Biomedical Research Involving Human Subjects – WHO and International Conference on Harmonization Guidelines for GCP, GMP, Good Clinical and Laboratory Practice (GCLP) – UNAIDS guidance document: Ethical considerations in HIV Preventive Vaccine Research – Any other relevant or applicable internationally accepted documents that may come into force hereinafter • Review research proposals and their supporting documents with emphasis on: – Scientific design, objectives, statistics and methods – Storage, disposal and repository of biological materials – Recruitment of participants – Care and protection of participants – Maintenance of confidentiality – Informed consent process – Vulnerable groups – Community considerations • Monitor ethical adherence through: – Regularly reviewing the principal investigator’s adherence to approved protocol and other aspects of the implementation of the HIV/AIDS vaccine trial – Supervising interim reports through systematic analysis – Appointing a committee to supervise the vaccine trial • Receive and review reports from an independent monitor appointed by the sponsor • Receive and review reports from the investigator regarding: – Protocol amendments, deviations and violations 30