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The nature and extent of disparities in health resources and research funding raise concern that the international health research potentially could be an exploitation of the host country.
The ethical issues raised in international research collaborations involving human subjects are certainly not new or unique. However, when it comes to sponsoring research in another country, especially among vulnerable people in resource poor countries, research ethics is more than a mere “protection” against potential harms. The issues of beneﬁt sharing, local sociocultural sensitivity, standard of care, and availability of the research product, if proven effective, are among others that should be examined carefully.
This chapter elaborates on some of the existing concerns and ethical issues that may arise in international research collaboration. Special concern is in the situations in which vulnerable populations in resource-poor countries are likely to be exploited and/or where there is no guarantee of any beneﬁt from the research product, if proven successful, to the local community. By presenting the existing related international ethics guidelines, ethical challenges in international health research and the role of local research ethics committees in protecting the rights and welfare of the individual participants as well as the local communities are examined.
In developed and developing countries alike, biomedical research is an essential component of improving human health and welfare. Few decades ago, biomedical research was limited to geographical borders conducted by local research institutions. However, turning to the new millennium, due to global health threats such as AIDS, resistance to antimicrobial agents, SARS, and pandemics of infectious diseases, health research at the global level has become the focus of large-scale health science initiatives. Currently, due to inadequate research capacity and healthcare infrastructure, many developing countries are unable to address their research-based health needs. Therefore, in developing effective drugs and interventions to deal with these challenges, international health research plays a central role, and research collaboration is an inevitable strategy in global health programs. As a result and over the last two decades, clinical research conducted by sponsors and researchers from developed countries to be carried out in developing countries has increased dramatically. For instance, from 1990 to 2000, the US Food and Drug Administration (FDA) alone has recorded a 16-fold increase in the number of foreign clinical investigators conducting research on new medicines (Nufﬁeld Council on Bioethics 2002). In this so-called externally sponsored research, research protocols are designed or funded by research institutes in developed countries, but human subjects are recruited from resource-poor countries. The ethical concerns raised in international research collaborations are certainly not new or unique. However, when it comes to conducting research in other countries, especially among vulnerable people in resource-poor countries, research ethics is more than a mere “protection” against potential harms. There are several other ethical concerns that need to be examined carefully. Issues such as respecting local sociocultural beliefs, health research priority, beneﬁt sharing, standard of care, and availability of the research product, if proven effective, are among others that should be addressed. Given the fact that many countries especially developed countries have their own ethics review governance, the main question is whether the existing ethics guidelines and regulations that are applicable in their jurisdictions remain appropriate in the context of international research in another country. The issue of “double standards” in biomedical research sponsored by industrialized countries and carried out in developing countries is also a serious ethical concern in international research collaborations (Macklin 2004). Furthermore, in the context of international research collaboration, an argument has questioned the nature of research collaboration by asking whether there is a “real collaboration” between researchers in sponsoring institutes and host institutes. Usually, in many research collaborations, the research proposal has already been drafted and ﬁnalized by sponsoring institute and is only looking for a local body to assist on some practical issues such as recruiting the human subjects or to collect biological samples for the reference laboratory which is in the sponsoring country (Bagheri 2009).
All these concerns call for more ethical approach to international collaboration in biomedical research and a critical attention to the foundation of international health research with respect to its ethical dimensions.
Compared to the long history of medicine which is gloriﬁed by the ﬁght against diseases to cure millions of patients, the short history of research ethics started with scandals of abuse and exploitation of human subjects. The atrocities of Nazi physicians, abuse in US government-sponsored research, and Japanese physicians’ experiments on Chinese prisoners during the Second World War are just a few to mention. It should be noted that even after the existence of international ethical guidelines such as the Nuremberg Code, conducting unethical clinical research continued, e.g., the Tuskegee study which actually went on for 40 years (1932–1972) and radiation experiments on children at the Fernald and Wrentham schools (1943–1973) which violated the ethical codes in research.
The abuse of vulnerable individuals in the name of the science, expanding the frontiers of human knowledge, serving the interests of the larger community has always been a concern from the early time of human experimentations. As Claude Bernard, the pioneer of the experimental method, says, “the principle of medical and surgical morality consists in never performing on man an experiment which might be harmful to him to any extent, even though the result might be highly advantageous to science, or to the health of others” (Greenwald et al. 1982). This was also emphasized in the Declaration of Helsinki (2013), as it states, “while the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects” (General Principle, Para. 8).
