Table 8 Answers to question 9. “Which measures does your institution take “to avoid abuse of this option” as outlined in paragraph 32 of the Declaration of Helsinki?”
Safeguards | Country |
|---|---|
Ethic Committees/International Review Boards (IRBs) | Austria, Argentina, Cuba, Germany, Ireland, Malaysia, Namibia, Republic of Belarus, Senegal, The EU, United Arab Emirates, Uganda, USA |
Trial protocola | Canada, Czech Republic, Ghana, Israel, Slovakia, The EU, The Netherlands, |
During the trial: closely monitoring, short time period of trial, rescue medication, patients right to withdraw from the trial at any time | Chile, Cuba, the EU, Republic of Belarus Saudi Arabia |
Rejection of trial if not in accordance with requirements | Austria, Czech Republic, The EU, USA |
No difference between local and global standard | Botswana, The EU |
Add-on study | Germany |
No placebo use if effective treatment is available | Japan |
Informed consent | The EU |
None | United Kingdom |