See Meier, supra note 20, at 526-27 (recognizing CIOMS Guidelines' authority to grant or deny research protocols).
The causative relationship between concurrent medicine use and liver injury was categorized as suggestive, compatible, or incompatible according to CIOMS criteria (Benichou 1990) (Table 1).
CIOMS addressed medical research in a period of newly globalized research, including human investigations in less developed countries.
The items of the pre-test are based on qualitative criteria described in the qualitative CIOMS (Benichou, 1990) and the CIOMS (Danan and Benichou, 1993; Benichou et al.
Council for International Organizations of Medical Sciences, CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, available at http://www.
124) Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS: Geneva, 2002), online: CIOMS <www.
Regardless of country, Quintiles strictly adheres to ethical principles articulated by international guidelines such as ICH, the Declaration of Helsinki, CIOMS and The Belmont Report.
CIOMS released its revision late in 2002, while WMA issued a series of clarifications and a major revision in October 2008.
CIOMS Guideline 15 from 1993 reads "As a general rule, the sponsoring agency should agree in advance of the research that any product developed through such research will be made reasonably available to the inhabitants of the host community or country at the completion of successful testing.
CIOMS required an explicit, contract-like mechanism, agreed to before the trial, and it assigns this responsibility to the sponsors of research.
Wendy Stephenson, co-chair of the CIOMS Working Group and a highly accomplished industry expert, will release their recommendations on "Managing Safety Information from Clinical Trials" at the 2005 Clinical Trials Congress.
22) The consensus-building process and enforcement authority envisioned by CIOMS are much more inclusive and pluralistic than those considered explicitly in the two other statements, although most details are still to be spelled out.