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. 2000 Apr 29;320(7243):1179–1182. doi: 10.1136/bmj.320.7243.1179

Table.

Non-local and local changes requested by local research ethics committees after approval by multicentre research ethics committees

Non-local changes or comments requested No of times requested (% of committees) Local changes or comments requested No of times requested (% of committees)
Changes to information sheets 22 (18) Local staff to be notified 11 (9)
Changes to consent procedure 12 (10) Ethnic mix to be considered 10 (8)
Changes to questionnaire 9 (7) Local investigator to be identified 6 (5)
Changes to methods of recruiting subjects 9 (7) Information sheets to be on locally headed paper 4 (3)
Changes to protocol 5 (4) Approval required from local research and development office 3 (2)
Confidentiality issues 4 (3) Confirmation of locally incurred costs 3 (2)
Exclusions for subjects already in research 2 (2)
Maximum number to be recruited from local site 1 (1)
Researchers' credentials to be supplied 1 (1)
Local research ethics committee number to be written on local documents 1 (1)