Islamic Center of Southern California

International Ethical Guidelines for Biomedical Research Involving Human Subjects

Guideline 20

Strengthening Capacity for Ethical and Scientific Review and Biomedical Research

Many countries lack the capacity to assess or ensure the scientific quality or ethical acceptability of biomedical research proposed or carried out in their jurisdictions. In externally sponsored collaborative research, sponsors and investigators have an ethical obligation to ensure that biomedical research projects for which they are responsible in such countries contribute effectively to national or local capacity to design and conduct biomedical research, and to provide scientific and ethical review and monitoring of such research. Capacity-building may include, but is not limited to, the following activities:

establishing and strengthening independent and competent ethical review processes and committees;

strengthening research capacity;

developing technologies appropriate to health-care and biomedical research;

training of research and health-care staff; and

educating the community from which research subjects will be drawn.

Commentary on Guideline 20

External sponsors and investigators have an ethical obligation to contribute to a host country's sustainable capacity for independent scientific and ethical review and biomedical research. Before undertaking research in a host country with little or no such capacity, external sponsors and investigators should include in the research protocol a plan that specifies the contribution they will make. The amount of capacity building reasonably expected should be proportional to the magnitude of the research project. A brief epidemiological study involving only review of medical records, for example, would entail relatively little, if any, such development, whereas a considerable contribution is to be expected of an external sponsor of, for instance, a large-scale vaccine field-trial expected to last two or three years.

The specific objectives of building a host-country's research-conducting capacity should be determined and achieved through dialogue and negotiation between external sponsors and authorities of that country. External sponsors would be expected to employ and, if necessary, train local individuals to function as investigators, research assistants, or data managers, for example, and to provide, as necessary, reasonable amounts of financial, educational, and other assistance for capacity-building. To avoid conflict of interest and safeguard the independence of review committees, financial assistance should not be provided directly to them; rather, funds should be made available to appropriate authorities in the host-country government or to the host research institution. (See also Guideline 10: Research in Populations and Communities with Limited Resources)

The Islamic Point of View Concerning Guideline 20

Strengthening Capacity for Ethical and Scientific Review and Biomedical Research

Being an idea introduced by contemporary human thought and an outcome of accumulative knowledge and modern scientific human experimentation, the stipulation of this guideline is not discussed in any text of Islamic Law, nor any considered opinion by a Muslim jurist. It falls, however, under the general principle of enjoining justice and charity established by God, the Most Glorious, when He says, "God enjoins justice and charity" (Al-Nahl XVI: 90). God also says, "Cooperate in charity and piety" (Al-Maeda V: 2). Islamic Center of Southern California