INFORMED CONSENT DOCUMENT AGREEMENT TO BE IN A RESEARCH STUDY

Challenge/Study Title	Week of May 6th Fitness Schedule
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	Not Specified
Outcome Measures	Not Specified
Contact	help@efforia.com

Introduction to the Study:

Welcome to the "Week of May 6th Fitness Schedule" research study hosted on the Efforia platform. This study is unique as it is powered by your participation and financial contribution. The information presented here is designed to help you make an informed decision about joining this study. Please ensure you understand all aspects and seek answers to any questions you may have 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:

As a participant in this comprehensive fitness and wellness study, you have a structured schedule of activities designed to evaluate the effects of various exercise regimens on physical health and mental well-being. It is imperative that you follow this schedule meticulously to ensure your safety, maximize the benefits of the program, and contribute reliable data to the study's scientific findings.

Schedule and Timeline:

Your involvement will include a variety of workout sessions each week, each tailored to specific fitness goals such as cardiovascular health, muscle strength, flexibility, and stress relief. Here is a breakdown of your weekly activities:

• Cardiovascular Workouts:
  • 20 Minute Intervals Run: Go Hard
  • 20 Minute Cardio
  • 20 Minute Hip Hop Run
• Strength Training:
  • 30 Minute Glutes & Legs
  • 30 Minute Upper Body Strength
  • 20 Minute Arms & Shoulders
  • Chest Push 30 Minutes
  • Upper Body
  • Adrian 20 Minutes Legs
  • Upper Body Arms & Shoulders
• Yoga and Flexibility:
  • Sunday Night Restorative Yin Yoga
  • Yoga for Abs & Obliques
  • Core Strengthening Yoga
  • The Fix Yoga
  • Hip Flexibility
  • Recovery Flow
• Targeted Workouts for Specific Body Parts:
  • Lower Body & Core
  • Hips & Core for Stronger Knees
• Stress Relief and Recovery:
  • Evening Stress Relief
  • 10 Minute Upper Body Stretch
  • 20 Minute Stretch

Each of the listed sessions is crucial and should be attended as per the provided links. The activities are scheduled to ensure gradual progression and recovery, balancing intense workouts with adequate rest and recovery sessions.

Importance of Adherence:

• Participant Safety: Strict adherence to the timeline ensures that the exercise load is appropriately managed to prevent injuries.
• Optimal Outcomes: Following the schedule as outlined is essential to achieving the intended physical and mental health benefits.
• Scientific Validity: Your consistent participation provides reliable data necessary for the study's success and helps in drawing valid conclusions about the effectiveness of different exercise regimens.

It is essential that you commit to the schedule, participate in each session as planned, and report any difficulties you encounter. This dedication not only benefits your personal health objectives but also contributes significantly to the broader goals of the research study.

The Purpose of This Study:

This study aims to evaluate the effectiveness of a structured fitness and wellness program on improving participants' physical health and mental well-being. By closely monitoring the impact of specific exercise regimens, this study hopes to contribute valuable data to the scientific community, potentially leading to more effective fitness programs in the future.

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.

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 Efforia 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:

Introduction and Summary of Common Known Risks

The products in question, encompassing a variety of physical activities such as yoga, interval running, strength training, and other fitness routines, represent a broad spectrum of physical exertion levels and potential risks. While these activities are generally considered safe and beneficial when performed correctly, they are not devoid of risks, especially when performed improperly or without adequate preparation.

"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) Associated with the Treatment

While the treatments listed primarily involve physical exercise which is widely regarded as beneficial, there are serious adverse events (SAEs) that can occur, particularly if the exercises are performed improperly, excessively, or without appropriate supervision:

1. Incidence of Injury: Improper exercise techniques or overexertion can lead to acute injuries such as sprains, strains, or more severe injuries such as fractures or muscle tears. Chronic injuries can also develop over time due to repetitive strain.
2. Exacerbation of Pre-existing Conditions: Individuals with pre-existing health conditions such as heart disease, respiratory issues, or musculoskeletal problems may experience worsening symptoms.
3. Hospitalization: While rare, severe injuries or acute health events such as heart attacks triggered by exercise could lead to hospitalization.
4. Disability or Permanent Damage: Severe injuries sustained during exercise could lead to temporary or permanent disability.
5. Congenital Anomalies: There is no direct link between these physical activities and congenital anomalies; however, pregnant individuals should consult healthcare providers for appropriate activities.

Risks by Category:

• Gastrointestinal Symptoms: Excessive physical exertion, particularly on a full stomach, can lead to gastrointestinal discomfort. These are generally temporary and subside with rest.
• Skin & Hair Reactions: Activities like running or yoga may cause friction-related skin issues such as chafing. Proper attire can mitigate these risks.
• Headaches and Dizziness: Overexertion or dehydration during exercise can lead to headaches and dizziness. Ensuring proper hydration and pacing can mitigate these symptoms.
• Mood Changes: Exercise is generally beneficial for mood, but frustration or stress from performance issues can negatively affect some individuals.
• Sleep Disturbances: High-intensity exercise close to bedtime may disrupt sleep patterns for some individuals.
• Weight and Body Composition Change: While often a goal of exercise, unintended weight loss or gain can occur. Monitoring nutritional intake alongside exercise is crucial.
• Muscle or Joint Pain: Common, especially for beginners or those increasing intensity without proper progression. Proper technique and gradual progression are key.
• Mental Health Discomfort: Exercise can be a stress reliever, but it may also cause anxiety or stress in some, particularly in a competitive or group setting.
• Sexual Side Effects: There is anecdotal evidence suggesting that intense exercise might affect libido; this can vary widely among individuals.
• Cognitive Impairment: During intense physical exertion, temporary cognitive impairment due to fatigue or focus on physical activity may occur.
• Breathing or Respiratory Issues: Particularly in cardio-intensive exercises like running, individuals with asthma or other respiratory conditions should exercise caution.

In Case of an Adverse Event:

Seek immediate medical care if you experience significant pain, discomfort, or any acute physical or mental health issues during or after performing these activities.

Long-term Dependence:

There is generally no chemical dependence associated with physical exercise; however, psychological dependence due to endorphin release or habit formation is possible.

Legality for Use:

The activities described are legal and generally accepted by institutions like the World Anti-Doping Association, National Collegiate Athletic Association, and in corporate workplaces, though specific workplace policies on exercise during work hours may vary.

By considering these factors and adhering to recommended guidelines and personal limits, individuals can enjoy the health benefits of these activities while minimizing risks.

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:

Participating in citizen science trials like this one comes with unique responsibilities and some risks that you should understand. Efforia does not endorse or sponsor this trial; it is simply hosted on the Efforia platform. This means that while we provide the platform for the study, we do not influence the study's design, conduct, or outcomes.

Consider your Own Risk-Benefit Comfort Level

We encourage you to thoroughly weigh the risks and benefits of participation. "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.

How Efforia Makes Money on this protocol:

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. 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 handled with the utmost confidentiality. All personal data will be stored securely and will only be accessible to authorized personnel involved in the study.

California Experiential Research Subject’s Bill of Rights:

Participants in California are entitled to additional protections under the California Experiential Research Subject’s Bill of Rights. For more information, please visit the California Research Subject's Bill of Rights.

Additional questions and closing

If you have questions or need further information, please contact help@efforia.com. It is up to you to do additional research and talk to your physician before joining a study. Your participation is greatly appreciated and will contribute to valuable scientific insights.

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.