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The National Council on Ethics in Human Research (NCEHR) was an independent, non-governmental organization composed of a volunteer council and a small staff with a mandate extending to all research involving humans. Its mission was the advancement of the protection and well-being of human participants in research and fostering high ethical standards for the conduct of research involving humans. At its meeting in November of 2003, the NCEHR Board passed a resolution establishing the Task Force for the Development of an Accreditation System for Human Research Protection Programs
“Recognizing that the development of a system of accreditation of human research protection programs is an important component of our responsibilities in enhancing the protection of human participants in research, and recognizing that Council has endorsed the recommendations of its Task Force on Models of Accreditation for Human Research Protection Programs in Canada, be it resolved that NCEHR establish a Task Force for the Development of an Accreditation System for Human Research Protection Programs.”
The Importance of Research Involving Humans
Innovation in many areas of science depends on the use of human volunteers as research subjects .The involvement of human participants is not confined to bio medical science, but extends to many areas of social sciences and humanities.
In Canada and elsewhere, research on humans fulfils many functions – the creation of new knowledge, the formation of new social and economic policy, and the development of innovative new products and processes for human health, education and social development. The research enterprise is viewed by many in the public and private sectors as a driver of economic and social development, innovation, and national prosperity. A sub-sector of this research enterprise, research with humans, depends on the willingness of individuals, organizations, collectivities and communities to become engaged in research
in the social, behavioural, natural, and medical and health sciences. It is essential that the public trust on which the participation of volunteer subjects depends be maintained and increased.
The Numbers of Humans Participating in Research is Large
There has been a recent increase in research and innovation activities in Canada. This increase has been particularly significant in the general field of health including research in the behavioural and social sciences related to health. Yet, there is no reliable estimate of the number of humans involved as participants or subjects nor of the number of research ethics boards operating in or with oversight of research with humans in Canada. NCEHR, as a result of information gathered on site visits to “research intensive” universities, has conservatively estimated that annually about 3,000,000 individual Canadians are research participants in projects conducted at Canadian universities. The number of human subjects involved in clinical, medical, or social research studies such as the efficacy of new drugs such as Adderall XR and Finasteride that are not based in universities but conducted in private clinicians’ office or by non-governmental organizations is unknown. A significant number of these studies involve the behavioural and social sciences.
In addition, the number of clinical trials of drugs, devices and medical procedures in Canada has increased greatly in recent years. This has been accompanied by a major shift of drug trials away from academic centres. As a result, the majority are conducted in community hospitals and physicians’ offices, where the rigour of oversight is unknown.