**3. Background**

Poverty accounts for almost one-third of the global burden of disease and there is a definite relationship between wealth/poverty and health/disease, although this relationship is not linear [41]. In "developing" countries, where cultural, linguistic, economic, and other barriers may prevail between researchers and subjects, it is especially important to ensure effective communication [42, 43].

The medical industry is not exempted from the development of globalization, and the number of medical research studies conducted in developing nations, instead of in Western countries, has rapidly increased to gain more financial and scientific benefits [44, 45].

#### **3.1. Advantages of conducting medical research in developing countries**

When the United States' National Bioethics Advisory Commission (US-NBAC) asked a pharmaceutical researcher why the industry seeks to conduct studies in developing countries, the answer was that the pharmaceutical industry is not a charitable business. It is a profitable Wall Street hard-core business [46]. There are several reasons that attract these companies to conduct their research in developing countries. Ruth Macklin divides these reasons into financial and scientific [45].

From sponsors' point of view, the main financial reasons are that the speed of research is faster in the developing country due to less oversight, thereby enabling the company gain approval for marketing and realize a profit sooner [46]. Research can often be done faster in those areas as time-consuming legislative requirements and local ethical review committees are not as well established in developing countries as in Western countries. Macklin points out that financially it is cheaper to carry out research in developing countries as they can offer lower costs for all of the ancillary goods and services necessary to set up and support the research, including labor costs for technical and scientific personnel [47].

Lack of awareness among participants about the methods and reasoning of research in healthcare may lead to therapeutic misconception as participants believe that the main goal of research is to provide them with therapy not to obtain information. For this reason, the US-NBAC recommended that investigators working overseas must indicate in their research protocols how they intend to minimize the possibility of therapeutic fallacy [48, 49].

#### **3.2. Excellence in medical research**

Regrettably, 50 years after the Nuremberg trials and the Nuremberg Code, unethical medical research on humans continues, even in highly privileged countries [50–52]. Similarly, the continuation of human and patient rights abuses for 50 years after the Universal Declaration of Human Rights, even in wealthy industrialized countries, illustrates how difficult it is to achieve such universal moral aspirations [53, 54]. How research be regulated to avoid the errors and indiscretions of the past and to avoid new forms of discrimination and victimization in the increasingly complex era of biotechnology?

Early in 1993, the Council for International Organizations of Medical Research (CIOMS) launched its guidelines endorsing that ethical values must reinforce respect for the dignity of research subjects and to minimize risk, maximize benefits, make convenient compensation for time, provide reparation for any damage occurring during the research, protect confidentiality, and avoid conflict of interest [55–60].

#### **3.3. Methods to achieve universal standards**

may prevail between researchers and subjects, it is especially important to ensure effective

The medical industry is not exempted from the development of globalization, and the number of medical research studies conducted in developing nations, instead of in Western coun-

When the United States' National Bioethics Advisory Commission (US-NBAC) asked a pharmaceutical researcher why the industry seeks to conduct studies in developing countries, the answer was that the pharmaceutical industry is not a charitable business. It is a profitable Wall Street hard-core business [46]. There are several reasons that attract these companies to conduct their research in developing countries. Ruth Macklin divides these reasons into

From sponsors' point of view, the main financial reasons are that the speed of research is faster in the developing country due to less oversight, thereby enabling the company gain approval for marketing and realize a profit sooner [46]. Research can often be done faster in those areas as time-consuming legislative requirements and local ethical review committees are not as well established in developing countries as in Western countries. Macklin points out that financially it is cheaper to carry out research in developing countries as they can offer lower costs for all of the ancillary goods and services necessary to set up and support the

Lack of awareness among participants about the methods and reasoning of research in healthcare may lead to therapeutic misconception as participants believe that the main goal of research is to provide them with therapy not to obtain information. For this reason, the US-NBAC recommended that investigators working overseas must indicate in their research

Regrettably, 50 years after the Nuremberg trials and the Nuremberg Code, unethical medical research on humans continues, even in highly privileged countries [50–52]. Similarly, the continuation of human and patient rights abuses for 50 years after the Universal Declaration of Human Rights, even in wealthy industrialized countries, illustrates how difficult it is to achieve such universal moral aspirations [53, 54]. How research be regulated to avoid the errors and indiscretions of the past and to avoid new forms of discrimination and victimiza-

Early in 1993, the Council for International Organizations of Medical Research (CIOMS) launched its guidelines endorsing that ethical values must reinforce respect for the dignity of research subjects and to minimize risk, maximize benefits, make convenient compensation for time, provide reparation for any damage occurring during the research, protect confidential-

protocols how they intend to minimize the possibility of therapeutic fallacy [48, 49].

tries, has rapidly increased to gain more financial and scientific benefits [44, 45].

**3.1. Advantages of conducting medical research in developing countries**

research, including labor costs for technical and scientific personnel [47].

communication [42, 43].

48 International Development

financial and scientific [45].

**3.2. Excellence in medical research**

tion in the increasingly complex era of biotechnology?

ity, and avoid conflict of interest [55–60].

Universal ethical standards are still a debatable complex issue, which requires reflection on some issues. First, the best interests of subjects that may differ significantly according to personal and cultural priority and the magnitude of achievement in any situation. Second, what is considered truly universal? Third, is the entity of contextual issues that could be considered moral without resorting to ethical relativism [61–64]. Among those, recognition and dealing with contextual differences is a must to avoid both ethical imperialism and ethical relativism [65, 66].

#### **3.4. International ethical guidelines**

Different countries have different laws, different views on human rights, and different ethical principles. Most countries in the developed world have their own set of laws and regulations concerning research with human subjects. These laws and regulations emphasize the key principles of human research such as informed consent, risk minimization, reasonable riskbenefit ratio, and confidentiality [67].

Developing countries may not possess such regulations or if they do, the regulations are weaker. Additionally, there are no international laws on medical research that apply in all countries to which all researchers conducting studies in another country must follow. However, there are international ethical guidelines for conducting medical research that can be followed in order to design and conduct an ethical research in a developing country. The most widely accepted are the Nuremberg Code, the DH, and the guidelines developed by the CIOMS [67].

#### **3.5. Research ethics committees in developing countries**

In many developing countries, ethics has been paid insufficient attention. There is minimal similarity in the organization of research ethics committees (RECs) and little if any public responsibility. Existence of self-appointed private RECs lacking in expertise and liability, the absence of rational discourse, and possibilities of undeclared conflict of interest express most problems in some countries [59, 60].

#### **3.6. Comprehensive guidelines for research ethics in developing countries**

Many categories of issues require special consideration in formulating new guidelines for biomedical research on human subjects in "developing" countries. Incommensurable load of diseases aggravated by the extent of destitution and high levels of illiteracy is a major issue to be considered. Differences between patients' categories lead to added rights and ethical consideration in special groups by age or disease. Imbalance between the needed and actual resources available for research and basic health care with wide differences in access to health care is another important category. Finally, inadequate scientific and ethics infrastructures for the required reviewing process are a key issue [68, 69].
