How to Review a Protocol

1. 1 How to Review a Protocol

2. 2 Reference Documents WHO/TDR Operational Guidelines for Ethical Committees that Review Biomedical Research, 2000. International Conference on Harmonization, Good Clinical Practice: Consolidated Guidelines, 1997. World Medical Association, Declaration of Helsinki, 2004. CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, 2002. Code of Federal Regulations: 21CFR50&56; 45CFR46 It is very important that the Ethics Committee keep up to date with applicable documents and policies, nationally and internationally. It is equally important that it list them as well as the version used for the benefit of the researchers and research sponsors.It is very important that the Ethics Committee keep up to date with applicable documents and policies, nationally and internationally. It is equally important that it list them as well as the version used for the benefit of the researchers and research sponsors.

3. 3 The Ethics Committee The Ethics review systems are important societal mechanisms involved in the protection of human subjects. Their work should be characterized by: Competence of members as per requirements Quality of the implementation of regulations and policies Transparency of procedures Consistency in review both at the Ethics Committee level and between committees Independence from all those having an interest in the research The various international policies, as well as national requirements almost unanimously agree on the basic composition of The various international policies, as well as national requirements almost unanimously agree on the basic composition of

4. 4 Need to Review Research Protocols � This protocol should be submitted for consideration, comment, guidance, and where appropriate, approval to a specially appointed ethical review committee, which must be independent of the investigator, the sponsor or any other kind of undue influence. Helsinki Declaration, B13 The independence of the ethics committee is critical to ensure the integrity of the overall process. Often times, ethics committees are pressured to approve trials to ensure the accompanying benefits. The pressures may come from researchers, sponsors, institutions, governments, even from the public. The independence of the ethics committee is critical to ensure the integrity of the overall process. Often times, ethics committees are pressured to approve trials to ensure the accompanying benefits. The pressures may come from researchers, sponsors, institutions, governments, even from the public.

5. 5 Respect for Persons First In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society. Helsinki Declaration, A5 There is a long lasting and general consensus on the primacy of the interest of the individual on interests of science or the state in the case of research. All other options have been explored and lead to incommensurate abuse. There is a long lasting and general consensus on the primacy of the interest of the individual on interests of science or the state in the case of research. All other options have been explored and lead to incommensurate abuse.

6. 6 Respect for Persons First Does it still hold true that respect for individuals will still come first when a deadly epidemic hits the country? � and what happens then with ethics review?

7. 7 What Must the Ethics Committee Assess? Scientific Design and Conduct of the Study Risks and Potential Benefits Budget and Trials Agreement Recruitment and Retention of Research Participants Care and Protection of Research Participants Protection of Research Participants Confidentiality Informed Consent Process Community Considerations

8. 8 1. Scientific Design and Conduct of the Study

9. 9