Summary Information to Help you Decide Whether to Join this Study

Study Title	MCP Kate test challenge
Study Author
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 join this research study on the Efforia platform. Efforia is a registered Delaware B Corporation, which means we consider the public good in business decision-making alongside traditional financial considerations. This study is made possible with your support through participation.

This document provides crucial information to help you decide if you want to take part in this study. Participation is completely voluntary, and you can leave at any time without penalty. Even if you decide to withdraw, you can continue using the products and services you’ve purchased. If you prefer not to continue using them, you may be eligible for a partial or full refund, depending on the timeline of the study. Please reach out to us at help@efforia.com for more details.

If you have any questions, please contact us at Efforia, do your own research with reputable sources, and speak with a healthcare professional familiar with your personal health situation.

Purpose of the Study

The study aims to explore [insert study aims], contributing to scientific knowledge and societal benefits. We will use [insert full names of measures, products, and services] throughout the study. Each will be thoroughly explained so you understand their purpose and how they will be used.

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.

Once you have completed enrollment, payment (if applicable), and entered your personal details, shipping details (if applicable), and communication preferences, you will be responsible for adhering to a predetermined schedule and engaging in specified treatment activities. These tasks must be conducted at regular intervals as outlined in the study’s timeline. Each activity and subsequent measurement is crucial to the study’s success, requiring your strict compliance with the timeline. This meticulous adherence ensures the accuracy and reliability of the study’s outcomes. Participants are expected to follow the detailed description of treatment activities and complete any associated measurements with the frequency specified by the study protocol.

The Risks, Discomforts & Benefits of Being in this Study

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

Consider your Own Risk-Benefit Comfort Level

Thoroughly weigh the risks and benefits of participation. You have more responsibility 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 as well as overall findings. These findings will be available at various data collection points during 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

The safety profile and risk assessment of the treatment are crucial components of the Interventional New Drug Application. This document outlines the potential risks, side effects, allergies, and adverse reactions associated with the treatment in question. As the product details such as name, treatment type, and ingredients are undefined, this report will provide a general overview based on typical categories observed in pharmaceutical and therapeutic interventions.

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 side effects, it is crucial to seek immediate medical attention by calling 911 or visiting the nearest emergency room. After addressing any acute situations, please contact Efforia to report the incident. This will help us to monitor the safety of our product and provide necessary support.

Serious Adverse Events (SAEs)

Theoretical side effects	Relative incidence	Recovery
Frustration and irritation	Moderate likelihood	Symptoms subside with use
Incidence of Cancer	Very low likelihood	Not applicable
Exacerbation or escalation to acute or chronic disease	Low likelihood	Depends on underlying condition
Death	Very low likelihood	Permanent
Life-threatening experience	Low likelihood	Potential lasting effects
Hospitalization (initial or prolonged)	Low likelihood	Recovery possible with medical care
Disability or permanent damage	Very low likelihood	Potential permanent effects
Congenital anomaly/birth defect	Very low likelihood	Permanent
Required intervention to prevent permanent impairment or damage	Low likelihood	Recovery possible with intervention

Efforia’s Limitations in Providing Direct Medical Support

Efforia is primarily a research organization and does not provide direct medical support. Participants are encouraged to maintain regular contact with their healthcare providers to manage any adverse effects or concerns that arise during the course of the treatment.

Long-term Dependence Issues

Long-term dependence on the treatment is not typically expected, but dependency risks can vary based on the individual and the nature of the treatment. Continuous monitoring and consultation with healthcare providers are recommended.

Legality for Use

The legality of using the treatment in various institutions such as the World Anti-Doping Association, National Collegiate Athletic Association, and corporate workplaces has not been fully established. Participants should verify the acceptability of this treatment within their specific organizational or institutional context to avoid conflicts or violations of policies.

Inappropriate Participants Inclusion/Exclusion

To create a table identifying individuals who should avoid or critically evaluate their participation in this trial, please provide detailed information about the risks informed consent, the specific intervention being tested, and the outcome measures associated with the trial. This information is necessary to accurately determine potential contraindications and reasons for avoiding the study for certain categories of individuals.

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: https://efforia.com/privacy-policy/

There may be very 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 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 us if you experience any problems, side effects, or study-related injuries after receiving 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

Since this study is for research only, the only other choice would be not to be in the study. If this study does not seem quite right or too expensive for your specific purposes, Efforia is dedicated to making other studies available. You may click on the Efforia logo in the upper portion of the page and 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 a participant fail to disclose such a conflict of interest or if a breach of this policy is discovered, the participant 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

Describe how data will be collected, used, and protected, ensuring compliance with data protection laws. You own your own data, and it will be housed on Efforia indefinitely until you tell us to delete it 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 email, 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 email 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: https://efforia.com/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 information about your rights as a participant, please review the California Experiential Research Subject’s Bill of Rights and the Efforia privacy policy here: https://efforia.com/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.