Regulation 21

Subject to paragraph (2), the chairperson of an institutional review board or a member authorised under section 17(2) of the Act (called in this regulation the authorised member) may, pursuant to section 17(2)(a) of the Act, exempt a research proposal from review by the board if the chairperson or authorised member is satisfied that the proposal involves less than minimal risk to the research subjects.

To avoid doubt, no proposal for restricted human biomedical research may be exempted from review.

A researcher must submit to the chairperson of the institutional review board or the authorised member every application for exemption from review of a research proposal for determination by the chairperson or the authorised member.

The chairperson of an institutional review board or the authorised member must inform all the members of all research proposals that have been exempted from review.

The institutional review board must ensure that the operational procedures on the exemption of research proposals from review by the board mentioned in paragraph (1) must be clearly documented including but not limited to the authorisation of a member to carry out the duties of the chairperson pursuant to section 17(2) of the Act and the method of reporting and ratification of decisions to the board.