ETHICS COMMITTEES AND EXTERNALLY-SPONSORED RESEARCH IN IRAN (2002-2003)

Abstract

Background: Globally, there have been considerable debates on the ethical conduct and review of collaborative international research. One of the great challenges is to conduct clinical trials in developing countries as Externally-Sponsored Researches (ESR). Methods and Materials: This descriptive survey has reviewed the status of this type of researches in Iran during 2002-2003. The project was carried out in 44 universities of medical sciences and 32 research centers. The questionnaires containing close and open-ended questions were sent to their ethics review committees (ECs). After collecting data and coding, they were analyzed by means of SPSS software version 11.5. Results: Forty one universities and 25 research center have been responded but only 35 ECs have been retrieved questionnaire. According to the data, 26 and 54 studies have been carried out as a collaborative research or externally-sponsored research in Iran in 2002 and 2003, respectively. Although more than half of ECs members have received necessary preliminary educations but there were professional educational courses in only 25% of ECs. About 17% of ESR projects have not been examined in ECs, although they have been evaluated in the Scientific Research Council. Only one of the evaluated ESR proposals has been rejected and the rest have been approved and conducted. Socio-cultural issues and religious beliefs, scientific validity, and national priorities were the most important factors for proposals evaluation. Conclusion: The ethical issues concerning international collaboration for clinical research with developing countries are complex. We should enhance educational programs for researchers and establish appropriate regulatory guidelines at national and international levels.

Keywords

• international research
• externally-sponsored research
• research ethics
• ethics committee
• research sponsor
• developing countries
• iran