Participant Information Sheet & Consent Forms (PISCFs)
St Vincent’s Hospital HREC will only accept forms that are based on the current NHMRC templates (available at NHMRC - Ethical Issues and Resources) with standard sections and section wording used as appropriate throughout
- Please note that Witness to Signature is not required however a Witness to Signature and/or Witness to Consent may be required in cases where the conditions of GCP 4.8.9 apply.
- Where a study involves optional sub-studies, for example consent to tissue or data banking, or pharmacogenetic testing, a separate specific Participant Information and Consent Form is required.
- Please note the following St Vincent's Hospital HREC’s preferred text regarding insurance implications of genetic testing. Please delete the 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 Sheet & 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 can be used where appropriate be 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]
St Vincent's Hospital Standard Compensation Language for Investigator Initiated Clinical Trials
For non-commercially sponsored clinical trials insert the following information about compensation:
'If you suffer any injuries or complications as a result of this study, you should contact the study team as soon as possible and you will be assisted in arranging appropriate medical treatment. In the event of loss or injury, the parties involved in this research project have agreed that you may be entitled to seek compensation for any injuries or complications resulting from the study if your injury or complication is sufficiently serious and is caused by unsafe Investigational Product or by the negligence of one of the parties involved in the study (for example, the researcher, the hospital, or the treating doctor). You may wish to seek legal advice to explore your options. You do not give up any legal rights to compensation by participating in this study.
If you receive compensation that includes an amount for medical expenses, you will be required to pay for any medical treatment required for your injury or complication from those compensation monies. If you are not eligible for compensation for your injury or complication under the law, but are eligible for Medicare, then you can seek medical treatment required for your injury or complication free of charge as a public patient in any Australian public hospital. If you are not eligible for Medicare you may be able to claim compensation back via your private health insurance.'
St Vincent's Hospital Standard Compensation Language for Investigator Initiated Qualitative Research
A shorter form of complaints and compensation clause is appropriate for those projects where the research is qualitative and involves questionnaires and interviews. Even though it is unlikely that this type of research may cause damage, the possibility cannot be eliminated. For example, damage arising from inappropriate selection of participants, inadequate monitoring of participants during the project or where participation exacerbates the participant’s condition.
For non-commercially sponsored qualitative clinical research insert the following information about compensation:
If you experience any adverse effect or reaction as a result of participating in this research study, contact the study team who will assist you in obtaining appropriate medical treatment. You may also be able to seek compensation through the courts.
St Vincent's Hospital Research Office Contact Details
Please use the Research Office Contact Details to populate the appropriate tables in the standard Participant Information Sheet & Consent Forms
Other Submission Templates
Protocol Template Updated April 2017
Consort Statement: guidance on clinical trial protocol development
NIH e-protocol Guidance
Study Budget Template
Template - eCTN Study Details Form
Self Monitoring Tool
Guidance - Monitoring of Approved Research
OHMR Safety Reporting Webpage (for SSI and Local SUSAR/USADE/URSAE Notification Forms)
Changes in Research Personnel
- This form should only be submitted (via email to SVHS.email@example.com) for non-PI/CPI Changes in Research Personnel for PRIVATE Hospital Sites (St Vincent’s Private Hospital, The Mater Hospital, Victor Chang Cardiac Research Institute)
- Please note that all Changes in CPI and PI are processed via the ETH project in REGIS
- All other Changes in Research Personnel for studies being conducted at St Vincent's Hospital are processed via the submission of an STE amendment in REGIS.