Research at Bond

Research Ethics

Application Process

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 and also the provision for an ethics committee to set fees associated with any ethics review.  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.  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 delays, refer to the following requirements:

  • Obtain a BUHREC Protocol Number from the secretary (Phone: +61 7 5595 4194 or buhrec@bond.edu.au).
  • Complete the NEAF application form electronically using non-technical language.
  • Save the file using the surname of the principal investigator.
  • Ensure all Items on the application form have been addressed.
  • You have detailed a clear purpose of study using non-technical language.
  • Details, duration and length of participation have been addressed.
  • Risks have been outlined.
  • Benefits of this research have been addressed.
  • Signatures of all researchers and the employer and/or operator of the facility where research will be conducted.
  • Include all appendices, instrument(s) if applicable, explanatory statement(s), participants consent form(s), indemnity agreement (primarily for clinical trials and contract work), clinical trial notification form (primarily clinical trials).
  • Print one copy of the form, attach all appendices as stated above and obtain the signatures required. Forms without this authorisation will be returned to applicants for completion, prior to consideration by BUHREC.
  • NOTE: The original must be on single sided paper. Double-sided printing will not be accepted.
  • Mail or deliver to the secretary the ORIGINAL PRINT-OUT.
  • Submit an electronic copy of the application including all appendices by e-mail attachment to buhrec@bond.edu.au
  1. Participant Consent Form Specifically in relation to the supply of unapproved therapeutic goods, TGA recommends that the consent forms and/or patient information conveys the following information adequately:
    • the product is not approved (i.e. registered or listed) in Australia;
    • any risks and side effects that are known;
    • the possibility of unknown risks and immediate/ long term side effects; and
    • any alternative treatments using approved products which are available.
  2. Explanatory Statement Note: for External Use - forms should be released on letterhead and contain the Bond University Ethical Paragraph.
  3. Questionnaire (if applicable)
  4. Indemnity Agreement (primarily for clinical trials and contract work)
  5. Clinical Trial Notification (CTN) Form (primarily for clinical trials)

Fees for external applications

Bond University Research and Consultancy Services will charge a non-refundable fee, for access to the review and monitoring of research proposals by BUHREC which involve research activities initiated by commercial sponsors or external applicants.

What is the justification for charging fees?

Partial cost recovery for the administration of the ethics review of research incurred by BURCS, where the research is initiated by a commercial sponsor or external party.

Who is to be charged?

Commercial sponsors or the external party are to be charged the fee, where the research is initiated by the sponsor or external party as part of the development of the research activities or services for commercial marketing.

What is the fee?

  • For full review involving pharmaceutical, medical, invasive or clinical trials - $3,300 incl GST
  • For all other reviews involving corporate sponsors or external parties to the University - $1,980 incl GST
  • For amendments involving corporate sponsors or external parties to the University $660 incl GST

Bond University Research & Consultancy Services will issue a tax invoice upon receipt of the application. Once payment has been made to BURCS, BUHREC will consider the application. The fee is to be paid as a once-off fee to cover the administrative costs of the review and monitoring of such research, regardless of the outcome of the review, or the length of the study.

For further information or queries regarding fees contact research@bond.edu.au.

How will the fee be administered?

An invoice will be raised by BURCS upon receipt of a commercially sponsored or external ethics application. The tax invoice will be sent directly to the commercial sponsor or external applicant to be paid within 14 days. The fee will be paid to Bond University, through the Research and Consultancy Services Office. Administration and use of the fees will be separate from administration of BUHREC activities.

Adverse Affects 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.