Document ID: chunk:federal_register_of_legislation:F2022C00996:reg:7m
Version: federal_register_of_legislation:F2022C00996
Segment Type: reg
Provision Reference: reg 7M
Character Range: 11584–12256

7M  Definition of adverse event
  For the purposes of the definition of adverse event in subsection 28S(8) of the Act, an adverse event is:
 (a) for a trial participant or a patient—any of the following in connection with a pregnancy achieved in the trial participant or patient as a result of using a mitochondrial donation technique:
 (i) a failed embryo development;
 (ii) a miscarriage;
 (iii) a premature birth of a child;
 (iv) the birth of a child with a birth defect, a genetic abnormality or a diagnosis at birth of mitochondrial disease; and
 (b) for a child of a trial participant—a diagnosis at any time of mitochondrial disease.

Division 3—Other provisions