1. Research Governance Where Does Ethical Review Fit?

2. Relationship Between RECs and Competent Authorities What are competent authorities? –Drug agencies –Ministries of Health –Authority can be delegated to other agencies What are RECs? –National ethics committees –Institutional committees

3. Country Examples Romania State administrative agency deals with bureaucratic decisions (GCP) National ethics committee for drug studies reviews ethical issues of protocols

4. Country Examples (cont.) Norway Developing new law, in response to researchers complaints about requirement for multiple approvals All research protocols will go first to ethics committee Ethics committee will be responsible for dealing with all other approvals Researcher only needs to communicate with one entity

5. Country Examples (cont.) Ethiopia Institutional ethics board National ethics committee (part of Ministry of Science and Technology) Drug Administration and Control Authority (independent authority) can override national ethics committee decision –More common to override approvals (e.g., if participants < 18 years old) than rejections

6. Country Examples (cont.) Estonia Prior review by institutional committee (e.g., do researchers have enough time to do project?) Bioethics committee (two committees in country; applicants can choose where to submit) Drug agency must approve studies involving investigational drugs; doesnt consider issues addressed by bioethics committee All committees are independent, but they coordinate work Ministry of Health oversees entire process

7. Country Examples (cont.) EU Must consult REC for clinical trials Trial cannot be conducted without REC approval Also need approval of member state authority

8. Should REC Decision Be Legally Binding? REC process should be mandatory But REC shouldnt have final say Ministry of Health should have option of overriding REC decision

9. Grounds for Overriding REC Decision View #1: CA should be permitted to override REC decision based on different interpretation of ethical guidelines View #2: CA should be permitted to override REC decision on other grounds as well –I.e., it should be permitted to override RECs rejection of a study because it believes that the value of the study overrides the ethical considerations

10. Underlying Question: What Is the Status of International Ethics Guidelines? Are international guidelines legally binding or just advisory? Do some guidelines (e.g., Helsinki) have the status of customary international law? Even if countries dont have to follow international ethical guidelines, should they be encouraged to do so? National laws may limit grounds for overriding REC decisions

11. Relationship Between Ethical and Scientific Review Arguments for separating scientific and ethical review Do RECs have competent to look at scientific issues? Should there be limits on RECs ability to question scientific determinations made by other review bodies? Would giving RECs responsibility for scientific review be inconsistent with goal of creating diverse REC membership (including ethicists, lawyers, etc.)?

12. Relationship Between Ethical and Scientific Review (cont.) Arguments for combining scientific and ethical review But judgments of scientific merit incorporate value judgments; should not be left solely to scientists Practical considerations: burden of having to establish two different committees