Important Information
Summary Information to Help you Decide Whether to Join this Study
| Study Title | Randomization Process Test |
|---|---|
| Study Author | Zeeshan Web |
| Principal Investigator | Matthew Amsden, CEO Efforia. Dr. Viral Patel Sub-Investigator for Adverse Events |
| Sponsor | This study is made possible by your payment to join. |
| Cost of Products, Services & Information to Participant | $0 |
| Included Products & Services | |
| Outcome Measures | |
| Contact | help@efforia.com |
Introduction & Summary
Welcome to this research study on the “Efforia” platform. This study is made possible by your participation and support. Efforia is a registered Delaware B Corporation, which means we consider the public good in our business decisions, not just profits. We invite you to learn more about this study to decide if you want to participate.
The purpose of this study is to test the randomization process and gather data that can help us understand its effectiveness. Your participation is entirely voluntary, and you can leave the study at any time without penalty. If you decide to leave, you may continue to use any products or services you’ve purchased, and a partial or full refund may be possible by contacting us at help@efforia.com.
Before you decide, we encourage you to ask questions by reaching out to Efforia, conducting your own research, and consulting with a healthcare professional familiar with your health.
Purpose of the Study
This study is conducted to explore the effectiveness of a randomized process in dividing participants into groups for research purposes. The goal is to enhance scientific understanding of randomization methods, which can contribute to better study designs in the future. By participating, you contribute to the advancement of research methodologies that can benefit society.
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 complete enrollment and enter your personal details and communication preferences, you will participate in a series of structured activities according to a schedule. This timeline is crucial for data integrity.
The schedule includes:
- Randomization Task: Assigns participants to groups based on predefined criteria, setting the foundation for the study’s methodology.
- Random Task 1 and Random Task 2: Gather baseline data through various activities or assessments tailored to the study’s objectives.
- Task 2: Engage in treatment activities central to the research hypothesis, involving experimental interventions or control activities.
Treatment activities are scheduled regularly, and it’s important to follow these intervals for consistency. Measurements will be conducted at specified points to track progress and gather data on outcomes. Adhering to the timeline is essential to avoid discrepancies that might affect the study’s results.
The Risks, Discomforts & Benefits of Being in this Study
There are unique risks, discomforts, and potential benefits to participating in this study that you should understand.
Consider your Own Risk-Benefit Comfort Level
We encourage you to thoroughly weigh the risks and benefits of participation. We place more responsibility on you to make the right decision than in a traditionally sponsored trial. Since this is an experimental exercise, there may be possible unknown side effects that the authors are unaware of. Participants have the responsibility to consult with their healthcare providers and conduct further research at sources they find reputable before enrolling in the study.
Personal and Overall Findings
Efforia will provide you with both personal outcomes and overall findings. These findings will be available at various data collection points during your study experience or as they are discovered by Efforia. The results and findings may affect your interest and willingness to continue in the study. Remember, participation is voluntary, and you may exit at any time by emailing help@efforia.com.
Possible Benefits of Participation
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.
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 Serious Adverse Events & Side Effects
Safety and Risk Assessment for Efforia Treatment Interventions
The Efforia treatment interventions, known as “Random Task 1”, “Random Task 2”, “Task 2”, and “Randomization Task”, are currently under review for potential risks and side effects associated with their use. This document outlines the known risks, serious adverse events (SAEs), and safety recommendations based on the information available.
Introduction to Known Risks and Safety Profile
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.
Common Known Risks
Limited information is available on specific risks due to the undefined nature of the treatment details. However, general risks applicable to most interventions could include:
- Gastrointestinal symptoms such as nausea or upset stomach
- Skin and hair reactions including rashes or hair loss
- Mood changes and sleep disturbances
- Cognitive impairment and dizziness
- Respiratory issues such as difficulty breathing
It is crucial to note that these risks are largely hypothetical in the absence of specific treatment details and ingredients.
In the Case of an Adverse Event
If you experience any severe or unexpected symptoms, seek immediate medical care by calling 911. Once any acute situations have been addressed, please contact Efforia to report the incident. This will help in monitoring the safety and efficacy of the treatment and in improving future interventions.
Serious Adverse Events (SAEs)
| Theoretical side effects | Relative incidence | Recovery |
|---|---|---|
| Frustration and irritation | Medium likelihood | Symptoms subside with use |
Due to the lack of specific treatment details, other SAEs cannot be accurately identified or assessed at this time.
