Dietary Intervention on Atopy
Phase: NA
Conditions: Atopic Dermatitis, Atopic, Allergic Diseases, Allergic Rhinitis
Sponsor: National University of Singapore

 
 
 
 
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PARTICIPANT INFORMATION SHEET  
 
 
 
 
You are invited to participate in a research study. This information sheet provides 
you with information about the research study. Where “personal data” is used, it 
means data about you which makes you identifiable: (i) from such data or (ii) from 
such data and other information which the National University of Singapore (NUS) 
has or is likely to have. The Principal Investigator (the research doctor or the person 
in charge of this research) or his/her representative will also describe this research 
to you and answer all your questions. Read the information below and ask questions 
about anything you don’t understand before deciding whether or not to take part. 
 
PART I: General Information   
 
1. 
Protocol title: Dietary Intervention on Atopy (NUS-IRB-2024-28) 
 
2. 
Principal Investigator and co-investigators, with the contact number and 
address of organisation: 
 
Principal Investigator 
Associate Prof. Chew Fook Tim  
Molecular Immunology Laboratory,  
Department of Biological Sciences, Faculty of Science 
National University of Singapore.  
Tel: 65161685; email: dbscft@nus.edu.sg 
 
Co-investigator 
Dr. Liu Mei Hui  
Department of Food Science and Technology, Faculty of Science 
National University of Singapore.  
Tel: 65163523; email: fstlmh@nus.edu.sg 
 
Co-investigator 
Assistant Prof. Kim Jung Eun 
Department of Food Science and Technology, Faculty of Science 
National University of Singapore.  
Tel: 65161136; email: fstkje@nus.edu.sg 
 
Co-investigator 
Mr. Lim Jun Jie, study coordinator 
Molecular Immunology Laboratory,  
Department of Biological Sciences, Faculty of Science 
National University of Singapore.  
Tel: 65161685; email: nus.allergy.study@nus.edu.sg 
 
 
 
 

 
 
 
 
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3. 
Whom should I call if I have any questions or problems? 
 
Please contact the Principal Investigator, Assoc Prof. Chew Fook Tim at 
telephone 65161685 (between 9.00 AM – 6.00 pm Monday to Friday) and email 
at dbscft@nus.edu.sg for all research-related matters and in the event of 
research-related injuries. 
 
This study has undergone an ethics review by the National University of 
Singapore Institutional Review Board (NUS-IRB). For an independent opinion 
regarding the research and the rights of research subjects, or if you have 
complaints about the research, you may contact a staff member of the NUS-IRB 
(at telephone (+65) 6516 1234 [Mondays to Thursdays from 8.30am to 6pm, and 
Fridays from 8.30am to 5.30pm, except public holidays] or email 
at irb@nus.edu.sg). 
 
 
4. 
Who can participate in the research? What is the expected duration of my 
participation? What is the duration of this research? 
 
You may participate in the research if you are between 21 and 65 years old 
and having a personal symptomatic history of an atopic dermatitis itchy rash.  
The study requires you to attend five visit (1 screening and 4 study visits) that 
will take approximately 1 hour 30 minutes each. The total duration of the study 
will be 13 weeks, not including the screening visit.  At each visit, you will need 
to complete all questions in a provided questionnaire, undergo a skin physiology 
measurement to assess skin pH, sebum level, hydration, and trans epidermal 
water loss, undergo basic anthropometric measurements for height, weight, 
body composition, and blood pressure, provide a 20 mL whole blood sample, 
and provide a stool swab. You cannot take part in the study if you have a needle 
phobia or if you are currently having food allergy or uncomfortable in answering 
the mandatory questions in the questionnaire. In addition, food logs will be 
collected from you at multiple time points. You may be assigned to a whole-meal 
intervention where meals will be provided for lunch and dinner daily for the entire 
2-month intervention period.  
 
 
 
You will only be allowed to participate once throughout the whole period of this 
study. As meal provision may be provided locally, participants who will be 
travelling out of Singapore during the study period will not be eligible to 
participate in this study. Participants who are on regular strong use of medication 
(western and/or traditional), therapies, alternative medications, or concurrently 
participating in other research studies are not encouraged to participate in this 
study. You should not be applying any moisturizer, cosmetics, and/or any topical 
cream on your skin throughout the entire duration of the study. The research 
team will advise you accordingly based on your eczema condition should you 
require the use of any anti-itch or moisturizing medication during the course of 
this study.  
 
A member of the research team has discussed with you the requirements for 
participation in this study. It is important that you are completely truthful with the 
staff about your past medical history as well as any symptoms experienced 
during the study. It may be harmful to you or other people who participate in this 

 
 
 
 
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study if you are not truthful with the staff. You should not participate in this study 
should you not meet all qualifications. 
 
