Singapore legislation
Regulation 20
Regulation 20
Expedited review
Subregulation 1
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)(b) of the Act, decide that a research proposal or a class of research proposals may be reviewed through an expedited process if the proposal or class of proposals involves no more than minimal risk to the research subjects.
Subregulation 2
For the purposes of section 17(2) of the Act, the following criteria may be considered by the chairperson of the institutional review board or the authorised member for expedited review:
one or more minor changes to a research proposal which do not affect the substance of research proposals approved by that board;
a research proposal that involves analysis of patient information without interaction with research subjects where the chairperson or the authorised member is satisfied that the researchers will take appropriate measures to protect the confidentiality of information relating to the research subjects.
Subregulation 3
To avoid doubt, no proposal for restricted human biomedical research may be reviewed through an expedited process.
Subregulation 4
The institutional review board must ensure that the operational procedures on the expedited review of research proposals 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.
Subregulation 5
The chairperson of an institutional review board or the authorised member must inform all the members of all research proposals that have been reviewed through an expedited process.