Submission of Documents (Secondary)

Resubmissions (Major modifications).

Studies who receive a decision of Major modifications must make the necessary changes to their protocol and resubmit to AUPERB using the Resubmitted Study Protocol Form (FM-URC-028). The submission must also include a copy of the revised protocol and informed consent forms, with the changes highlighted. Resubmissions will undergo a full board deliberation and must be submitted to the URC office at least seven working days before the next board meeting.

Resubmissions (Minor modifications).

Studies who receive a decision of Minor modifications must make the necessary changes to their protocol and resubmit to AUPERB using the Resubmitted Study Protocol Form (FM-URC-028). The submission must also include a copy of the revised protocol and informed consent forms, with the changes highlighted. Resubmissions under this category only require an expedited review by the Chair.

Amendments.

All research protocols that have been approved by the board must notify the board of any future amendments to the study that may have ethical implications, such as changes in study population, intervention, data gathering procedure, informed consent wordings and process, data storage and confidentiality, and the like. These changes must be reported to AUPREB using Study Protocol Amendment Submission Form (FMURC-029) together with the amended documents. Upon receipt of FM-URC-029, the Chair decides whether the amendment requires full board deliberation or expedited review. Amendments will be considered under the expedited category if they:

  • Do not involve changes in study populations
  • Do not involve the collection of stigmatizing information
  • Do not change approved use of anonymized or archived samples
  • Do not involve further recruitment of participants
  • Involve study protocols previously classified under expedited review
  • Are administrative in nature (such as contact details of study personnel)
  • Do not materially affect the risk-benefit ratio of the approved protocol or increase risks to study participants

Amendments that do not meet the above criteria will undergo a full board deliberation and must be submitted to the URC office at least seven working days before the next board meeting.

Continuing review.

Ethical clearance is usually issued for one year. Studies that will continue for more than a year and are nearing the expiry date are advised to submit the Continuing Review Assessment Form (FM-URC-030) at least 60 days before the expiry date. The Chair decides whether the continuing review application requires full board deliberation or expedited review.

Final Report.

Researchers/PIs should provide AUPERB with a summary of the outcome of the study using the Final Report Form (FM-URC-031). This must be submitted to the board after completion of the study. It is the responsibility of the Secretariat to track studies that are due for final reports, usually at the end of the academic year.