Monitoring, reporting and changes after approval

To ensure continued ethical acceptability of the research and/or conformity to the approved protocol, various monitoring mechanisms pertain. Importantly, monitoring of approved Swinburne human research is a responsibility both shared and separately carried out by researchers, ethical review bodies, Swinburne or other appropriate authority or body.

Monitoring by Swinburne and its ethical review bodies usually occurs by way of timely submission by researchers of reports or requests. It can also occur by planned or random inspections, interviews or audits by Swinburne or other authority. Contact with research participants can also occur such as when complaints or concerns are expressed by research participants or other another interested party. Researchers themselves can, as part of their own monitoring arrangements, use the adapted Self-Audit Tool to assist with ensuring on-going ethics clearance.

When to submit progress or final reports

A standard condition of ethics clearance for all human research is that the chief investigator/supervisor is responsible for submitting reports on the conduct of a project in compliance with the approved protocol:

  • Immediately upon (or asap thereafter of) any serious or unexpected adverse effects/events on participants (eg, loss of data, harm or significant distress to a participant, harm to a researcher, etc) and the appropriate measures taken
  • Upon unforeseen incidents or events that might affect continued ethical acceptability of the project
  • At least annually
  • Upon abandonment of the project prior to or after commencement of human research or data collection
  • Upon completion of active human research activity (ordinarily at the end of data collection)
  • Additionally as required by Swinburne and/or the Swinburne ethical review body or external authority
  • As part of requests to modify or add to the approved project (see below for requests for changes/additions to approved protocols)

When to submit an 'HDR Student' report

  • This section of the ‘Progress/Final Report’ form should be completed when a higher degree by research student (professional doctorate, PhD or Masters by research student) has completed their involvement in a project that is otherwise still continuing. The student will receive a statement from the Ethics Office confirming that ethics reporting requirements were met. The student should provide a copy of this statement to the Graduate Studies unit as part of their thesis submission. [Note that if the end of a student’s involvement coincides with the end of the study overall, only a Final Report is required.]

The reports must be sufficiently detailed, use the prescribed form where applicable, and be submitted in a timely manner to Swinburne Research.

Requests for changes/additions to approved protocol

Ethics clearance, when issued, is conditional. Only what has been submitted to, and approved by, the relevant Swinburne (or Swinburne-endorsed) ethical review body has coverage and is subject to standard and any special conditions for ethics clearance. Thus any addition or variation to or change from what was approved to date needs timely ethical review and clearance, be it a change in key research personnel, changes to recruitment or consent arrangements, changes in research direction or method or instrument etc. What is not properly approved to date cannot be undertaken (unless, for instance and quite exceptionally, the measure(s) taken can be shown to be necessary in an emergency to ensure the rights and interests of those participating in the approved project are protected).

Some points to note/consider:

  • Additions or variations proposed to approved human research remain subject to the same Swinburne and/or external standards or requirements as applicable.
  • Additions or variations cannot ordinarily be implemented until proper ethics clearance has been given in writing.
  • One or more addition(s) or variation(s) should be considered in the context of the whole approved protocol, thus, for example, a request to add a survey instrument may also require revision to the recruitment and consent instruments.
  • The addition/modification proposed may require additional expert or higher level review, compared to the prior or existing type/level of review, depending on the circumstances or detail.
  • Additional detail or documentation may be required or requested to process the request or to conduct or complete the ethical review.
  • Additional Swinburne, external ethical review body or other authority may be needed to ensure viability or validity for what is now proposed.
  • Please note project extensions can also be requested via Swinburne Research Analytics [staff login]. To access the Ethics section, log into SRA -> My Profile -> Ethics. There are help materials in our wiki [staff login] if you require assistance.

How and when to submit ethics clearance applications for additions or variations to approved protocols

Requests to add to or modify the approved protocol should be submitted to the Research Ethics Office as soon as practicable using the applicable prescribed format. Requests can be made at any time, but in the event of a request warranting full SHUREC review, then the published application deadlines relative to a scheduled SUHREC meeting should be noted.