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ICF V4 Eng2

The HELIOS Study aims to investigate the influence of lifestyle, environment, and genetics on health in Singapore, recruiting up to 50,000 participants aged 30-84. Participants will undergo health screenings, provide biological samples, and consent to long-term health monitoring, with the potential to receive health reports based on findings. Participation is voluntary, and all procedures are free, with a token payment provided upon completion.

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0% found this document useful (0 votes)
12 views17 pages

ICF V4 Eng2

The HELIOS Study aims to investigate the influence of lifestyle, environment, and genetics on health in Singapore, recruiting up to 50,000 participants aged 30-84. Participants will undergo health screenings, provide biological samples, and consent to long-term health monitoring, with the potential to receive health reports based on findings. Participation is voluntary, and all procedures are free, with a token payment provided upon completion.

Uploaded by

wallace
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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PARTICIPANT INFORMATION SHEET


1. Study Information
Protocol Title: The Health for Life in Singapore (HELIOS) Study
IRB reference: IRB-2016-11-030
Principal Investigator & Contact Details:
Professor John Chambers, Professor of Cardiovascular Epidemiology, Nanyang Technological University
(NTU), Lee Kong Chian School of Medicine (LKCMedicine)
Email: HELIOS@ntu.edu.sg
Tel: +65 6904 7077 (Health Screening Centre Reception)

Study Sponsor: NTU, LKC Medicine

2. Purpose of the Research Study


We are inviting you to participate in the HELIOS research study. It is important that you first take time to read
through and understand what this research study involves, including reading the information provided in this
information sheet. In addition, we will explain the study to you in person and give you the chance to ask
questions. After you are properly satisfied that you understand this study, and that you wish to take part in this
study, you must complete and sign the informed consent form accompanying this information sheet. You will
be given a copy of both the information sheet and consent form to take home with you.

The HELIOS study aims to find out how lifestyle, environment and genes influence the current and future health
of people living in Singapore. The overall purpose of the study is to improve the prevention, diagnosis, and
treatment of a wide range of chronic and acute health conditions, such as heart disease, diabetes, cancer,
dementia, vision disorders, mental disorders, respiratory disorders and joint problems. We will be collecting a
broad range of measurements and biological samples, such as blood, urine and stool from participants, which
will enable us to investigate why some individuals develop diseases while others do not.

We will recruit up to 50,000 men and women from the Singapore population. The eligibility criteria are:

Inclusion criteria:
• Singaporean citizen or permanent resident
• Age 30-84 years at the time of visit
• Able to read and write in English, Chinese, Malay or Tamil. You may bring someone to help you.

Exclusion criteria:
• Currently pregnant or breast-feeding. We will carry out a pregnancy test on women aged <55 years old; a
positive pregnancy test will exclude participation.
• Current acute illness or recent major surgery (within the last 3 months)
• Age <30 years (including minors)
• Individuals with mental incapacities that prevent them from understanding giving informed consent.

3. What procedures will be followed in this study


If you take part in this study, you will be asked to:

 Enrolment. Attend a HELIOS screening centre for about 4 hours. During this visit we will ask you questions
about yourself and your family, take some clinical measurements and collect biological samples from you,
including blood, urine and stool. The tests carried out are listed in the table below.

 Research. Give your consent to use of the data and samples collected from you, for investigation and
understanding of the lifestyle, environmental and genetic factors underlying a wide range of health
conditions, including (but not limited to) heart disease, diabetes, cancer, dementia, vision disorders, mental
disorders, respiratory and joint problems. We also seek your consent to use the data and samples to
understand fundamental aspects of human biology.

 Follow-up. Consent to have your health and wellbeing followed for many years by the HELIOS study
through linkage to disease registers, and to medical, health, social and economic and other records held
on you that are relevant to health. This includes records held in electronic and other formats (e.g. paper
copy), as well as results of screening or diagnostic tests carried out on you. Linkage relevant to health may

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involve (but is not limited to) healthcare providers, organisations involved in health promotion, government
agencies, statutory boards and ministries in Singapore (e.g, Ministry of Health, Ministry of Education, and
Health Promotion Board).

 Recontact. Agree to be re-contacted by the HELIOS study team at some time in the future, so that we can
invite you to complete additional health related questions and/or to attend further health assessments or
participate in other research studies. This is important to give us a deeper understanding of health in the
Singapore population over the longer term.

All women of child-bearing age will be tested for pregnancy using a urine sample. We do this because
pregnancy is an exclusion criterion of the study.

