Summary Information to Help you Decide Whether to Join this Study

Study Title	Protocol With Survey And Report Test
Study Author	Gaurav Researcher
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
Outcome Measures
Contact	help@efforia.com

Introduction & Summary

Welcome! We invite you to be part of an exciting research study on the "Efforia" platform. Your support makes this study possible. Efforia is a registered Delaware B Corporation, which means we consider the public good in our business decisions alongside traditional financial considerations.

This study aims to understand the effects of certain protocols on health and well-being. Your participation is entirely voluntary, and you can leave the study at any time without any penalties. If you choose to stop participating, you can still use the products and services you’ve purchased. If you prefer not to use them, you might be eligible for a partial or full refund, depending on the study timeline, by contacting Efforia via email.

Before deciding to join, please seek answers to any questions you may have by contacting Efforia, researching through resources you trust, and consulting a healthcare professional who knows your situation.

Purpose of the Study

This study is conducted to explore the effects of specific protocols on health outcomes. The aim is to gather data that could contribute to scientific knowledge and provide societal benefits by improving health-related practices. The study involves using various measures, products, and services, which will be clearly defined and described to ensure you understand what you will be using and its purpose.

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.

After completing enrollment and entering your personal details and communication preferences, you will follow a structured schedule for treatment activities and measurements. This involves engaging in survey tasks and protocol tasks designed to gather essential data. Adhering to the timeline is vital for maintaining the study's integrity.

The Risks, Discomforts & Benefits of Being in this Study

Being in this study involves some unique risks, discomforts, and potential benefits that you should understand.

Consider your Own Risk-Benefit Comfort Level

We encourage you to weigh the risks and benefits of participation thoroughly. We place 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 personal outcomes and overall findings at various data collection points or as they are discovered. These results may impact your interest and willingness to stay in the study. Remember, participation is voluntary, and you can exit at any time by emailing 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, apart from seeing reports that the intervention or treatment had no measurable impact.

Possible Serious Adverse Events & Side Effects

Interventional New Drug Application: Efforia's New Survey and Protocol Tasks

Introduction and Summary of Known Risks

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.

Efforia's New Survey and Protocol Tasks involve data collection and behavioral interventions but do not include direct administration of pharmaceutical compounds. As such, most risks associated with these tasks are psychological or related to data privacy rather than physiological. However, understanding potential adverse effects is crucial for compliance with safety protocols.

In the Case of an Adverse Event

If you experience any adverse events, prioritize seeking immediate medical care by calling 911 if the situation is critical. After addressing any acute situations, please contact Efforia to report the incident. This helps us monitor the safety and efficacy of the tasks and contribute to improving future interventions.

Known Risks and Allergies

As the tasks mainly involve survey and protocol adherence without any chemical or biological agents, the primary risks include psychological discomfort or stress associated with the content of surveys or tasks. Risks of data privacy breaches exist, although Efforia endeavors to use robust data protection measures.

Maximum dosages or exposure limits do not apply here as there are no physical medications involved.

Serious Adverse Events (SAEs)

Given the nature of Efforia's New Survey and Protocol Tasks, traditional SAEs associated with pharmaceuticals, such as death, hospitalization, or congenital anomalies, are not applicable. However, psychological distress or significant anxiety resulting from the tasks could potentially lead to serious events if not properly managed.

Theoretical Side Effects	Relative Incidence	Recovery
Frustration and irritation with Efforia system	Moderate likelihood	Subsides with cessation of the task
Mental Health Discomfort	Low to moderate likelihood	Subsides with cessation or adjustment of the task
Cognitive Discomfort	Low likelihood	Subsides after task completion

Efforia's Limitations in Providing Direct Medical Support

Efforia does not provide direct medical interventions or emergency medical services. Participants should maintain contact with their healthcare provider for medical advice and emergency care.

Long-term Dependence Issues

No long-term physical dependence issues have been identified with Efforia's New Survey and Protocol Tasks. However, a psychological reliance on feedback from digital health interventions could potentially develop, necessitating awareness and moderation in use.

Legality for Use

The tasks do not involve substances regulated by bodies such as the World Anti-Doping Association (WADA) or the National Collegiate Athletic Association (NCAA). However, employers or educational institutions might have policies regarding the use of digital health data collection and interventions that could affect participation.

