Informed Consent form for Volunteers
This Informed Consent Form is for men and women, whom we are inviting to participate in research project, on Impact of Weather on Health of an Individual.
The title of our research project is “Impact of Weather on Health of an Individual based on Personal Medical History, Location, Weather, Environment, and Mental Wellness.”
Principal Investigator
GenBioCa Sciences Pvt. Ltd.: Dr. Col. Maninder Pal Singh – MBBS, MD(PSM)
You are being invited to participate in this research project.
This Informed Consent Form has two parts:
- Information Sheet (information on the research project with you)
- Certificate of Consent (to be signed, if you agree to take part)
You will be given a copy of the full Informed Consent Form.
PART I: Information Sheet
Introduction
I am, Dr. Col. Maninder Pal Singh – MBBS, MD(PSM), representing GenbioCa Sciences Pvt Ltd. We are doing a research project, on impact of Weather on Health of an Individual based on Personal Medical History, Location, Weather, Environment, and Mental Wellness. I am going to give you information and invite you to be part of this research. You do not have to decide today, whether or not you will participate in the research. Before you decide, you can talk to anyone you feel comfortable with about the research.
There may be some words that you may not understand. Please ask me to stop as we go through the information, and I will take time to explain. If you have questions later, you can ask me, the research doctor, or the staff.
It is important that you understand this research so that you can make a decision. This process is called informed consent. To make your decision, you will need to consider all of the information provided here and ask questions about anything you do not understand. You may want to talk with your family, friends, or others to help you decide if you want to be part of this research project.
Purpose of the research
The purpose of this research is to use technology which is a mobile application called “moringa”, which will collect your personal identification information, personal health information which will be stored in the server in encrypted form, will be visible only to you or person authorized by you. This information will be used, only when you develop any symptoms due to changes in weather conditions, to provide you prognosis of the disease. The application will also send you alerts, notifications and motivate you to set a goal for yourself based on the input provided by you during registration process. This data will help GenBioCa Sciences to validate the model, methodology adopted while developing this application.
What will happen during this Observatory Research project?
If you agree to participate in this Observatory Research project, you will be asked to do the following things:
Step 1: You will register yourself by providing honest inputs as required during registration.
Step 2: Provide the symptom input, in case you are not feeling well and also follow the alerts, notifications received during the day.
Step 3: Every day or alternate day, a notification will be sent to you on usage of application, to get feedback on ease of use and correctness of the outcome.
How long will I be in the research project?
The research project has been planned for a minimum of 60 calendar days. Post signing informed consent, you are expected to use “moringa” application for approximately 15 -30 minutes, every day over this period.
If you wish to continue using the application post 60 days, please inform us.
What precautions do I need to take before and during the research project?
- Duly understand this document and sign the informed consent form.
- Provide honest inputs during registration.
- Provide honest inputs while answering questionnaires.
- Read and act on related application notifications.
- Respond to health agent calls every day or whenever received and provide honest answers.
*A sheet detailing these inputs/data will be given to you after you are enrolled in the research.
How many people will be in the research project?
We have planned to recruit 100 participants in this research project who are either heathy or associated with certain health conditions.
What are the possible health risks or discomforts associated with this research project?
There is no health risk associated with this research project, as we are not administering any drug or using medical devices. We are only collecting data from you.
You may feel discomfort in answering some of the questions in the questionnaire packet. However, these questions are to understand your current state of health to guide you accurately.
Is there any security or privacy concern with my data?
There is no security and privacy concerns with your data as all entries in the application are being encrypted and stored in a secured web server. We are maintaining optimum security and privacy measures to avoid any data breach and/or hacking. GenBioCa Sciences will keep the records in encrypted form and can be accessed only by you or person duly authorized by you.
All conversations with health agents are also being captured in a form which is encrypted before storing in server. Calls are being recorded or stored for training purposes.
Paper copies of data will be kept for up to 3 years. Electronic copies of your data will be kept indefinitely. Your data may be used for future research studies or given to other researchers for future research studies without your permission. In this case, only your de-identified data will be made available.
When the results of the research are published or discussed in conferences, no information will be included that would reveal your identity to others. Authorized representatives of the following groups may need to review your research and/or medical records as part of their responsibilities to protect identity of research participants.
What are the possible benefits from being in this research project?
You will be benefitted as follows:
- Health Score: This is an approximate value of your immunity at any given point in time. With this score you will be able to know how vulnerable you are to any illness.