Participants must meet all the inclusion criteria to participate in this study: 
 
Inclusion criteria are: 
• Presence of current, mild-to-moderate atopic dermatitis/eczema at the 
flexural areas 
• 21 to 65 years of age (inclusive) at screening 
• Must be English-literate and able to give informed consent in English 
• Be residing in Singapore and will not be travelling outside of Singapore 
during the study period 
• Reliable and willing to follow study procedures and be available for the 
duration of the study 
• Non-smokers (tobacco and e-cigarette)  
• Non-drinker (no regular or frequent consumption of alcohol)  
• Overtly healthy with no pre-existing medical conditions (e.g., diabetes, 
hypertension, cancer, blood disorders, 
degenerative/liver/autoimmune/immune/renal diseases, or psychiatric 
conditions) 
• No food allergies to test foods 
• No needle phobia 
• Be willing to follow the instruction provided by the investigators on the use 
of any moisturiser, cosmetics, and/or topical cream on the skin throughout 
the entire duration of the study. 
You cannot participate in this study if you are or have: 
• Concurrent participation in other research studies 
• Pregnant or lactating  
• Known or ongoing psychiatric disorders within 3 years 
• Known severe nutritional deficiency  
• Vegetarian or vegans (as meat will be included in the diet) 
• Individuals who made a significant dietary change in the past 12 months 
• Having a pre-existing dietary restriction that would interfere with the 
adherence to a whole diet meal 
• Regular use of strong medication (western and/or traditional), therapies, and 
alternative medications 
• Regular nutritional supplements in the past 12 months 
• Regular consumption of oral contraceptive pills and/or steroid hormones 
• Antibiotic use in the past 2 months 
• Any long-term hospitalisation or surgery during the 6 months before 
enrolment in study 
• Significant change in weight (+/- 5.0%) during the past month 
• History of bleeding diathesis or coagulopathy (or any bleeding disorders) 
• Having donated blood of more than 500 mL within 4 weeks of study 
enrolment  
 
5. 
What is the approximate number of research subjects involved? 
 
We aim to recruit 110 participants to this study. 

 
 
 
 
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6. 
What will be done if I take part in this research study? 
 
This research study involves a total of five on-site visits (1 screening visit and 4 
study visits); each scheduled approximately one month apart. The different parts 
of the research study are described below. 
 
Screening 
The research team will first contact you over phone call to explain the study 
details and interview you on your demographic background, health and medical 
history, medications, use of tobacco and alcohol, and dietary habits (information 
related to the inclusion and exclusion criteria). No in-person visit is required.  
  
However, if you fulfilled the basic eligibility criteria, you will be contacted further 
for face-to-face interview. During the actual screening, it will involve a face-to-
face visual screening for the presence of atopic dermatitis (AD) rash and 
clarifying questions for the inclusion and exclusion criteria for the study in more 
detail. If you are selected for the study, you will be contacted further for the first 
study visit.  
 
Study Visit (s) 
The research team will arrange an appointment for you to attend the study at a 
suitable venue (NATIONAL UNIVERSITY OF SINGAPORE (S13), Level 3, 1 
Science Drive 3 Singapore 117550). All study procedures will be performed by 
trained staff. 
 
To summarise, you will undergo the following procedures in this research: 
 
1. Questionnaires: (i) 1st Study Visit only: ISAAC questionnaire for basic 
demographic information; (ii) All Study Visits: Drug Usage Questionnaire, 
Dermatology Quality of Life Index Questionnaire and Asthma Quality of Life 
Questionnaire (only for those who report as having asthma). 
  
2. Eczema assessment using validated questionnaire tool (Scoring Atopic 
Dermatitis [SCORAD]) 
3. A skin physiological measurement involving pH, sebum level, hydration, and 
water loss 
4. Anthropometric measurement  
5. Blood collection 
6. Nutritional counselling (only for those assigned into the diet group)  
The total time you will spend at the study will take about 1hr to 1 hour 30 
minutes for each study visit. For more information, please kindly refer to the 
proposed systematic flow of the entire dietary intervention timeline image 
below. 

 
 
 
 
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• ISAAC questionnaire – The survey questionnaire you need to complete 
relates to you and your family history of allergy and its related symptoms, 
personal lifestyle preferences, dietary habits, and basic demographic 
information such as age, gender, socioeconomic status, and parental 
education level. This will only be done during the first study visit and not 
required for remaining study visits.  
 
• Drug usage questionnaire – This short survey asks about the usage of 
17 types of drugs related to allergy and its related diseases, over the past 
4 months. It will be administered during every study visit.  
 
• Dermatological Quality of Life Index questionnaire – This is a ten-
question questionnaire used to measure the impact of skin disease on the 
quality of life of an affected person.  
 
