Malaysia

|

EN

|

PARTICIPANT INFORMATION SHEET AND INFORMED CONSENT FORM FOR

NON-INVASIVE HEMOGLOBIN MONITORING WATCH FOR MATERNAL HEALTH

  1. Name of Study: Wellness Watch Programme (Non-Invasive Hemoglobin Monitoring Watch for Maternal Health Advancement)

  2. Name of Investigator: Ms. Moon (MLS(ASCP)CM)

  3. Name of Institution: Sonobee Holding Sdn. Bhd. in collaboration with University Malaysia Perlis (UniMAP)

  4. Name of Sponsor/Organisation: 

Introduction 

This Informed Consent Form consists of two parts. The first part is the Information Sheet, which provides you with information about the research study, including its purpose, procedures, duration and frequency, benefits, risks, result, confidentiality and your rights as a participant. The second part is the Certificate of Consent, which you will be asked to sign if you voluntarily agree to participate in the study. Please take your time to read through and consider this information before you decide if you are willing to participate. You will be given a copy of the full Informed Consent Form.

This particular study has been registered under the National Medical Research Registrar and has been approved by the Medical Research and Ethics Committee under Ministry of Health Malaysia (KKM). 

Purpose of Research 

Haemoglobin deficiency, commonly known as anaemia, is one of the most prevalent health conditions affecting pregnant women worldwide and remains a significant public health concern in Malaysia. Current estimates indicate that approximately 30–40% of pregnant women in Malaysia experience some degree of anaemia during pregnancy. If left undetected or inadequately managed, anaemia may increase the risk of adverse maternal and fetal outcomes, including fatigue, reduced physical capacity, preterm birth, low birth weight, postpartum complications, and, in severe cases, increased maternal and neonatal morbidity.

This research is necessary to develop a non-invasive, wearable haemoglobin monitor watch device that addresses a critical gap in our current maternal healthcare. Currently, existing haemoglobin assessment methods rely primarily on invasive blood sampling conducted during scheduled antenatal visits, limiting the ability to monitor haemoglobin levels continuously and detect deterioration between appointments. By leveraging advanced biosensing technologies and wearable health monitoring capabilities, this study aims to establish the accuracy, reliability, and usability of a continuous haemoglobin monitoring solution for pregnant women and anaemic individuals alike. 

Study Procedures

If you agree to participate in this study, the following procedures will be conducted:

  1. Informed Consent

  • The study will be explained to you in detail and you will be given an opportunity to ask any questions.

  • Written informed consent will be obtained before any study-related procedures are performed.

  1. Basic Health Data Collection

  • Basic demographic and health information may be collected and recorded, including your age, pregnancy status, gestational age (if applicable), height, weight, blood pressure, heart rate, and oxygen saturation.

  • You may be asked questions regarding any history of anaemia or other relevant medical conditions or your current medications or supplements.

  1. Blood Sample for Reference Haemoglobin Measurement

  • A qualified healthcare professional will obtain a blood sample through routine venepuncture or finger-prick testing to measure your haemoglobin level using standard clinical laboratory methods.

  • This reference measurement will serve as the comparator against which the wearable device readings will be evaluated.

  1. Wearable Device Application

  • Our investigational wearable haemoglobin monitor watch will be placed on your wrist according to the manufacturer's instructions.

  • The device uses non-invasive optical and biosensing technologies and does not penetrate the skin. No medication, injection, or treatment will be administered through the device.

  1. Simultaneous Data Collection

  • While wearing the device, haemoglobin-related measurements and physiological signals will be collected continuously or at predetermined intervals.

  • Device readings will be compared with laboratory haemoglobin measurements to assess accuracy and performance.

  1. User Experience Evaluation 

Participants may be asked to complete questionnaires or interviews regarding:

  • Comfort while wearing the device;

  • Ease of use and user experience;

  • Acceptability of the technology; and

  • Willingness to use the device in routine monitoring.

  1. Comfort and Safety Monitoring

  • Researchers will monitor for any discomfort, skin irritation, or adverse events associated with device use.

  • Participants should immediately report any unexpected symptoms or concerns to the research team.

  1. Repeat Measurements

  • Participants may be asked to attend multiple study visits or undergo repeated assessments over a specified period. During follow-up visits for further hemoglobin device study and usability, additional blood samples may be collected. Feel free to refuse if you do not want to participate with the subsequent visits. 

  • The frequency and timing of visits will be determined later by the research team, depending on the research progress. 

  1. Completion of Participation

  • Your identity will remain confidential. Any information collected during your participation will continue to be stored, managed, and analysed in accordance with the study protocol, applicable ethical requirements, and the Personal Data Protection Act 2010. Furthermore, any reporting or publication of the study findings will be anonymous. 

  • At the end of the study period, all wearable device prototype will need to be returned to the research team (if applicable).

