Consent to Participate in the Somos BioBank
You are being asked to give a sample to the SOMOS Biobank. The SOMOS Biobank has two arms, the Latino DNA
Biobank and the Pan-American Biobank. The Latino DNA Biobank stores
your DNA/Saliva sample for use of future research. The other arm, the Pan-American biobank, is used
to store DNA, blood and tissue samples from indigenous nations in the Latin American continent for future research
in the health sector. You may choose to participate or not participate at all.
Please read the following information carefully. There is no cost to participate in either the Latino DNA
Biobank or Pan-American Biobank.
What is DNA?
DNA contains genetic information that acts as a blueprint for how parts of your body are made and work, determining
such things as eye and hair color. DNA is made up of long strands of repeating letters that form a code. These
letters, A, C, T and G represent individual chemical units that form DNA. The order in which these letters are
written is very precise. In the same way that a spelling mistake in a word could change its meaning entirely (for
example, mean and meat), a single change in the sequence of DNA can lead to a change in how the body works, which
may lead to disease or influence how you respond to medication.
What is genetic testing?
Genetic testing involves taking your DNA sample and determining the sequence of your genetic code. Changes in your
genetic code may help your healthcare team choose the best course of treatment for you.
What is Genetic Inheritance?
Both your mother and father contribute DNA sequences that make up your genetic code. This is called inheritance.
Often, changes in DNA sequence can be passed from parent to offspring and it may be important to study not only your
DNA, but also the DNA of your parents and other family members, to identify the underlying causes of disease.
LATINO DNA BIOBANK
What is involved in the Latino DNA Biobank?
SOMOS is offering you the opportunity to have a sample of your DNA/Saliva preserved for use in future clinical
diagnostic testing. This DNA/Saliva will be stored by SOMOS and will solely be used for research and development.
A sample of your DNA will be obtained through your saliva sample once you purchase any of services offered by SOMOS.
What are the risks of providing a sample for the Latino DNA Biobank?
There are no risks associated with providing saliva samples.
Who will have access to my DNA
sample?
Your DNA/Saliva sample will be stored by SOMOS for future clinical/research and development use. Until your sample is
needed for testing, no access will be granted. When access to your DNA/Saliva sample is needed for further research,
you will be notified before any use. Any results from that testing can be incorporated into your medical record only
you approve.
What happens with the data generated through my samples?
The extracted data from your physical bio sample is used by SOMOS to generate reports as part of our service
provision. Reports may include ancestry, genetic traits, health, disease risk scores or any other/similar genetic or
health reports. Your biological data will always be deidentified of any personal data for research or other
purposes, SOMOS will have access to the collected data and agrees ensure in a strictly secure manner that individual
level data is kept confidential, unless required to be released by law. Somos reserves the right to use
cryptographic technologies such as blockchain/PKI to ensure data governance, security and traceability towards its
donors.
This data is generated for your exclusive benefit. If you shall choose to participate in any additional research
studies or authorize any other use of your data, your data will be used only as per such authorization. You will be
notified before any third party data sharing and you have to approve it before any of your data can be used.
SOMOS uses third party technologies to decentralize data storage and management such as GenoBank.io platform. All
your permissions for data usage are recorded on the GenoBank.io platform and GenoBank.io is responsible to police
participating laboratories and researchers against usage or retention of any physical bio sample or data.
The
raw data generated in this Biobank consists of genetic and phenotypic data
and will not be sold or made commercially available. The intended use of this data is to be analyzed by the Parties,
and future collaborators, all of whom are able to commercialize their findings as long as they are the results of
data analysis and not individual-level genetic and/or phenotypic data.
Withdrawal of the SOMOS Biobank
You may choose to withdraw from the Latino DNA
Biobank at any time by informing the SOMOS Biobank, GenoBank.io or directly using your blockchain
identity (your personal ID card), received when you collected your Saliva sample. In all cases, your revocation will
be recorded publicly and permanently on the GenoBank.io blockchain. Your revocation applies to SOMOS Biobank or any
service provider and/or previous authorized parties that SOMOS Biobank had shared or jointly used your data.
If any deidentified data has been used and published as part of a research protocol or scientific publication,
SOMOS Biobank cannot erase such results.
