The Regulation defines the purpose of establishing the Commission, its rights and scope of responsibility, and the fundamental principles of its operation. It also sets out the key requirements for assessing compliance with ethical, moral, and legal standards in research that may be conducted among the population or that uses existing data relating to individuals as research participants.

It covers: the procedure for determining the composition of the Commission; the procedure for planning and conducting Commission meetings and informing Commission members about meetings; the list of documents required for submission to the Commission; the procedure for submitting documents and the requirements for documents to be reviewed by experts; the timeframe for conducting a bioethical review; the procedure for adopting expert decisions; the nature of the decisions recorded in the Commission’s decision statement, and other related matters.

(1) Application for document review (online form); (2) Research protocol; (3) List and detailed description of the research methods and instruments; (4) Informed consent form for participants; (5) Confidentiality agreement form for the researcher (if required by the research design); (6) Curriculum Vitae (CV) or background information of the Principal Investigator and members of the research team; (7) Other supporting documents (if required by the research design or upon the Commission’s request).