PARTICIPANT INFORMATION SHEET TO BE A PART OF AMILI’S MICROBIOME REFERENCE LIBRARY
For more information about the microbiome reference library, please read the research participant information form carefully. If you have any questions, please contact us at firstname.lastname@example.org or at +65 6977 7199.
Why is this study being done?
Asian Microbiome Library (AMILI) is Southeast Asia’s first and only precision gut microbiome company serving as a hub for gut microbiome innovation and therapy. Our aim is to advance microbiome research, grounded in science and compassion, to address unmet and critical needs in healthcare with the potential to positively impact millions of lives across Asia.
The gut microbiome is known to be influenced by diet and environmental factors (such as sleep quality, and physical activities). In recent years, there have been a proliferation of studies in animal models and specific diseased patient population showing h3 links between the role/presence of microorganisms in the gut to diseases such as gastrointestinal disorders, diabetes, cancer and neurological disorders in the US and European region. United by a shared belief that science can be a powerful driver for the greater good when combined with ethically- and scientifically-backed tools, our goal is to build up a regional gut microbiome repository to support fundamental discovery into the impact of the gut microbiome on human health in Asia as we h3ly believe that the gut microbiome of Asian population differs from that of our western counterparts (due to diet, environment and lifestyle).
It’s a long journey, and it will take time for our scientists to analyse these data to determine the impact of it. We hope these studies will help researchers develop better ways to prevent, detect, and treat disease.
If you are not already an existing member, you may be asked to join AMILI to participate in all facets of the microbiome reference library.
What will happen during this study?
To accelerate our mission, and understand your health better, AMILI will ask that you provide the following information to the extent that you are willing:
Details about you and your health such as your age, medical conditions, symptoms and treatments.
Multiple questionnaires (that pertain to various areas of AMILI’s targeted disease or health states) that each take approximately 5 – 10 minutes to complete.
You will be given the choice to select questionnaire(s) on areas of studies in which you would like to contribute towards
Contribution of stool (faeces) sample
Each specimen will be coded for anonymization purpose before processing, and transferred securely to the biorepository.
No additional sample will be required as AMILI will extract from the sample that you have given for BIO & ME
Your stool sample will be sequenced and analysed along with the data provided in the questionnaires, and the results will be added to AMILI’s growing digital gut microbiome database.
What biological measurements might be taken from my biosamples?
AMILI may elect to do an “omic” profile on your sample. This means we will take many measurements at once. For example, we will send your sample for whole genome sequencing to profile the bacteria, viruses, fungi, & other microbes in the gut. We may also wish to look at the metabolites in your stool produced by your gut microbiome.
How are my samples and health information stored in the biorepository?
AMILI will randomly assign a de-identified code (unique identifier) to your samples and health information.
Your name, AMILI user ID, or other information that easily identifies you will not be stored directly with your samples.
The key to the code will be stored securely in a separate file, accessible only to key personnel working at or contracted with AMILI.
The coded samples will be held under secure conditions and accessible only to key personnel at or contracted by AMILI.
How long will AMILI keep my samples and information?
We may securely store your samples and donated data without a defined end date.
What are the potential risks of being in the study?
It is possible that a participant could be identified using information shared on AMILI (and/or combined with your sample or other data sources). Although we endeavour to minimize any risks by only sharing de-identified information with partners and others, there is some risk that your sensitive data could be associated with your identity.
As with any online related activity, the risk of a data breach is always possible. AMILI takes commercially reasonable administrative, procedural, and technical precautions to help keep our members’ data secure.
Does being in this study provide any benefit and/or individual results?
There are no anticipated absolute benefits to participants. However, through your participation, we will have a better understanding of the gut microbiome and health states. These insights will be crucial for future research into these topics, particularly for the potential future development of a more personalised treatment and disease management.
Other information about the study
AMILI may request participation and/or enrolment into other AMILI initiatives. Lack of acknowledgement or enrolment into additional research opportunities will not automatically withdraw your participation in the microbiome reference library.
You may receive a newsletter or other information that will tell you about the research discoveries and status updates from this or other projects from the microbiome reference library.
As this project continues, you may be asked for other types of participation including:
Permission to access other medical information including your health records and medical images including standardized video exams.
Linkage to and/or access to data you are collecting with digital devices such as mobile health apps, sensors or trackers.
Who is paying for this study?
AMILI assumes all costs associated with the study.
Will it cost me anything to be in this study?
You will not be asked to financially contribute to your participation.
Do I have to be in this study?
Your participation in this study is completely voluntary and you can withdraw at any time without penalty or loss of benefit.
Can I stop allowing my specimens and data to be stored and used for research?
Your participation in this study is completely voluntary and you can withdraw your permission at any time. If you do, your samples stored in the AMILI biorepository will be destroyed. However, it will not be possible to destroy samples and information that have already been given to researchers. Once a specimen has been analysed by a researcher, AMILI cannot remove your sample or information from their research process.
You can choose not to respond to any invitations for biospecimen and/or other forms of data collection at any time.
The investigator or the IRB can also stop your participation at any time.
If you decide to withdraw from the microbiome reference library, please contact us in writing at email@example.com or give us a call at +65 6977 7199.
Who will have access to my samples and/or medical information?
The research team at AMILI, and any research partners working with AMILI, will have access to your donated data and unique coded samples.
Your coded samples and health information may also be shared with researchers at other institutions or with for-profit companies that are working with AMILI researchers.
Your samples and information may be used to develop a new product or medical test to be sold. AMILI researchers and partners may benefit if this happens. There are no plans to pay you if your samples and information are used for this purpose.
We will not share information that identifies you with researchers outside AMILI without your express permission.
We may share your de-identified samples and/or microbiome information, your health information, and results from research with other central tissue or data banks, such as those sponsored by the Ministry of Health, and with researchers from around the world so they can use them to study many conditions.
If we publish the results of the research, we will only include de-identified information.
Personally Identifiable Information will not be included in any report to partners or in any publications or presentations that come from this research.
We do not release any individual information to insurance companies.
For what research, might my data and samples be used?
It is not possible for us to list every research project that may be done. Also, we cannot predict all the research questions that will be important in the future. As we learn more, we may use your samples and information to answer new types of research questions related to human diseases.
AMILI plans to do many types of biological research with your samples, for example, research on gastrointestinal diseases, obesity, diabetes, to mental illness to name a few.
AMILI may share your samples, microbiome information, health information, and results from research (in aggregated form) with other central tissue or data banks, such as those sponsored by the Ministry of Health, and with researchers from around the world so they can use them to study many conditions.
AMILI may ask you about your experience and attitudes in participating in this type of research and/or in receiving research results back to you in the form of data derived from collected samples.
Who do I contact if I have questions about the study?
For questions, feedback, complaints, concerns or more information about this research or your rights as a research subject, contact us at firstname.lastname@example.org or +65 6977 7199.
We will contact you if there is any new information that might affect your willingness to continue in the study.