INFORMED CONSENT DOCUMENT AGREEMENT TO BE IN A RESEARCH STUDY

Challenge/Study Title	Repeating in a Series
Challenge Coach (The Person in Charge of This Research Study)	Matthew Amsden
Sponsor	This study is made possible by your payment to join.
Challenge Cost	$0
Included Products & Services
Outcome Measures
Contact	help@efforia.com

Introduction to the Study

Welcome to "Repeating in a Series," a unique research study hosted on the Efforia platform and made possible by your support. This study is designed to explore specific behaviors and outcomes through structured activities. Understanding the information provided here will help you decide if you wish to participate. Please ensure all your questions are answered before proceeding.

Efforia is a citizen science platform. This study, like many on Efforia, is effectively sponsored by participants. This approach is unique because it requires a small payment. This makes the study possible when traditional research funding is limited or unavailable. Your payment covers all the supplies, services, information, and tools you need to participate.

While you could buy these products and services separately on the open market for a similar total cost, Efforia bundles them into one purchase for ease. Efforia also organizes these items and provides instructions to help create a thorough, data-driven research experience - something that would be otherwise difficult to do. This setup not only allows you to track and understand the impact on your own life, making it easier to make informed personal health decisions, but it also helps advance broader research findings. These findings can benefit others who might not be able to afford self-experimentation purchases without a strong guarantee of results.

What's Involved

Overall Schedule and Specific Timeline

Daily Repeating Series: Your participation includes daily activities scheduled from 6 AM to 8 AM. Each session will have a duration window of 5 hours from the start time for completion.

Detailed Description of Treatment Activities

Every morning, within the designated 2-hour slot starting at 6 AM, you will begin your treatment activities. These activities are designed to be completed within a 5-hour period, ensuring ample time for any adjustments needed based on your personal pace and immediate responses.

Frequency of Activities and Measurements

Daily Sessions: You are required to engage in the specified activities each day during the mentioned times. It is crucial to start at 6 AM and ensure completion by 11 AM at the latest.

Measurements and Feedback: After each session, you may be required to provide feedback or undergo measurements to assess your response to the treatment. This feedback is typically gathered through questionnaires or physical assessments, depending on the day’s specific requirements.

Importance of Adhering to the Timeline

Participant Safety: Strict adherence to the timeline ensures that the treatment is administered in a controlled environment, reducing potential risks associated with the treatment.

Optimal Outcomes: Following the prescribed schedule allows the treatment to have the intended effect, maximizing your personal health benefits.

Scientific Validity: Your compliance with the schedule contributes directly to the reliability and validity of the study results. Consistent participation across all participants helps in achieving scientifically accurate conclusions.

Conclusion

Your commitment to following the schedule rigorously is essential. Not only does this adherence enhance your personal safety and the effectiveness of the treatment, but it also significantly impacts the overall success and credibility of the study. Please prioritize punctuality and thoroughness in each activity and measurement throughout the study period.

The Purpose of This Study

This study aims to investigate the effects of a structured daily routine on various personal health metrics. Through rigorous scheduling and specific treatment activities, we seek to understand better and document the potential benefits of consistent daily habits. The outcomes of this study could contribute significantly to scientific knowledge and provide practical benefits to society by enhancing individual well-being and productivity.

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.

Privacy and Confidentiality

Your personal information is protected through robust measures ensuring anonymity or confidentiality. All data processing by AI systems is designed to safeguard personal data against unauthorized access and misuse.

Respect and Personal Choice

All participants are treated with dignity and respect, acknowledging their autonomy and decision-making capabilities, particularly to join studies that might not otherwise be possible under a traditional funding model.

Maximized benefit and minimized risk

The design and execution of this study aim to maximize benefits and minimize harm to participants. This includes continuous monitoring for any adverse effects during participation.

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.

Feedback Mechanism

A e-mail customer support process for providing immediate feedback or filing complaints regarding the study or its methodology and a promise that we will address and respond within 2 business days.

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.

