Project title: Public Attitudes Toward the Application of Gene Technology in Healthcare

Short title: Public Attitudes Toward Gene Technology

Protocol number: 1

Project sponsor: Centre for Eye Research Australia

Principal Investigator: Associate Professor Guei-Sheung Liu
Tel: 03 9929 8360 Email: cera@cera.org.au

Associate investigators: Dr Jiang-Hui Wang, Ms Layal El Wazan, Mr Satheesh Kumar, Dr Myra McGuinness.

Location: online survey

You are invited to take part in the research project, Public Attitudes toward the Application of Gene Technology in Healthcare. You are eligible if you are an Australian resident over 18 years of age.

This Participant Information page tells you about the research project. It explains the processes involved with taking part. Knowing what is involved will help you decide if you want to take part in the research.

Please read this information carefully. Contact the investigators if you don’t understand or want to know more about the study. Before deciding whether or not to take part, you might want to talk about it with a relative, friend or local health worker.

Participation in this research is voluntary. If you don’t wish to take part, you don’t have to.

If you decide you want to take part in the research project, you will be asked to acknowledge the consent section. By participating you are telling us that you:

• Understand what you have read.
• Consent to take part in the research project.
• Consent to be involved in the research described.
• Consent to the use of your personal and health information as described.
• You can request a copy of this Participant Information to keep.

We aim to administer a questionnaire to understand public awareness and knowledge of gene technology being used in healthcare. The overall goal of the study is to gain an understanding of the level of knowledge the public possesses regarding the use of gene technology in healthcare, identify specific factors that influence their knowledge and awareness as well as understand their outlook for the future of gene technology-based healthcare.

Gene technology is a field that has seen rapid advances in the last decade, especially since the advent of genome editing technology. Recent events in the last five years have had a significant impact on the discussions that surround gene technology in healthcare.

An online questionnaire will allow us to obtain data provided by a publicly recruited sample population. This will facilitate how future awareness campaigns are carried out and therapeutics are developed. Awareness of public concerns will remove hurdles in the implementation of translational research.

This research has been initiated by Associate Professor Guei-Sheung Liu, Principal Investigator and Head of Genetic Engineering Research at the Centre for Eye Research Australia (CERA). It is being sponsored and conducted by CERA.

The results of this research will be used by Mr Satheesh Kumar as part of their Doctor of Philosophy degree.

If you consent to participate, you will be asked to complete a brief questionnaire online which takes about 10-15 minutes to complete. You can consent to participate by acknowledging that you have read and understood the information provided on this page and on the survey landing page.

Your participation is completely voluntary, and you may decide to opt out even after consenting to participate.

At the end of the survey, your responses will be recorded in our database for analysis. You can contact the study investigators by the end of the study period if you want your responses removed from the study.

No identifiable data is to be collected through the questionnaire.  All responses will remain confidential and untraceable to individuals.

There is no reimbursement to participants for taking part in this study. Your contact information will not be collected. Contact with investigators will only occur if you decide to contact us for enquiries regarding the survey. The chief investigator will be contactable throughout the study period for enquiries.

Reponses collected will be monitored in real time through the REDCap platform. Only online written responses will be collected. No video or audio responses will be collected.

If you decide to take part in the research project, you will first be asked about your country of residence and age. This will determine if you are eligible to take part.

Completing the questionnaire will take approximately 10-15 minutes.

If you meet the requirements, you will be able to start the survey. If you do not meet the requirements, you will not be allowed to proceed with the survey.

This research project has been designed to make sure the researchers interpret the results in a fair and appropriate way and avoids investigators or participants jumping to conclusions.

There are no costs associated with participating in this research project, nor will you be paid.

We aim to collect responses from approximately 1000 respondents in Australia through this study. There will be no segregation of respondents by any demographic data.

Previously, the Principal Investigator similarly conducted an online survey to assess public attitudes toward gene therapy in China. This study is a follow-up to broadly understand Australian attitudes toward gene technology.

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 change your mind while completing the survey, you do not need to submit it.

If you do decide to take part, please keep a copy of the information on this page.

Your decision whether to take part or not to take part, or to take part and then withdraw, will not affect your routine care, your relationship with professional staff or your relationship with the Centre for Eye Research Australia.

There will be no clear benefit to you from your participation in this research.

However, possible benefits may include knowledge of public perceptions among the Australian public regarding gene technology in healthcare, that may influence future public policy and awareness campaigns.

You may feel that some of the questions we ask are stressful or upsetting. If you do not wish to answer a question, you may stop immediately.

