Singapore legislation

Regulation 10

of Human Biomedical Research Regulations 2017

Regulation 10

Notification of unexpected serious adverse event

Subregulation 1

For the purposes of section 23(3)(b) of the Act and subject to paragraph (5), a research institution conducting research must ensure that paragraphs (2), (3) and (4) are complied with in relation to any unexpected serious adverse event (called in this regulation the unexpected event) —

(a)

which occurred to a participant during the biomedical research, regardless of whether the participant is in or outside Singapore at the time of the occurrence; or

(b)

which the researcher knows or has reason to believe has occurred to a participant during another research that is conducted outside Singapore but which is connected with the research mentioned in sub-paragraph (a).

Subregulation 2

Where the unexpected event results in death or is life‑threatening, the research institution must ensure that —

(a)

all relevant information about the unexpected event is recorded;

(b)

the recorded information on the unexpected event is 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 unexpected event, whichever is the earlier; and

(c)

any additional relevant information about the unexpected event is recorded and submitted to the Director‑General within 8 days after the record is made.

Subregulation 3

Where the unexpected event does not result in death and is not life-threatening, the research institution must ensure that all relevant information about the unexpected event is —

(a)

recorded; and

(b)

submitted to the Director‑General as soon as possible and in any event not later than 15 days after the research institution or the principal person in charge designated by the institution first becomes aware of the unexpected event, whichever is the earlier.

Subregulation 4

The notification of the unexpected event must be made in the applicable form set out at the relevant website and submitted to the Director‑General.

Subregulation 5

A research institution is exempted from compliance with paragraphs (1), (2) and (3) where the institution is, with respect to substantially the same event, required to report and has reported —

(a)

any defect in the medical device or any adverse effect that has arisen from the use of the medical device under the Health Products (Medical Devices) Regulations 2010;

(b)

an unexpected serious adverse drug reaction under the Health Products (Clinical Research Materials) Regulations 2016; or

(c)

an unexpected serious adverse drug reaction under the Medicines (Medicinal Products as Clinical Research Materials) Regulations 2016.

Read in full context — Human Biomedical Research Regulations 2017 →