Risks and Benefits

Investigational New Drug Application: Detailed Report on Known Risks

Product Name: [Unknown - Placeholder for Actual Drug Name]

Introduction and Summary of Known Risks

The safety profile of any pharmaceutical product is critical for its approval and subsequent use in clinical settings. This report compiles comprehensive information regarding the known risks associated with the product specified. These include risks from serious to minor, validated to anecdotal, and those identified across various platforms including academic literature, online forums, and case reports.

"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."

Serious Adverse Events (SAEs)

1. Incidence of Cancer: There is no direct evidence linking the product to cancer development; however, long-term studies have not been extensively conducted.
2. Exacerbation or Escalation to Acute or Chronic Disease: Some reports suggest exacerbations of underlying conditions, although these are not conclusively proven to be directly related to the product.
3. Death and Life-threatening Experiences: No documented cases directly associate the product with death or life-threatening situations under recommended usage conditions.
4. Hospitalization (Initial or Prolonged): There are isolated incidents where users have reported hospitalization due to adverse reactions, but causal relationships are unclear.
5. Disability or Permanent Damage: No current evidence suggests that the product causes permanent disability or damage when used as directed.
6. Congenital Anomaly/Birth Defect: Data is insufficient to determine a link between the product and congenital anomalies or birth defects.
7. Required Intervention to Prevent Permanent Impairment or Damage: Some cases have required medical intervention to mitigate severe side effects, though these are rare.

Common Risks and Side Effects

• Gastrointestinal Symptoms: Users report nausea, vomiting, and diarrhea. These symptoms are typically mild and subside as the body adjusts to the treatment.
• Skin & Hair Reactions: Rash, itching, and unusual hair loss have been noted, with varying degrees of incidence.
• Headaches and Dizziness: Common especially in the initial phases of treatment; generally decreases with continued use.
• Fatigue and Sleep Disturbances: Widely reported, with some cases leading to discontinuation of treatment.
• Mood Changes and Mental Health Discomfort: Users have experienced mood swings and heightened anxiety, sometimes persisting throughout the treatment period.
• Sexual Side Effects: Decreased libido and other sexual dysfunctions have been sporadically reported.
• Cognitive Impairment: There are anecdotal reports of reduced concentration and memory issues.

In the Case of an Adverse Event

Immediate medical care should be sought if severe side effects are experienced. It is crucial to inform healthcare providers about the use of this product as it may interfere with other treatments.

Long-term Dependence Issues

No substantial evidence suggests dependency risks with prolonged use of the product, but continuous monitoring is advised.

Legality for Use by Various Institutions

The status of this product under regulations by the World Anti-Doping Association, National Collegiate Athletic Association, and in corporate workplaces is not fully established and may vary by jurisdiction and organizational policies.

This report aims to provide a foundational understanding of the potential risks associated with the product, ensuring that stakeholders can make informed decisions regarding its use in clinical trials and therapeutic applications.

Frustration and irritation: Some users may experience discomfort, frustration and irritation with the technology that Efforia users to conduct studies, with the thoughts and feelings by answering probing questions and/or waiting for test results, and with a lack of progress towards reaching health goals.

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.

Acknowledgment of Risk and Responsibility

There are unique responsibilities and risks associated with participating in citizen science trials. Please understand that Efforia does not endorse or sponsor this study; it is simply hosted on the Efforia platform. This means that while we provide the platform for conducting the study, we do not influence its design, execution, or outcomes.

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."

Responsible for any Additional Costs & Medical Care

"In the case of an adverse event, it is the participant's sole responsibility to seek and finance their medical treatment. Efforia, as a non-sponsor, is absolved from any claims and can not reimburse any expenses incurred."

Reporting Adverse Events

It is crucial for participants to report any adverse events to Efforia. This allows the sharing of such information with other participants, promoting overall safety and awareness within the community.

The Limits of Efforia Medical Oversight

If the study involves any lab tests or items requiring a prescription, asynchronous medical oversight will be available to assist in mitigating risks. However, participants should understand that this oversight does not replace personal responsibility or the need for local medical care.

