Standard Participant Information Sheet & Consent Form Templates (PISC)
- NH&MRC Standard PISC Forms
- 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.’
Text Relating to contraceptive advice in Participant Information Statement and Consent Forms
It is understood that some sites will have local requirements for wording in materials used in research study documents, on a number of issues.
Please note that the adoption of site specific wording in HREC review is part of the National Mutual Acceptance Scheme, for more information please refer to:
For studies involving a Catholic site/s, there are different forms of words that have been accepted in the context of providing written advice regarding avoidance of pregnancy in circumstances where there are risks associated with participation in a research study.
In Appendix Two of the National Mutual Acceptance Scheme there is an approved template for recommended wording, shown below in bold text. This would be used in a site specific version of the PISCF.
The effects of [Name of investigational product] on the unborn child and on the newborn baby are not known. Because of this, it is important that research project participants are not pregnant or breast-feeding and do not become pregnant during the course of the research project. You must not participate in the research if you are pregnant or trying to become pregnant, or breast-feeding. If you are female and child-bearing is a possibility, you will be required to undergo a pregnancy test prior to commencing the research project. If you are male, you should not father a child or donate sperm for at least [number] months after the last dose of study medication.
Both male and female participants must avoid pregnancy during the course of the research and for a period of [number] months after completion of the research project. You should discuss effective methods of avoiding pregnancy with your study doctor.
[For female participants] If you do become pregnant whilst participating in the research project, you should advise your study doctor immediately. Your study doctor will withdraw you from the research project and advise on further medical attention should this be necessary. You must not continue in the research if you become pregnant.
[For male participants] You should advise your study doctor if you father a child while participating in the research project. Your study doctor will advise on medical attention for your partner should this be necessary.
An alternative approach is to add a prefix-template below in bold, to be added to detailed information provided in a master Participant Information Statement and Consent Form. This approach has been noted by the SVHNS Bioethics Committee and is acceptable to SVH HREC. Note that researchers may wish to confirm that individual study sites accept this HREC approved approach.
“Because of the unknown risks of this study medication, it is important that you do not become pregnant during this trial. For legal reasons, the pharmaceutical company requires us to provide you with the following information about methods of avoiding pregnancy. Not all of this information is endorsed by (insert site name), nor reflects its ethical standards as a Catholic hospital. You should discuss with the study doctor and/or your own doctor and ethical advisor an effective way for you to avoid pregnancy that is in keeping with your beliefs and values”.
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]
Protocol TemplateUpdated April 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 40KB)
Template - eCTN Study Details Form (DOCX 26.2KB) (June 2016)
Self Monitoring Tool (DOC 325KB)
Guidance - Monitoring of Approved Research (DOC 266.5KB)
The Significant Safety Issue Form (SSI) can be found on the OHMR Safety Reporting Webpage.
The Local SUSAR/USADE/URSAE Notification Form can be found on the OHMR Safety Reporting Webpage.
Changes in Research Personnel
Notification of Change in Personnel (DOC 57KB) (Updated December 2016)
Please use this form when adding new staff to a study however note that changes in CPI or PI are processed via REGIS.
Application for HREC Endorsement for the purpose of becoming an Authorised Prescriber (DOCX 101.7KB)