Standard Participant Information Sheet & Consent Form Templates (PISC)
- St Vincent’s Hospital HREC will only accept forms that are based on the current NH&MRC template documents, with standard sections and section wording used as appropriate throughout.
- Where a study involves optional sub-studies, for example consent to tissue or data banking, or pharmacogenetic testing, a separate specific Information and Consent Form is required.
- Please note the HREC’s preferred text regarding insurance implications of genetic testing; delete NHMRC standard wording and replace with:
‘Genetic information actually acquired by you as a result of your participation in this research may have implications for your (or your relatives’) ability to obtain cover for certain risk rated insurance products offered either alone or as part of a superannuation product (eg insurance products providing cover for: life, disability (income protection), trauma, or any business or bank loans which require a policy for life, disability or trauma) and may impact upon the amount you pay for and scope of protection provided by such products.’
- Link to NH&MRC Standard PISC Forms
- Text Relating to Pregnancy
- For studies involving at least one Catholic site, SVH HREC will accept the pregnancy wording in Appendix 2 of the National Mutual Acceptance Standard Principles for Operation.
- Advice from the Australian Health Ethics Committee (AHEC) on acceptable text relating to reproductive risk wording in Participant Information and Consent Forms for Catholic institutions (November 2016)
- Radiation Safety Text for Master Participant Information Sheet & Consent Forms
- Insert the following text in the risks section as necessary where sites for multi-centre studies require different wording for radiation safety as per site radiation safety assessments:
[Insert site specific radiation safety wording as required - Please note, either the radiation safety report, or a statement from Investigator stating that all radiation exposure falls within the sites standard of care must be submitted to the HREC and acknowledged/approved prior to inclusion]
Refer to Radiation Safety for additional guidance.
Protocol Template Updated January 2017
Please refer to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist for guidance on clinical trial protocol development
Study Budget Template XLS [40 KB]
Template - eCTN Study Details Form (June 2016)
Reporting & Monitoring
NOTED DOCUMENTS Instructions and template for submission of ethics documents (Updated 21 June 2016)
Annual Progress and Final Report Form (Updated February 2017) DOC [156 KB]
Line Listings and Annual Safety Report Letter Template (Updated May 2016) DOC [25 KB]
Self Monitoring Tool for Researchers DOC [90 KB]
Serious Adverse Event and Suspected Unexpected Serious Adverse Event Form (Updated June 2016) DOC [34 KB]
Changes in Research Personnel
Notification of Change in Personnel (Updated December 2016) DOC [58 KB]
Amendments / New Site Letter
Both the hard copy and e-mail submission must be received in the Research Office by submission deadline. Submission deadline is 5 p.m. on the Thursday before the HREC Executive meeting. Late submissions will not be accepted.
Amendment to an Approved Research Project (Updated May 2016)
New Site Letter Template (Updated May 2016) DOC [23 KB]
For site addition requests where the study involves radiation - either a site radiation safety assessment report, or a statement from Investigator stating that all radiation exposure falls within the sites standard of care must be submitted to the HREC along with the site addition request letter. Refer to Radiation Safety for additional guidance.
Application for HREC Endorsement for the purpose of becoming an Authorised Prescriber (updated February 2017)