Summary Information to Help you Decide Whether to Join this Study

Study Title	Immunity for Skiers Study — Email 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	Sense of Agency Scale
Contact	help@efforia.com

Introduction & Summary

Welcome! We invite you to join this research study on the Efforia platform, which is made possible by your support. Efforia is a registered Delaware B Corporation, meaning we consider the public good in addition to traditional financial factors. This study aims to explore the sense of agency among participants. The information provided here will help you decide whether to participate. Remember that your participation is voluntary, and you can leave at any time without penalty. If you choose to leave, you may continue to use any products or services you've acquired, or you may request a refund, depending on the timeline, by reaching out to Efforia via email. We encourage you to seek answers to any questions by contacting Efforia, conducting your own research using credible sources, and consulting with a healthcare professional familiar with your circumstances.

Purpose of the Study

This study is being conducted to evaluate how different factors influence the sense of agency among skiers. The primary aim is to gather data that can contribute to understanding the psychological and physiological aspects of agency in sports and other activities. The Sense of Agency Scale, a structured questionnaire, will be used to assess participants' perceived control over their actions and outcomes.

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, and entered your personal details, here's what's involved:

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

Thoroughly weigh the risks and benefits of participation. 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 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 may impact your interest and willingness to continue 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

Participation in this study may provide you with insights into your own sense of agency and contribute to broader scientific knowledge. 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

Risk Assessment and Safety Profile for Sense of Agency Scale

Introduction and Summary: The Sense of Agency Scale is designed to measure an individual's perceived control over their actions and environment. As it primarily involves psychological assessment rather than pharmacological intervention, the risks associated directly with its use are minimal and primarily psychological in nature. However, it's critical to address both the inherent and contextual risks associated with psychological assessments.

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 discomfort or distress during or after completing the Sense of Agency Scale, seek immediate medical attention by calling 911. Once any acute situations have been addressed, please contact Efforia to report the incident. This allows for the continuous improvement of the assessment and ensures the safety of all participants.

Serious Adverse Events (SAEs)

The Sense of Agency Scale, being a non-pharmacological, psychological assessment tool, is not typically associated with Serious Adverse Events (SAEs) that are biological or physical in nature. However, psychological distress or a significant negative emotional response could potentially occur, particularly in individuals with pre-existing mental health conditions. It is important to monitor and report any severe psychological reactions.

Theoretical Side Effects, Relative Incidence, and Recovery

Theoretical side effects	Relative incidence	Recovery
Mental Health Discomfort	Low to Moderate	Symptoms typically subside after completion of the assessment; may require further psychological support if persistent.
Cognitive Distress	Low	Generally resolves after discontinuation of the assessment.
Frustration and irritation	Moderate	Often temporary and subsides after the assessment period.

Efforia's limitations in providing direct medical support

Efforia does not provide direct medical interventions. Should any psychological distress or adverse effects occur, it is advised to consult with a healthcare provider.

Potential Long-term Dependence Issues

As the Sense of Agency Scale is a diagnostic tool and not a treatment, there are no known risks of long-term dependence associated with its usage.

Legality for Use by Various Institutions

The use of psychological assessment tools like the Sense of Agency Scale is generally permitted across various institutions, including the World Anti-Doping Association, National Collegiate Athletic Association, and corporate workplaces. However, it is important to consider the privacy and data protection policies of your specific organization or sector when administering such assessments.

This assessment should be used responsibly under the guidance of qualified professionals, especially when interpreting the results in a clinical or high-stakes environment.

Inappropriate Participants Inclusion/Exclusion

I'm sorry, but I need more specific information regarding the risks informed consent and the intervention involved in the trial to provide a detailed and relevant table. Please provide these details so I can assist you accordingly.

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 a 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, it's important to contact Efforia 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 is 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 high ethical standards in research, similar to those 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:

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:

Data will be collected, used, and protected 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 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, make sure your phone or desktop computer and your e-mail accounts are protected by a password, pin, or other form of “access control.” 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 more information about your privacy rights, please review the Efforia privacy policy: 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.