Tests carried out in the HELIOS study


- Health and Lifestyle and Medications
1 Questionnaires - Diet
- Memory and Thinking
- Weight, height
- Waist and hip circumference
- Blood pressure
- Hand grip strength
- Lung function
- Electrocardiogram (ECG, heart trace)
- Stiffness of the arteries
- Ultrasound scan of the arteries in the neck
2 Clinical measurements
- Eye assessment
- Treadmill walking test
- Bone density and body composition scan (DXA)
- Skin assessment
- Hearing assessment
- Infrared body scan (fully-clothed, no facial scan)
- Physical activity monitoring (subject to availability, for
7 days)
- Blood (up to 70mls, which is roughly 5 tablespoons)
- Saliva
3 Biological samples - Urine
- Skin tape
- Stool (optional)

4. What research will be done using my information and samples?


• We will use the information and samples collected from you to investigate the lifestyle, environmental and
genetic factors underlying a wide range of health conditions, and to understand fundamental aspects of
human biology. Our research will include (but is not limited to) determining patterns of genetic variation,
profiling of gene regulation and gene transcription, and measurement of protein and metabolite levels, and
microbial composition of samples.

• Some of the research and testing on your sample(s) will be genetic in nature as this can be the most
powerful way to discover the causes of disease/defects and to treat and deal with these by developing new
drugs and treatments. For example, we may try to find variants in genes that protect against or increase
the risk of heart attack and stroke. This may include “sequencing” the DNA samples to read all the genetic
information in it.

Our aim is always to work towards the benefit of patients and communities. In doing so, it may be beneficial
for us to work with other hospitals, universities, research institutes, pharmaceutical, bio-technology and
other commercial companies, including research, academic, healthcare, and commercial organisations in
other countries. They may have expertise, technology, and resources unavailable to us, which would be
helpful in driving research forward to everyone’s benefit. Our aim is always to work towards the benefit of
patients and communities. In doing so, it may be beneficial for us to allow researchers from outside the
HELIOS study team to analyse the data independently from us. This may include researchers from
universities, hospitals, pharmaceutical, bio-technology and other commercial companies, and may include
researchers from organisations in other countries. These researchers may have expertise, technology, and

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resources unavailable in the HELIOS study team, and which could be helpful in driving research forward
to everyone’s benefit. Sharing data and samples collected by the HELIOS study with these external
partners aims to enable the best research and maximise benefit to the community. Any sharing will pay
careful attention to your privacy as a participant in the research, as described in section 17 below.
• The data and samples collected during this study may also be used for purposes other than research such
as teaching or training future researchers, or development of health policy.

5. Your responsibilities in this study


• We will ask you to visit the HELIOS screening centre to undergo the procedures that are outlined above.
We always aim to complete all the tests in a single visit. On some occasions, we may not be able to complete
all procedures described (for example, if the machine is undergoing maintenance). If this happens, we may
ask you to come for a second visit to complete the procedures. However this will be voluntary, and you
would receive an additional token of appreciation. Alternatively, the procedure may be omitted.

• Results from the blood tests will be more accurate if you come fasted. If your appointment is in the morning
(before midday), we would like you to come after an overnight fast (water only after midnight). If your
appointment is in the afternoon, we would like you to have a light early breakfast (e.g. 6am) on the day of
the appointment and to fast (water only) until you are seen. Refreshments will be provided after blood draw.

• We also ask that you bring a list or a photograph of all your medications with you (over-the-counter and
medical prescriptions), including oral contraceptives and hormone replacement therapy, and vitamins or
supplements. If you are unwell (for example, flu, cough, sore throat etc.) on the day of your appointed visit,
please call us to postpone your visit to the study.

• For the physical activity monitoring, we will give you the wearable device and an envelope stamps to take
home. You will need to wear and return the device by mail according to the instructions provided.

• For the optional stool sample collection, if you are unable to provide this during the visit day, we will give
you a stool collection kit and an envelope stamps to take home. You will need to collect, store, and return
the stool samples by mail according to the instructions provided.

6. What is not standard care or is experimental in this study


There are no treatments or experimental treatments involved in this research. We are carrying out a range of
physical and biological measurements to better understand their importance in predicting or diagnosing health
and disease. All of the procedures carried out are well established. The clinical significance of the
measurements being taken is the focus for the research.

7. The HELIOS research health report and other Incidental Clinical Findings
• Health concerns. The HELIOS assessments are being done for research purposes, and are not a clinical
evaluation. If you have health concerns, you should seek guidance from your usual doctor.