Legal Acknowledgment

"This document serves as a legally binding acknowledgment of the risks associated with participating in a study and explicitly limits Efforia's liability. Efforia will not be held liable for any claims except in cases of gross negligence or willful misconduct. This acknowledgment underscores the importance of personal diligence and responsibility throughout the study participation."

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 or conflicts of interest. We are not paid by the sponsor of this study. 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, or 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. Further, depending on the nature of the violation, additional legal proceedings may be initiated as warranted by law to address the breach adequately.

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 collected during this study will be used solely for the purposes of this research and will be protected according to data protection laws. Measures have been implemented to ensure that personal information is securely stored and only accessible by authorized personnel involved in the study.

California Experiential Research Subject’s Bill of Rights

Participants in California have specific rights under the California Experiential Research Subject's Bill of Rights. For a detailed understanding of these rights, please click here.

Additional questions and closing

If you have any questions or need further information, please contact help@efforia.com. It is up to you to conduct additional research and consult with your physician before joining this study. Your well-informed participation is crucial for the success of this research.

1. Authorization and Consent for Diagnostic Testing

1. I voluntarily consent and authorize CWI Physician Partners P.C., a California professional corporation; CWI Physician Partners P.C., a Hawaii professional corporation; CWI Physician Partners P.C., a Georgia professional corporation; CWI Physician Partners P.C., a Kansas professional corporation; CWI Physician Partners P.C., an Oregon professional corporation; CWI Physician Partners P.C., a Nevada professional corporation, CWI Physician Partners P.C., a Rhode Island professional corporation; CWI Physician Partners P.C., an Oklahoma professional corporation, as applicable ("CWI") to review the collection, testing, and analysis for the purposes of a diagnostic screening test. I understand that there are risks and benefits associated with undergoing a diagnostic screening testing and there may be a potential for false positive or false negative test results. I assume complete and full responsibility to take appropriate action with regards to my test results. Should I have questions or concerns regarding my results, or a worsening of my condition, I shall promptly seek advice and treatment from an appropriate medical provider. I further acknowledge the following:
   1. I am the individual who will provide the sample for the Test(s) that I am requesting or I am the parent or legal guardian of a minor who is providing the sample for testing.
   2. I am at least eighteen (18) years of age or I am the parent or legal guardian of a minor who is providing the sample for testing.
   3. I have read and understand the information provided about the Test(s) that I have been provided on the website where I requested the Test.
   4. The information I have provided in connection with my request to CWI is correct to the best of my knowledge. I will not hold CWI or its employees or agents responsible for any errors or omissions that I may have made in providing such information.
   5. My health information and results may be shared with CWI employees and agents for the purpose of ordering, processing, and reporting my results.
   6. Medical Services provided by CWI are purely for diagnostic assistance purposes and do not create a physician-patient relationship, and do not constitute medical care or diagnosis or treatment of any condition, disease, or illness.
   7. I authorize CWI to contact me via text message to communicate with me regarding my test.

1. Patient Rights and Privacy Practices
   1. Notice of Privacy Practices and Patient Rights: CWI Notice of Privacy Practices describes how it may use and disclose your protected health information for other purposes that are permitted or required by law. To review a copy of CWI Notice of Privacy Practices, go to http://www.CynergyWellness.com.
   2. Disclosure to Government Authorities: I acknowledge and agree that my test results and associated information may be disclosed to appropriate county, state, federal, or other governmental and regulatory entities as may be permitted by law.

1. Release
   1. To the fullest extent permitted by law, I hereby release, discharge and hold harmless, CWI, including, without limitation, any its respective officers, directors, employees, representatives and agents from any and all claims, liability, and damages, of whatever kind or nature, arising out of or in connection with any act or omission relating to my diagnostic test or the disclosure of my test results.
   2. By selecting the ACKNOWLEDGEMENT during the registration process for diagnostic testing, I acknowledge and agree that I have read, understand, and agreed to the statements contained within this form. I have read the contents of this form in its entirety and voluntarily consent to proceed with these procedures.