INFORMED CONSENT DOCUMENT AGREEMENT TO BE IN A RESEARCH STUDY

Study Title	Testing from one to the next
Study Author	Reviewer User
Sponsor	This study is made possible by your payment to join.
Cost of Products, Services & Information to Participant	$0
Included Products & Services
Outcome Measures	General Anxiety Disorder (GAD-7),
Contact	help@efforia.com

Introduction

Welcome! We invite you to join this research study on the Efforia platform, made possible by your participation and support. The purpose of this document is to provide you with all the information you need to decide whether to take part in this study. Your participation is voluntary, and you may leave the study at any time without penalty. If you have any questions, please seek answers before proceeding.

Purpose of the Study

This study aims to gather data on Generalized Anxiety Disorder using the General Anxiety Disorder (GAD-7) questionnaire. The GAD-7 is a screening tool that measures the severity of anxiety symptoms. By participating, you contribute to a broader understanding of anxiety disorders and potentially help develop better treatments and interventions.

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, and communication preferences, you will be involved in the study as follows:

The Risks & Benefits of Being in this Study

There are some unique risks 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.

Possible Benefits of Participation

Your participation may contribute to a better understanding of Generalized Anxiety Disorder and help develop better treatments. Additionally, you may gain personal insights into your own anxiety levels. However, 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 Adverse Events & Side Effects

Interventional New Drug Application: Safety Profile and Risk Assessment

Introduction

The purpose of this document is to provide a comprehensive overview of the known risks, side effects, allergies, and adverse reactions associated with the treatment outlined in the provided protocol. This treatment involves a series of tasks and assessments primarily related to General Anxiety Disorder (GAD-7). Due to the lack of specific information on ingredients and dosages, this assessment focuses on the procedural and psychological aspects of the treatment.

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 during the treatment, it is crucial to seek immediate medical attention by dialing 911. After addressing any acute medical needs, please inform Efforia about the adverse event to help improve the safety and effectiveness of the treatment.

Known Risks and Side Effects

Since the treatment involves psychological assessments, most risks are related to mental health and emotional well-being. Here are some identified risks:

Theoretical side effects	Relative incidence	Recovery
Mental Health Discomfort	Low to Moderate	Subsides with discontinuation
Frustration and irritation	Low to Moderate	Subsides with discontinuation
Cognitive impairment	Very Low	Subsides after treatment

Efforia's limitations in providing direct medical support

Efforia does not provide direct medical interventions or emergency support. Participants should maintain contact with their healthcare provider throughout the treatment process.

Serious Adverse Events (SAEs)

Given the non-invasive nature of the treatment, SAEs such as life-threatening experiences, hospitalization, or permanent disability are extremely unlikely. However, psychological distress should not be underestimated, and appropriate psychological support should be available.

Long-term Dependence

No long-term dependence is expected with this treatment as it primarily involves assessment rather than pharmacological intervention.

Legality for Use

The treatment does not involve any substances that are regulated or banned by institutions such as the World Anti-Doping Association, National Collegiate Athletic Association, or in a typical corporate workplace. However, participants should consider the privacy of their health data and the potential emotional impact of personal information used during the treatment.

This assessment is based on the available information and may need to be revised as more data becomes available or as further studies are conducted.

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/

What to do if you have a study related injury

If you experience any problems, have any side effects, or have any study related injury, please seek local medical care first if necessary. Efforia cannot provide emergency medical care or diagnosis. However, it is important to contact Efforia after you’ve received any necessary treatment 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

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 quite right or too expensive for your specific purposes, Efforia offers other studies. You may 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

Ethical Considerations: 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.

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

We are committed to protecting your data. Data will be collected, used, and protected in 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

Participants in California have specific rights under the California Experiential Research Subject Bill of Rights. You can review the Efforia privacy policy for more details: 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.