If you become upset or distressed as a result of your participation in the research project, you may contact any of these following helplines:

• FriendLine: 1800 424 287
• Lifeline: call 13 11 14, or text 0477 13 11 14
• MindSpot: 1800 61 44 34

Alternatively, you may also:

• Take a break.
• Have a discussion with family and friends.
• Choose to not proceed with the survey.

As the survey is hosted online, technical difficulties may occur resulting in you not being able to participate. If this happens you may try again later or contact the investigators if the issue persists.

You may leave the survey at any stage, even after you have consented.

There are no penalties or implications for not completing the full survey.

If you decide to leave the research survey before finishing it, that is not pressing “submit” at the very end, the data will not be included in our final data analysis.

This research project may be stopped unexpectedly for a variety of reasons. These may include reasons such as ethical issues that are identified with the questionnaire or significant life events (e.g., a pandemic or researcher illness).

If this occurs, then the study may be postponed or terminated to address the relevant concerns.

At the end of the study period, the responses will be collated for data analysis.

Findings from the analysis will be written as a report and submitted to a scientific journal for publication. The publication will be advertised through the CERA website and other communication channels for participants to access.

By completing this survey, you consent to the research team collecting and using your responses for the research project. Any information obtained in connection with this research project that might identify you will remain confidential.

Data will be stored on a password protected server at the Centre for Eye Research Australia, accessible only to the Research Study Members. The data will be stored for five years. After this the  data will be deleted from the server.

As we aim to keep the survey completely anonymous, participants will not have access to their own responses. Do note that, as responses are anonymous, we are unable to identify your responses individually after you have submitted them.

Your information will only be used for the purpose of this research project, and it will not be disclosed, except as required by law.

The only personal information that the research team will collect and use is your demographic characteristics, socioeconomic status and health status.

It is anticipated that the results of this research project will be published and/or presented in a variety of forums. No identifiable information will be included in any publication and/or presentation.

As the study is of low risk, no loss or injury is expected from this study.

Complaints will be recorded on the Research Complaints Register held in CERA’s Research Governance Unit. The register includes information to track the progress of the complaint and provides a history of all referrals and actions taken, as well as dates of receipt and resolution of the complaint.

The decision as to whether an incident/complaint is minor or serious will be made by CERA’s Deputy Director of Research in consultation with the Chair of the relevant Committee and, where necessary, the Director of Research.

The first person designated to receive complaints from research participants is the Research Governance Officer. It is expected that most complaints from research participants will be able to be dealt with by the Research Governance Officer in conjunction with the relevant associates.

Serious complaints, which cannot be readily resolved, will be referred for consideration by the Deputy Director, Chair or the relevant research-related committee and, where necessary, the Director of Research.

In circumstances where a complaint cannot be resolved using CERA’s internal complaint resolution processes, external, independent advice will be sought. This may include consultation with the Office of the Health Services Commissioner or with senior staff from other organisations.

Complaints which highlight problems warranting amendments to the research protocol will be reviewed by the Chair of the relevant research-related committee who will provide written advice to the Principal Investigator. Complaints will also be reported to the relevant committee and an update provided on each subsequent committee meeting agenda.

This research project is organised and funded by the Centre for Eye Research Australia (CERA). CERA may benefit financially from this research project if, for example, the project assists CERA in any commercial enterprise.

You will not benefit financially from your involvement in this research project even if, for example, knowledge acquired from your information proves to be of commercial value to CERA.

In addition, if knowledge acquired through this research leads to discoveries that are of commercial value to CERA, the researchers or their institutions, there will be no financial benefit to you or your family from these discoveries.

No member of the research team will receive a personal financial benefit from your involvement in this research project (other than their ordinary wages).

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 HREC of St. Vincent’s Hospital Melbourne.

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.

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 problems which may be related to your involvement in the project, you can contact the Principal Investigator, Associate Professor Guei-Sheung Liu, on 03 9929 8360.

Research contact person

Name: Associate Professor Guei-Sheung Liu
Position: Principal Investigator
Telephone: 03 9929 8360
Email: cera@cera.org.au

Complaints contact person

Position: Research Governance Officer
Telephone: (03) 9929 8263
Email: cera-rgo@cera.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 Human Research Ethics Committee (HREC)

Reviewing HREC name: St. Vincent’s Hospital Melbourne HREC
Position of contact person: HREC Executive Officer
Telephone: (03) 9231 6970
Email: research.ethics@svhm.org.au

By proceeding, you agree that you have read the above information and voluntarily agree to participate.