In recent years, international multicenter randomized clinical trials have become the excellent model of research, especially on new medications. However, many resource-poor countries lack the necessary infrastructure to conduct medical research and therefore rely on the international health research collaborations to address their health problems. As a result, most of the health research conducted in such countries is sponsored by multinational pharmaceutical companies and research funding institutions in developed countries. This may highlight further concerns about the power of the market in clinical research. It has been argued that accessibility of human subjects, lower costs of research, lack of a clear research policy, and ethics review in resource-poor countries are the main reasons behind the fact that these countries have become a target by developed countries to conduct clinical trials (Bagheri 2009). For instance, the GlaxoSmithKline, a multinational pharmaceutical company, explains why in their sponsored trials they have extended patient recruitment into Asia, South America, and Eastern Europe, “the recruitment costs per patient in these countries can often be lower and also clinical trial capabilities in certain other parts of the world have improved and therefore the wider the geographic scope, the faster patients can be recruited, and the faster recruitment, the sooner new medicines will be available” (GlaxoSmithKline Position Paper 2006).
As stated by the National Bioethics Advisory Commission’s report (Nufﬁeld Council on Bioethics 2002), there are three reasons to design international collaborative research: one is to help the host country to address its public health problem; conducting a particular clinical trial in the host country would provide a more convenient, efﬁcient, or less troublesome site for the sponsoring country; and a research collaboration would give an opportunity to address an important common health problem for the host as well as sponsoring countries. Although in any international research collaboration, ethical issues should be identiﬁed and addressed, when a host country is selected because it will provide a more convenient, efﬁcient, and less troublesome option, it raises serious ethical concerns, and the proposal should be examined carefully.
International Research Collaborations: Existing Ethical Guidelines
Prior to 1906, when the food and drug act was passed in the United States, there were no regulations regarding the ethical aspect of using human participants in research. However, the most well-known and the ﬁrst international document is the Nuremberg Code which was promulgated in 1947 as a consequence of the trial of physicians who had conducted atrocious experiments on prisoners without their consent during the Second World War. The Nuremberg Code has been designed to protect the integrity of the research subject and set out conditions for the ethical conduct of research involving human subjects, and it places much emphases on their voluntary consent to research. It also makes it clear that the beneﬁts of research must outweigh the attendant risks.
In the late 1990s, the increasing number of collaborative international biomedical research sponsored by developed countries and carried out in resource-poor countries raised concerns about ethical standards in those research collaborations, i.e., maternal-to-child HIV transmission. To address these concerns, several ethical guidelines have been developed by international organizations. The International Ethical Guidelines for Biomedical Research Involving Human Subjects, issued by the Council for International Organizations of Medical Sciences (CIOMS 2002), and the Declaration of Helsinki (2013), developed by the World Medical Association, are two important documents which are used for guidance by the World Health Organization, investigators in both developed and developing countries, and also by national and local committees that review ethical issues in biomedical research. Furthermore, some other guidelines such as the UNESCO Declaration on Bioethics and Human Rights (2005) and the Nufﬁeld Council of Bioethics report entitled The ethics of research related to healthcare in developing countries (2002) have speciﬁcally addressed ethical issues in international research collaboration. Following are some related guidelines issued by international organizations in the context of international health research.
The International Ethical Guidelines For Biomedical Research Involving Human Subjects
The document was ﬁrst developed in 1982 by the Council for International Organizations of Medical Sciences (CIOMS) and has been undergone some revisions (e.g., in 1993 and 2002). As emphasized in the document, the ethical concerns about international research collaborations between developed and developing countries were the main reason in revising the document. It stated that “after 1993, ethical issues arose for which the CIOMS Guidelines had no speciﬁc provision. They related mainly to controlled clinical trials, with external sponsors and investigators, carried out in resource-poor countries and to the use of comparators other than an established effective intervention. The issue in question was the perceived need in those countries for low-cost, technologically appropriate, publichealth solutions and in particular for HIV/AIDS treatment drugs or vaccines that poorer countries could afford” (CIOMS 2002). The following provisions of this document are applicable in international research collaborations:
– In general, the research project should leave low-resource countries or communities better off than previously or, at least, no worse off. It should be responsive to their health needs and priorities in that any product developed is made reasonably available to them and as far as possible leave the population in a better position to obtain effective healthcare and protect its own health.
– Justice requires also that the research be responsive to the health conditions or needs of vulnerable subjects (General Ethical Principles).
