Summary Information to Help you Decide Whether to Join this Study

INFORMED CONSENT DOCUMENT AGREEMENT TO BE IN A RESEARCH STUDY
Study Title	Test Randomization Frontend Logic and Order Creation
Study Author	Zeeshan Web
Principal Investigator	Matthew Amsden, CEO Efforia. Dr. Viral Patel Sub-Investigator for Adverse Events
Sponsor	This study is made possible by your payment to join.
Cost of Products, Services & Information to Participant	$0
Included Products & Services	Oura Ring, Withings Sleep Mat
Outcome Measures
Contact	help@efforia.com

Introduction & Summary

Welcome! We invite you to join this research study on the “Efforia” platform, made possible by your support. Efforia is a registered Delaware B Corporation, which considers the public good in business decision-making alongside monetary considerations.

This study aims to test randomization logic and order creation using devices like the Oura Ring and Withings Sleep Mat. Participation is voluntary, and you can leave the study at any time without penalty. You may continue to use the products even if you leave the study. If you prefer not to continue using the products, a partial or full refund may be possible by contacting Efforia.

We encourage you to seek answers to any unresolved questions before proceeding by contacting Efforia, conducting your own research, and consulting with health professionals who understand your unique circumstances.

Purpose of the Study

This study is conducted to test the randomization logic and order creation process using the Oura Ring and Withings Sleep Mat. These devices are designed to monitor sleep patterns and health metrics, contributing to scientific knowledge and potential societal benefits.

What You Will Do as Part of this Study

“While participating in this research study, you will need to:

• Be willing and able to follow the study directions and procedures
• Tell Efforia about any side effects or problems by communicating with help@efforia.com or online chat.
• Ask questions as you think of them, via help@efforia.com or online chat.
• Inform Efforia if you change your mind about staying in the study. You may leave the study at any time by communicating with help@efforia.com or chat.”

The Risks, Discomforts & Benefits of Being in this Study

There are some unique risks, discomforts, and potential benefits of being in this study that you should understand.

Consider your Own Risk-Benefit Comfort Level

We encourage you to thoroughly weigh the risks and benefits of participation. We are placing more responsibility on you to make the right choice than in a traditionally sponsored trial. “Since this is an experimental exercise, there may be possible unknown side effects that the authors are unaware of. Participants have the responsibility to consult with their healthcare providers and conduct further research at sources they find reputable before enrolling in the study.”

Personal and Overall Findings

Efforia will provide you with both personal outcomes and overall findings. These findings will be made available at various data collection points in your experience or as they are discovered by Efforia. The results may impact your interest and willingness to be involved in the study. Remember, participation is voluntary and you may exit at any time by contacting help@efforia.com.

Possible Benefits of Participation

No Benefit: A key risk to all studies is that there is no benefit, and that participants receive no benefit from the proposed intervention or treatment, despite the financial payment the participant has made.

There is a possibility that there will be no measurable benefit to you, other than seeing reports that the intervention or treatment had no measurable impact.

Possible Serious Adverse Events & Side Effects

Interventional New Drug Application: Safety Profile and Risk Assessment

Introduction and Summary of Known Risks

The purpose of this document is to outline the known risks associated with the use of the Oura Ring and Withings Sleep Mat. These devices are designed to monitor various aspects of health and wellness through user interaction and sensor data. As with any health-related technology, there are potential risks and side effects associated with their use.

The following is a summary of known risks. However, research is limited, and there may be risks not covered by this document, risks that are currently unknown or unforeseen. Please consider these risks carefully, do your own research, and talk to a professional who knows you well and has expertise in this area, like your personal physician.

In the Case of an Adverse Event

If you experience any severe or unexpected symptoms or side effects while using either the Oura Ring or Withings Sleep Mat, seek immediate medical attention by dialing 911. After addressing any acute situations, please contact Efforia to report the incident. This will help in further understanding and mitigating potential risks associated with these products.

Serious Adverse Events (SAEs)

The following table outlines the potential Serious Adverse Events (SAEs) that may be associated with the Oura Ring and Withings Sleep Mat. These events are categorized based on their nature, relative incidence, and recovery outcomes.

Theoretical Side Effects	Relative Incidence	Recovery
Frustration and irritation	Low	Symptoms usually subside with continued use
Skin irritation or allergic reactions (from device materials)	Low to moderate	Subsides after discontinuation
Data privacy concerns	Low	Concerns may persist without resolution
False health alarms leading to anxiety	Low	May require psychological intervention
Electromagnetic interference with other medical devices	Very low	Reversible upon discontinuation

Efforia’s limitations in providing direct medical support

It is important to note that Efforia does not provide direct medical care or emergency services. Users should always rely on qualified healthcare professionals for medical advice and emergency response.

