Are sponsors responsible, as the original CIOMS
guideline called for?
National Bioethics Advisory Commission, 2001); Council for International Organizations of Medical Science (CIOMS
) in collaboration with the World Health Organization (WHO), International Ethical Guidelines for Biomedical Research involving Human Subjects (Geneva: CIOMS
document, they claim, holds that "researchers working in developing countries have an ethical responsibility to provide treatment that conforms to the standard of care in the sponsoring country, when possible.
SAN FRANCISCO) NetForce Announces Support for CIOMS
We agree with the CIOMS
guidelines and with many observers that in order to be judged ethical and nonexploitive in the final analysis, such research must not only address local problems, but the results must also be made reasonably available to local populations.
NetForce today announced their enthusiastic support for the CIOMS
V Good Safety Practices and has fully integrated the four proposed topics into their product EventNet, the world's most advanced software for medical product safety surveillance and pharmacovigilance.
guidelines state that investigators undertaking research involving subjects in underdeveloped communities (guideline 8), whether in developed or developing countries, must ensure that:
Like other human research codes, the CIOMS
guidelines combine the protection of subjects' rights with protection of' their welfare; as subjects become less able to protect their own rights (and therefore become more vulnerable), researchers and reviewers must increase their efforts to protect the welfare of subjects.
Again, the most relevant document is the CIOMS
guidelines, notably guideline 8, entitled "Research Involving Subjects in Underdeveloped Communities," including developing countries.
One hundred and twenty-three participants from thirty nations and from differing spiritual families debated these issues from 22 through 27 July 1990 in Japan, under the auspices of CIOMS
, World Health Organization (WHO), United Nations Educational, Scientific and Cultural Organization (WHO), United Nations Educational, Scientific and Cultural Organization (UNESCO), and the Science Council of Japan.
10) The Council for International Organizations of Medical Sciences (CIOMS
), International Guiding Principles for Biomedical Research Involving Animals (Geneva: CIOMS
Health Policy, Ethics and Human Values--An International Diologue, XVIII CIOMS
Round Table Conference, Z.