Summary Information to Help you Decide Whether to Join this Study

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 its business decisions.

This study is designed to explore how the Polar Heart Rate Monitor can impact your personal health. Participation is voluntary, and you can leave the study at any time without penalty. You may continue using the products and services you’ve purchased, or request a partial or full refund by contacting Efforia.

Before deciding, ensure all your questions are answered. Reach out to Efforia, conduct your own research, and consult your healthcare provider to make an informed decision.

Efforia is a citizen science platform where studies are effectively sponsored by you, the participants. You pay for all the supplies, services, information, and tools needed for participation in one transaction. This structure makes possible studies that might not be otherwise viable.

Although you could buy these products and services separately for a similar cost, Efforia bundles them for convenience, organizing them into a comprehensive, data-driven research experience. This setup allows you to track and understand the impact on your own life via detailed reports, making informed personal health decisions easier. It also advances broader research findings, benefiting others who might not afford such purchases without guaranteed results.

Efforia is committed to equitable inclusion. If the cost is too high for you, click the Efforia logo at the top of the screen to explore other protocols. Efforia offers protocols at different price points, including free options, so you can find one that suits your goals and budget.

Purpose of the Study

This study aims to investigate the effectiveness of the Polar Heart Rate Monitor in tracking cardiovascular health. By participating, you contribute to scientific knowledge and potential societal benefits. The Polar Heart Rate Monitor is a wearable device that measures your heart rate in real-time, providing insights into your fitness level and helping you optimize your health routines.

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, shipping details, and communication preferences:

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 available at various data collection points or as they are discovered. The results may impact your interest and willingness to continue the study. Remember, participation is voluntary, and you may 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, other than seeing reports that the intervention or treatment had no measurable impact.

Possible Serious Adverse Events & Side Effects

Risk Analysis Report: Polar Heart Rate Monitor – Test

Introduction and Summary of Known Risks

The Polar Heart Rate Monitor is designed to track heart rate metrics during physical activities. While generally safe, the use of such devices may carry potential risks, particularly in sensitive populations or when used improperly.

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 serious or unexpected symptoms while using the Polar Heart Rate Monitor, seek immediate medical attention by calling 911. Once any acute issues have been addressed, please inform Efforia about the event.

Serious Adverse Events (SAEs)

Efforia's limitations in providing direct medical support

Efforia does not offer direct medical support or emergency services. Users are advised to contact healthcare professionals or emergency services directly in the event of health issues.

Risks Overview

• Skin & Hair Reactions: Some users might experience skin irritation or allergic reactions to materials used in the monitor. These issues are generally mild and resolve upon discontinuation of use.
• Mental Health Discomfort: Frustration and irritation may occur, especially related to the complexities or limitations of the device.

Long-term Dependence

There are no known issues of long-term dependence associated with the use of the Polar Heart Rate Monitor. Users can stop using the device at any time without adverse health consequences.

Legality for Use

The use of the Polar Heart Rate Monitor is legal and does not generally conflict with regulations of institutions such as the World Anti-Doping Association, National Collegiate Athletic Association, or typical Corporate Workplace guidelines. However, users should verify the acceptability of wearable technology in their specific competitive or professional environment.

This report provides a comprehensive overview of potential risks associated with the Polar Heart Rate Monitor. It is crucial for users to understand these risks and consult healthcare providers for personalized advice.

Inappropriate Participants Inclusion/Exclusion

To proceed, I need additional information regarding the risks outlined in the informed consent and details about the intervention being studied. Please provide these details so I can generate a table identifying individuals who should avoid participating in the trial.

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 certain limits to your privacy rights:
- 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.

Seek local medical care first if necessary. Efforia cannot provide emergency medical care or diagnosis. However, it is important to contact Efforia if you experience any problems, have any side effects, or have any study-related injury after receiving 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 cace 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 participate. If this study does not seem quite right, 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 violate Efforia's overall terms and conditions, privacy policy, or have a conflict of interest. Efforia may also remove you from the study 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:

You have a role in reducing conflicts of interest as well. It is crucial that you do not have any financial relationship with the intervention methods or measurement providers used in the trial, nor should you be an employee, investor, stakeholder, or protocol author 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:

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 otherwise 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, 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: 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, such as 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
- 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:

Learn about the California Experiential Research Subject Bill of Rights. Review 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 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. It is up to you to do additional research and talk to your physician before joining a study.