– An external sponsoring organization and individual investigators should submit the research protocol for ethical and scientiﬁc review in the country of the sponsoring organization, and the ethical standards applied should be no less stringent than they would be for research carried out in that country. The health authorities of the host country, as well as a national or local ethical review committee, should ensure that the proposed research is responsive to the health needs and priorities of the host country and meets the requisite ethical standards (CIOMS Guideline 3).
– As a general rule, research subjects in the control group of a trial of a diagnostic, therapeutic, or preventive intervention should receive an established effective intervention. In some circumstances it may be ethically acceptable to use an alternative comparator, such as placebo or “no treatment” (Guideline 11: Choice of control in clinical trials).
– Placebo may be used: (i) when there is no established effective intervention, (ii) when withholding an established effective intervention would expose subjects to, at most, temporary discomfort or delay in relief of symptoms, (iii) when the use of an established effective intervention as comparator would not yield scientiﬁcally reliable results, and when the use of placebo would not add any risk of serious or irreversible harm to the subjects.
– Guidelines 4, 5, and 6 focus on the informed consent process. The Guideline 8 states that the investigator must ensure that potential beneﬁts and risks are reasonably balanced and risks are minimized. In Guideline 12, it emphasizes that the burdens and beneﬁts of the research should be equitably distributed in groups and communities that provides research subjects.
– External sponsors are ethically obliged to ensure the availability of healthcare services that are essential to the safe conduct of the research, treatment for subjects who suffer injury as a consequence of research interventions, and services that are a necessary part of the commitment of a sponsor to make a beneﬁcial intervention or product developed as a result of the research reasonably available to the population or community concerned (Guideline 20).
It should be noted that the 2002 CIOMC guidelines are under revision, and the focus is on the use of placebo as one of the most controversial issues in international research collaboration.
Declaration Of Helsinki
In 1964, the World Medical Association established recommendations to guide researchers involved in biomedical research on human participants. The Helsinki Declaration governs international research ethics and deﬁnes rules for “research combined with clinical care” and “nontherapeutic research.” It is important to note that the Declaration has been revised in 1975, 1983, 1989, 1996, 2000, 2008, and 2013. Some of the relevant contents include:
– Physicians must consider the ethical, legal, and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal, or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration (General Principle, Para. 10).
– Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm. All vulnerable groups and individuals should receive speciﬁcally considered protection (Para. 19).
– Medical research with a vulnerable group is only justiﬁed if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should stand to beneﬁt from the knowledge, practices, or interventions that result from the research (Para. 20).
– The research protocol must be submitted for consideration, comment, guidance, and approval to the concerned research ethics committee before the study begins. This committee must be transparent in its functioning; must be independent of the researcher, the sponsor, and any other undue inﬂuence; and must be duly qualiﬁed. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards (Para. 23).
– In advance of a clinical trial, sponsors, researchers, and host country governments should make provisions for posttrial access for all participants who still need an intervention identiﬁed as beneﬁcial in the trial. This information must also be disclosed to participants during the informed consent process (Post-Trial Provisions, Para. 34).
It is important to note that regarding the use of placebo, one of the most controversial issue in international research, the Declaration stated that “the beneﬁts, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances: (i) Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or (ii) Where for compelling and scientiﬁcally sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efﬁcacy or safety of an intervention and (iii) the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention”. And it emphasizes that the extreme care must be taken to avoid abuse of this option (Use of Placebo Para. 33).
However, it has been argued that speciﬁc items in the Declaration of Helsinki and the CIOMS international ethical guidelines were open to different interpretations, and it suffers from internal consistency. Therefore, in the past couple of years, both documents were under revision, and in 2013 the new version of the Declaration of Helsinki was released, and the CIOMS guidelines are still under revision, and the new version is expected to be released in 2016.
Ethical Considerations In HIV Preventive Vaccine Research
In response to the vast criticism of the HIV international research especially in terms of placebo use and beneﬁt sharing, this document was developed by the Joint United Nations Program on HIV and AIDS (UNAIDS). The UNAIDS guidelines also touch upon ethical issues in international research collaborations:
– As long as there is no known effective HIV preventive vaccine, a placebo control arm should be considered ethically acceptable in a phase III HIV preventive vaccine trial (Guidance Point 11: Control group).
– Care and treatment for HIV/AIDS and its associated complications should be provided to participants in HIV preventive vaccine trials, with the ideal being to provide the best proven therapy, and the minimum to provide the highest level of care attainable in the host country in light of.. .circumstances listed (Guidance Point 16: Care and treatment) (UNAIDS 2000).