• HELIOS research health report. After you have completed your enrolment visit study, we would like to
send you a structured report comprising clinically relevant results from your health assessments that have
been reviewed by the research clinicians on the team. This report will include the following results (where
they have been measured):
o Height, weight, body mass index (BMI), body composition, e.g. body fat percentage)
o Blood pressure
o Electrocardiogram (ECG)
o Blood test results: full blood count, lipid panel, blood glucose, kidney function
o Bone density (DXA scan)

• Incidental Clinical Findings. In addition to the routine health report above, if the research team do identify
an abnormality which they believe might be of clinical significance during the course of your HELIOS
assessment, we would feed back the results to you. An example of this would be a severe narrowing in the
artery to the neck, or an abnormality at the back of the eye. Please note that we cannot guarantee that we
will identify all abnormalities from the HELIOS tests, as this is a research study, not a clinical service.

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• Your choice about your results. There is a chance that your research health report shows an
abnormality, or we find other incidental clinical findings. Such detection has the benefit of starting treatment
early which may improve future health outcomes, especially for conditions about which you were unaware.
However it may also have implications for your future healthcare, employment and insurance. Receiving
the health report and other incidental clinical findings is therefore optional, and you may choose
whether you want to receive them, when you sign the consent form at the end of this document. However,
if the research team do identify an abnormality during the course of your HELIOS assessment, which they
believe might be potentially life-threatening, we will still feed back the results to you.

• What about research results? The results of most research tests within the HELIOS assessment are not
suitable for clinical decision making. Feeding back these research findings could lead to inappropriate
anxiety or other indirect harm. Therefore, apart from the situations described above, we will NOT be
reporting back the results of any additional tests done on your samples. Specifically, we will NOT be
reporting back the results of genetic evaluation, or results generated by analysis of your data or samples
in the future, except in setting of possible recontact for future research studies.
8. Possible risks and side effects
• Joining the HELIOS study will involve donating a small sample of your blood. Qualified, experienced nurses
or phlebotomists will collect the samples; however, blood sampling can cause some discomfort when the
needle is placed in the vein and the blood is drawn. There is also a possibility that a small bruise may
develop at the site of blood collection.

• There is a small chance of tripping and falling down when you are performing the treadmill test. The risk
of this happening is minimised by keeping the test to a walking pace and there will also be an assistant to
guide you throughout the procedure. You are also free to stop the test at any point if you feel that you are
unable to continue with the procedure.

• The test to measure bone density and amount of body fat in the body involves exposure to a very low dose
of X-rays. This test is done routinely in hospitals and research institutions and carries minimal risk (it is
equivalent to 3 hours of daily X-ray exposure from your normal surroundings).

• Some people (fewer then 1/100) develop itchy skin from wearing the physical activity monitor for a week.
This is an allergy, and the itch will be on the skin around where you are wearing the monitor. If you start to
get itchy skin, just take off the monitor and let us know. The itch should quickly resolve by itself (1-2 days).

9. Possible benefits from participating in the study

• You will benefit from getting a research health screening through your involvement in this study. The tests
undertaken during the screening may reveal potential current and future health risks that you may not be
aware of, for example diabetes, high blood cholesterol level, high blood pressure, and heart problems. Such
detection has the benefit of starting treatment early, which will help you to avoid future complications.

• The most important health benefits from the HELIOS study will be realised many years from now, and will
largely help future generations. The HELIOS study is intended to benefit the general population as a whole
in the years to come. It will improve our understanding of the lifestyle, environmental and genetic factors
that affect health. It will also provide a resource for future research that will contribute to public health
improvement. Results from this study may also contribute to more effective strategies for predicting and
preventing future disease.

10. Important information for women


If you are pregnant and/or breastfeeding, we ask that you delay taking part in the study until after the pregnancy
and/or breastfeeding is complete. This is because the effects of some measurements in the HELIOS study on
a baby’s development, such as the DXA scan, are not known. An on-the-spot pregnancy test will be provided
at no cost to all women less than 55yrs old, and the results must be negative at study entry.

11. Alternatives to participation


Not applicable.

12. Use of human tissue in restricted biomedical research involving human-animal combination

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We confirm that the human biological material collected will not be used in restricted human biomedical
research involving human-animal combinations.

13. Costs & payments if participating in the study


If you take part in this study, all the procedures listed in Section 3 (above) will be performed at no charge to
you. You will receive $50.00 on completion of the HELIOS study as a token of appreciation, if this is done on
one day. If we need to break the assessment over more than one day, we will give you an additional S$50 for
each day that you attend.
14. Voluntary participation and withdrawal
• Your participation in this study is voluntary. We will describe the study and go through this information
sheet, a copy of which will be yours to keep. If you agree to take part, we will ask you to sign the consent
form at the end of this information sheet.

• You are free to withdraw from the study at any time, and without giving a reason. You can initiate the
process of withdrawal by calling +65 6904 7077 or by writing an email to helios@ntu.edu.sg. You will then
be sent a withdrawal form to complete and sign. This will be overseen by the HELIOS study research team
and you will receive a letter to confirm your withdrawal. Your decision not to take part in this study or to
stop your participation will not affect your medical care or any benefits to which you are entitled.

