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Project Variations

Once your research project has approval from the HREC, any changes you wish to make must be submitted for approval by the HREC. These include changes to:

  • Participants
    • Selection of participants (e.g. changing the inclusion/exclusion criteria for participants or participant groups)
    • Organisations involved in the research (e.g. recruiting from a new organisation not previously approved, or deciding not to use a previously approved organisation)
    • Sample size (e.g. if your approved protocol was to conduct 10 focus groups but it was decided that 12 are needed, then approval must be sought before conducting the additional two focus groups)
  • Recruitment materials (Altering the wording or any material including recruitment flyers, information sheets, consent forms, letters sent to participants/potential participants and media advertisements)
    • Honorarium (introducing, removing or altering)
    • Research tools (e.g. new research tools (new surveys, interview/focus group questions etc.) or removing or changing approved research tools)
      • Questionnaire
      • Interview or Focus Group questions
      • Data collection protocols
  • Project Team and/or Funding
    • Addition or removal of any investigators
    • Change to HDR student supervision team
    • Project funding and/or contractual arrangements
    • Study Status (e.g. study is placed on hold or suspended)

To request a variation, the Project Variation Form must be submitted to the Human Research Ethics Office (humanethics@unisa.edu.au) along with copies of any relevant documents (e.g, participant information sheets, research tools, recruitment materials) affected by the variation. Variations must be justified and be consistent with the original research aims and research questions.

Two copies of all amended documents are to be submitted:

  • One copy of the document(s) using track changes
  • One clean copy of the amended document(s)

Documents must have a version number and date.

The Human Research Ethics Officer will liaise with the Chair or Deputy Chair of UniSA HREC who will consider your amendment(s). Feedback from the UniSA HREC should occur within 5 working days of receipt of your variation request.

Formal notification of approval from UniSA HREC/Chair must be received prior to implementing the change(s).