Singapore legislation

Regulation 11

of Human Biomedical Research Regulations 2017

Regulation 11

Appointment and composition of institutional review boards

Subregulation 1

A research institution must appoint in writing an institutional review board in accordance with this Part.

Subregulation 2

Every institutional review board must comprise at least 5 individuals, of whom —

(a)

one must be the chairperson who must be a medical practitioner;

(b)

at least one must be an external scientific person; and

(c)

at least one must be an external lay person.

Subregulation 3

A research institution must not appoint or re‑appoint an individual as a member of the institutional review board unless that individual has furnished to the research institution a declaration that he or she is not disqualified under the Act or these Regulations from acting as a member.

Subregulation 4

The research institution may appoint one or more secretaries to the institutional review board who need not be a member.

Subregulation 5

The Director‑General may, on a written application by the research institution, waive any requirement mentioned in paragraph (2)(a) in respect of any particular chairperson.

Subregulation 6

For the purposes of paragraph (2), an individual is treated as external in relation to a research institution if the individual is not a researcher of, not employed by and not in a commercial relationship with the research institution.