• In the event that you withdraw from the study, we will not include your data or samples in any future
research or analyses. Please note that it will not be possible to remove your data from research work that
has already been done before your withdrawal. You may also ask the Principal Investigator to discard or
destroy any remaining samples that have been collected from you. However, this can only be done for
samples that have not been anonymized and that can still be traced to you.

• Your doctor, the Investigator and/or the Sponsor of this study may stop your participation in the study at
any time if they decide that it is in your best interests. They may also do this if you do not follow instructions
required to complete the study adequately. If you have other medical problems or side effects, the doctor
and/or nurse will decide if you may continue in the research study.

15. Compensation for injury


• In the unlikely event that something untoward happens during the course of the study, you can contact us
for advice by phone (+65 6904 7077) or by email (HELIOS@ntu.edu.sg).

• LKC Medicine, without legal commitment, will compensate you for the injuries arising from your
participation in the study without you having to prove that LKCMedicine is at fault. There are, however,
conditions and limitations to the extent of compensation provided. You may wish to discuss this with your
Principal Investigator.
• By signing this consent form, you will not waive any of your legal rights or release the parties involved in
this study from liability for negligence.

16. Storage and ownership of data and samples


• The data and biological specimens collected from you during the course of this study will be stored long
term (at least 20 years). Your data will be held in secure databases. Biological samples will be stored in a
secure facility, which meets relevant international security and safety standards. They will only be
accessible to authorised researchers and regulatory authorities.

• The data and samples collected will be deemed to be gifted to the HELIOS study. Lee Kong Chian School
of Medicine, Nanyang Technological University will act as the custodian of the data and samples.

• The role of an individual sample/set of information in any commercial project is likely to be minimal and
impossible to quantify. Therefore, it is not possible to trace back any benefit to individual donors and you
should regard participation in the project as being for the benefit of the community at large. No financial
benefits from exploiting the results of the study will come back to you.

17. Confidentiality and sharing of data and samples

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In this consent form, we are asking your permission to store your name, date of birth, NRIC, address, phone
number and other contact details long term, so that we can monitor your health and study other factors that
affect health in the long term by linking to relevant records. We may also recontact you in the future to
participate in other studies or inform you of clinically relevant incidental findings if appropriate.

We take confidentiality very seriously and will take all reasonable measures to ensure that the information
collected from and about you is kept confidential. Your personal identifiable individual records, to the extent of
the applicable laws and regulations, will not be made publicly available. In order to keep your information
confidential, numerous safeguards are in place. In particular, we will:

• Keep your personal identifiers (name, date of birth, NRIC, address, phone number and other contact
details) separate from your research data and samples.

• Remove your personal identifiers from the research data and samples, and replace your identity with a
unique anonymous ‘code number’

• Ensure that your personal identifiers, and the ‘code number’ that links you to the research data and
samples, can only be accessed by a small number of personnel, directly authorised by the Principal
Investigators.

• Use stringent security measures to protect all the data collected, and to prevent unauthorized use,
including: strict access controls, computer security and data encryption techniques, confidentiality
agreements and staff training.

Use of the research data and samples will be regulated by the HELIOS Study “Scientific and Data Access
Committee”. This Committee includes senior management, clinicians and researchers from the LKCMedicine
and National Healthcare Group. Permission to use the data will be evaluated based on written applications,
according to scientific merit. Applications must be for specific research purposes, within the remit of the HELIOS
research program approved by the IRB, and will provide time-limited access to the data needed to complete
the research.

When data are shared with researchers, service providers, regulators or third parties, this will typically be done
in one of the following ways:

• Anonymised. Here, not only will we remove your personal identifiers, but we will also remove the code
number that links the research data/samples to your identity. As a result it should not be possible to use
traditional approaches to identify you from the data shared. This will be the typical approach that we will
use to carry out research on completed datasets, or for publishing results of the study.

• Coded. Here a unique code number is shared that identifies the data and samples collected from you (but
not your personal identity). This is typically done when the research will lead to generation of new
information that we need to link back to existing data (for example running laboratory tests on the stored
samples). This is also sometimes called “De-identification”.

• Identifiable. Here we will share one or more of your personal identifiers (such as NRIC) with another
researcher or organisation. This will be only done in a small number of specific circumstances, typically
when we want to identify your health outcomes from hospital and national datasets. No alternate
mechanism currently exists to make this link possible. In this situation we will use the highest degree of
security possible to transfer the identifiable information (e.g. high-level data encryption). Transfers of
identifiable information will only be done where necessary for the research, and with the guidance and
supervision of information governance experts.

