Summary Information to Help you Decide Whether to Join this Study

Study Title	Timing Test – Again
Study Author	[object Object],[object Object],[object Object]
Sponsor	This study is made possible by your payment to join.
Cost of Products, Services & Information to Participant	$0
Included Products & Services	Oura Ring, , , , , , ,
Outcome Measures	PHQ-8, Sense of Agency Scale, Oura Sleep,
Contact	help@efforia.com

Introduction & Summary

Welcome to this research study on the Efforia platform. Your participation in this study, made possible by your support, is entirely voluntary. The purpose of this study is to help us understand specific health outcomes and behaviors. We aim to provide you with comprehensive information to help you decide whether to participate. You may leave the study at any time without any penalty. Please ensure you understand everything and have all your questions answered before deciding to join.

Purpose of the Study

This study is being conducted to understand the effects of specific interventions on health outcomes. We aim to gather data using tools like the Patient Health Questionnaire-8 (PHQ-8), the Sense of Agency Scale, and the Oura Ring's sleep tracking features. The findings could benefit scientific knowledge and society by providing insights into health and wellness.

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 required), and entered your personal details, shipping details (if applicable), and communication preferences, you will be involved in the following:

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

It is possible that not all risks and benefits are currently known. Participants have the responsibility to consult with their healthcare providers and conduct further research before enrolling in the study.

Personal and Overall Findings

Efforia will provide you with both personal outcomes and overall findings at various data collection points during your experience in the study. These results may impact your interest and willingness to continue your involvement. Remember, your 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

In the Case of an Adverse Event

In the event of an adverse reaction, it is imperative to seek immediate medical attention by dialing 911. Once any acute situations have been addressed and medical care has been provided, please contact Efforia to report the incident. This will help in ongoing safety monitoring and improving the understanding of the product's impact.

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.

Common side effects associated with the use of the Oura Ring in clinical and non-clinical settings have included skin reactions, mood changes, and disturbances in sleep patterns. The maximum tolerable doses identified in studies vary, but side effects tend to increase with prolonged exposure to the device beyond recommended usage guidelines.

Serious Adverse Events (SAEs)

Serious Adverse Events associated with Oura Ring, though rare, can include skin and tissue damage under the device, severe allergic reactions, and possible exacerbation of pre-existing conditions such as eczema or psoriasis. While not commonly reported, these events require prompt medical attention to prevent long-term damage.

Theoretical Side Effects	Relative Incidence	Recovery
Gastrointestinal Symptoms	Low	Subsides after discontinuation
Skin & Hair Reactions	Medium	Subsides after discontinuation
Frustration and irritation	Medium to High	Subsides after discontinuation
Mental Health Discomfort	Low to Medium	Subsides after discontinuation
Cognitive impairment	Low	Subsides after discontinuation
Breathing or respiratory issues	Very Low	Subsides after discontinuation

Efforia's Limitations in Providing Direct Medical Support

It is important to note that Efforia does not provide direct medical services or emergency response. Users should maintain contact with their healthcare providers and seek direct medical attention as needed.

Long-term Dependence

No long-term dependence has been directly associated with the use of Oura Ring. However, reliance on the device for daily health monitoring can potentially lead to psychological dependence on technology for health management.

Legality and Regulatory Considerations

While the Oura Ring is generally recognized as safe and legal for personal use, its data should not be used as a sole measure for health management in settings governed by the World Anti-Doping Association, National Collegiate Athletic Association, or in a corporate workplace without additional validation and context from healthcare professionals.

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 are 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 any problems, side effects, or study-related injuries, seek local medical care first if necessary. Efforia cannot provide emergency medical care or diagnosis. However, it is important to contact Efforia to ensure 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 offers other studies that may be more appropriate. Click on the Efforia logo to explore other options.

Your Rights as a Participant

Ethical Considerations

Efforia upholds high ethical standards in research. Your participation is completely voluntary, and you can withdraw at any time without any adverse consequences. You are not giving up any rights by signing this document.

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:

Participants should 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:

Your data will be collected, used, and protected, ensuring compliance with data protection laws.

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.

California Experiential Research Subject’s Bill of Rights:

You can learn more about your rights and our privacy policy by visiting 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 If you are unable to reach anyone at the number(s) listed above and you require immediate (life-threatening) medical attention, please 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 IntegReview. IntegReview is a group of people that have reviewed this research study. The main goal of this review is to protect the rights and well-being of the human subjects participating in research studies. IntegReview’s policy indicates that all concerns/complaints are to be submitted in writing for review at a convened IRB meeting to: Chairperson BRANY 123 Main Street Suite 320 NY, NY 78704 email@BRANY.com If you are unable to provide your concerns/complaints in writing or if this is an emergency situation regarding subject safety, contact our office at: 555-326-3001 or toll free at 1-800-123-4567 between 8 a.m. and 5 p.m. Eastern Standard Time

Additional questions and closing

Efforia and BRANY have approved the information in this consent form and has 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.