WHO Guideline TDR/PRD/Ethics/2000.1 – Ethics Committees

EC members have a need for initial and continued education regarding the ethics and science of biomedical research. The conditions of appointment should state the provisions available for EC members to receive introductory training in the work of an EC as well as ongoing opportunities for enhancing their capacity for ethical review. These conditions should also include the requirements or expectations regarding the initial and continuing education of EC members. This education may be linked to co-operative arrangements with other ECs in the area, the country, and the region, as well as other opportunities for the initial and continued training of EC members.

5 SUBMITTING AN APPLICATION

5.1 Application

An application for review of the ethics of proposed biomedical re-search should be submitted by a qualified researcher responsible for the ethical and scientific conduct of the research.

5.2 Application Requirements

The requirements for the submission of a research project for ethical review should be clearly described in an application procedure. These requirements should include the following:

5.2.1 the name(s) and address(es) of the EC secretariat or member(s) to whom the application material is to be submitted;

5.2.2 the application form(s);

5.2.3 the format for submission;

5.2.4 the documentation (see 5.3);

5.2.5 the language(s) in which (core) documents are to be submitted;

5.2.6 the number of copies to be submitted;

5.2.7 the deadlines for submission of the application in relation to review dates;

5.2.8 the means by which applications will be acknowledged, including the communication of the incompleteness of an application;

5.2.9 the expected time for notification of the decision following review;

5.2.10 the time frame to be followed in cases where the EC re-quests supplementary information or changes to documents from the applicant;

5.2.11 the fee structure, if any, for reviewing an application;

5.2.12 the application procedure for amendments to the protocol, the recruitment material, the potential research participant information, or the informed consent form.

5.3 Documentation

All documentation required for a thorough and complete review of the ethics of proposed research should be submitted by the applicant. This may include, but is not limited to,