How long will my DNA sample be available?
Your DNA/Saliva sample will be stored for as long as the SOMOS Biobank is in operation.
There is a possibility that DNA/Saliva samples may be lost in transit or will be inadequate for a future test, due to
unforeseen power failures, equipment failures, floods, or other circumstances. It is also important to know that a
DNA/Saliva sample is not permanent. If used for one test it may be depleted so that sufficient DNA/Saliva might not
be available for additional testing. SOMOS is not liable for damage to or loss of a DNA sample.
WHAT
IS THE PURPOSE OF THE SOMOS BIOBANK?
The purpose of the SOMOS Biobank is to collect, process, and store samples for research and/or until
researchers need them to do research. A major obstacle in health research is that researchers normally study
diseases in patients after the disease develops, by which time many changes have already taken place in the body. We
would like to store blood and tissue samples if possible, along with health information obtained from your medical
record or any other data points that can be integrated in the future, such as but not limited to wearables, smart
sensors, etc. so that SOMOS Biobank and/or researchers can study potential markers related to disease onset.
This may help researchers to understand the causes of disease, how to treat them, and how disease might be
prevented.
The samples we collect will act as a library for SOMOS biobank and/or researchers who are interested in studying a
wide variety of human health conditions; instead of looking for volunteers for each new research study, researchers
will have access to a large collection of blood, tissue and DNA samples along with medical histories all in one
place, therefore greatly accelerating the pace of research.
Taking part in this SOMOS Biobank does not mean we think you will develop a disease. Your samples
may be used as healthy control subjects in future research studies.
WHAT PERSONAL HEALTH INFORMATION
WILL BE USED OR DISCLOSED?
You are authorizing SOMOS Biobank personnel to copy and use information contained in your medical record. The health
information that may be used or disclosed for the research includes: results of physical examinations, medical
history, lab tests, or certain health information indicating or relating to a particular condition.
ARE MY RECORDS CONFIDENTIAL?
The records of the SOMOS Biobank will be kept confidential in accordance with the GenoBank.io
blockchain technology implementation.
With your permission, you may also be contacted in the future by SOMOS to
invite you to take part in a research study. You may decide whether or not to take part in these future studies at
that time.
Your samples may also be used by researchers who are not associated with SOMOS but they will not receive any
identifying information about you.
ARE THERE BENEFITS TO TAKING PART?
While there may be no direct benefits to you, other people might benefit from knowledge gained from using your
samples in future research studies.
WHO IS FUNDING THE PAN-AMERICAN BIOBANK?
The Pan-American Biobank is being sponsored by SOMOS and other commercial, research, funding and
grant relationships, always under our strict data ownership and governance policies.
IS THIS PAN-AMERICAN BIOBANK VOLUNTARY?
Your participation is voluntary. You may choose not to participate or you may discontinue your participation at any
time without penalty or loss of benefits to which you are otherwise entitled. If you decide to withdraw your
participation, you must contact the SOMOS BioBank in writing or digitally. Any health information already obtained
about you may still be used or disclosed as necessary to maintain the integrity or reliability of the current
research. Your decision whether or not to participate will not affect your current or future relations with SOMOS
Biobank.
WHO MAY I CONTACT IF I HAVE QUESTIONS?
For general questions about the Latino DNA Biobank and the Pan-American Biobank,
please contact SOMOS Biobank at [email protected]
By clicking on the Submit button and registering into the SOMOS platform, you agree with the following:
I have read and understand the Information Leaflet, and have had the opportunity to ask
questions.
I understand that my participation is voluntary and that I am free to withdraw at any time without giving any reason by
previous notification.
I understand that I may be re-contacted by SOMOS biobank (e.g. to answer some more questions and/or attend another
assessment visit, take additional samples), but this is optional.
I give permission for access to my biological, medical and other health-related records, and for long-term use of this
and other information about me, for health-related research purposes (even after my incapacity or death).
I give permission for long-term storage and use of my blood, saliva and/or DNA samples for health-related research
purposes (even after my incapacity or death), and relinquish all rights to these samples which I am providing to SOMOS
Biobank.
I understand that some results and/or reports will be given to me.
I agree to take part in SOMOS Biobank.