Summary Information to Help you Decide Whether to Join this Study

INFORMED CONSENT DOCUMENT AGREEMENT TO BE IN A RESEARCH STUDY
Study Title	Protocol with Referral Test
Study Author	Reviewer User
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 to the Efforia platform, where you are invited to join our research study. This study is made possible by your participation. Efforia is a registered Delaware B Corporation, which means we consider the public good in our business decisions alongside traditional monetary considerations.

This document provides key information to help you decide if you want to participate in this study. Participation is voluntary, and you can leave the study at any time without penalty. You may continue to use the products and services you've purchased, and if you choose not to, partial or full refunds might be possible by contacting us at help@efforia.com.

If you have questions, please reach out to Efforia, conduct your own research, and speak with a healthcare professional familiar with your circumstances.

Purpose of the Study

This study is conducted to explore [insert purpose]. Our aim is to contribute to scientific knowledge and societal benefits by [insert detailed aims]. We will use various measures and tools like [list full names of measures, products, and services] to achieve our study objectives. Definitions and descriptions for these items are provided to ensure clarity and understanding.

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. You are responsible for making the right choice, more so 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 in the study or as they are discovered by Efforia. The results and findings may impact your interest and willingness to be involved in the study. Remember, participation is voluntary and you may exit at any time with an email to 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

Introduction and Summary of Known Risks

The product in question is currently under review for potential risks, side effects, allergies, and adverse reactions associated with its use. Due to the absence of specific treatment or product details including active ingredients and their concentrations, this report will provide a generalized overview based on common components and similar products found in pharmaceutical and therapeutic contexts.

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, it is critical to seek immediate medical attention by dialing 911. After addressing any acute medical needs, please inform Efforia about the incident to help improve safety and efficacy assessments.

Serious Adverse Events (SAEs)

Potential Serious Adverse Events associated with the treatment could include, but are not limited to:

Theoretical side effects	Relative incidence	Recovery
Incidence of Cancer	Very low likelihood	Potentially permanent
Exacerbation or escalation to acute or chronic disease	Low to moderate likelihood	Varies
Death	Very low likelihood	Permanent
Life-threatening experience	Low likelihood	Varies
Hospitalization (initial or prolonged)	Low likelihood	Varies
Disability or permanent damage	Low likelihood	Potentially permanent
Congenital anomaly/birth defect	Very low likelihood	Potentially permanent
Required intervention to prevent permanent impairment or damage	Low likelihood	Varies
Frustration and irritation	Low to moderate likelihood	Subsides with discontinuation

Efforia's limitations in providing direct medical support

Efforia may not be able to provide immediate or direct medical support in the event of an adverse reaction. Participants are advised to contact local emergency services first in the case of a serious health issue.

Long-term Dependence Issues

Long-term dependence on the treatment has not been clearly established due to limited data. However, psychological dependence or habitual use could potentially develop based on the nature of the treatment and its effects on the body and mind.

Legality for Use by Various Institutions

The legality and acceptance of this product by major regulatory bodies such as the World Anti-Doping Association, National Collegiate Athletic Association, and corporate workplaces are yet to be determined. These bodies typically have strict regulations on the use of substances that may enhance performance or alter mental state, which could affect participation or employment.

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
Individuals with a history of cancer	High risk of exacerbation or new cancer development	The intervention has a theoretical risk of cancer, albeit very low.
Pregnant or planning to become pregnant women	Risk of congenital anomaly/birth defect	There is a very low likelihood of congenital anomalies, but the risk is potentially permanent.
Individuals with chronic diseases	Exacerbation or escalation to acute or chronic disease	The intervention could exacerbate existing chronic conditions.
Individuals with severe allergies	Potential for unpredictable allergic reactions	Lack of specific ingredient information makes allergy risk assessment challenging.
Individuals with mental health disorders	Risk of psychological dependence or exacerbation of symptoms	Long-term dependence issues and frustration/irritation could impact mental health stability.
Athletes or regulated professionals	Potential legal issues with regulatory bodies	Legality for use by institutions like the World Anti-Doping Association is undetermined.
Individuals with a history of hospitalization or disability	Risk of hospitalization or permanent damage	There is a low likelihood of hospitalization and disability, but risks could be significant.

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 the rights of your privacy:

• We may reach out to local help if we have reason to 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.

If you have 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 in the case 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 for you or is too expensive for your specific purposes, Efforia is dedicated to making other studies available. Click on the Efforia logo in the upper portion of the page to find a different study that may be more appropriate.

Your Rights as a Participant:

Efforia upholds the same high ethical standards in research as seen in pharmaceutical and academic studies, despite only hosting and not sponsoring or conducting these studies. Your participation in this study is completely voluntary, and you are free to withdraw at any time without any adverse consequences. You are not giving up any rights by signing this document.

Efforia may remove you from the study if you have violated Efforia's overall terms and conditions, privacy policy, or have a conflict of interest. Efforia may also remove you from the study in the interest of safety 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:

You 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:

Your data will be collected, used, and protected in compliance with data protection laws. You own your own data, and it 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 via e-mail, SMS, or push notification when new study tasks like questionnaires and reminders 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 from this study, 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, you should make sure your phone or desktop computer and your e-mail accounts are protected by a password, pin, or other form of “access control.” You should also avoid sharing your accounts with others or sharing your account passwords. As this study is hosted in Efforia, it is governed by a set of privacy and confidentiality standards that put you, as a participant, in control. You can learn more about Your Privacy and Security rights on Efforia here: Efforia Privacy Policy.

Who will have access to your data?

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

What will we do with your data

We will use the data to show you your own 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:

For further details on your rights as a participant, please review the California Experiential Research Subject Bill of Rights. Also, you can find more about our privacy policy here: 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 Univo 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.