- Notifications: You will get notifications on health, suggestion, alerts and tasks. These will assist you to take immediate action on your health, habits and environment.
- Goals: You will be suggested personalized goals to improve your health based on your health score.
- Research: Your participation will also contribute to the medical knowledge and scientific investigation of possible uses for this type of model, methodology used in the application.
Will the research project results be shared with me?
The research results will not be shared with you as it may contain confidential information of other volunteers.
What are my other options if I do not participate in this research project?
There are no other options available to you for this research project at this time, if you choose to not participate.
Will I have to pay for anything if I take part in this research project?
You don’t have to pay for anything to participate in this research project. GenBioca Sciences and any our representatives will not ask for any payments before or during and after the course of this research project.
Will I be paid to take part in this research project?
You will not be paid for during this research project.
What happens if I am injured because of taking part in this research project?
This research project is solely being conducted remotely based on mobile application without using any drug or devices, hence your chances of getting injured due to this research project is unlikely. We advise you to use “moringa” application while you are not involved in activities like crossing the road, driving, cycling, running, eating etc. as these may cause loss of concentration in your primary activity.
What if I decide not to participate in this research project?
It is your choice whether you want to participate in this research project. You can choose not to be in the research project now or stop taking part in this research project at any time without any penalty or loss of benefits to which you are entitled.
If you withdraw from the research project, the data collected up to the point of your withdrawal will still be used for analysis.
What could end my participation in the research project?
GenBioCa Sciences may withdraw you from participating in this research project, if circumstances arise which warrant doing so. These circumstances may include: if you are unable to complete the tasks, if it is determined that it is in your best interest to stop your participation in the research project, if questionnaire data suggests that your answers are not reliable (this is determined after your participation). GenBioCa Sciences will make the decision and let you know if it is possible for you to continue or not.
Additional Details
The table below summarizes some key things to think about. After reading this summary, if you think you might be interested in participating, read the rest of the form for more details about the research.
Following are the procedures you will follow while in the research project:
- Complete questionnaires.
- Provide your feedback verbally to health agents.
- Receive Alerts, Notifications on your mobile and follow the instructions.
Eligibility
Inclusion Criteria
- Participant must be more than 18 years old.
- Must be suffering from either Diabetes Type I or II, Cardiovascular Disease, Respiratory Disorder viz. Asthma.
- Healthy volunteers are also eligible.
- Participants can be from any geography.
Exclusion Criteria
- Suffering from severe health condition which requires immediate medical help.
- Less than 18 years old.
Who should I call if I have questions or concerns about this research project?
If you have questions about the research at any time, you should contact Mr. Shashidhar Shastri +91 98204 30868, or email Mr. Shashidhar Shastri at shastri@genbioca.com.
PART II: Certificate of Consent
By signing below, I agree that I have been provided time to read the information describing the research in this consent form. The content and meaning of this information have been explained to me. I have been provided with the opportunity to ask questions. I voluntarily consent to participate in this research.
By signing this form, I have not given up any of my legal rights as a research participant.
Printed Name of Participant __________________________________________
Signature of Participant ______________________________________________
Place:
Date __________________________________ (Day/Month/ Year)
If illiterate or minor
I have witnessed the accurate reading of the consent form to the potential participant, and the individual has had the opportunity to ask questions. I confirm that the individual has given consent freely.
Printed Name of Witness __________________________________________
Signature of Witness ______________________________________________
Place:
Date __________________________________ (Day/Month/ Year)
Thumb print of the participant (if illiterate)
Statement by the researcher/person taking consent
I have accurately read out the information sheet to the potential participant, and to the best of my ability made sure that the participant understands that the following will be done:
- Registration inputs will be collected.
- Provide symptom data in case of illness.
- Alerts and notifications will be sent through “moringa” app.
- Every day or alternate day, a notification will be sent on usage of application, to get feedback on ease of use and correctness of the outcome.
- Health Agents will call the participants every day to understand their health and to note any critical observation.
I confirm that the participant was given an opportunity to ask questions about the research, and all the questions asked by the participant have been answered correctly and to the best of my ability. I confirm that the individual has not been coerced into giving consent, and the consent has been given freely and voluntarily.
A copy of this ICF has been provided to the participant.
Print Name of Researcher/person taking the consent______________________________
Signature of Researcher /person taking the consent_______________________________
Place :
Date_____________________________ (Day/Month/ Year)