  • No further study procedures will be performed unless you consent to participate in any future related research.

Duration and Frequency of Study

The research takes place over ___ (number of days/months)___ in total. During that time, we will require your visit 1/2/3 times for the collection of blood sample/survey/interviews.  

Benefits of this Study for Pregnant Women

You may or may not receive any direct benefit from participating in this study as this investigational wearable haemoglobin monitoring device is being evaluated for research and development purposes and is not intended to replace standard medical care or clinical haemoglobin testing.

However, the information obtained from this study may contribute to the development and validation of a non-invasive, wearable haemoglobin monitoring device. If successfully developed, this technology may provide future benefits to pregnant women and also individuals at risk of anaemia by enabling convenient, continuous monitoring of haemoglobin levels without the need for frequent blood sampling or waiting for routine clinic appointments. The findings from this research may also contribute to improved early detection and management of anaemia and help advance maternal healthcare and patient monitoring technologies.

Possible Risks 

The risks associated with participation in this study are expected to be minimals. The wearable device is non-invasive and does not penetrate the skin. Some participants may experience minor discomfort, pressure, warmth, or temporary skin irritation from wearing the device for prolonged periods. / If blood samples are collected as part of the study for comparison with standard laboratory haemoglobin measurements, there may be minor risks associated with blood collection, including temporary pain, bruising, bleeding, swelling, dizziness, or, rarely, infection at the blood sampling site as our medical research team will ensure the correct procedures are administered during the blood sample collection. There is also a small risk of loss of confidentiality of your personal data if there is event of data breach. However, all reasonable measures will be taken by our side to protect your privacy and the confidentiality of your personal information. Your data will be securely stored and handled in accordance with applicable laws, ethical guidelines as required under the Personal Data Protection Act 2010.

Study Results

Individual results obtained from the investigational wearable haemoglobin monitoring device will not be routinely shared with participants because the device is being evaluated and has not yet been approved for clinical use. The readings generated during the study are for research purposes only and may not be sufficiently validated to guide healthcare decisions. The results may contribute to scientific publications, regulatory submissions, or future improvements to healthcare technologies; however, participants will not receive individual reports or feedback regarding their study data. If any clinically significant findings are identified through standard clinical assessments conducted as part of the study, the research team will advise you to consult your healthcare provider or seek appropriate medical attention. A summary of the overall study findings may be made available upon request after the study has been completed.

Voluntary Participation

Your participation in this study is voluntary. You do not have to be in this study if you do not want to. You may ask any question if you are unclear or when you need more information. If you volunteer to be in this study, you may withdraw from it at any time. If you withdraw, any data collected from you up to your withdrawal will be deleted and disposed upon request. 

Your refusal to participate or withdrawal will not affect any medical or health services to which you are otherwise entitled. You may also refuse to answer any questions you do not want to answer.  You do not have to give us any reason for not responding to any question, or for refusing to take part in the survey/interview/blood sample collection (if any).

Your Rights as Participant 

This is a reconfirmation that your participation is voluntary and includes the right to withdraw and to refuse to answer any questions or participate in any procedure that makes you feel uncomfortable at any time or research phase. 

Confidentiality of Your Personal Data

All your information obtained in this study will be kept and handled in a confidential manner, in accordance with applicable laws and relevant principles of data confidentiality under the Personal Data Protection Act 2010. When publishing or presenting the study results, your identity will not be revealed without your expressed consent. Individuals involved in this study, qualified monitors and auditors, and governmental or regulatory authorities may inspect the study data, where appropriate and necessary. Thus, you as a participant may submit a request to know, access, correct or delete the information we have collected from or about you here or by sending your request to the physical address provided in the “Contact Us” section below.

Have This Research Been Approved? 

This medical research on Wellness Watch Programme (Non-Invasive Hemoglobin Monitoring Watch for Maternal Health Advancement has been registered under National Medical Research Register and has been reviewed and approved by Medical Research & Ethics Committee, Ministry of Health Malaysia which is a committee whose task it is to make sure that research participants are protected from harm. If you wish to find about more about the validity of this medical research, please visit the National Medical Research Register at https://nmrr.gov.my/ under Research Directory of Medical Research which lists all medical researches or studies that has been registered in various field. 

Contact Us 

If you have any questions or inquiries relating to this medical research and your rights as a participant, you may contact our research team, Ms. Moon at 03-_____________ or through our research team email address at _______________.  You may also contact our legal team at [email protected] relating to any concern you have regarding your rights as a participant. If you have any concern or question regarding your personal information, you may contact our Data Protection Officer at [email protected] (Subject: “Attn: DPO”).

If you have any questions or concern relating to this medical research, you may contact the Secretary, Medical Research & Ethics Committee, Ministry of Health Malaysia, which are reachable at telephone number 03-3362 8407/8205/8888.