REGIS Checklist - LNR Submission

St Vincent's Hospital Sydney - Checklist for Low/Negligible Risk Study Submission - REGIS

Submission Instructions
  1. The HREC Chairperson must first confirm that the study is appropriate for review as low or negligible risk. Please submit a protocol or study outline to the Research Office e-mail:
    You will be informed of the Chairperson’s decision as soon as possible. Please submit this confirmation email with your study documents in REGIS.
  2. HREC Executive meets approximately every 2 weeks. To be reviewed at a given meeting, the submission must reach the Research Office, Translational Research Centre by 5 p.m. on the Thursday before the meeting.
  3. We do not require hard copy submissions of studies submitted in REGIS
  4. Applications must be submitted, via REGIS system Please refer to the Quick Reference Guides for Research Applicants on the website for information about making a submission
  5. A cover letter, signed by the Principal/Coordinating Investigator must be submitted with any LNR application and list the following:
    • Name of CPI
    • ALL documents submitted for review (including document version and dates) as you wish them to appear on the approval email
    • Name of Sponsor (the entity taking overall responsibility for the conduct of the study)Sites for which HREC approval is sought (including private sites) – if you wish to include private sites, please contact they Research Office before you make your submission to determine whether an External Entity Agreement is required
    • List of students (if any) who are participating in the study and their degree pathway
  6. All documents must have a document version and date printed on them.  However, please ensure you do not include version and date in the document file name.
  7. Incomplete applications may be deemed ineligible or result in delayed review

  • Complete Project Registration – Note that information entered at this stage cannot be amended so please ensure you enter the correct details. Please ensure you select a site in project registration
  • Complete HREA Form. Please note the HREA form only appears after Project Registration has been completed.
  • Please note that all investigators listed on the HREA must have a REGIS account
  • All studies including single site studies will have a Co-ordinating Principal Investigator. Please ensure you answer Q 1.9.10 as Co-ordinating Principal Investigator/Researcher for them and Q 1.9.11 as ‘Yes’. All other researchers should answer ‘No’ to Q 1.9.11
  • Only the Co-ordinating Principal Investigator can ‘certify’ the study and make the submission to the Research Office
  • For student projects: Students cannot be listed as the Coordinating Principal Investigator, unless they are also a St Vincent’s Hospital employee. Contact details must include University and Faculty.
Study protocol / summary
  • Submission of a study protocol or outline is MANDATORY for all projects submitted to SVH HREC for review. Templates are available on the Research Office website.
Participant Information Sheet & Consent Form/s if applicable
  • The use of standard NHMRC PIS&CF templates and wording is MANDATORY. Templates are accessible from the Research Office website.
  • If referring to drugs: use the ‘generic’ rather than the ‘brand’ name, include ‘witness to consent’ signature box on the consent page, do not use the term ‘de-identified’ (refer to National Statement 3.1,Element 4f or guidance on terminology), and do not use specific research office staff names in the contacts section of the form.
  • Insert the institutional logo (page 1, consent and revocation of consent pages).
All documents to be used in the study (all must have a version number and date printed on them)
  • E.g.Questionnaires (if not validated), advertisements, letters of invitation, diaries, interview questions, telephone scripts.

Fee Payment if applicable

Contact the Research Office if assistance is required:

(02) 8382 4960 | | Translational Research Centre, 97-105 Boundary Street