical Ethics And Research Ethics In The Developing World And Pakistan: Is There Any Solution?
- Zoheb Rafique
Abstract: Health research plays an important role in addressing the inequities in human development and health, but in order to achieve these objectives, research should be based on ethical principles and sound scientific knowledge. Although it is accepted fact that bioethics play a pivotal role in health related research in the developing countries, much of recent debate has focused on the controversies surrounding internationally sponsored research and it has taken place largely without the adequate participation of developing countries. The relationship between the ethical guidelines and regulations, and also indigenously/locally sponsored and public health research is not adequately explored and so needs further exploration.
Globally, there are wide inequalities in the economic development, in health outcomes, in burden of diseases and it is certain that the accelerating course towards globalization, without requisite safeguards and the protection of human rights, will only worsen the health inequalities. The funding of research in the developing countries has been the subject and debate of much attention recently. The forum for global health research has indicated that less than 10 % of the world’s research resources are earmarked for 90 % of the health problems. Recently, there was considerable debate regarding ethical conduct and the reviewing of health related research, but this debate has mostly taken place among the bioethicists and researchers in the industrialized countries. The view points of public health researchers and practitioners from the developing countries have been underrepresented. Research needs to respond to the community needs and also national priorities, and development of a national research agenda in the developing countries must be firmly grounded in the process of priority setting. However a more difficult challenge is to involve communities themselves in the research questions and to link their research to their development. Pakistan, being a poor country, has very limited health care resources. Treatment options for individual patients and between patients for free and subsidized treatments are common ethical dilemmas. Thus, prioritizing illnesses and people is an enormous ethical challenge and a very common part of every day medical practice in Pakistan. A review of published discourse on ethics in Pakistan reveals several general trends. These include a focus on ‘medicine’ as defined by formal western medical practice, delivered by physicians only. There is no pursuit of ethics as a focus of the work of other health professionals. The physician-authors of papers, the types of journals where papers have been published, and the physician dominant mode of health care, especially curative health care, in Pakistan make this understandable. Research ethics have not been captured in the published papers in Pakistan. This is an area of great importance that has escaped notice of the national thinkers and policy-makers. The conduct of appropriate and ethical research in international settings has been the focus of recent international reports. Ethical review committees, institutional review boards, and other national mechanisms to protect human subjects need to be discussed and put into place in Pakistan, as may be the case in other developing countries. Additional work is required to explore this important area within the context of the developing world. (1). The vital links between clinical and research ethics and human rights are perhaps of even greater significance in developing countries, where human rights are frequently ignored and violated. Conducting research in hierarchical, traditional countries such as Pakistan adds yet another dimension to the difficulties in assuring that it is done in an ethical manner; an “indigenous” layer of cultural norms makes it even more of an uphill task, but it is a task that we are morally bound to shoulder. The historical and social construct of the Pakistan culture, the socioeconomic realities (with similarities to other countries in this region) and some of the deeply rooted values and customs pose challenges that are specific to this part of the world. We who live here know them, and only we can address them. Perhaps the most important factor that places human subjects at risk in this part of the world is the magnification of “power differentials” inherent in hierarchical societies such as Pakistan. This difference is particularly pronounced in the interactions between physicians and scientists and those they take care of or enroll in research projects. In Pakistan, scientists and physicians constitute the “elite” section of society. They are by and large the “English-Speaking”, affluent, highly educated minority in a society where the majority of those they deal with in their professional lives are “Urdu-Speaking”, poor, generally illiterate or misinformed and disadvantaged in many other ways. (2). Local researchers trained within the country have no concept of research ethics. There is a growing awareness that research cannot progress without better research ethics systems in developing countries. At the close of the last century several of the international agencies involved in funding health research, including WHO, tried to seriously examine the role of health research as an important contributor to sustainable human development. They also attempted to assess how governance of research at national, regional and global levels be made more effective and efficient. Ethical practice in health care and research is not only needed to ensure equity in health care and research, but also to project individuals and communities from unnecessary risks and harm. (3).We can make clinical research more ethical in Pakistan by following all the International guidelines regarding clinical research ethics. Health research can play a crucial role in improving national and global health by developing and evaluating interventions and by exploring strategies that can empower individuals to alter unhealthy