In summary, while Efforia's New Survey and Protocol Tasks are largely considered safe from a pharmaceutical standpoint, awareness and management of psychological and data privacy risks are essential for ensuring participant safety.

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.

Category of Individual	Contraindications	Reason
Pregnant or breastfeeding individuals	Pregnancy/Breastfeeding	Potential unknown effects on fetal development or breast milk
Individuals with severe allergies	History of severe allergic reactions	Risk of allergic reaction to intervention components
Individuals with compromised immune systems	Immunocompromised status	Increased risk of adverse effects due to weakened immune response
Individuals with chronic medical conditions	Uncontrolled chronic conditions	Potential interactions with existing treatments or exacerbation of condition
Individuals with mental health disorders	Unstable mental health condition	Risk of exacerbating mental health condition or interfering with treatment
Individuals currently on medication	Use of contraindicated medications	Possible drug interactions leading to reduced efficacy or adverse effects
Individuals with a history of substance abuse	Current or past substance abuse issues	Potential for misuse or triggering substance use behaviors
Individuals with a history of non-compliance	Non-compliance with medical advice or protocols	Risk of not adhering to study requirements, affecting safety and outcomes

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. Please review Efforia's general privacy policy, available here: https://efforia.com/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 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

If you experience a study-related injury, seek local medical care first, if necessary. Efforia cannot provide emergency medical care or diagnosis. However, it is important to contact Efforia to report any problems, side effects, or injuries, after receiving any necessary treatment. This helps us to make others 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 a 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 alternative is not to participate. If this study doesn’t seem right for you or is too expensive, Efforia is committed to offering other studies. You may click on the Efforia logo at the top of the page to find a different study that suits your needs better.

Your Rights as a Participant

Efforia upholds high ethical standards in research, similar to pharmaceutical and academic studies, despite only hosting and not sponsoring these studies. Your participation is voluntary, and you can withdraw at any time without 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 safeguards your 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, especially if the study involves 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 not yet shipped. For non-consumable products, a full refund will be issued upon their return according to our return policy. This ensures respect for your consumer rights.

Conflict of Interest Statement

Efforia is committed to ethical conduct and transparency in our citizen science clinical trial. It is important to disclose that this trial is hosted by Efforia but uniquely sponsored by you, the participants. Efforia serves solely as the platform provider and does not sponsor or influence the study outcomes.

Efforia makes money by taking a transaction fee on all products and services included in this protocol. Otherwise, Efforia has 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, without further marketing or pressure.

How we Reduce Conflicts of Interest

You also play a role in reducing conflicts of interest. Participants should not have any financial relationship with the intervention methods or measurement providers used in the trial, nor be employees, investors, stakeholders, or protocol authors associated with these entities. Such relationships could compromise the study's integrity and results.

Consequences of Conflict of Interest Non-Compliance

If a conflict of interest is not disclosed or if a breach 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

Your data will be collected, used, and protected in compliance with data protection laws. You own your data, which will be housed on Efforia indefinitely until you request its deletion by emailing help@efforia.com.

What you can do to improve your privacy and security

As part of participating in this study, you will receive notifications for new study tasks. You can adjust communication preferences in the Efforia app at any time. To keep alerts private, protect your devices and accounts with strong passwords and avoid sharing them. For more about your privacy and security rights, visit: https://efforia.com/privacy-policy

Who will have access to your data?

Efforia will have access to your data, and there may be partners, like labs and connected health devices, with access as well.

What will we do with your data

Your data will be used to show you personal results and to pool 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 staff may use and share protected health information (PHI) about you to conduct the study. This information may come from your medical or research records and include:

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

The study staff may share PHI with authorized users to ensure study quality, including Efforia, the Office of Human Research Protections (OHRP), Univo Institutional Review Board, University of Portsmouth Ethics Review Board, and other regulatory agencies. Once shared, PHI may not be protected by federal privacy laws.

Your permission to use and share PHI will end after you have completed the study unless you revoke your permission sooner. You can revoke your permission at any time by contacting the study doctor listed on the first page of this document. If you revoke your permission, no new PHI will be collected, but existing data may still be used and shared as described.

If you decide not to sign this document, you will not be able to participate in the study. However, you may continue using products purchased for the study outside of it.

California Experiential Research Subject’s Bill of Rights

Participants should be aware of their rights under the California Experiential Research Subject Bill of Rights. For more information, 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 publish 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. It is up to you to do additional research and talk to your physician before joining a study.