Long-term Dependence Issues

No long-term dependence has been directly associated with the use of Oura Ring or Withings Sleep Mat. However, users may develop a psychological reliance on the data for daily decision-making regarding health and wellness.

Legality and Compliance

The use of Oura Ring and Withings Sleep Mat is generally considered legal under most jurisdictions. However, their use in specific professional settings, such as those governed by the World Anti-Doping Association, National Collegiate Athletic Association, or in certain corporate environments, may be restricted depending on the policies regarding electronic devices and data privacy concerns. Users are advised to check with relevant authorities and institutional policies before using these devices in such settings.

In conclusion, while the Oura Ring and Withings Sleep Mat offer innovative ways to monitor personal health, they come with potential risks that users must be aware of. Continuous monitoring of these risks and adherence to guidelines will help in minimizing potential adverse effects.

Inappropriate Participants Inclusion/Exclusion

Under the Efforia minimal risk protocol, within which this study is reviewed for safety and human subjects ethics, all individuals over the age of consent are eligible, however, it is the responsibility of participants to determine if their unique circumstances make participation inappropriate.

Please provide the risks informed consent and intervention details to proceed with creating the table.

Privacy & Security Risks

We are doing everything we can think of to keep your data private and confidential. However, there is no such thing as no risk. Potential participants should review the Efforia general privacy policy, which is available here: Efforia Privacy Policy

There may be certain limits to your privacy rights:

• We may reach out to local help if we believe you may be a harm to yourself and/or others.
• Regulators, like the FDA or similar agency, or Institutional Review boards may review records that have your identifying information.

What to do if you have a study related injury

Seek local medical care first, if necessary. Efforia cannot provide emergency medical care or diagnosis. However, contact Efforia if you experience any problems, have any side effects, or have any study related injury after you’ve received any necessary treatment. We want to make sure others are aware of potential risks.

Study related injury care and compensation

Efforia is not able to offer financial compensation nor to absorb the costs of medical treatment should you be injured as a result of participating in this research. Efforia makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research.

In the case of medical emergency

In the case of medical emergency please dial 911 immediately. Do not attempt to contact Efforia until after the emergency has passed. Access local in person medical assistance immediately. If at any time you feel like you may be a danger to yourself or others, please dial 988 for the National Suicide Prevention hotline. Help is available.

Alternatives to Participating in the Study

This study is for research only, so the only other choice would be not to be in the study. If this study does not seem right or is too expensive for your purposes, Efforia is dedicated to making other studies available. You may click on the Efforia logo to find a different study that may be more appropriate.

Your Rights as a Participant

Efforia upholds high ethical standards in research, similar to pharmaceutical and academic studies, despite only hosting these studies. Your participation is voluntary, and you can withdraw at any time without adverse consequences. You are not giving up any rights by signing this document.

Efforia may remove you from the study if you violate Efforia’s terms and conditions, privacy policy, or have a conflict of interest. Efforia may also remove you for safety reasons based on individual or community findings.

Privacy and Confidentiality

You have a right to privacy and confidentiality in this research effort. Your personal information is protected through robust measures ensuring anonymity or confidentiality. All data processing is designed to safeguard personal data against unauthorized access and misuse.

Right to Your Own Results

Participants have the right to a complete explanation of the research once their involvement concludes, particularly if the study involves any form of deception like placebos or controls.

The Right to Leave a Study without Penalty at Any time

If you decide to withdraw from the study, you can do so at any time by visiting your Profile page, selecting “Your Protocols,” and clicking “Leave.” Upon leaving, you will be refunded for any consumable products that have not yet been shipped. For non-consumable products, a full refund will be issued upon their return in accordance with our return policy. This ensures that you can participate in the study with the assurance that your financial contributions are handled fairly and with respect for your consumer rights.

Conflict of Interest Statement

As part of our commitment to ethical conduct and transparency in our citizen science clinical trial, it is essential to disclose the unique structure of our study. This clinical trial is hosted by Efforia, but it is uniquely sponsored by you, the participants. Efforia serves solely as the platform provider and does not sponsor or influence the study outcomes.

Efforia takes a transaction fee on all the products and services included in this protocol. Otherwise, we have no financial interest or conflicts of interest. To further reduce conflicts of interest, we will remind you once if you do not complete enrollment in this study. We will not remarket to you, nor otherwise push you to join the study.