We plan to publish the results of the research based on the HELIOS Study in medical journals. You will not be
identified in any publication. The results of the research may also be shared through open access (public)
scientific databases, including internet databases (www.internationalgenome.org is an example of such an
approach). This will enable other researchers to use the data to investigate other important research questions.
In publications and open databases, the results will be fully anonymised by removing all traditional identifying
information (e.g. name, address, date of birth), as well as any code number linking your identity to the data.

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The relevant Institutional Review Board and Ministry of Health may also access your original medical records
and research data for audit, research and/or regulatory purpose (for example, to check study procedures have
been followed correctly), without making any of your information public.

By signing the Informed Consent Form attached, you (or your legally acceptable representative, if relevant) are
authorizing (i) collection, access to, use and storage of your “Personal Data”, and (ii) disclosure to authorised
service providers and relevant third parties.

18. Consent for ‘Future Research


• Because medical healthcare, health related databases and records, technology and analysis tools develop
all the time, it isn’t possible to give you an exact list of everything that might be done with your samples or
information over the years ahead (‘in the future’).

• If the proposed ‘future research’ goes beyond what is described in this consent form, we shall seek
approval from the ethics committee, who may approve the research if they agree it is ethical, scientifically
justifiable and in the public interest.

• We will not usually contact you directly about individual ‘future research’ studies done using your stored
data and samples, as this would be impractical given the number of people participating in the research.

19. Consent to be recontacted

• We would also like permission to recontact you in case we need to obtain new consent (“reconsent”) for
a specific component of the research. We will contact you for reconsent if the IRB recommends this.

• We would also like to invite you to take part in further research studies, including research directly relevant
to the HELIOS study. We may provide you with letters of invitation to additional studies on the day that you
attend, or as part of your research health report, or at some point in the future.

• The following HELIOS sub-studies are currently active, and we would like to invite you to take part in them.
Further details are provided in the Appendix to this ICF, including details of the additional token of
appreciation:

1. The Asian Skin Microbiome Project. This project aims to collect samples and measurements from
the skin of different body sites. This information will help to better understand the factors that determine
the health and wellbeing of skin in Asians. This sub-study will take about 1 hour and can be done on
the same day as your HELIOS assessment.

2. The HELIOS Brain and Body Imaging Program. This aims to capture MRI images of the brain and
body. The images have information for brain health, maturation and ageing that can be used to better
understand biology and health. This sub-study takes about 2 hours and requires a separate visit.

3. LKCMedicine medical student project. We are committed to support the medical student education
and training. The projects include comparisons of blood pressure and lung function, using different
devices. The measurements will help to improve our study protocols and will teach the next generation
of doctors important research techniques. This optional component will take about 1 hour and can be
done on the same day as your HELIOS assessment.

4. The Food Preference Test Development This project aims to develop food preference test for
broader use in HELIOS study and research in Singapore. It involves 30 minutes of face-to-face
interview. This sub-study is optional and can be done on the same day as your HELIOS assessment.

5. CT scan @ SingHeart. A Computed Tomography (CT) of the heart is a scan to see calcium deposit
in the heart and takes only 5 minutes. This scan is done in the Singapore General Hospital (SGH) in
the Outram campus and requires a separate visit.

• The list of additional studies will grow as the HELIOS studies progresses.

• You will be free to decide whether or not to “reconsent” or to accept any invitation to take part in further
research. Your decision will not affect your medical care or any benefits to which you are entitled.

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20. Who To Contact if You Have Questions

If you have questions about this research study, you may contact the Principal Investigator, Professor John
Chambers, or the HELIOS study team at

Email: HELIOS@ntu.edu.sg
Phone: +65 6904 7077 (Monday-Friday 8am to 5pm)
Address: Professor John Chambers, HELIOS Study, Level 18, Clinical Sciences Building, Lee Kong Chian
School of Medicine, 11 Mandalay Road, Singapore 308232.
The study has been reviewed by the NTU Institutional Review Board for ethics approval.If you want an
independent opinion to discuss problems and questions, obtain information and offer inputs on your rights as
a research participant, you may contact the NTU Institutional Review Board:

Email: irb@ntu.edu.sg
Tel: +65 6592 2495
Address: NTU-Institutional Review Board, Research Integrity and Ethics Office, Blk N1.2, B1-02A, 62
Nanyang Drive, Singapore 637459

Thank you very much for taking the time to read this information

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INFORMED CONSENT FORM


Protocol Title: The Health for Life in Singapore (HELIOS) Study
Components that are REQUIRED for participation in the HELIOS study I agree
1. I confirm that I have read and understood the informed sheet version 5.4, dated 20/04/2023 for the Health
for Life in Singapore (HELIOS) study. I have fully discussed and understood the purpose and procedures
of this study. This study has been explained to me in a language that I understand. I have been given
enough time to ask any questions that I have about the study, and these questions have been answered 
to my satisfaction.

2. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving
any reason, with no obligations and penalty, and without my medical care or legal rights being affected. 
3. I know how to contact the research team if I need to. 
4. I agree to the research team taking the health-related and clinical and physical measurements described
in information sheet version 5.4, dated 20/04/2023. 
5. I agree to the collections of blood, urine, saliva, and skin tape samples. 
6. I understand that I will be asked for a stool sample today or post-screening, but this is optional. 
7. I understand that I will NOT necessarily receive feedback on any tests or analyses done on my samples
or data that are carried out purely for research, including the results of any genetic studies. 
8. I confirm that any data and samples I give will be treated as a donation to Lee Kong Chian School of
Medicine, Nanyang Technological University, and I will relinquish any commercial rights in the data and
samples once donated.

9. I understand that my personal details (including NRIC), data collected about me and any samples I provide
will be stored long-term (20 or more years) for research. 
10. I agree that the samples I have donated and the information gathered about me can be stored and used
for research studies aimed at identifying and understanding health, wellbeing, and the causes, natural
history, prevention, prediction, diagnosis, and treatment of diseases.

11. I agree to genetic studies being conducted on my samples, including determining the entire genetic code.
I understand that I will not be contacted directly for further permission for these genetic studies. 
12. I agree to laboratory analyses being conducted on my samples for research purposes that may cover a
range of biological measures and processes, including gene regulation, protein and metabolite levels, and
microbial composition. I understand that I will not be contacted directly for further permission.

13. I agree that HELIOS study investigation may have access to records about me that are relevant to my
health and wellbeing, and that are held by healthcare providers, health promotion organisations, statutory
boards, government agencies and ministries in Singapore, even if I can no longer make decision for 
myself, or after my death.
14. I agree that my data and samples may be made available to other research and healthcare groups in the
public and private sector, as well as to commercial entities involved in biomedical research subject to
prevalent regulations, in Singapore or other countries. I understand that anonymized research data and
other results of the research may be shared through open-access (public) scientific database on the

internet.
15. I agree that no compensation will be given to me, nor will funds be forthcoming to me due to any
invention(s) resulting from research and development and commercialisation using my data and samples. 
16. Having agreed to all of the points above, I agree to join the HELIOS study. 

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CONFIDENTIAL
Components that are OPTIONAL for participation in the HELIOS study YES NO

17. Health report. I would like to receive the HELIOS research health report that summarized
the clinically relevant health-related results from my baseline HELIOS screening
assessment, as described in Section 7.
 
18. Incidental clinical findings. I would like to be informed of findings that may be of clinical
significance that are identified by the research team, during the course of the HELIOS
assessment, as described in Section 7.
* Please note that if an abnormality is identified which the research team think is
 
potentially life-threatening, they will still pass on this information.
19. Future research using my data and samples. I agree to my data and samples being
used for future research for public benefit that is approved by the IRB. I understand I will
not be contacted again personally.
 
20. Recontact. I agree that I may be re-contacted in the future to be invited to participate in
research, or for reconsent. However, I understand that I will be free to decide whether or
not to take part in this additional research or to give this reconsent. My decision will not  
affect my medical care or any benefits to which I am entitled.
I agree to be contacted by

 Phone  Email  Mail  Others ___________________________

The following projects are optional and subject to availability:


21. ASMP. I also agree to take part in the Asian Skin Microbiome Project.  
22. MRI. I also agree to take part in the HELIOS Brain and Body Imaging Program  
23. I also agree to take part in the LKCMedicine medical student project.  
24. I also agree to take part in the Food Preference Test Development.  
25. CT scan @ National Heart Centre Singapore. I also agree for an additional CT scan to
be done at National Heart Centre Singapore.  
26. INvestigating the Diagnostic, Epidemiologic and Predictive measures that define
Osteosarcopenia (INDEPTHOS). I also agree to take in INDEPTHOS.  
_______________________________ ________________________________ ___________________
Name of Participant Signature Date

Translator Information
The study has been explained to the participant / legally acceptable representative in ________________<insert
language> by _________________________<insert name of translator>

Witness Statement
I, the undersigned, certify that: i. I am 21 years of age or older; ii. To the best of my knowledge, the participant/ the
participant’s legally acceptable representative signing this informed consent form has the study fully explained in a
language understood by him/ her and clearly understands the nature, risks, and benefits of his/ her participation in
the study; iii. I have taken reasonable steps to ascertain the identity of the participant/ the participant’s legally
acceptable representative giving the consent; and iv. I have taken steps to ascertain that consent has been given
voluntarily without any coercion or intimidation.

