What You Need to Know to Participate
This document provides information to help you decide whether to join this research study. It is important you understand the responsibilities, risks and benefits of participating.
INFORMED CONSENT DOCUMENT AGREEMENT TO BE IN A RESEARCH STUDY
| Challenge/Study Title | Beetroot Juice Impact on Blood Pressure |
|---|---|
| Challenge Coach (The Person in Charge of This Research Study) | Efforia Advanced Author |
| Sponsor | This study is made possible by your payment to join. |
| Challenge Cost | $149 |
| Included Products & Services | Adam Health |
| Outcome Measures | Withings Blood Pressure |
| Contact | help@efforia.com |
Introduction to the Study
Welcome and thank you for considering participation in the "Beetroot Juice Impact on Blood Pressure" study hosted on the Efforia platform. This study is made possible through your support and financial contribution. The information provided below will help you understand the purpose of this study and what your participation involves. Please take the time to read this document carefully and seek answers to any questions you may have before you decide to participate.
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 otherwise be 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.
The Purpose of This Study
The primary aim of this study is to examine the impact of daily consumption of beetroot juice on blood pressure levels. This study will utilize the Withings Blood Pressure Monitor to measure changes in participant's blood pressure over time to ascertain the efficacy of beetroot juice in managing blood pressure. The outcome of this research may contribute significantly to scientific knowledge and could offer societal benefits by providing a potential natural remedy for managing hypertension.
Your Rights as a Participant
Ethical Considerations
Efforia upholds high ethical standards comparable to those seen in more traditional pharmaceutical and academic studies. Your participation in this study is entirely voluntary, and you can withdraw at any time without any 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
The specific risks associated with this study include the potential for an allergic reaction to beetroot juice, and possible gastrointestinal discomfort. These risks were determined based on the known side effects associated with beetroot consumption. 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
The expected benefits of participating in this study include potential improvements in blood pressure management, which has been scientifically verified to some extent. Anecdotal evidence also suggests that beetroot juice may improve athletic performance and blood flow.
In Case of an Adverse Event
Should you experience any serious adverse effects, it is important to seek immediate medical care. Efforia's limitations in providing direct medical support must be understood by all participants.
Acknowledgment of Risk and Responsibility
As a participant in this citizen science trial, it is important to understand that there are unique responsibilities and risks involved. Efforia does not endorse or sponsor this trial; it is simply hosted on the Efforia platform.
Consider Your Own Risk-Benefit Comfort Level
Participants are encouraged 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 cannot 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 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. 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 in compliance with data protection laws. Measures have been put in place to ensure the security and confidentiality of your data.
California Experiential Research Subject’s Bill of Rights
Participants in California may refer to the California Experiential Research Subject’s Bill of Rights for additional information.
Additional Questions and Closing
If you have further questions, please contact help@efforia.com. Remember, it is up to you to do additional research and consult with your physician before joining a study. Thank you for considering participation in this important research initiative.
- Authorization and Consent for Diagnostic Testing
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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:
- 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.
- 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.
- 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.
- 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.
- My health information and results may be shared with CWI employees and agents for the purpose of ordering, processing, and reporting my results.
- 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.
- I authorize CWI to contact me via text message to communicate with me regarding my test.
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Patient Rights and Privacy Practices
- 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.
- 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.
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Release
- 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.
- 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.