BIOBANKING & RESEARCH CONSENT

For Babypass Services

Purpose Of Biobanking and Research

It is becoming clear that the human microbiome plays an important role in health, but the exact identity of functional microbes and the mechanism of action remains unclear, partially because of the lack of high-quality longitudinal studies and publicly available data.

The purpose of our research is to collect health data and microbiome samples from Babypass customers at different life stages to better understand the link between the dynamics of microbiome composition and health. We aim to characterize the composition of the human gut, milk, and other human microbiome to identify the key microbiome signatures that characterize both healthy and diseased populations overtime. Investigating microbiome dynamics during the entire spectrum of health and disease status will help us understand the causal relationships of microbiome and diseases, with potential to open the way to new prediction and diagnostic tools and therapies.

Consenting to Participation in Research and Biobanking

We seek your permission to keep your data and stool, milk, and/or other microbiome-relevant  samples submitted for Babypass services for future research. The data and sample will be kept with BluMaiden Biosciences Pte Ltd. Except if you withdraw your consent or there are limits imposed by law, there is no limit on the length of time we will store your data and sample. Researchers will use your data and stool sample for research long into the future.

The stored data and sample will be anonymized with the removal of all information that directly identifies you so that no one can identify which data and stool sample came from you. This means that even if you decide at a later time that you do not want your data or stool sample    to be used for future research, we will not be able to remove your data and stool sample and discontinue from future use. The use of your data and stool sample in future research may result in intellectual property rights and commercial profits. If this should occur, you will not be compensated and will not receive any financial benefits or proprietary interest.

By consenting to biobanking and research, you allow:

  • BluMaiden to store your sample and data for further analysis in future research and commercial programs.

  • BluMaiden to send you follow-up questionnaires/newsletters for the purpose of enquiring the intention and assessing the suitability of participation in future research studies, only if collection of additional samples is required. We may also access to additional medical information and/or sample with further consent obtained from you.

Further details of sample storage, utility and data protection are explained in other sections of this document.

Possible Risks

No physical risk is expected if you follow the sample collection guidelines of Babypass sampling kit. There is a risk of data breach for any online activities. BluMaiden Biosciences takes precautions for our administrative, and technical operations to keep your data as safe as possible. Even if data breach occurs, the deidentification mechanisms will ensure your identify is untraceable.

Potential Benefits

There is no immediate direct benefit from participation in our studies. However, we may invite you for future studies and provide microbial analysis and report free-of-charge or provide cash-voucher incentives to Babypass services, if your profile fit recruitment criteria for future studies. In the long term, your participation in the research will eventually contribute to leaps in healthcare solutions that benefits mankind, including you and your family.

Costs & Payments for Research Participation

There is no cost to you for participation to our research. You will be reimbursed for any expenses occurred, if invited for future research programs.

Incidental Findings

There will not be any incidental findings arising in our research. “Incidental findings” are findings that have potential health importance to research participants like you and are discovered in the course of conducting the study, but are unrelated to the purposes, objectives or variables of the study.

Details on Your Sample and Its Utility

The stool/milk or other microbiome-related samples collected for Babypass test will be deemed to be donated to BluMaiden Biosciences Pte Ltd, as a gift. By agreeing to this, you give up your rights to the stool/milk or other microbiome-related samples. If the use of your samples and/or your data results in intellectual property rights and commercial benefits, you will not receive any financial benefits or proprietary interest.

You will also grant us permission to store a portion of the stool/milk samples and any chemical material (such as DNA) derived from them, as well as your biodata for future research in our biobank and database respectively hosted by BluMaiden Biosciences Pte Ltd.

Personal Privacy and Confidentiality

Your participation in our research will involve the collection of Personal Data. “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  name, national registration identity card (NRIC), nationality, passport information, date of birth, and telephone number.

Any information containing your Personal Data that is collected for the purposes of this research will be stored in Singapore. To protect your identity, your Personal Data will be labelled with a unique code number. The code will be used in place of your name and other information that directly and easily identifies you. A separate file that links your code number to your Personal Data will be kept in a safe place with restricted access, in accordance with the rules and acts of regulatory agencies including Ministry of Health of Singapore.

By Consenting to participate in our research, you consent to (i) the collection, access to, use and storage of your deidentified Personal Data and (ii) the disclosure of such deidentified Personal Data to our authorised service providers and third parties relevant to research activity.

Personal Data collected for this study will be kept confidential. Your study records and data, to the extent required by the applicable laws and regulations, will not be made publicly available. In the event of any publication regarding this study, your identity will remain confidential. However, the monitor(s), the auditor(s), the Ethics Committee, and the regulatory authority(ies) will be granted direct access to your study records to verify study data, without making any of your information public.

As there will be a link between the code and your identifiable information, there is still a possibility of data breach. A data breach is when someone sees or uses data without permission. If there is a data breach, someone could see or use the data we have about you. Even without your name, there is a chance someone could figure out who you are. They could misuse your data. We believe the chance of this is very small, but it is not zero.

To know more about our policy on personal data protection, you can refer to BluMaiden Privacy and Data Protection Policy here at https://www.babypass.health/data-protection.

Participant’s Rights

Your participation in this study is entirely voluntary. You have a right to ask questions, which will be answered clearly and to your satisfaction.

In the event of any new information becoming available that may be relevant to your willingness to continue in this study, you (or your legal representative, if relevant) will be informed in a timely manner and will be contacted for further consent if required.

You may choose not to respond to any invitation of participation in future research programs or requests for data collection at any time.

Withdrawal From Research

You are free to withdraw your consent and discontinue your participation in the relevant research programs at any time.

However, any of your data that has been collected will be still kept and analysed for Babypass services of your choice, especially when you are still an active user.

Contact For Further Enquiries

If you have questions about this biobanking and research consent, you may contact customer service through the Babypass App.

 

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