National Statement on Ethical
Conduct in Research Involving Humans
Part 3 - Multi-Centre Research
3.1 Multi-centre research may include:
(a) a research project conducted at more than one institution or organisation either by the same or different researchers, eg. a clinical drug trial;
(b) a research project conducted jointly by researchers affiliated with different institutions or organisations; and
(c) a research project being conducted by a researcher who changes affiliation from one institution or organisation to another.
3.2 A research proposal that involves multi-centre research will have additional implications for both review and monitoring by a Human Research Ethics Committee (HREC).
3.3 In order to minimise unnecessary duplication in review of multi-centre research, HRECs are encouraged to ascertain whether the same protocol has been reviewed by another HREC, including reviews conducted overseas.
3.4 With a view to prompt and efficient consideration of multi-centre research protocols an individual HREC may:
(a) communicate with, and give advice to or receive advice from, any other HREC;
(b) accept a scientific/technical assessment of the research by another institution or organisation;
(c) review and, where the same research project is conducted at two or more institutions or organisations, adopt the reasons for ethical approval or disapproval of another HREC in reaching its own decision; or
(d) adopt other administrative procedures to accelerate timely consideration and avoid unnecessary duplication.
3.5 With a view to prompt and efficient consideration of multi-centre research protocols, the principal researchers may agree that the primary ethical and scientific assessment be made at one agreed institution or organisation, and copies of the approvals be sent with the protocols to the other institutions or organisations involved. Where there is such an agreement, the other HRECs may accept a scientific/technical assessment of the research by another institution, organisation or HREC and adopt the reasons for ethical approval or disapproval of the protocol by the primary HREC.
3.6 Where an HREC is satisfied that there has been full and thorough consideration of the protocol (by another HREC under 3.4 or by a primary HREC under 3.5) the HREC may, after tabling of the protocol, accept the decision of another institution, organisation or HREC in relation to multi-centre research. The HREC may still give further consideration to ethical and administrative aspects of the research which are specific to its own institution or organisation.
3.7 The principal researcher shall:
(a) inform each HREC of all other Australian sites at which the research is being proposed or conducted, at the time of submission of the research project;
(b) disclose to each HREC any previous decisions regarding the research made by another HREC; and
(c) inform each HREC of whether the protocol is presently before another HREC.
3.8 An HREC must determine how the conduct of multi-centre research will be monitored and what roles each of the institutions or organisations and their HRECs will have. Consultation and agreement between and among HRECs and the institutions or organisations involved will be essential to ensure that the research is monitored and that each institution or organisation fulfils its obligations under this Statement.
[Preamble] [Part 1] [Part 2] [Part 3] [Part 4] [Part 5] [Part 6]
[Part 7] [Part 8] [Part 9] [Part 10] [Part 11] [Part 12] [Part 13]
[Part 14] [Part 15] [Part 16] [Part 17] [Part 18] [Part 19]
[Appendix 1] [Appendix 2] [Appendix 3]