(1) An investigator or sponsor shall immediately give notice in writing to the Ethics Committee or National Competent Authority of any substantial modification in the particulars or documents relating an opinion or authorization.
(2) A notice under subsection (1) must —
(a) include details on how the modification may affect the rights, safety, dignity, well-being and confidentiality of the subject; and
(b) be accompanied by the opinion or authorization to which the notice relates.
(3) Upon receipt of a notice under subsection (1), the Ethics Committee or National Competent Authority may pursuant to sections 12, 14 and 15 amend or issue another opinion or authorization.