Results of the Inquiry and Citation Review

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Bioethics issues in human studies

The role of Ethics Committees

Scientists' inquiry

Of the 61 scientists who answered the questionnaire, 18 had experiences with multi-centre studies (9 with international multi-centre studies). Of them 9 experienced the situation that at least one Ethics Committee did not give approval. Inquired about how the situation was handled, 4 reported that the centre without approval was withdrawn from the study, 3 changed the protocol to follow more strict rules and 1 reported about seeking personal communication with the Ethics Committee. One scientist answered that he or she did not know what was done about the situation. There were no specific countries more frequently affected by rejection of ethical approval than others.

Inquired about the Ethics Committee's monitoring of the adherence to the study protocol, about half of the scientists who gave a valuable answer (14 of 29) reported that there was no monitoring at all. Of those reporting monitoring 2 mentioned only an existing right of the Ethics Committee to access documents, etc. The most popular method of monitoring is the delivery of reports (annually or final). Internal audits, letters, sending in the manuscripts and publications, or questionnaires were less common. From the inquiry it appears that the UK scientists of NuGO are the most stringent monitored, in one case even with internal audits and annual reports.

Of the 23 scientists who answered the question about how monitoring by the Ethics Committee should be done, 21 were in favour of monitoring. About the method scientists think that checking the final publications would be appropriate as well as requesting reports or audits. Some scientists would also welcome personal communication about the study with their Ethics Committees. One scientist answered that this should be included in the quality assurance of good clinical practice and one scientist remarked the new UK legislation makes adequate provision for such a monitoring.

Sixteen NuGO scientists reported that there are other agencies or institutions that have to authorize their research proposal. Of those, 13 reported the agency or institution had requested changes or at least more detailed information (2 major, 11 minor). The requests concerned methodological (mainly sampling) but also financial and ethical issues. The ethical issues regarded in all cases the rewording of the informed consent.

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