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It outlines the purpose and administrative requirements for submitting ethics applications, including guidance on researcher eligibility and study types. The guide details when ethics review is exempt from formal processing, the limits on retrospective approval after data collection begins or ends, and the need to submit sufficiently in advance for an ethics review 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notes.......................................................................................................................................... 4  \nSubmission deadlines and Meeting dates .............................................................................................. 5  \nContact details for HSREC Administration and the RIMS Office ............................................................. 6  \nReview Fee Structure .............................................................................................................................. 7  \nGetting started: UFS Affiliated Researchers ........................................................................................... 9  \nGetting started: External Researchers .................................................................................................. 10  \nUmbrella studies, basket studies and linked studies ............................................................................ 13  \nApplication documents ......................................................................................................................... 15  \nWhat to expect after initial application submission ............................................................................. 21  \nHow to respond to comments from the HSREC.................................................................................... 22  \nPossible review outcomes from a full convened meeting of the HSREC .......................................... 22  \nApproval ............................................................................................................................................ 22  \nConditional approval......................................................................................................................... 22  \nModifications required ..................................................................................................................... 22  \nModifications required-Held over................................................................................................... 23  \nRejected/Disapproved ...................................................................................................................... 23  \nSubsequent submissions and reporting requirements on HSREC approved research .........................24  \nDefinition .......................................................................................................................................... 24  \nPaper vs electronic initial applications and RIMS ............................................................................. 24  \nProgress and final reports ................................................................................................................. 24  \nAmendments..................................................................................................................................... 24  \nMinor amendments....................................................................................................................... 24  \nMajor or substantive amendments ............................................................................................... 25  \nUnexpected Problems and Adverse Events ...................................................................................... 25  \nWhen to report Unexpected Problems or Adverse Events ............................................................ 25  \nAppendix 1: Example of Cover Letter..................................................................................................... 27  \nAppendix 2: Example of Head of Department permission letter– must be printed on the Department letterhead.............................................................................................................................................. 28","cbCaitak9ZBJzWyp","https://ap.wps.com/l/cbCaitak9ZBJzWyp","pdf",934038,35,"English","# General notes\n## Online ethics review management system (RIMS)\n## Purpose and scope of the guide\n## Exempt research categories\n## Limits on retrospective approval\n# Submission and review process\n## Submission deadlines and meeting dates\n## Review fee structure\n## Getting started (UFS affiliated and external researchers)\n## Umbrella, basket, and linked studies\n## Application documents\n## What to expect after initial submission\n## How to respond to HSREC comments\n## Review outcomes (approval, conditional approval, modifications, rejection)\n## Subsequent submissions and reporting requirements\n## Paper vs electronic initial applications\n## Progress and final reports\n## Amendments (minor, major/substantive)\n## Unexpected problems and adverse events\n## When to report unexpected problems or adverse events\n# Appendices\n## Example of cover letter\n## Example of head of department permission letter\n## Ministerial delegation guidelines for non-therapeutic research on minors\n## Broad ethical principles for ethics review (DOH2015)\n## Eight key ethical norms and standards (DOH2015)\n# Version history","[{\"question\":\"Which submissions are exempt from the formal HSREC ethics review process?\",\"answer\":\"Exempt research includes studies relying exclusively on publicly available information (or accessible via legislation/regulation), observation in public spaces without interaction or privacy intrusion, and research relying exclusively on secondary use of anonymised information.\"},{\"question\":\"Can HSREC grant retrospective approval after data collection has started or finished?\",\"answer\":\"No. HSREC cannot grant retrospective approval when data collection has commenced or is completed, so ethics review applications must be submitted well in advance.\"},{\"question\":\"What system does HSREC use to manage ethics applications and reviews?\",\"answer\":\"HSREC uses the online ethics review management system called Research Information Management System (RIMS) to manage the application and review process.\"}]","HSREC Preparation Guide - Application for Ethics Clearance - Version 08.01 - August 2023 | PDF",1789281823]