• Asthma Quality of Life Index questionnaire – This is a patient-reported 
questionnaire that measures the impact of asthma on daily life by 
assessing functional impairments in four main areas: symptoms, activity 
limitations, emotional function, and environmental stimuli. 
This 
questionnaire is only applicable to those diagnosed with asthma.  
 
• Eczema assessment – Trained research personnel will assess your 
eczema/atopic dermatitis condition accordingly with a validated clinical 
rubric known as SCORAD (Scoring Atopic Dermatitis). There is no need 
to remove any clothing during the entire skin assessment, and no 
photographs will be taken from you.  
 
• Skin physiological measurement– This test is carried out on the face 
(cheek), forearms, and two main lesional areas affected by eczema/atopic 
dermatitis, particularly the flexural areas including the folds of the elbows, 
behind the knees, in front of the ankles, or around the neck and face. All 

 
 
 
 
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probes used for skin measurement will be sterilized with alcohol swabs 
before and after each measurement.  
• Blood samples – A 20 mL of blood sample (with allocations of 5 mL, 5 
mL, and 10 mL) will be collected from you, which will be used to assess 
lipid levels, immune cell counts, serum cytokine levels, and extract 
peripheral blood mononuclear cells. 
• Stool samples – Stool sample collection kits will be issued, and you are 
required to bring back the stool samples on your next visit. Stool samples 
will be used for gut microbiota analysis.  
 
Intervention 
You will be randomly assigned to either the diet (intervention) group or control 
group. 
If you are randomly assigned to the diet group, you will be provided with bento-
styled meals for lunch and dinner daily during the 2-month intervention period. 
The meals will encompass a variety of nutrient-rich ingredients, including whole 
grains, lean proteins, fruits and vegetables, and healthy fats. The meals are also 
designed in a convenient bento-style format. The food will be prepared and 
delivered by our partnered licensed food caterer company. The research team 
will provide you with periodical reminders regarding the transport and 
consumption of your meals whenever necessary.  
However, you will neither receive the meals provided by the research team nor 
will you receive any nutritional advice if you are randomly assigned to the control 
arm. Instead, you will continue to follow and maintain your usual dietary habits 
throughout the study period. 
All participants will be required to maintain detailed food logs for three days per 
week – specifically, two selected weekdays and one weekend day – every other 
week throughout the study duration. The estimated duration required to complete 
the food log for each meal is around 10 minutes. Food logs will be collected at 
multiple time points, including baseline (week 0) and subsequent intervals at 
0,2,4,6,8,10 and 12 weeks. Food logs will be regularly reviewed to assess your 
adherence to the prescribed healthy eating dietary pattern. 
Post-intervention Assessment (follow-up) 
If you are assigned to the diet group, the provision of bento-styled meals will 
conclude immediately after the 2-month intervention period. However, it is 
imperative that you continue to adhere closely to the provided nutritional advice 
for an additional month. Regardless of your group assignment, you are required 
to attend the final study visit.  
 
7. Will there be reimbursement for reasonable transport costs and time spent 
from my participation?  
 
You will be reimbursed for your time and transport to participate in this study. The 
reimbursement will be made only on completion of the study. In the event the study 
ends early for a participant, the reimbursement will be pro-rated for the actual time 
and travel involved. However, no pro-rated reimbursement will be provided if your 
participation is withdrawn due to non-compliance issue as determined by the 
research team and investigators. Upon the completion the entire study, you will 
be paid a $280 SGD as described below: 

 
 
 
 
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Visit 
Amount 
to 
be 
reimbursed 
Mode of 
reimbursement 
Actual Screening (first visit) 
$20.00 
Cash via 
PayNow 
Visit 1 (pre-intervention) 
$50.00 
Cash via 
PayNow 
Visit 2 (mid-intervention) 
$50.00 
Cash via 
PayNow 
Visit 3 (post-intervention) 
$80.00 
Cash via 
PayNow 
Visit 4 (follow-up; final visit) 
$80.00 
Cash via 
PayNow 
Total amount  
$280.00 
 
 
8. 
How will my privacy and the confidentiality of my research records be 
protected? 
NUS has established data management policies and rules for protection of the 
personal data of human research subjects in NUS studies, including the 
collection, use and storage of such data. Additionally, our researchers are 
required to comply with the Human Biomedical Research Act (HBRA) and other 
applicable laws. Under the HBRA and the Personal Data Protection Act (PDPA), 
researchers must take all reasonable steps and safeguards as needed to protect 
individually identifiable information or material against accidental or unlawful loss, 
modification or destruction, or unauthorised access, disclosure, copying, use or 
modification.  
For purposes of validating the research findings and supporting future research 
work, research data (without personal identifiers) used in any publication will be 
kept for a minimum of 10 years before being discarded in accordance with the 
NUS Research Data Management Policy.  
PART II: Information on this Human Biomedical Research  
 
9. 
What is the nature of this biomedical research? 
 
 
This research is a clinical study, and the aim of this research study is to assess 
the effectiveness of an improved dietary pattern of lowered saturated fats, 
higher wholegrains, fruit, and vegetables in reducing the severity of atopic 
dermatitis (eczema) symptoms among individuals with existing volunteers from 
Singapore. In this way, we will be able to determine the effectiveness of a 
healthy and balanced dietary intervention on atopic dermatitis in our local 
population which is useful in improving public health. 
 