Universal Declaration On Bioethics And Human Rights
The UNESCO Universal Declaration on Bioethics and Human Rights was adopted in 2005, and in Article 2 (Aims), it emphasizes on promoting equitable access to medical, scientiﬁc, and technological developments as well as sharing of beneﬁts, with particular attention to the needs of developing countries (Art. 2;f).
– In applying and advancing scientiﬁc knowledge, medical practice, and associated technologies, direct and indirect beneﬁts to patients, research participants, and other affected individuals should be maximized, and any possible harm to such individuals should be minimized (Art. 4: Beneﬁt and harm).
– Beneﬁts resulting from any scientiﬁc research and its applications should be shared with society as a whole and within the international community, in particular with developing countries. In giving effect to this principle, beneﬁts may take any of the following forms: (a) special and sustainable assistance to, and acknowledgement of, the persons and groups that have taken part in the research, (b) access to quality healthcare, (c) provision of new diagnostic and therapeutic modalities or products stemming from research, (d) support for health services, (e) access to scientiﬁc and technological knowledge, (f) capacity-building facilities for research purposes, (g) and other forms of beneﬁt consistent with the principles set out in this Declaration (Art. 15-1: Sharing of beneﬁts).
– When research is undertaken or otherwise pursued in one or more States and funded by a source in another State, such research should be the object of an appropriate level of ethical review in the host State(s) and the State in which the funder is located. This review should be based on ethical and legal standards that are consistent with the principles set out in this Declaration (Art. 21-2, Transnational practices).
– Transnational health research should be responsive to the needs of host countries, and the importance of research contributing to the alleviation of urgent global health problems should be recognized (Art. 21-3, Transnational practices).
– When negotiating a research agreement, terms for collaboration and agreement on the beneﬁts of research should be established with equal participation by those parties to the negotiation (Art. 21-4, Transnational practices).
It should be noted that despite consensus on the major issues, controversies and disagreements exist about some other issues such as the use of placebo control in new drug trials. However, in practice, applying these guidelines is often fraught with difﬁculty and sometimes provides conﬂicting advice (Nufﬁeld Council on Bioethics 2002). In addition, there is no documentation on the application of these guidelines, or how ethics committees in developing countries deal with research proposals from foreign research institute or pharmaceutical companies.
The Role Of Local Ethics Committees
In the last two decades, establishing necessary infrastructure for ethics review of biomedical research has become an international demand. The role of the research ethics committees as an expert body is to evaluate the acceptability of research proposals through a consensual weighing of different moral considerations. Countries are increasingly devoting signiﬁcant resources to creating or strengthening research ethics committees, but there has been insufﬁcient attention to assessing whether these committees are actually improving the protection of human research participants especially in developing countries.
It has been argued that research ethics committees face numerous obstacles to achieving their goal of improving research participants’ protection. To improve the ethics review, it has been suggested that outcome assessment of research ethics committees should address these questions: ﬁrst, does research ethics committee review improve participants’ understanding of the risks and potential beneﬁts of studies? Second, does it reduce the riskiness of research? Third, does it result in more of international research becoming responsive to the local community’s self-identiﬁed needs? Finally, is research ethics committees’ guidance to researchers actually being followed? (Coleman and Bouësseau 2008). However, it is important to identify what prospective research participants and their communities hope to get out of the ethics review process. In fact, research ethics committees in many poor-resource countries have insufﬁcient experience to address these issues. For instance, a survey of 15 research ethics committees shows that more than 70 % reported moderate, limited, or no capacity to review HIV vaccine trial protocols (Milford et al. 2006). The concern about the safety and protection of human subjects who take part in clinical trials should be the focus of research ethics regulatory framework. However, when it comes to international research, the responsibility of local research ethics committees is beyond the mere protection of vulnerable research participants. These committees should also be concerned about the health priority of their community, sharing the beneﬁt of research to the local research participants, and respecting local sociocultural issues and standard of care.
