Guidelines for External Applicants
The National Statement on Ethical Conduct in Research Involving Humans sets out guidelines for ethics committees. These include the provision for considering research protocols by researchers from outside the institution normally represented by the committee (Sections 2.2 and 2.4) and also the provision for an ethics committee to set fees associated with any ethics review (Section 2.13). Our Committee has agreed that it is within our ability to review external research protocols. An HREC should not communicate directly with a research sponsor on matters relating to the protocol or ethics of a project, but the institution or organisation and the sponsor may have direct communication on matters relating to administration, indemnity and insurance. (2.23) What constitutes an external application? Anyone who is conducting research totally independently from Bond University, including Bond University staff members performing research in a private capacity.
Requirements for submitting an external application
To ensure your project may be expedited without unnecessary delays, refer to the documented requirements for submitting an external application (pdf 81k).
Adverse Effects or changes to the Protocol
In accordance with TGA recommendations, BUHREC requires all researchers to advise the secretariat immediately of any adverse events that occur during the trial, including those that have occurred at other sites involved in the study [see below]:
- new information from other published or unpublished studies which may have an impact on the continued ethical acceptability of the trial or which may indicate the need for amendments to the trial protocol; and
- deviations from, or changes to, the protocol that either eliminate immediate hazards to trial participants, significantly affect the conduct of the trial, or increase risks to participants. BUHREC also requires that any such information be accompanied by comment from the researchers on what implications, if any, they believe the new information has for the trial.
Serious adverse events are those noxious and unintended responses to the drug that:
- result in death;
- require in-patient hospitalisation or prolongation of existing hospitalisation;
- result in persistent or significant disability/incapacity;
- result in birth defects;
- are life threatening.
An event should be considered unexpected if the nature, severity or frequency of that event is not documented in the current Australian Product Information if the product is approved for marketing, or in the most current Investigator’s Brochure if the product is unapproved.
For further information contact:
The Research Ethics Manager
Office of Research Services
Building 1C, Level 4
Bond University QLD 4229
T: +61 7 5595 4194
F: +61 7 5595 1120