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Post-Approval Requirements

Conditions of ethics approval

Human Research Ethics Committee approval is always granted on the basis of a number conditions, detailed in this document:

Reporting requirements: annual reports, completion reports and requests for extension of ethics approval

Ethics approval is normally granted for a period of three years. As a condition of ethics approval, UniSA HREC (and the National Statement on Ethical Conduct in Human Research) requires researchers to provide an annual progress report and a summative report on completion of the project. If your ethics approval is due to expire and the research is to continue, you must apply for an extension of ethics approval before the expiry date. A maximum of 12 months extension can be granted at any one time. However, another extension request may be submitted at the end of this period if required.

A project progress report must be submitted to the Human Research Ethics Officer (humanethics@unisa.edu.au) every 12 months after the approval date for the protocol.

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Amending an Approved Protocol

Ethics approval must be obtained from UniSA HREC if you wish to change an approved ethics protocol. The Protocol Modification Request Form must be submitted to the Human Research Ethics Officer (humanethics@unisa.edu.au) along with copies of any relevant documents (e.g, participant information sheets, research tools, recruitment materials) affected by the amendment. Amendments must be justified and be consistent with the original research aims and research questions.

Once received, 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 amendment request.

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Types of changes that require approval

Ethics approval must be obtained from UniSA HREC/Chair if you wish to make changes to an approved ethics protocol. These changes include:

  • Conducting or administering additional or fewer interviews/focus groups/questionnaires than originally approved (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).
  • Altering the wording of any recruitment material. This includes recruitment flyers, information sheets, consent forms, letters sent to participants/potential participants and media advertisements.
  • Use of new research tools (new surveys, interview/focus group questions etc.) or removing or changing approved research tools.
  • Changing the inclusion/exclusion criteria for participants or participant groups.
  • Recruiting from a new organisation not previously approved, or deciding not to use a previously approved organisation.
  • Introducing, removing or altering the honorarium given to participants.
  • Changes to the research team (i.e. adding new researchers, or removing researchers who are no longer involved in the project).
  • Changes to the project funding or other contractual agreements.

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

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Adverse Events

Any serious or unexpected adverse effects on research participants must be reported immediately to the Human Research Ethics Officer ( humanethics@unisa.edu.au) using the Adverse Event Form:

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Complaints Process

Human Research Ethics Complaints process (refer UniSA policy (RES-2))
http://w3.unisa.edu.au/policies/policies/resrch/res02.asp

Any complaints relating to research projects approved by UniSA's HREC or any complaints about UniSA HREC or decisions made by UniSA HREC should be directed to the Executive Officer of UniSA HREC, who will forward them to the Chair/ Deputy Chair. Depending on the nature and severity of the complaint, the Chair/Deputy Chair will either investigate the matter in consultation with the appropriate parties (chief investigator, supervisor, dean of research etc) or forward the complaint to the Deputy Vice Chancellor (Research and Innovation) for further investigation.

Where a conflict of interest exists (potential or actual), the complaint will be either referred to one of the Deputy Chairs and/or the Deputy Vice Chancellor and Vice President (Research and Innovation). The Deputy Vice Chancellor and Vice President (Research and Innovation) will determine procedures by which the complaint is investigated.

Contact Details for complaints:

Executive Officer
UniSA Human Research Ethics Committee
Tel: 08 8302 3118; Email: humanethics@unisa.edu.au

 

 

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