Therefore, in international research collaborations, to protect the rights of the research participants as well as local communities, it is crucial to recognize the important role of local ethics committees in the host country. As Zawati and colleagues argue “if research is increasingly global, a system for mutual recognition of substantial equivalency of ethics review and of oversight in different jurisdictions is a key for collaborative science generally, but genomics and multi-centred clinical trials speciﬁcally” (Zawati et al. 2015). It has been argued that revision of international ethical guidelines or any other research ethics code (per se) is unlikely to make research more ethical without some means of strengthening capacity to promote and implement such standards. The author continues by saying that strengthened capacity in research ethics review is needed in both developed and developing countries, though the need is particularly acute in developing countries (Singer 2001). The ethics committees, researchers, and sponsors have an obligation to make sure that conducting particular research collaboration “leaves something behind” when the research is completed. To fulﬁll this obligation, it is important to help developing countries to build their own capacity in conducting research independently. Elements of capacity building include training scientists and other research personnel, contributing to the research and healthcare infrastructure in the community or country, and providing training for scientiﬁc and ethical review of research (Macklin 2004). It has been suggested that because of the complexity of ethics review of international research proposals, assigning the national ethics committee or an ethics committee speciﬁcally charged with the task of reviewing these proposals would bring better results in protecting human subjects as well as ensuring beneﬁt sharing with the local community (Bagheri 2009).
Ethical Challenges In International Health Research Collaboration
The following are some of the long-lasting ethical challenges in international research collaboration: National Health Priorities: In international health research, several studies have indicated that research agendas are largely dictated by the donor agencies and often with little attention to the research priorities in the host countries. A situation that best reﬂects a general problem is named “donor culture.” This means that fund receiving countries are largely without a voice in major decisions made by the donor companies in developed countries.
Evidences show that there is a continued imbalance in international health research, which is resulting in market failure for needed interventions and limited access to the beneﬁts of research, especially for developing countries. The so-called 10/90 gap tries to draw attention to the fact that of all the funds invested in global health research by the public and private sectors, less than 10 % is devoted to research into the health problems that account for 90 % of the global disease burden. Striking a balance between health needs in resource-poor countries with international research activities related to their health needs can make a difference and help to ﬁll the gaps. It should be noted that the World Health Organization has acknowledged the need for a more harmonized approach by developing a ﬁrst-ever organization-wide strategy on research for health (WHO 2009). This approach focuses around the four goals of priority setting, capacity building, setting of norms and standards, and translation of knowledge into policy and practice. However, the research ethics committees in those countries should focus on how biomedical research can contribute to the health needs of the local community while at the same time contain adequate protections for the rights and welfare of the research participants recruited for the study.
Beneﬁt Sharing, Availability, Accessibility, and Affordability of New Interventions: The issue of beneﬁt sharing brought to the global attention, particularly within the context of access to antiretroviral treatments for HIV/AIDS in 1990s, questions such as: what should happen once a research project in a developing country is completed? Or should the products of the clinical trials – new therapeutic methods or drugs – be made available to the local community in which the trial was conducted or not? Tensions also exist around equitable sharing of research results, because developing countries may fear the possibility that ﬁnding of a research, i.e., new vaccines or drugs, may be sold to them at prices they cannot afford.
In fact, when it comes to resource-poor countries, there is a huge gap between availability of a new drug with accessibility and affordability to receive that new medication. Although widespread agreement exists on the general principle, disagreement surrounds its interpretation. Is research responsive to the health needs of the population just so long as it addresses a health problem that is prominent in the country or region? Or must some steps be taken before the research is initiated to seek to ensure that successful products are made available to the population at the conclusion of the research? Another concern in the governance in international health research is the lack of transparency and accountability of research in the developing world. There are worrying reports of unethical conduct of clinical trials in these settings, especially in terms of beneﬁt sharing (National Bioethics Advisory Commission 2001; UNESCO Declaration 2005). As mentioned earlier, special concern in international health research is in the situations in which vulnerable populations in resource-poor countries are likely to be exploited. Exploitation in this context has been described as unfair distribution of research’s beneﬁts when there is no guarantee of any beneﬁt from the research product, if proven successful, to the local community. In fact individuals and communities in developing countries bear the risk of research, but people in developed countries receive most of the beneﬁts. If the goal is to avoid this potential exploitation in international research collaboration, post-study access to interventions identiﬁed as beneﬁcial in the study or access to other appropriate care or beneﬁts to the local participants should be guaranteed by the sponsoring countries. It is expected that the implementation of the principle of “beneﬁt sharing” which has been emphasized in the UNESCO Declaration on Bioethics and Human Rights can help those countries to enjoy the beneﬁts of biomedical research.
