INFORMED CONSENT DOCUMENT AGREEMENT TO BE IN A RESEARCH STUDY

Challenge/Study Title	Mars Men Testosterone Supplements Impact on Anxiety
Challenge Coach (The Person in Charge of This Research Study)	Matthew Amsden, Reviewer User, Gaurav Patel
Sponsor	This study is made possible by your payment to join.
Challenge Cost	$189
Included Products & Services	90 Days of MarsMen Natural Testosterone Supplements
Outcome Measures	General Anxiety Disorder (GAD-7),
Contact	help@efforia.com

Introduction to the Study:

Welcome to this unique research opportunity on the "Efforia" platform. This study on the impacts of Mars Men Testosterone Supplements on Anxiety is supported by your participation and financial contribution. The information provided here will help you understand the purpose of the study, what you will be doing, and how this can benefit both you and the wider community. Please read through this document carefully and 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:

As a participant in this study, your role is crucial to the success and integrity of the research. Below is a detailed outline of your responsibilities, including the overall schedule, specific treatment activities, and the frequency of these activities and subsequent measurements.

Overall Schedule and Timeline:

• Protocol Introduction (Task ID: 24267)
  • Start by familiarizing yourself with the study protocol through the introductory session. This includes reviewing all necessary materials provided in the online platform, illustrated by the screenshot in your first task. Ensure you understand the study's purpose, procedures, and your role.
• General Anxiety Disorder (GAD-7) Assessments (Task IDs: 24274 & 24275)
  • You will complete the GAD-7 form twice during the study. This form is a widely used scale for assessing general anxiety symptoms and measuring the severity of your anxiety.

Detailed Description of Treatment Activities:

• Understanding the Protocol: Review all the information provided in the Protocol Introduction. This includes understanding the aims, expectations, and safety measures of the study.
• Completing GAD-7 Forms: You are required to complete the GAD-7 form at two different points in the study. The form will be accessed and submitted via the online platform. It is crucial to answer all questions truthfully and to the best of your ability.

Frequency of Activities and Measurements:

• Initial GAD-7 Form: Complete this form at the beginning of the study or as instructed in your schedule.
• Follow-up GAD-7 Form: Complete this form towards the end of the study or as instructed. This will help in measuring any changes in your anxiety levels after participating in the study.

Importance of Adhering to the Timeline:

It is imperative that you adhere meticulously to the timeline provided. Following the prescribed schedule is essential for several reasons:

• Participant Safety: Timely completion of activities and assessments ensures that any potential risks are monitored and addressed promptly.
• Optimal Outcomes: Accurate adherence to the schedule allows for the treatments and assessments to have their intended effect, providing you with the maximum possible benefit.
• Scientific Validity: Your compliance affects the reliability and validity of the research findings. Data collected at the wrong time can lead to incorrect conclusions.
• Success of the Study: Each participant's data contributes to the overall outcomes of the research. Inconsistent data can compromise the study's success and its potential benefits to wider community understanding of anxiety.

In conclusion, your commitment to following the schedule and engaging fully with all required activities is vital. Your active participation not only benefits your personal health but also contributes to important scientific research. Thank you for your dedication and cooperation.

Risks and Benefits:

Specific 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.

• Allergies and Adverse Reactions: Hypersensitivity to components of [Generic Drug Name] may cause reactions ranging from mild rashes to severe anaphylaxis.
• Side Effects: Common side effects include nausea, headache, and dizziness. These are typically mild and often resolve without discontinuation of the drug.
• Serious Adverse Events (SAEs):
  • Incidence of Cancer: No direct link has been established between [Generic Drug Name] and cancer; however, long-term studies are still ongoing.
  • Exacerbation of Chronic Diseases: There may be a risk of exacerbating pre-existing conditions such as liver or kidney diseases.
  • Death and Life-Threatening Experiences: Very rare cases reported, usually under circumstances of extreme overdose or interaction with other medications.
  • Hospitalization: Required in cases of severe adverse reactions or overdoses.
  • Disability or Permanent Damage: Rare, but potential for liver or kidney damage in predisposed individuals.
  • Congenital Anomalies/Birth Defects: Currently, no data suggest a direct link to congenital anomalies when taken during pregnancy, but caution is advised, and use should be discussed with a healthcare provider.
  • Other Serious Medical Events: Cardiovascular events such as arrhythmias have been reported in predisposed patients.

Specific Known Risks and Their Nature

• Gastrointestinal Symptoms: Common, including nausea and diarrhea. These usually subside as the body adjusts to the medication.
• Skin & Hair Reactions: Rashes, itching, or alopecia have been noted. Often reversible upon discontinuation.
• Mental Health Discomfort: Reports of mood swings and depression, particularly in patients with a history of psychiatric disorders.
• Cognitive Impairment: Some users report mild cognitive impairment, particularly in higher doses. Reversible after discontinuation.

Long-term Dependence Issues

There is no current evidence suggesting that [Generic Drug Name] leads to physical or psychological dependence; however, continued surveillance is recommended.

Legality for Use in Various Institutions

• World Anti-Doping Association (WADA): Not currently listed as a prohibited substance.
• National Collegiate Athletic Association (NCAA): Permissible under current guidelines, subject to any future review.
• Corporate Workplace: Generally accepted, barring any specific corporate policies against its use.

Conclusion

While [Generic Drug Name] offers significant benefits for the treatment of [Specified Condition], it carries risks that must be carefully managed through close monitoring and consultation with healthcare professionals. Ongoing research and post-marketing surveillance will continue to provide important data on its safety profile.

This detailed risk assessment aims to aid healthcare providers, patients, and regulatory bodies in making informed decisions regarding the use of [Generic Drug Name]. Further inquiries and detailed studies are encouraged to continuously update the safety profile of this medication.

Frustration and irritation: Some users may experience discomfort, frustration and irritation with the technology that Efforia uses 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.

The Purpose of This Study:

This study is being conducted to explore the effects of Mars Men Testosterone Supplements on General Anxiety Disorder (GAD-7) scores. Our aim is to provide valuable insights into how testosterone supplementation can influence anxiety levels. The findings from this study could contribute to scientific knowledge and offer societal benefits by improving understanding and treatment options for anxiety.

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:

Specific Risks:

Detail the specific risks associated with the study based on the treatments and measures included, including potential side effects or discomforts, and how these risks were determined. Explicitly state, that we may not know all of the risks associated with the study. Potential participants should do their own research and talk to their physician, therapist or life coach before joining if they have concerns.

Specific Benefits:

Describe the expected benefits, both scientifically verified and anecdotal based on the included treatments and measures included.

In the Case of an Adverse Event:

Include instructions for seeking immediate medical care and clarify Efforia's limitations in providing direct medical support.

Acknowledgment of Risk and Responsibility:

There are some unique responsibilities for participants in citizen science trials. This include some risks that participants should understand. Explain to participants that Efforia does not endorse or sponsor this trial. It is simply hosted on the Efforia platform. Explicitly explain what this means in the following headings.

Consider your Own Risk-Benefit Comfort Level:

Encouraged participants to thoroughly weigh the risks and benefits of participation. Explain to the participant we are placing more responsibility on them to make the right choice than in a traditionally sponsored trial. This section must include the following sentences in quotes. Please also underline the items in quotes "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.

This section must include the statement in quotes "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:

Explain 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:

Explain to participants that 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. Explicitly explain that 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:

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

California Experiential Research Subject’s Bill of Rights:

Provide a relevant summary for participants in California and a link to the policy.

Additional questions and closing

If you have questions please contact help@efforia.com. Also, explicitly state it is up to the participant to do additional research and talk to their physician before joining a study.