10. 
What is the purpose of this biomedical research? 
 
The main objective of this study is to assess the effectiveness of a dietary pattern 
characterized by lower saturated fats, higher wholegrains, fruit, and vegetables 
in reducing the severity of atopic dermatitis in young Singapore adults over a 2-
month intervention period. The study also aims to evaluate if the improved dietary 
pattern impacts on the quality-of-life, skin barrier functions, immunity functions, 
and gut microbiota composition and diversity.  

 
 
 
 
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11. 
What are the possible risks, discomforts or inconveniences to me if I 
participate in this research? 
 
Stool collection and skin physiology measurements are unlikely to cause 
discomfort 
and 
are 
minimally 
invasive 
techniques. 
Skin 
physiology 
measurements are taken by probes and will be sanitised for each participant. 
Stool collection kits are given to the participants for use at their best 
convenience.  
 
The process of blood collection may cause some discomfort and pain at the site 
of needle insertion. Occasionally, some individuals may experience fainting or a 
vasovagal response during or after blood collection. These are some common 
and expected side effects of the procedure. Participants should be informed 
about this aspect beforehand. Bruising and bleeding at the site of blood collection 
are potential side effects. This occurs when blood leaks into the surrounding 
tissues, leading to discoloration and swelling. These effects are usually mild and 
temporary. If a participant experiences serious effects from the blood collection, 
the participant will be immediately transported to NUH A & E (within proximity to 
study site). At NUH emergency, the team of doctors on duty will assess and 
provide medical support. In the case of a collapsed vein, our trained 
phlebotomists 
will 
attempt 
to 
draw 
blood 
from 
a 
different 
vein.  
 
Standard meal provided in this study will be prepared by a licensed food catering 
service. In a rare unfortunate event, food allergy or acute gastroenteritis is 
possible. In such cases, you should contact our research coordinator or the 
Principal Investigator as soon as possible. Medical attention will be given 
immediately, and you will be directed to proper health treatment or admitted to 
hospital 
for 
treatment.  
 
There is a potential risk of discomfort and exacerbation of eczema rash among 
participants due to the lack of application of moisturizers and/or topical creams 
throughout the study duration. To mitigate the risk of discomfort and exacerbation 
of eczema rash, participants will be advice accordingly to manage eczema 
symptoms, such as avoiding known triggers and maintaining proper hydration. 
Regular monitoring of participants' skin condition will be conducted, and any 
signs of discomfort or exacerbation of eczema rash will be promptly addressed 
to ensure participant comfort and well-being. 
 
12. 
What benefits can I expect from participating in the research?  
There is no direct medical benefit from participation in this study. Study 
procedures will be provided at no cost to the participant. A skin physiology 
measurement will be conducted and explained which may be beneficial to 
participants in understanding their skin health. The results of the skin physiology 
measurement will be made known to you before you leave the study. Apart from 
this, we will not be reporting back results of analyses or future analyses of your 
data or samples, unless these results are of serious health importance.  
 
13. 
Are there any alternative procedures or treatments available to me? What 
are the potential benefits and risks of such alternatives?” 
 
There are no alternative procedures or treatments available.  

 
 
 
 
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14. 
Do I have to incur any expenses by participating in this research?  
If you take part in this study, you will not have to pay for any procedures. 
However, you may incur transport expenses to the study venue. 
15. 
What will happen to the biological material taken from me? 
If you consent, the blood and stool samples obtained from you will be de-
identified and stored at the Allergy and Molecular Immunology Laboratory (Lee 
Hiok Kwee Functional Genomics Laboratories, Block S2, Level 5, 14 Science 
Drive 4, Singapore 117543) for five years upon the completion of this research 
study. Stored samples may be used in future biomedical research, subject to an 
Institutional Review Board’s approval. There are 2 types of future studies: 
 
Type a) Involving the use of your biological material without the need to recontact 
you. 
Type b) Studies that need some information from your end. 
 
For Type a studies (the studies that only require the use of your biological 
material), your consent is requested for in the consent form. If you do consent for 
the use of your biological samples for future studies, they will be used in research 
involving allergies and skin conditions. Your samples will be stored using only 
study codes in a locked freezers and accessible only by authorised personnel. 
No tissues or primary data will be transferred to other institutions. 
 