The Issues of Standard of Care and Placebo Control: In 1997, the issue of standard of care fueled controversies and disagreements, when the US-funded research into the prevention of mother-to-child transmission of HIV in Thailand was criticized in The Lancet. In those trials, participants in the control group were given a placebo, rather than a long course of antiretroviral treatment, which had been demonstrated to be effective in developed countries. In her book, Double Standards in Medical Research in Developing Countries, Ruth Macklin elaborates the tension and controversy in international health research between developed and developing countries. She explores the double standards as an ethical issue that have surrounded international medical research sponsored by industrialized countries and carried out in developing countries (Macklin 2004). The main concern is that research subjects in resource-poor countries may be exploited because sponsors of research employ double standards.
The question focuses on whether the standard of care provided to subjects of medical research in developing countries should be the same as that which research subjects receive in North America and Europe. Other questions such as should standard of care be provided to participants in control groups in clinical trials continue to be relevant in international health research. There also may be disagreement concerning the criteria for identifying the standard of care. Is it the best available treatment? And what do best and available mean in “best available treatment”?
The critics argued that all participants should be provided with the best available treatment anywhere in the world to prevent the exploitation of those in control groups, regardless of where the research is conducted. However, other researchers and research sponsors argued that it is not always possible, affordable, or appropriate to supply a “universal” standard of care in developing countries and that the difﬁculties of meeting such a requirement would prevent beneﬁcial medical research from being conducted. In fact, in the past several years, the inﬂuential research ethics guidelines such as the Declaration of Helsinki and CIOMS Guidelines have been revised mostly because of this ethical challenge in international research collaborations. The policy whether to approve placebo control or not has a great impact on pharmaceutical companies in testing new drugs. Weijer and Anderson call this situation the ethics wars over international research among international organizations. They say; “These disputes have become wars. Neither one could reasonably be described as an open and thorough examination of the thorny ethical issues at stake. Rather each side has joined a political struggle to rewrite the Declaration of Helsinki and the CIOMS guidelines in accordance with its own views” (Weijer and Anderson 2001). It should be noted that the impossibility of providing everything that might be interpreted as “best current prophylactic, diagnostic, and therapeutic methods” does not lead to the conclusion that the only alternative is local standards of care.
The Issue of Informed Consent and Its Quality: From its root through the 1947 Nuremberg Code, all ethics guidelines in biomedical research have stressed the importance of informed consent. Although informed consent has been recognized as a major component of clinical research, it remains a challenging issue especially in international health research. For instance, a study to compare voluntary participation and comprehension of informed consent among research participants in a genetic study in the United States and Nigeria illustrates different standard between developed and developing countries. The study found that while 99 % of participants in the United States were told about the study purpose, only 72 % of Nigerians were giving this information. Also in the United States, 97 % reported that they knew that they could withdraw from the study, compared with 67 % in Nigeria (Marshall et al. 2006).
In conducting health research in different cultural settings, participants’ understanding of the components of informed consent is one of the most challenging issues. A meta-analysis of a systematic review shows that the proportion of participants in clinical trials who understood different components of informed consent varied from 52 % to 75 %. The study concludes that the proportion of participants who understood informed consent had not increased over 30 years (Nguyen et al. 2015). For this reason, the 2013 version of the Declaration of Helsinki has emphasized on informed consent by providing more details about its components. It reads as: “In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conﬂicts of interest, institutional afﬁliations of the researcher, the anticipated beneﬁts and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study” (Para. 26). To achieve the goals of informed consent in international health research, it is important to make sure that informed consent is obtained through a process and not just as an event to sign a paper. Special attention must be given to ensure that the participants understand all components of informed consent.
In practice, given the cultural as well as legal diversities between sponsoring and host countries – developed and developing countries – it is evident that the issue of informed consent would be one of the most challenging issues in international research collaborations. For instance, a very simple issue, “literacy” and imbalance in knowledge between sponsoring country and a resource-poor country, is usually unnoticed in preparing informed consent form. In result, the consent process does not appear to address this imbalance, and the basic concepts of the research do not appear to be appropriately understood by research participants.
Given the global health problems, collaboration in international health research is inevitable and, in fact, can contribute to global health enormously. However, due to speciﬁc concerns that arise when a health research is sponsored by a developing country but human subjects are recruited from resource-poor countries, it is ethically imperative to safeguard vulnerable populations in the host countries against exploitation and harms.
It is crucial that the research ethics committees in the sponsoring country as well as the host country give special consideration to the health problems of poor nations and ensure that fairness prevails in setting research priorities, in addition to ensuring that individuals and local community beneﬁt from the outcomes of biomedical research collaboration.
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