_______________________________ ________________________________ ___________________


Name of Witness Signature Date
Investigator Statement
I, the undersigned, certify that I have explained the study to the participant and to the best of my knowledge the
participant signing this informed consent form clearly understands the nature, risks, and benefits of his / her
participation in the study.

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_______________________________ ________________________________ ___________________


Name of Investigator / Signature Date
Person administering consent

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Appendix 1. The Asian Skin Microbiome Program


• The Asian Skin Microbiome Program is a collaborative study involving LKC Medicine, A*STAR, and Skin
Research Institute of Singapore (SRIS). We aim to better understand the factors that determine the health and
wellbeing of skin in Asians.

• The study will involve:


1. Measurement of skin water level on cheek and arm.
2. Skin observation.
3. Collection of skin samples using tape and swab from arm, back, leg, face, scalp, underarm and groin.
4. Skincare questionnaire. For female participants, this will include additional detailed questions regarding
your menstrual cycle.
5. Skin imaging to measure spots, wrinkles, pores, and other measures of skin health on the face.

• All procedures are safe. None of the procedures are invasive. None of the procedures involve drugs or X-Rays.
They are not expected to create any pain.

• Participation in this sub-study is optional. If you agree to participate, you will be assessed on the same day as
the HELIOS Study. The additional assessment will take about an hour.

• Depending on the results of your skin samples, you may be contacted for a follow-up assessment on another
day. This will include additional collection of skin tapes/swab from arm, back, leg, face, scalp and underarm
as well as follow-up measurements of skin water level, skin observation and skincare questionnaire. This
follow-up assessment is optional. The additional assessment will take about an hour.

• You will receive an additional $50.00 token of appreciation per visit for added inconvenience.

Informed Consent Form Version 5.4, Dated 20/04/2023 Page 12 of 17


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Appendix 2. The HELIOS Brain and Body Imaging Program

• The HELIOS Brain and Body Imaging Program aims to collect the MRI images of the brain and body. This
information will be used to better understand the trajectories for brain health, maturation and ageing and can
be used to better predict or prevent various diseases including Alzheimer’s disease and diseases that affect
other organs.

• Participation in this sub-study is optional. If you agree to participate, you will be contacted to arrange an
appointment for your MRI scan.

• The MRI scan will be done on a separate day at one of our collaborating MRI centres. We are currently working
with the Center for Cognitive Neuroimaging centre (CoNiC), Level 7, Experimental Medicine Building, NTU
LKC Medicine Yunnan Garden campus. Other sites are anticipated in the future.

• The session is one-time visit only and is expected to last about 2 hours. Participants will be given additional
$100.00 as a token of appreciation for the time and inconvenience caused.

• The MRI scans are being done purely for research purposes. The results of these research tests may not
always be suitable for clinical decision making, and as a result, we will not routinely report these back to you.
However, in line with the incidental finding policy, if the research team do identify an abnormality during the
course of participants’ HELIOS assessment, which they believe might have important clinical significance, we
will feed back the results.

• For your safety, we will not able to perform the scan if you have an implanted device such as a pacemaker/
defibrillator, cochlear implant, insulin pump, or history of working with sheet metal. We will go through a full list
of ‘contraindications’ to having an MRI, before the scan starts.

• If you have phobia of small space, the MRI machine may make you worried or stressed. If you have tattoos, it
is possible that MRI scan may cause swelling or heating sensation at the site of tattoos. We may have a
familiarization session under a Mock MRI machine to screen for any signs of discomfort before the actual scan.

Informed Consent Form Version 5.4, Dated 20/04/2023 Page 13 of 17


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Appendix 3. The LKCMedicine Medical Student Project

• The LKCMedicine Medical student project is part of the education and scientific training for Year 4
LKCMedicine medical student education. The project aims to both train future doctors in research
methods, but also to improve the HELIOS Study protocol. The project is divided into 2 parts.

• Evaluating alternative blood pressure devices: We will measure your blood pressure using 3 different
blood pressure devices. The measurements will be done 6 times for each device. The measurements will
be done in alternate fashion on single arm according to standard protocol. You will be given rest period in
between the measurements. You may stop the assessment at any points of discomfort.
• Evaluating alternative lung function devices: We will ask you to perform lung function test with 2
devices. In total 8 assessments will be taken (4 for each device). The measurements will be done in
alternate fashion according to standard protocol. You will be given rest period in between the
measurements. You may stop the assessment at any points of discomfort.

• Participation in this sub-study is optional. If you agree to participate, you will be assessed on the same day
as the HELIOS Study. The additional assessment will take about an hour.

• You will receive an additional $50.00 token of appreciation for added inconvenience.

4. The Food Preference Test Development

• This project aims to develop food preference test for broader use in HELIOS study and research in Singapore.

