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Clinical case study endorsement process

To conduct a clinical case study, researchers are required to obtain endorsement from the Gold Coast Health HREC.

Refer to the additional contacts page for ethics assistance.

Obtaining ethics endorsement for clinical case studies

1. Complete the clinical case study form

You are required to complete the Clinical Case Study and the HREC form.

2. Obtain consent from participants

You are then required to obtain consent from participants with the Case Study Report Participant Consent Form and Request to publish case study information sheet.

3. Does the clinical case study involve using clinical images?

In addition to obtaining consent to publish the case study, consent must also be obtained from participants using the Consent to Clinical Digital Images Form. Please contact our Research Office to access this document.

4. Upload all completed documents through Ethics Review Manager (ERM)

To upload the Clinical Case Study and the HREC form, and other supporting documents, through Ethics Review Manager, follow these steps:

  1. Log in to the Ethics Review Manager.
  2. Select the tile Create Project from the list of Actions on the left-hand side.
    • Enter the Project Title, choose Queensland Health as the jurisdication and LNR Form as the Main Form type, then select Create Project.
  3. Select PRE LNR QUESTIONS to begin completing the form and complete the questions as prompted.
    • For question 2, please choose the Gold Coast Hospital and Health Service Human Research Ethics Committee
      (EC00160)       to ensure that you submit the project to the GCHHS HREC for review.
    • Please ensure all project team members are listed under question 4a. The Primary Applicant should be
      listed as the Principal Investigator and must be a GCHHS staff member. List additional project team members
      as Associate Investigators.
  4. Upload the completed and signed Clinical Case Study and the Human Research Ethics Committee application form
    under question 6a (select Study Plan / Project design) along with any other supporting documents.
  5. Once you complete the LNR form, with all supporting documents uploaded, the Coordinating/Principal Investigator should complete the Signatures and Declarations page and sign the form. You can do this electronically (recommended) or alternatively, print the form, obtain the "wet-ink" signature and upload the page to the form.
  6. Select the Submit tile from the list of Actions on the left-hand side and follow the prompts. This will submit the application to the GCHHS HREC Office for processing.
5. Application undergoes ethical consideration

 If your project is endorsed as a clinical case study, the project will be registered with the HREC and you will be provided with a letter that can be used for publication purposes.

Last updated 29 May 2020