Table 1 Sample questions on survey questionnaire

Theme 1: Existence of national framework for governing ethical review

• Is there a law/policy establishing a national ethics committee?

• What are the main functions of the national ethics committee?

• Are there written guidelines for constituting (i.e. selecting members) the national ethics committee?

• What year was the first national ethics committee established?

• Is there a policy/law in your country that establishes the applicable ethical standards for research involving human subjects?

• Are regional or international guidelines referred to in the national laws?

• Are all health research institutions in your country required to adopt a policy regarding research ethics?

Theme 2: Existence of mechanisms for ethical review

• Does the national ethics committee have standard operating procedures to guide its work?

• If some members of the committee disagree with the majority’s decision, is the substance of the disagreement recorded and communicated?

• Is there an explicit mechanism for excluding committee members with a direct interest in a proposal for review from participating in its assessment?

• Are there penalties for non-compliance with the regulations and decisions of the national ethics committee?

- If so, what are the penalties?

• Are there mechanisms in place for monitoring ongoing research?

• What types of mechanisms are applied for monitoring ongoing research?

- Annual ethical review of previously approved projects

- Required periodic written report from principal investigator

- Unannounced audit of research by representatives of ethical review committee

- Other

Theme 3: Continuous ethics training and capacity requirements

• Is training/capacity building opportunities provided to members of the national ethics committee?

• Is this training required or optional for members of the ethics committee?

• Is the ethics committee familiar with the following: CIOMS guidelines, WHO guidelines, declaration of Helsinki, Nuremberg Code?

• Does the committee engage the services of consultants from time to time for technical support?

• Is there any secretarial and administrative support for the national ethics committee?

• What in your view are the specific capacity needs of the national ethics committee?

• What in your opinion could be done to improve the performance of the national ethics committee?