Participant Information Sheet, and Terms & Conditions
St. Vincent’s Hospital, Sydney
Title | Prospective Assessment of the Impact of an Evidence-Based Educational Platform Offering Complimentary Training for Imaging-Based Diagnosis of Clinically Significant Prostate Cancer: PRIMARY Educational Platform (PEP) |
Project Sponsor | St Vincent's Hospital Sydney |
Principal Investigator | A/Prof Narjess Ayati |
Site | St Vincent’s Hospital, Sydney (Nuclear Medicine and Theranostics) |
Part I – What does my participation in the study involve?
1. Introduction
You are invited to take part in this research study because you are a clinician or medical researcher who uses 68Ga-prostate-specific membrane antigen (PSMA)–11 PET/CT (68Ga-PSMAPET) imaging in their routine clinical practice and/or medical studies for initial staging of prostate cancer and you are willing to attend an online course.
This Participant Information Sheet tells you about the research project. Knowing what is involved will help you decide if you want to take part in the research. Please read this information carefully. Ask questions about anything that you don’t understand or want to know more about. Participation in this research is voluntary.
If you decide you want to take part in the research project, you will be asked to check the consent section. By checking the “I consent to be enrolled in this educational program” box, you are telling us that you:
- Are more than 18 years old
- You are either health practitioner or medical researcher
- Understand what you have read
- Consent to take part in the research project
2.What is the purpose of this research?
Prostate cancer is the second most common cancer diagnosed in men in Australia and the third most common cause of cancer death. One in six men will be diagnosed with prostate cancer by the age of 85.
3. Do I have to take part in the research?
Participation in any research project is voluntary. If you do not wish to take part, you do not have to. If you decide to take part and later change your mind, you are free to withdraw from this research study at any stage. If you do decide to take part, you will be given this Participant Information and Consent Form to accept your participation.
4.What does participation in this research involve?
This consent form must be read and formally accepted before any training is performed. There are no additional costs associated with participating in this research project, nor will you be paid. All training materials required as part of the research project will be provided to you free of charge from St. Vincent’s hospital, Sydney.
This is a single site study at St. Vincent’s Hospital and aims to recruit approximately 100 participants within a 6-month period.
Once you sign up, agree to the terms & conditions (current document) and confirm your email address, you will be able to participate in the educational program via primaryscore.com. The website will include the following:
- Homepage - Explaining the purpose of the study.
- Baseline (pre-course) survey which includes 10 questions to be completed prior to the course.
- Training – Access to video recordings of training provided and online panel discussions
- Case Series –5 online case series each including 10 multiple-choice questions (MCQs)
- Final (post-course) survey which includes 10 questions to be completed after the teaching sessions and case series.
Training will be provided by qualified specialists working at department of Nuclear Medicine and Theranostics at St. Vincent’s Hospital, and will include:
- Cross sectional anatomy of the prostate gland
- Definition of PRIMARY scoring system
- Online panel discussion
5 What are the alternatives to participation?
You do not have to take part in this research project in order to continue using PSMA PET scans as part of your routine clinical practice.
6. What are the possible benefits of taking part?
We cannot guarantee or promise that you will receive any benefit from this research directly.
7. What are the possible disadvantages and risks in taking part?
There are no foreseen risks to you when participating in this study, and you can drop out from the course anytime with no further contact thereafter.
Confidentiality
St Vincent’s Hospital will be responsible for the safe and appropriate management of study data on the website for this study. Your email address will be held confidentially in line with current local legislation governing health information and will not be made publicly available.
8. What do I do if I wish to withdraw from the research?If you wish to withdraw from the study once it has started, you can do so at any time by discontinuing the online course without having to give a reason.
If you do withdraw your consent during the study, the study staff will not use your baseline and post-course survey marks in evaluating the benefits of the platform. You should be aware that data collected up to the time you withdraw will form part of the study results. You will be unable to have your data already collected removed.
9. Could this study be stopped unexpectedly?
This research project may be stopped unexpectedly for a variety of reasons and in this case, you will be notified.
10. What happens when the study ends?
After the study ends, it is anticipated that the results of this study will be published and/or presented in a variety of medical forums. In any publication and/or presentation, information will be provided in such a way that participants cannot be identified.
11. What will happen to information about me?
By agreeing to the Terms & Conditions, you consent to the relevant research staff collecting your personal information such as your email address. Any information obtained in connection with this study that can identify you will remain confidential.
In accordance with relevant Australian and/or NSW privacy and other relevant laws, you have the right to request access to the information collected and stored by the study team about you. You also have the right to request that any information with which you disagree to be corrected. Please contact the study team member named at the end of this document if you would like to access your information.
12. Who is organising and funding the research?
This study is being sponsored and funded by the St Vincent’s hospital.
You will not benefit financially from your involvement in this study.
13. Who has reviewed the study?
All research in Australia involving humans is reviewed by an independent group of people, called a Human Research Ethics Committee (HREC). The ethical aspects of this research project have been approved by the St. Vincent’s Hospital, Sydney HREC (reference 2024/ETH00741).
This project will be carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement has been developed to protect the interests of people who agree to participate in human research studies.
14. Further information and who to contact
The person you may need to contact will depend on the nature of your query.
If you want any further information concerning this project or if you have any medical problems which may be related to your involvement in the project (for example, any side effects), you can contact the principal study doctor on 02 8382 2621:
Clinical contact person
Name | A/Prof Narjess Ayati |
Position | Principal Investigator |
Telephone | +61(02) 8382 1815 |
Narjess.ayati@svha.org.au |
Complaints contact person
Name | Research Office Manager |
Position | Research Office Manager |
Telephone | 02 8382 4960 |
SVHS.Research@svha.org.au |
If you have any complaints about any aspect of the project, the way it is being conducted or any questions about being a research participant in general, then you may contact:
Reviewing HREC approving this research and Research Officer details
Reviewing HREC name | St Vincent’s Hospital HREC |
Position | Research Officer |
Telephone | 02 8382 4960 |
SVHS.Research@svha.org.au |
Local Research Office contact (Single Site -Research Governance Officer)
Name | Research Governance Officer |
Position | Research Governance Officer |
Telephone | 02 8382 4960 |