• It involves 30 minutes of face-to-face interview about the computer test depicting food picture.

• Participation in this sub-study is optional. If you agree to participate, you will be assessed on the same day
as the HELIOS Study.

• You will receive an additional $25.00 token of appreciation for added inconvenience.

Informed Consent Form Version 5.4, Dated 20/04/2023 Page 14 of 17


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Appendix 5. CT Scan @ National Heart Centre Singapore

• CT scan is a non-invasive diagnostic test performed in the hospital to check for calcium build-up in the
heart. With this scan, we want to better understand about the role of calcium build-up in cardiovascular
problem, and whether this can be a cost-effective screening tool of heart health in Singapore.

• CT scan takes only 5 minutes. If you have taken this test in the last 5 years prior to your HELIOS visit,
you would not have to take it.

• Like the HELIOS bone DXA scan, CT scan involves exposure to a very low dose of X-rays. This test is
done routinely in hospitals and research institutions and carries minimal risk.

• Like MRI scan, CT scan requires you to be confined in a small partially enclosed space. If you have
phobia of small space, the CT scan may make you worried or stressed.

• The scan will take place in National Heart Centre Singapore in the Outram campus. Participation in this
sub-study is optional. If you agree to participate, we will pass your contact details (name, email and
phone numbers) to the NHCS study team, who will arrange a visit to the National Heart Centre Singapore
@ Outram.

Informed Consent Form Version 5.4, Dated 20/04/2023 Page 15 of 17


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Appendix 6. The Asian Skin Microbiome Program (Follow-up)


• The Asian Skin Microbiome Program is a collaborative study involving LKC Medicine, A*STAR, and Skin
Research Institute of Singapore (SRIS). We aim to better understand the factors that determine the health
and wellbeing of skin in Asians.

• The study will involve:


1. Measurement of skin pH, sebum and water levels on cheek, arm and leg
2. Skin observation
3. Collection of skin samples using tape and swab from arm, back, leg, face, scalp, and underarm.
4. Skincare questionnaire. For female participants, this will include additional detailed questions
regarding your menstrual cycle.
5. Skin imaging to measure spots, wrinkles, pores, and other measures of skin health on the face.

• All procedures are safe. None of the procedures are invasive. None of the procedures involve drugs or X-
Rays. They are not expected to create any pain.

• Participation in this sub-study is optional. If you agree to participate, you will be assessed on the same day
as the HELIOS Study. The additional assessment will take about an hour.

• Depending on the results of your skin samples, you may be contacted for a follow-up assessment on another
day. This will include additional collection of skin tapes/swab from arm, back, leg, face, scalp and underarm
as well as follow-up measurements of skin water level, skin observation and skincare questionnaire. This
follow-up assessment is optional. The additional assessment will take about an hour.

• You will receive an additional $100.00 token of appreciation per visit for added inconvenience.

Informed Consent Form Version 5.4, Dated 20/04/2023 Page 16 of 17


Attach sticky
Participant ID
label

Appendix 7. INvestigating the Diagnostic, Epidemiologic and Predictive measures that define
Osteosarcopenia (INDEPTHOS)

• The INDEPTHOS study is a collaborative study involving LKC Medicine, Tan Tock Seng Hospital, and
National Healthcare Group Polyclinics. We aim to study the prevalence and impact of osteosarcopenia (low
bone mass and loss of muscle mass, strength and function) in the local community.

• The study will involve:


1. Measurement of bone density of your wrist(s) during the DXA scan
2. A mobility test that includes assessment of assess walking, standing from sitting, and standing. This
is called the Short physical performance battery (SPPB) test
3. Questions about activities of daily living, frailty, healthcare use and fractures

• For participants with a recent wrist fracture, we will ask you to return for repeat of (1) DXA scan of the hip,
spine and non-dominant wrist, (2) SPPB, (3) Blood tests (10 mls), (4) Questionnaire, and (5) Hand grip
strength six months, one year and two years later.

• For those without a recent wrist fracture, you may be asked to return for repeat of (1) DXA scan of the hip,
spine and bilateral wrists, (2) SPPB, (3) Blood tests (10mls) , (4) Questionnaire, and (5) Hand grip strength
two years later

• The amount of radiation exposure is considered safe. The equipment will be operated by trained and
qualified clinical research staff, working under the supervision of the Radiology Department and the
Radiation Protection Advisors at Tan Tock Seng Hospital.

• Participation in this sub-study is optional. If you agree to participate, you will be assessed on the same day
as the HELIOS Study. The additional assessment will take about 30 minutes.

• You will receive an additional $10.00 token of appreciation for your 1st visit and $20.00 for each of your
subsequent visits.

Informed Consent Form Version 5.4, Dated 20/04/2023 Page 17 of 17

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