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The GASSI Study: Gut Health in Australia and Singapore for Science and Innovation

Participant Information Sheet

Consent Form Version:     Version 1.0
Consent Form Date:          20 August 2020

You are being invited to participate in a research study. This information sheet provides you with information about the research study. Please read the information below and ask questions about anything you don’t understand before deciding whether or not to take part. Please email your questions to gassi@sics.a-star.edu.sg. The Principal Investigator or his/her representative will answer all questions that you may have. 

Please read the information provided here carefully. If you agree to participate, please provide your consent to the participate at the end of this form. 

STUDY INFORMATION

Protocol Title: 
Gut health in Australia and Singapore for Science and Innovation (GASSI): Bilateral explorations of consumer understanding, expectations and experiences

Principal Investigator:
Prof David Cameron Smith
Senior Principal Investigator
Singapore Institute for Clinical Sciences (SICS), A*STAR Singapore
Brenner Centre for Molecular Medicine, 30 Medical Drive, Singapore 117609

PURPOSE OF THE RESEARCH STUDY 
The purpose of this study is to understand more of the gut health of Singaporeans. For this we are seeking your participation in the completion of a questionnaire that details aspects of gut health, including digestive symptoms. We are interested in understanding the relationship between gut health and food choice as well as in exploring what lifestyle strategies people adopt to maintain gut health. 

We hope to understand more about the issues related to gut health for Singaporeans. At the same time, we would like also to explore differences and similarities of gut health experiences, issues and self-management with Australians. Hence, this study is a funded collaboration between the Singapore Agency of Science Technology and Research (A*STAR) and gut health scientists from the Commonwealth Scientific and Industrial Research Organisation (CSIRO), Australia. 

This study will recruit up to 3000 Singapore participants (over a period of 3 months). Overall, a total of up to 6000 participants in both countries will be involved in this part of the study. 

STUDY PROCEDURES
If you agree to take part in this online questionnaire, you will be asked to answer a series of questions in relation to your gut health symptoms, any impact on your quality of life, gut health management strategies, sources of information and use of gut-health related products. It will take approximately 20 to 25 minutes to complete the questions that are applicable to you. All your responses will be confidential and kept anonymous. 

Storage, Supply, Use or Export of Health Information
To protect your confidentiality, your data will be coded. All identifiable information will be kept separate from the data. The link between your identifiable information and the code number will be kept confidential. Any de-identified health information obtained during the course of this study will be stored and used only for the purposes of this study for a period not exceeding 5 years, and all records will be destroyed after completion of the study. 

Any health information containing your personal data that is collected for the purposes described in this Participant Information Sheet and Consent Form will be stored securely under A*STAR, Singapore. The data will be anonymized and coded before any transfer out to CSIRO, Australia, for collaborative data analysis. A*STAR will take appropriate steps to ensure it complies with the data protection requirements in the Personal Data Protection Act while your personal data to be transferred remains in its possession or under its control. Any publications or press releases arising from the study will not contain any personal identifying information. 


POSSIBLE RISKS, DISCOMFORTS AND INCONVENIENCES
There are no anticipated risks or discomfort with your participation in this survey. 

POTENTIAL BENEFITS
There are no direct benefits for your participation in this study. However, your participation in this research study will add valuable contribution to the knowledge for developments in this field. 

REIMBURSEMENT FOR PARTICIPATION
There are no reimbursements involved for this questionnaire. 

INCIDENTAL FINDINGS
The questionnaire is specific and targeted to gut health. There are unlikely to be any incidental findings arising in this research. 

PARTICIPANT’S RIGHTS 
Your participation in this study is entirely voluntary.
By consenting and participating in the study, you do not waive any of your legal rights to revoke your consent and withdraw from the study at any time.  

CONFIDENTIALITY OF STUDY AND MEDICAL RECORDS
“Personal Data” means data about you which makes you identifiable (i) from such data or (ii) from that data and other information which an organisation has or likely to have access. Examples of personal data include names, contact information, medical conditions, medications, investigations and treatment history. 

Your participation in this study will involve the collection of Personal Data. Personal Data collected for this study will be kept confidential. Your records, to the extent of the applicable laws and regulations, will not be made publicly available. Only your Investigator(s) will have access to the confidential information being collected.

However, Regulatory Agencies, Institutional Review Board and Ministry of Health will be granted direct access to your original medical records to check study procedures and data, without making any of your information public. 

Data collected are the property of SICS, A*STAR Singapore. In the event of any publication regarding this study, your identity will remain confidential.

By signing the Consent Form, you consent to (i) the collection, access to, use and storage of your Personal Data by SICS, A*STAR Singapore, and (ii) the disclosure of such Personal Data to our authorised service providers and relevant third parties.

Research arising in the future, based on your “Personal Data”, will be subject to review by the relevant institutional review board.

By participating in this research study, you also confirm that you have read, understood and consent to the attached A*STAR Personal Data Protection Policy (Annex A).  

WHO TO CONTACT IF YOU HAVE QUESTIONS REGARDING THE STUDY
If you have questions about this research study, please email to gassi@sics.a-star.edu.sg or contact the Principal Investigator Prof David Cameron Smith at (+65) 6407 4341 / 6776 6840. 

WHO HAS REVIEWED THE STUDY
This study has been reviewed by the A*STAR Institutional Review Board (IRB) for ethics approval. 
If you have questions about your rights as a participant, you can contact the A*STAR IRB at hbro@hq.a-star.edu.sg.
If you have any feedback about this research study, you may contact the Principal Investigator or the A*STAR IRB.