However, if you do not consent to use your samples in the future, leftover 
samples will be destroyed at the end of this study. No further consent will be 
sought from you for the use of your samples at any later time. 
 
For Type b studies, you will be re-contacted if you consent for participation in 
studies that may require further health/lifestyle information from you.  
 
16. 
Will my participation in this research involve the use of any information 
that will identify me?  
 
Your personal data (i.e., name, email, phone number and residential address) 
will be collected in this study for the purpose of communication. If you are 
assigned to the diet group, your residential address is collected to facilitate the 
delivery of meals to your home as part of the dietary intervention. 
 
17. 
Will any identifiable information obtained from me be used for future 
biomedical research? 
As mentioned in paragraph 15, there might be future research that that requires 
some health/lifestyle information from you (Type b studies). If you consent to be 
re-contacted in the consent form, we might re-contact you to invite you participate 
in any of our future studies. Your personal data (i.e., name, email, phone number, 
and residential address) will be retained for a period of at least 10 years by the 
trusted third party so that we may re-contact you (only if you consent to this) for 
participation in future research and/or follow-up in this study. Your identifiable 
information will never be used for any other purpose. 
 
18. 
How will my personal identifiers collected from me be kept confidential? 

 
 
 
 
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Only the principal investigator, co-investigators, as stated in question 23, will 
have access to your personal data (e.g., names and contact information). This 
data will not be released to any other person, unless required by applicable laws 
and regulations e.g., Infectious Diseases Act. Your personal data will never be 
used in a publication or presentation. To protect your confidentiality, your 
biospecimens and data will to the extent feasible during the study, be coded (i.e., 
only identified with a code number). The link between your personal data and the 
code number will be kept confidential by the principal investigator or a trusted 
third 
party.  
  
  
We will do our best to protect your data and biospecimens during storage and 
when they are shared. However, there remains a possibility that someone could 
identify you. There is also the possibility that unauthorised people might access 
your data and biospecimens. In either case, we cannot reduce the risk to zero. 
 
19. 
Can I withdraw my consent to the research at any time? 
You can withdraw from the research at any time without giving any reasons, by 
informing the principal investigator verbally or in writing. Please note that the 
withdrawal of consent does not affect the research information obtained before 
the consent is withdrawn and such information may still be retained and used for 
research if you permit. There will be no penalties imposed on you should you 
withdraw your consent to participate in this research. You are entitled to refuse 
to participate or discontinue participation at any time in this research. Upon 
withdrawal, your data and your samples would be destroyed accordingly.  
 
20. 
Will I be re-identified in the event of incidental finding(s) arising during the 
biomedical research? 
It is possible that during the research we may find you have pre-existing medical 
issues that are unrelated to our research. These are called “incidental findings”. 
“Incidental findings” are findings that have potential health or reproductive 
importance to 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. 
 
You will be asked to indicate whether you wish to be re-identified and notified in 
the event of an important incidental finding that is related to you. The discovery 
of an incidental finding, at the discretion of the University, will be communicated 
to you for the purpose of seeking medical advice or treatment. In the event that 
you have indicated not to be re-identified and notified, but the University has 
determined that the incidental finding is of clinical significance, you may still be 
contacted to decide if you wish to be notified of the incidental finding at that time.  
    
21. 
Under what circumstances will I be re-contacted for further consent? 
We do not anticipate any significant changes to our study protocol that would 
require re-consent. 
 
PART III: Information on the Removal and Use of My Tissue(s) for this Research  
 
22. 
What are the tissue(s) that will be taken from me and what will they be used 
for? 
There will be four study visits and during each visit, a total of 20 mL whole blood 
and 500 mg stool samples (faecal) are collected through venepuncture 

 
 
 
 
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procedure and a standard stool collection kit. The blood sample collected will be 
used for a thorough analysis of lipid levels, immune cell counts, serum cytokines, 
and gene expression profiling, which is done by service providing companies. 
Your consent for the use of leftover samples in future research endeavours will 
be sought, and you will have the option to opt-in or opt-out as per your 
preference. Otherwise, leftover blood and faecal samples will be destroyed at 
the end of the study. Stool samples may undergo processing using commercial 
DNA kits. This process enables us to conduct 16S rRNA gene sequencing, a 
technique that helps identify and quantify different bacterial taxa within the 
microbiota. These samples may also be subject to metagenomic analysis, 
allowing us to study the genetic material of the entire microbial community. 
 
23. 
Will my personal data be shared and/or processed for use in research? 
Your personal data will only be shared and processed for use in research 
purposes with your explicit consent. We adhere to strict confidentiality measures 
and will not disclose your personal information without your prior authorization. 
Any data shared for research purposes will be anonymized or coded to protect 
your privacy. Additionally, all research activities involving your personal data will 
be conducted in compliance with applicable data protection laws and regulations. 
We prioritize transparency and will provide you with detailed information about 
how your data will be used and any potential risks involved before seeking your 
consent for its processing in research. 
 
