Research checklist - HREC applications - Amazon S3



THHS Research Application Checklist – ETHICS (HREA) SUBMISSIONAHREC submissions - mandatory items FORMCHECKBOX Cover Letter (Addressed to the HREC Chair, including a brief description of study, if the study is to be reviewed as Low or Negligible Risk (LNR) research or higher than low risk research, study sites and list of documents submitted for HREC review and approval) FORMCHECKBOX Human Research Ethics Application (HREA) form – completed online at and signed by the Principal Investigator FORMCHECKBOX Study Protocol – This is the specific plan for the research. (Must have a version number and date in footer). Find THHS template at FORMCHECKBOX CV for all investigators (signed/dated) BStudy specific documentation (if applicable to your study) FORMCHECKBOX Data Collection Tool(s) e.g. case report forms, data spreadsheetStudies prospectively recruiting participants (including opt out consent) FORMCHECKBOX Participant Information and Consent Form (PICF) (Must have a version number and date in footer). Find NHMRC standardised PICF templates: FORMCHECKBOX Questionnaire/Survey/Interview Guide or other instruments FORMCHECKBOX All Recruitment Documentation e.g. advertisement, poster, brochure, letter of invitation FORMCHECKBOX Other e.g. participant diary, letter to GP, identification cardIndustry or privately sponsored studies FORMCHECKBOX HREC only indemnity. See Medicines Australia Indemnity template: Clinical Trial FORMCHECKBOX Investigator’s BrochureGene Technology FORMCHECKBOX Institutional Biosafety Committee (IBC) approval For more info go to: adelaide.edu.au/ethics/genetech/working/committee.html FORMCHECKBOX Licence for dealings with a Genetically Modified Organism (GMO)Radiological procedures outside standard practice that are performed specifically for research FORMCHECKBOX Independent assessment report by a Medical Physicist or District Radiation Safety OfficerStudy site in Victoria to be included under this HREC approval FORMCHECKBOX Victorian Specific Module (sub form in )When and Where to submit: Documents must be uploaded in and project submitted online for all studiesLow or Negligible Risk Research: Submit online anytime (No hard copies of documents required)Greater than Low or Negligible Risk Research:Submit to HREC meeting (Four hard copies of all documents required)For THHS HREC meeting submission dates go to: to: Townsville Research Education Support and Administration, Office 8, Townsville Institute of Health Research & Innovation, Level 2, The Townsville Hospital, Douglas QLD 4814Post: TRESA Unit - IMB 101, The Townsville Hospital, PO Box 670, Townsville QLD 4810Questions? Contact 07 4433 1440 or TSV-Ethics-Committee@health..au ................
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