Section 63

the duties of research institutions, appointing bodies of institutional review boards, and researchers;

the qualifications of researchers;

the composition, duties, procedures, responsibilities and powers of institutional review boards;

the duties and responsibilities, qualifications of and training to be received by members of institutional review boards;

the practices, procedures and other requirements for the conduct of human biomedical research or tissue banking activity, including —

the standards to be adhered to in the conduct of any human biomedical research or tissue banking activity;

the procedures for the selection of research subjects for any biomedical research and for obtaining the appropriate consent for their participation as donors or subjects in such human biomedical research;

the appropriate consent required for the participation of minors and other vulnerable persons as research subjects in human biomedical research;

the records and documents to be maintained by research institutions, researchers or tissue banks and the information to be contained in such records and documents;

the furnishing to the Director of such information, returns and reports as the Director may require or as may be prescribed in connection with the administration and enforcement of this Act; and

the requirements pertaining to specific types of human biomedical research or tissue banking activity;

the procedures and requirements in relation to obtaining appropriate consent and the form of consent;

the requirements for the protection of the identity of individuals in relation to individually‑identifiable human biological material and health information;

the requirements in relation to the reporting of and investigations into any serious adverse event;

the duties, procedures, responsibilities and powers of inquiries committees;

the establishment of a scheme of accreditation for research institutions, researchers or institutional review boards (as the case may be) in relation to their compliance with the requirements of this Act;

the licensing of tissue banks and tissue banking activities;

the forms necessary for the administration of this Act; and

the fees and charges payable under or for the purposes of this Act.