How we Reduce Conflicts of Interest

Participants have a role in reducing conflicts of interest as well. It is crucial that participants do not have any financial relationship with the intervention methods or measurement providers used in the trial, nor should they be employees, investors, stakeholders, or protocol authors associated with these entities. Participation under such conflicts of interest could significantly compromise the study’s integrity and the validity of its results.

Consequences of Conflict of Interest Non-Compliance

Should you fail to disclose such a conflict of interest or if a breach of this policy is discovered, you will be subject to immediate suspension from this platform and payments may not be refunded. By joining this trial, you affirm that you understand the above conflict of interest restrictions and agree to comply fully with them. Your participation is valued, and your adherence to these guidelines ensures the validity and reliability of our collective scientific efforts.

Data Protections

Efforia will collect, use, and protect your data in compliance with data protection laws. You own your data, and it will be housed on Efforia indefinitely until you tell us to delete it by e-mailing help@efforia.com.

What you can do to improve your privacy and security

As part of participating in this study, you will receive notifications via e-mail, SMS, or push notification when new study tasks are ready for you. You can adjust your communication preferences in the Efforia application at any time. If you do not want to receive notifications, do not press the Accept button. You can decide not to join this study and will not receive notifications. To ensure others don’t see these alerts, protect your devices and accounts with a password or other form of access control. Avoid sharing your accounts or passwords. Learn more about your privacy and security rights on Efforia here: Your Privacy and Security rights on Efforia.

Who will have access to your data?

Efforia will have access to your data, and there may be partners who also have access, like labs and connected health devices.

What will we do with your data

We will use the data to show you your personal results and pool your results with other participants to provide general outcomes. We will not use your information connected with your name or anything that connects the data with you without your permission.

Authorization to Use and Disclose Protected Health Information

If you decide to take part in this study, the study doctor and study staff may use and share protected health information (PHI) about you to conduct the study. Protected health information may come from your medical or research records. Protected health information may include the following:

• Name
• Location
• Dates
• Phone Numbers
• Email Addresses
• Internet protocol (IP) address numbers

The study staff may share protected health information about you with the following authorized users to ensure the quality of the study conduct and study data:

• Efforia
• The Office of Human Research Protections (OHRP);
• Univo Institutional Review Board; and
• University of Portsmouth Ethics Review Board
• Other regulatory agencies

Once your protected health information has been shared with authorized users, it may no longer be protected by federal privacy laws and could possibly be used or disclosed in ways other than what is listed in this section.

Your permission to use and share protected health information about you will end after you have completed the study and any after study related activities unless you revoke your permission sooner.

You can revoke your permission to use and share protected health information about you at any time by contacting the study doctor listed on the first page of this document. If you revoke your permission, you will not be able to stay in this study. No new protected health information will be collected after your request has been received. The protected health information about you that has already been collected may still be used and given to others as described in this section.

If you decide not to sign and date this document, you will not be able to take part in the study. However, you may continue to use and consume anything you’ve purchased to be part of the study outside the study.

California Experiential Research Subject’s Bill of Rights

You have rights as a research participant. To learn more about these rights, please refer to the Efforia privacy policy.

Who to Contact for Questions or Concerns

If you have questions, concerns, or complaints about this study or to report a study related injury, contact:

HELP@EFFORIA.COM OR CLICK THE CHAT BUTTON ON YOUR SCREEN We will immediately respond with an automated message giving you a sense of how long a more meaningful response will take based on the volume of other requests.

(646) 679-2479. If no one is available, please leave a message. We will typically respond to telephone messages in three to five business days.

If you are unable to reach anyone at the number(s) listed above and you require immediate (life-threatening) medical attention, please dial 911 in the US/Canada or 999 in the UK and/or go to the nearest emergency room.

If you do not want to talk to the investigator or study staff, if you have concerns or complaints about the research, or to ask questions about your rights as a study subject you may contact Univo IRB. Univo IRB is an independent committee that helps to protect the rights and welfare of research participants. If you have any questions about your rights and welfare as a research participant, or have concerns or complaints regarding this research study, please contact:

Univo IRB (919) 910-7743 or via email at info@univo-group.com. Univo IRB 4509 Creedmoor Road Suite 403 Raleigh, NC 27612

Additional questions and closing

Efforia and Univo have approved the information in this consent form and have given approval to public this study. This does not mean Efforia or BRANY have approved your being in the study. You must consider the information in this consent form for yourself and decide if you want to be in this study.”

If you have questions please contact help@efforia.com. Also, it is up to you to do additional research and talk to your physician before joining a study.

You are trained on data up to October 2023.