1. Introduction
You are invited to contribute your health information (this could be health information pertaining to your medical condition, past medical history and information on future planned procedures, or personal information, pertaining to your demographic group) to a database of patients undergoing oncological surgery and reconstruction at Chris O’Brien Lifehouse, Royal Prince Alfred Hospital and Mater Hospital.
Researchers will use the information collected in this database to help better understand and improve oncological surgery and reconstructive procedures and assist in developing future clinical research.
The database is being established and overseen within this institution by A/Prof Sydney Ch’ng from the Department of Head and Neck Surgery.
The database is to be maintained within the study sites (Chris O’Brien Lifehouse, Royal Prince Alfred Hospital, Mater Hospital) by A/Prof Sydney Ch’ng (Department of Head and Neck Surgery), Dr Tam Quinn (Department of Head and Neck Surgery), and Miss Amanda Yung (medical student, Sydney Medical School).
Data from this database may be used for studies conducted by Miss Amanda Yung (with separate ethics approval) as part of the requirements for a Master of Philosophy (Medicine and Health) degree, under the supervision of A/Prof Sydney Ch’ng.
2. Contributing to the database
If you agree to contribute to this database, you will not be required to do anything other than sign the Patient Consent Form. Relevant information will then be obtained from your medical record and stored in the database. This will include information on the type of cancer that you have; the procedure that you have undergone and details of the techniques that were used in your surgery.
In the database your health information will be identified with a number to protect your privacy. Your name will be recorded in connection with this number, but information about you will only be linked to your number
Your information will always be treated confidentially, and only A/Prof Sydney Ch’ng (the database custodian), her assistants and authorised researchers will have access to it.
All data will be stored on a secure server hosted by the Sydney Local Health District (SHLD) with daily backups as per SHLD policy. Only the investigators of this study will be able to assess this data.
Data from this database may be used in future studies with separate ethics approval. Your data will only be made available to the investigators named in this Information Sheet, or other investigators affiliated with the SHLD approved by the Database Custodian, A/Prof Sydney Ch’ng. Analysis of any data extracted from the database may be conducted at any of the study sites by the named investigators or approved investigators.
3. Risks
This study is not expected to result in any physical or psychological injury. The pre-surgery consultation may be made longer by 10-15 minutes due to the need to upload information to the database, but this is not expected to result in any risks. No additional information not covered in the pre-surgery consultation will be required from you.
4. Benefits
While we intend this database to be used to further medical knowledge and to improve oncological surgery and reconstructive procedures in the future, it may not be of direct benefit to you.
5. Costs
Contributing to this database will not cost you anything, nor will you be paid.
6. Voluntary Participation
Contributing to this database is entirely voluntary. You do not have to do so. If you do, you can withdraw your health information at any time without having to give a reason. Whatever your decision, please be assured that it will not affect your medical treatment or your relationship with the staff who are caring for you.
7. Withdrawal Process
If you decide to withdraw from this research project, you will need to notify a member of the research team (details listed under further information section below) and you will need to complete a withdrawal of consent form.
If you decide to leave the research project, the research team will not collect additional health information about you, although information already collected will be retained to ensure that the results of the research project can be measured properly and to comply with law. If you do not want your data to be included, you must tell the researchers when you withdraw from the project.
8. Confidentiality and length of data storage/data destruction
All the information collected from you for the study will be treated confidentially and will be stored on an online research database on a server hosted by the SHLD. Only A/Prof Sydney Ch’ng (the database custodian), their assistants and authorised researchers will have access to it. Access to this database is password protected and strictly monitored.
Data will be recorded using in a re-identified form using unique ID codes assigned to each participant. The database will be maintained until the end of 2032, after which the use of the database will be reviewed. Should the database be discontinued, the data contained will be retained in a de-identified form for 5 years before deletion.
Signed participant consent forms will be scanned into the database and the original form will be destroyed.
The study results may be presented at a conference or in a scientific publication, but individual participants will not be identifiable.
9. Future use of Data
The data collected in this project may also be used in future research studies. The results of these studies will contain de-identified data, which may be shared in the future with national and international collaborators, however the use of the data will be subject to ethics approval. You can indicate your agreement to this on the Participant Consent Form.
10. Further Information
When you have read this information, A/Prof Sydney Ch’ng will discuss it with you further and answer any questions you may have. If you would like to know more at any stage, please feel free to contact them on +61 2 8514 1460 or email sydney.chng@sydney.edu.au
This information sheet is for you to keep.
11. Ethics Approval and Complaints
The establishment of this database has been approved by the Ethics Review Committee (RPAH Zone) of the Sydney Local Health District. Any person with concerns or complaints about it should contact the Executive Officer on 02 9515 6766 and quote protocol number X21-0300.
Contribution to this database by patients at Chris O’Brien Lifehouse, Royal Prince Alfred Hospital and Mater Hospital has been authorized by the Sydney Local Health District.