24. 
Will my personal data be processed overseas for use in research? 
Your personal data will only be processed overseas for use in research if it is 
necessary for the specific aims of the study and with your explicit consent. We 
prioritize the protection of your personal information and ensure that any 
overseas processing complies with applicable data protection laws and 
regulations. Additionally, we take measures to safeguard your data during 
international transfer, such as utilizing secure encryption methods and selecting 
reputable partners who adhere to strict privacy standards. The overseas 
recipients of your personal data are bound by legally enforceable obligations to 
protect your personal data to a standard comparable to the data protection laws 
of Singapore.  
 
25. 
Will my tissue(s) be used for any purpose other than research? 
The biological samples collected from you (blood and faecal) will not be used for 
any purpose other than research.  
 
26. 
What risks, discomforts and inconveniences will I expect if my tissue(s) is/ 
are removed from me? 
Some individuals may also experience fainting or a vasovagal response during 
or after blood collection. As the blood collection procedure will only be conducted 
in a room designated for blood draw, and you will be sitting comfortably on a 
chair throughout the procedure. There are beds in the room, and you can use 
them to rest if you experience faint spells during the event. Some discomfort, 
pain, bleeding or bruising at the site of the needle stick may occur during 
collection of blood samples. There is a risk of vein collapse during venepuncture. 
In the case of a collapsed vein, phlebotomists will attempt to draw blood from a 
different vein. 
 

 
 
 
 
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27. 
Does this study involve the removal of human tissues from persons who 
lack mental capacity or understanding and intelligence to consent to the 
donation of their tissues for the study? If so, what are the proposed area(s) 
of research approved by the Institutional Review Board (IRB), where the 
IRB has waived the requirement that the removal of my tissue(s) be for 
therapeutic or diagnostic purposes? 
No, this study will not involve the removal of human tissues from individuals who 
lack the mental capacity or understanding and intelligence to consent to the 
donation of their tissues.   
 
28. 
Will I still retain my rights to my tissue(s) after it has/ have been removed 
from me? 
Donation of your tissues is voluntary. By donating your tissues, you will relinquish 
your rights to your tissues and any intellectual property rights that may be derived 
from the use of your tissues. 
 
29. 
Do I have to incur any expenses if I donate my tissue(s) for this research?  
You do not have to incur any expenses for donating tissues in this research. 
 
30. 
If I am injured as a result of donating my tissue(s), what are the 
compensation and treatments available to me? 
If you follow the directions of the PI in charge of this research study and you are 
physically injured, the NUS will pay the medical expenses for the treatment of 
that injury. 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.  
 
31. 
Will my donated tissue(s) be used in any ways that can identify me? 
Your personal data (i.e., name, email, phone number, and residential address) 
will be collected in this study for the purpose of communication. The samples will 
be coded immediately and there will be no attempts to reidentify you with the 
sample code. The samples will never be studied in an individually identifiable 
form. The research team will never use any identifiable information to store or 
transfer the samples.  
 
32. 
Will the records that identify me in relation to my tissue(s) donation be kept 
confidential? 
To protect your confidentiality, your blood and faecal samples will be coded (i.e., 
only identified with a code number). All personal data (e.g., names and contact 
information) will be kept separate from your blood and faecal samples. The link 
between your personal data and the code number will be kept confidential by the 
faculty which is the trusted third party. The data will be stored in password-
protected files under a data manager of the trusted third party.  
 
33. 
Will the identifiable information obtained from me in the course of tissue 
donation be used for future research? 
If you consent, your personal data (i.e., name, email, phone number, and 
residential address) will be retained for a period of at least 10 years by a trusted 
third party so that we may re-contact you for participation in future research 
(allergy or skin condition research) and/or to communicate with you regarding 
incidental findings. If you agree to be re-contacted for future related studies your 

 
 
 
 
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consent will be sought for that particular study. The identifiable information will 
not be used in anyway in future research other than to re-contact you.  
 
34. 
What will happen to the tissue(s) taken from me upon completion of the 
research? 
     Leftover blood and faecal samples will be destroyed at the end of the study if 
you did not give consent for their use in future related research.  
 
As mentioned in paragraph 15, future research that is of Type a) Involving the 
use of your biological material without the need to re-contact you. For these 
studies, we only require the use of your biological material, your consent is 
requested in the consent form. If you consent for the use of your biological 
samples for future studies, they will be used in research involving allergies and 
skin conditions. Your samples will be stored using only study codes in a locked 
freezers and accessible only by authorised personnel. No tissues or primary data 
will be transferred to other institution. No further consent will be asked at any 
later time for the use of your biological samples.  
 
