Singapore legislation

Regulation 22

of Human Biomedical Research Regulations 2017

Regulation 22

Documentation and communications

Subregulation 1

Every chairperson of an institutional review board must ensure that all documentation and correspondence of a board in areas other than the review of the research proposal, such as the assessment of the qualifications of a researcher, must be dated, filed and archived according to standard written procedures for the board.

Subregulation 2

Every chairperson of an institutional review board must ensure that all correspondence and other communications in relation to the review of the research proposal and other proceedings of the board, must be fully documented in writing.

Subregulation 3

Without limiting paragraphs (1) and (2), every chairperson of an institutional review board must ensure that all of the following documents, information and particulars be recorded and documented:

(a)

copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by the researchers and reports of injuries to the research subjects;

(b)

minutes of the board meetings which must be in sufficient detail to show —

(i)

attendance at the meetings;

(ii)

actions taken by the board, and the vote on these actions including the number of members voting for, against, and abstaining;

(iii)

the basis for requiring changes in or disapproving research; and

(iv)

a written summary of the discussion of controverted issues and their resolution;

(c)

copies of all correspondence between the board and the researchers that are relevant and material to the review of the research proposal.

Read in full context — Human Biomedical Research Regulations 2017 →