Singapore legislation
Regulation 8
Regulation 8
Notification under section 23(3)(a) of Act
Subregulation 1
For the purposes of section 23(3)(a) of the Act, a research institution must ensure that all relevant information (except for the information specified in paragraph (3)) required under that paragraph in relation to human biomedical research conducted under the supervision and control of that research institution is —
recorded; and
submitted to the Director‑General as soon as possible and in any event not later than 7 days after the research institution or the principal person in charge designated by the institution first becomes aware of the information, whichever is the earlier.
Subregulation 2
The notification of the relevant information mentioned in paragraph (1) must be made in the applicable form set out at the relevant website and submitted to the Director‑General.
Subregulation 3
For the purposes of section 23(3)(a) of the Act, a research institution must ensure that relevant information relating to contraventions in relation to human biomedical research conducted under the supervision and control of that research institution and that did not cause harm to and had no potential to cause harm to any research subject is recorded and submitted to the Director‑General —
at the same time the declaration of compliance is submitted in accordance with regulation 7(3); and (b)on an annual basis aggregating the information in the applicable form set out at the relevant website.