35. 
Will my tissue(s) be used in restricted human biomedical research? 
Your tissue(s) will not be used in restricted human biomedical research involving 
human-animal combinations.  
 
36. 
Will my tissue(s) be exported overseas or removed from Singapore? 
Your tissue may be exported or removed out of Singapore in order to perform 
targeted genotyping, as the service providers maybe located in regions other 
than in Singapore. Any export of samples will be done only if you expressly agree 
to this.  
 
37. 
Will I be re-identified in the case of incidental finding(s) arising from the 
use of my tissue(s) in future research? 
It is possible that during the research we may find you have pre-existing medical 
issues that are unrelated to our research. These are called “incidental findings”. 
“Incidental findings” are findings that have potential health or reproductive 
importance to 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. 
 
You will be asked to indicate whether you wish to be re-identified and notified in 
the event of an Important incidental finding that is related to you. The discovery 
of an incidental finding, at the discretion of the University, will be communicated 
to you for the purpose of seeking medical advice or treatment. In the event that 
you have indicated not to be re-identified and notified, but the University has 
determined that the incidental finding is of clinical significance, you may still be 
contacted to decide if you wish to be notified of the incidental finding at that time.  
    
38. 
Can I withdraw my consent to the removal of my tissue(s) and/or use of my 
tissue(s) in research at any time? 
You can also withdraw from the research at any time without giving any reasons, 
by informing the principal investigator and all your tissue(s) collected will be 
discarded. However, this only applies if the tissue is individually-identifiable and 
has not been used for research, or has been used for research but the PI has 

 
 
 
 
Page 14 of 18 
 Version 6, 10 September 2025 
determined that the sample quality does not suit the research purpose. Please 
also note that the withdrawal of consent does not affect the research information 
obtained before the consent is withdrawn and such information may still be 
retained and used for research. There will be no penalties or damages imposed 
on you should you withdraw your consent to participate in this research. 
 
39. 
Will I be re-contacted for further consent for the use of my tissue(s)? If so, 
under what circumstances? 
We do not anticipate any significant changes to our study protocol that would 
require re-consent.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
Page 15 of 18 
 Version 6, 10 September 2025 
Consent Form for Research Subjects  
Protocol title: Dietary Intervention on Atopy  
 
Principal Investigator with the contact number and organization: 
Associate Prof. Chew Fook Tim  
Allergy Molecular Immunology Laboratory,  
Department of Biological Sciences, Faculty of Science 
National University of Singapore.  
Tel: 6516 1685; email: dbscft@nus.edu.sg 
 
Part A. I hereby acknowledge that: 
1. My signature is my acknowledgement that I have agreed to voluntarily take part 
in the above research.  
2. I have received a copy of this Participant Information Sheet that explains the use 
of my human biological material and data in this study.  
3. By signing this consent form, I understand its contents and agree to donate my 
human biological material and data for the use purpose of this research. I confirm 
that I consent to the collection, disclosure and processing of my human biological 
material and data for the purposes of the study. 
4. I can withdraw from the research at any point of time by informing the Principal 
Investigator although if I have donated tissue for the research, I can only withdraw 
my consent to use my tissue if the tissue is individually identifiable and has not 
been used for research or it is practicable to discontinue further use of my tissue 
for research. I am aware that that the withdrawal of consent does not affect the 
research information obtained before the consent is withdrawn and such 
information may still be retained and used for research. 
 
5. I will not have any financial benefits that result from the commercial development 
of this research. 
 
Part B. For human biological materials and data (including personal data) 
collected for use in future research, please select 1 of the four choices below: 
I agree to donate my human biological material and data collected for this 
research to be used in future research OR 
 
I agree to donate my human biological material and data collected for this 
research to be used in future research. However, I would like all personal data 
removed from my biological samples so that no one can link the sample to me 
OR 
 
I agree to donate my human biological material and data collected for this 
research to be used in future research which may include testing and 
development by commercial firms. However, I would like all personal data 
removed from my biological samples so that no one can link the sample to me 
OR 
 
 
 
Participant copy 

 
 
 
 
Page 16 of 18 
 Version 6, 10 September 2025 
I do not agree to donate my human biological material and data collected for 
this research to be used in future research and would like to have my leftover 
biological samples destroyed after the completion of this research. 
 
Part C. For human biological materials and data (including personal data) 
collected for overseas exportation. 
 
6. I agree / do not agree that my data and the research data derived from the 
research may be processed and transferred to any overseas recipient. Such 
recipients are bound by legally enforceable obligations to protect my personal 
data to a standard comparable to the data protection laws of Singapore. 
 
