Principles  Benchmarks
Collaborative partnership  Develop partnerships with researchers, makers of health policies, and the community. Involve partners in sharing responsibilities for determining the importance of health problem, assessing the value of research, planning, conducting, and overseeing research, and integrating research into the health-care system. Respect the community’s values, culture, traditions, and social practices. Develop the capacity for researchers, makers of health policies, and the community to become full and equal partners in the research enterprise. Ensure that recruited participants and communities receive benefits from the conduct and results of research. Share fairly financial and other rewards of the research.
Social value Specify the beneficiaries of the research—who. Assess the importance of the health problems being investigated and the prospective value of  the research for each of the beneficiaries—what. Enhance the value of the research for each of the beneficiaries through dissemination of knowledge, product development, long-term research collaboration, and/or health system improvements. Prevent supplanting the extant health system infrastructure and services.
Scientific validity Ensure that the scientific design of the research realizes social value for the primary beneficiaries of the research. Ensure that the scientific design realizes the scientific objectives while guaranteeing research participants the health-care interventions to which they are entitled. Ensure that the research study is feasible within the social, political, and cultural context or with sustainable improvements in the local health-care and physical infrastructure.
Fair selection of study population Select the study population to ensure scientific validity of the research. Select the study population to minimize the risks of the research and enhance other principles, especially collaborative partnership and social value. Identify and protect vulnerable populations.
Favorable risk-benefit ratio Assess the potential risks and benefits of the research to the study population in the context of its health risks. Assess the risk-benefit ratio by comparing the net risks of the research project with the potential benefits derived from collaborative partnership, social value, and respect for study populations.
Independent review Ensure public accountability through reviews mandated by laws and regulations. Ensure public accountability through transparency and reviews by other international and nongovernmental bodies, as appropriate. Ensure independence and competence of the reviews.
Informed consent   Involve the community in establishing recruitment procedures and incentives. Disclose information in culturally and linguistically appropriate formats. Implement supplementary community and familial consent procedures where culturally appropriate. Obtain consent in culturally and linguistically appropriate formats. Ensure the freedom to refuse or withdraw.
Respect for recruited participants Develop and implement procedures to protect the confidentiality of recruited and enrolled and study communities participants. Ensure that participants know they can withdraw without penalty. Provide enrolled participants with information that arises in the course of the research study. Monitor and develop interventions for medical conditions, including research-related injuries, for enrolled participants at least as good as existing local norms. Inform participants and the study community of the results of the research.
Reproduced from Emanuel et al, 2004. (with permission from University of Chicago Press)
Table 1: Ethical principles and benchmarks for multinational clinical research.
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