behaviors. However, health research involves human subjects and such individuals might be harmed by their participation in research. Accordingly, a strong system of ethical review is needed to enhance the protections of the rights and welfare of human subjects. Also, to enhance the public trust in research activities, investigators need to subscribe to a strict code of ethics that equals the highest standard of respect for human rights. This framework thus places ethics at the very core of a country’s programs for health and development. (4). There are five key ethical principles of ethical research that appear across the ethical codes of research institutions and associations. These are a) informed and voluntary consent; b) confidentiality of information shared; c) anonymity of research participants; d) beneficence or no harm to participants; and e) reciprocity. Researchers are expected to obtain informed consent from all those who are directly involved in research or in the vicinity of research. This principle adheres to a larger issue of respect to the participants so that they are not coerced into participation and have access to relevant information prior to the consent. Usually consent is obtained through written consent forms, and necessary elements of consent are identified by the review committees. These usually include prior information on key elements of research such as purpose, procedures, time period, risks, benefits, and a clause stipulating that participation is voluntary and the participants have the right to withdraw from the study. The principles of confidentiality of information shared and Anonymity of Research participants is also concerned with offering respect and protection to research participants through assurance of confidentiality of information shared and anonymity by not revealing the identity of the individuals and institutions involved. Typically anonymity is provided through the use of pseudonyms. The principles of Nonmaleficence, Beneficence and Reciprocity bounds the researchers to provide the participants with an outline of the risks and benefits involved to the participants in the study. The principle of reciprocity requires that the researchers consider actively ways through which participants could be compensated for their time and effort. Typically information about risks and benefits are expected to be provided in summary in the consent form and/or in a brief write up attached with the consent form. These principles and procedures of an ethical engagement with a research study are laid out with the best of intentions to protect participants from malpractices and breach of ethics. However, the approach is taken from a mainly clinical medical research perspective with a concomitant view of epistemology and ontology. Hence, it is assumed that there is a well stated hypothesis which is to be tested, the relationship between the researcher and researched is clearly divided and bounded, and it is possible to outline the potential risks and benefits in some detail prior to the study. (5).The two salient concerns of public-health ethics in our Pakistan case are social justice as a background motivation and accountability as the primary operational objective. The formation of Pakistan’s NBC resulted from PMRC’s active involvement in documenting the under-distribution of global health research benefits to populations in LMICs (low and middle income countries). While this disparity might be seen as a failure of social justice on a global scale, redressing the 10/90 gap is in part a matter of domestic social justice, i-e, of how the benefits and burdens of social cooperation are distributed within each Sovereign State. Closing the gap would require governments of LMICs, such as Pakistan, to participate in dramatically increasing the amount of health research undertaken for the benefit of their own populations. Ensuring accountability for the conduct of this research with human subjects requires that protocols undergo independent ethical review. (6). A systems perspective will enable research stakeholders to improve their understanding and implementation of a national health research system (HRS) in order to improve health outcomes and health equity. Knowledge produced by health research, if disseminated widely, is a global public good. Knowledge contributes to the policies, activities, and performance of health systems, and to the improvement of individual’s and population’s health. The process of conducting research ethics and utilizing knowledge is a highly complex one. One glaring symptom of the current weakness of HRS across countries is that the research process and the policy process tend to exist in different worlds, with the result that research often has a limited impact on policy. Researchers and decision-makers tend to interact only around the “products” of their processes-for example, the results of a study for the researchers and a set of priorities for the decision-maker. Clearly, more attention needs to be given to establishing and maintaining ongoing links between the two words and, as noted previously, taking stock of the non-linearity of the research-policy-practice processes. (7). Bleak and confusing as the field may be, the last few years have been a watershed in international bioethics and the heightened debate has pushed ethical issues surrounding health research in developing countries into the limelight. The challenge is to develop sound plan for expanding this ethics debate to larger issues of the global justice and equity, and to make the process as participatory and democratic as possible. The main goal in all these activities should be reduction of the global inequalities in health. Most of public health related problems in South Asia and their immediate causes are related to distal factors such as illiteracy, poverty, societal and gender inequities. The underlying issues must be understood to develop meaningful and sustainable solutions. (8).This will take time, but this is the only way to bring about true change in ethics of international health research.
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