7. I agree / do not agree for my leftover human biological materials to be exported 
or removed out of Singapore. 
 
Part D. For purposes of re-contact: 
8. I agree / do not agree to be re-contacted for future related studies. I understand 
that future studies will be subject to an Institutional Review Board’s approval. 
 
9. I agree / do not agree that I may be contacted if a medical issue is found during 
the course of this study or in future research, in order to facilitate my seeking 
proper medical advice. I understand that my participation in the research is not 
considered medical treatment, and that the researchers are not qualified medical 
practitioners able to provide diagnoses. 
 
 
 
 
_______________________________ 
___________ 
Name and Signature (Research Subject) 
      Date 
 
I, the undersigned, certify to the following:  
(a) 
I am 21 years of age or older.  
(b) 
I have taken reasonable steps to ascertain the identity of the research subject.  
(c) 
To the best of my knowledge, the research subject had 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.  
(d) 
I have taken steps to ascertain that the consent has been given voluntarily 
without any coercion or intimidation. 
 
 
 
________________________________ 
___________ 
Name and Signature (Witness) 
        Date 
 
_______________________________ 
___________ 
Name and Signature (Consent Taker) 
        Date 
 

 
 
 
 
Page 17 of 18 
 Version 6, 10 September 2025 
Consent Form for Research Subjects  
Protocol title: Dietary Intervention on Atopy  
 
Principal Investigator with the contact number and organization: 
Associate Prof. Chew Fook Tim  
Allergy Molecular Immunology Laboratory,  
Department of Biological Sciences, Faculty of Science 
National University of Singapore.  
Tel: 6516 1685; email: dbscft@nus.edu.sg 
 
Part A. I hereby acknowledge that: 
1. My signature is my acknowledgement that I have agreed to voluntarily take part 
in the above research.  
2. I have received a copy of this Participant Information Sheet that explains the use 
of my human biological material and data in this study.  
3. By signing this consent form, I understand its contents and agree to donate my 
human biological material and data for the use purpose of this research. I confirm 
that I consent to the collection, disclosure and processing of my human biological 
material and data for the purposes of the study. 
4. I can withdraw from the research at any point of time by informing the Principal 
Investigator although if I have donated tissue for the research, I can only withdraw 
my consent to use my tissue if the tissue is individually identifiable and has not 
been used for research or it is practicable to discontinue further use of my tissue 
for research. I am aware that that the withdrawal of consent does not affect the 
research information obtained before the consent is withdrawn and such 
information may still be retained and used for research. 
 
5. I will not have any financial benefits that result from the commercial development 
of this research. 
 
Part B. For human biological materials and data (including personal data) 
collected for use in future research, please select 1 of the four choices below: 
I agree to donate my human biological material and data collected for this 
research to be used in future research OR 
 
I agree to donate my human biological material and data collected for this 
research to be used in future research. However, I would like all personal data 
removed from my biological samples so that no one can link the sample to me 
OR 
 
I agree to donate my human biological material and data collected for this 
research to be used in future research which may include testing and 
development by commercial firms. However, I would like all personal data 
removed from my biological samples so that no one can link the sample to me 
OR 
 
 
 
 
Investigators copy 

 
 
 
 
Page 18 of 18 
 Version 6, 10 September 2025 
I do not agree to donate my human biological material and data collected for 
this research to be used in future research and would like to have my leftover 
biological samples destroyed after the completion of this research. 
 
Part C. For human biological materials and data (including personal data) 
collected for overseas exportation. 
 
6. I agree / do not agree that my data and the research data derived from the 
research may be processed and transferred to any overseas recipient. Such 
recipients are bound by legally enforceable obligations to protect my personal 
data to a standard comparable to the data protection laws of Singapore. 
 
7. I agree / do not agree for my leftover human biological materials to be exported 
or removed out of Singapore. 
 
Part D. For purposes of re-contact: 
8. I agree / do not agree to be re-contacted for future related studies. I understand 
that future studies will be subject to an Institutional Review Board’s approval. 
 
 
9. I agree / do not agree that I may be contacted if a medical issue is found during 
the course of this study or in future research, in order to facilitate my seeking 
proper medical advice. I understand that my participation in the research is not 
considered medical treatment, and that the researchers are not qualified medical 
practitioners able to provide diagnoses. 
 
 
 
_______________________________ 
___________ 
Name and Signature (Research Subject) 
      Date 
 
 
I, the undersigned, certify to the following:  
(e) 
I am 21 years of age or older.  
(f) 
I have taken reasonable steps to ascertain the identity of the research subject.  
(g) 
To the best of my knowledge, the research subject had 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.  
(h) 
I have taken steps to ascertain that the consent has been given voluntarily 
without any coercion or intimidation. 
 
 
________________________________ 
___________ 
Name and Signature (Witness) 
        Date 
 
_______________________________ 
___________ 
Name and Signature (Consent Taker) 
        Date