Ethics of international collaboration.

Education and research together are vital components of academic institutions and globalization has improved health care education and research in numerous ways, one of which is multinational/transnational research/international collaboration. Usually academic institutions of high-income countries and institutions in low-income countries participate in collaboration. These collaborative research are guided by international ethics codes proposed by the international ethics committee to avoid stringent follow/unethical practices.

“Your corn is ripe today; mine will be so tomorrow. Tis profitable for us both, that I should labor with you today and that you should aid me tomorrow. I have no kindness for you and know you have as little for me. I will not, therefore, take any pains upon your account; and should I labor with you upon my own account, in expectation of a return, I know I should be disappointed, and that I should in vain depend upon your gratitude. Here, then I leave you to labor alone; you treat me in the same manner. The seasons change; and both of us lose our harvests for want of mutual confidence and security.”

Medical Education and Research are exquisite components of higher academic institutions and are inter-dependent. Globalization has improved medical education and research in numerous ways, one of which is multinational/transnational research. Collaborations between institutions, national and international have recently taken the limelight in the advance of research. Usually, academic institutions of high-income countries and institutions in low-income countries participate in collaboration.

The term “ethics of international collaboration” or commonly known as the “Ethics of externally sponsored research” is research undertaken in a host country but sponsored and financed partly/completely by the external international organization/institution in collaboration/agreement with the authoritative medical organization/institution of the host country. This agreement usually called the Memoranda of Understanding.

Objectives of international collaboration include:

Exchange of scientific information

Exchange of manpower (scientists, technical staffs etc.,) for training under the projects

Combined accomplishment of the goals of the scientific project

Organization of medical education sessions, scientific meetings, symposia, seminars, workshops, etc.[1]

Although these transnational/multinational researches are highly beneficial for the low-income/developing countries, ethical issues exist in the implementation of these collaborative projects. These biomedical research projects are guided by the research ethical guidelines proposed by the Council for International Organizations of Medical Sciences in collaboration with WHO - International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002 – latest version). These guidelines are based on the World Medical Association's “Declaration of Helsinki” wherein it is stated that all researchers need to abide by the regulatory norms and standards for research involving human subjects laid down in their own countries as well as those available internationally. These norms should not be manipulated or altered at any point as such an event is likely to result in the compromise of protection of the research subject or volunteer.[2]

The health authority/organization and the ethics review committees should ensure that the proposed research project is ethically justified and scientifically valid to implement, meeting the health priorities of the host country and its ethical regulations. The project proposals are to be subjected to one or more review committee meetings (scientific and ethical) for approval and subsequent assessment of progress. The review committees should be independent of the research team. The research protocol submitted by the sponsoring organization/institution should abide by the international ethics regulations/their own country's ethics codes to avoid stringent follow of ethical guidelines. Usually, approval by both the committees (sponsoring and host country) is required, but the host country ethics committee approval requires more competence to assess its acceptability to local customs and traditions. When the host institute/organization is inefficient to independently judge the ethical review of the project, extensive review is to be performed by the committees of external sponsoring country/international ethics committee.[34]

Informed consent is as important component of multinational/transnational research. It is the decision taken by the organization/institution of the host country to participate in research. The organization should be competent to perceive and understand the research information completely including the disadvantages of the research and given the right to accept or decline the proposal without any pressure or persuasion. International collaboration/multinational research can arise due to requisition by a host country or rendered without invitation by the sponsoring external organization. In any case, informed consent with complete unveiling of the risks and benefits of the proposed research for both host and external sponsoring organization. Informed consent should be documented once obtained appropriately, and it is a continuous process requiring renewal when changes are introduced in the project design/procedure. In addition to the consent by the host organization, informed consent is necessary from the participating subjects/individuals. Waiving of the consent can only be done if the procedures employed in the study design is not “more than minimal risk” and obtaining consent makes the conduct of the project impracticable. The participating subjects in the project should be paid emoluments for the time spent, travel, and inconvenience. The emoluments paid should not be large to induce subject's consent/participation. These emoluments are to be analyzed by the ethical review committee. The risks and benefits involved in the projects should be clearly stated and completely communicated to the participants, taking adequate measures to minimize the risk. Minimal risk may be acceptable given the importance of the knowledge procured.[35]

Prior to initiating the research work, the risks and benefits to the individuals involved should be determined carefully. Thereafter, this assessment should be continuous, and all the observations should be clearly documented. All efforts should be focused to minimize the risks involved.[2]

The standard of education implemented during the project should be relevant for the host country's interest and not to the interest of the visiting professionals. The education rendered should be able to implement practically in the improvisation of health care/services in the host country. Exploitation is an issue in transnational/multinational research where one group (external sponsoring institution/organization) takes advantage over the host country. These usually exist when there is inequality in education, class/wealth, race, etc. More commonly this occurs in international collaboration when adequate knowledge/result has been derived from the project, and the benefits obtained from these projects are minimal to the host country/institute/organization. Hence, it is necessary that the scientific and ethics review committees of sponsoring and host countries ensure that the benefits obtained are equivalent.[36]

It is often observed that some groups are more vulnerable to harm than the others. Thus, any research involving such individuals or groups should be permitted only when the groups are beneficiaries from the research or that a similar research cannot be carried out otherwise.[2]

In conclusion, international collaboration/transnational research has gained importance in recent years since these research projects are undertaken very commonly across the globe for rapid development of quality research. Similar to any research, ethical codes and guidelines are to be strictly followed especially in low-income countries that are vulnerable to misconduct and exploitation.