11. Appointment and composition of institutional review boards

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

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

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

at least one must be an external scientific person; and

at least one must be an external lay person.

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.

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

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.

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.

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

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

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

at least one must be an external scientific person; and

at least one must be an external lay person.

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.

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

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.

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.