Efforia’s Limitations in Providing Direct Medical Support
Efforia may not be equipped to provide direct medical support or emergency services. Participants should have arrangements for accessing medical care in their local area and should not rely solely on support from Efforia in the event of a health crisis.
Long-term Dependence
There is no current evidence to suggest long-term dependence issues with the described tasks, but continuous monitoring and research are recommended to further assess this risk.
Legality for Use in Various Institutions
The legal status of participating in Efforia treatment interventions, such as “Random Task 1” and others, should be verified with relevant authorities such as the World Anti-Doping Association, the National Collegiate Athletic Association, and corporate workplace policies. These institutions may have rules that restrict the use of certain treatments or interventions, especially if the components or methods are not fully disclosed or understood.
This document aims to provide a comprehensive overview of the potential risks associated with Efforia treatment interventions, keeping in mind the limited information available. Continuous updates and research are essential for a more accurate and detailed safety profile.
Inappropriate Participants Inclusion/Exclusion
I'm sorry, but it seems some necessary information is missing to complete your request. In order to create the table, I need details about the risks and informed consent process, as well as the specific intervention being studied. Could you please provide more information on these aspects?
Privacy & Security Risks
We are doing everything we can 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/
There may be certain limits to the rights of your privacy:
- We may reach out to local help if we have reason to believe you may be a harm to yourself and/or others.
- Regulators, like the FDA or similar agencies, or Institutional Review Boards may review records that have your identifying information.
What to do if you have a study related injury
If you experience a study-related injury, seek local medical care first if necessary. Efforia cannot provide emergency medical care or diagnosis. However, it’s important to contact Efforia after receiving any necessary treatment to report any problems, side effects, or injuries. We want 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
Since this study is for research only, the only other choice would be not to be in the study. If this study doesn’t seem right for you, or if it’s too expensive for your purposes, Efforia is dedicated to making other studies available. You can click on the Efforia logo at the top of the page to find a different study that may be more appropriate.
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. You are not giving up any rights by signing this document.
Efforia may remove you from the study if you have violated Efforia’s overall terms and conditions, privacy policy, or have a conflict of interest. Efforia may also remove you from the study in the interest of safety based on individual or community findings.
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.
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 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
Your data will be collected, used, and protected in compliance with data protection laws. You own your data, and it will be housed on Efforia indefinitely until you tell us to delete it by emailing help@efforia.com.
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, make sure your phone or desktop computer and your e-mail accounts are protected by a password, pin, or other form of “access control.” Avoid sharing your accounts with others or sharing your account passwords. This study is hosted in Efforia, governed by a set of privacy and confidentiality standards that put you, as a participant, in control. 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, and there may be partners such as labs and connected health devices who also have access to your data.
What will we do with your data
We will use your data to show you your 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.
Authorization to Use and Disclose Protected Health Information
If you decide to take part in this study, the study doctor and study staff may use and share protected health information (PHI) about you to conduct the study. Protected health information may come from your medical or research records. Protected health information may include the following:
- Name
- Location
- Dates
- Phone Numbers
- Email Addresses
- Internet protocol (IP) address numbers
The study staff may share protected health information about you with the following authorized users to ensure the quality of the study conduct and study data:
- Efforia
- The Office of Human Research Protections (OHRP);
- Univo Institutional Review Board; and
- University of Portsmouth Ethics Review Board
- Other regulatory agencies
Once your protected health information has been shared with authorized users, it may no longer be protected by federal privacy laws and could possibly be used or disclosed in ways other than what is listed in this section.
Your permission to use and share protected health information about you will end after you have completed the study and any after study related activities unless you revoke your permission sooner.
You can revoke your permission to use and share protected health information about you at any time by contacting the study doctor listed on the first page of this document. If you revoke your permission, you will not be able to stay in this study. No new protected health information will be collected after your request has been received. The protected health information about you that has already been collected may still be used and given to others as described in this section.
If you decide not to sign and date this document, you will not be able to take part in the study. However, you may continue to use and consume anything you’ve purchased to be part of the study outside the study.
California Experiential Research Subject’s Bill of Rights
Participants should be aware of the California Experiential Research Subject Bill of Rights. For more information on privacy, you can view the Efforia privacy policy here: 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
We will immediately respond with an automated message giving you a sense of how long a more meaningful response will take based on the volume of other requests.
(646) 679-2479. If no one is available, please leave a message.
We will typically respond to telephone messages in three to five business days.
If you are unable to reach anyone at the number(s) listed above and you require immediate (life threatening) medical attention, please dial 911 in the US/Canada or 999 in the UK and/or 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 Univo IRB. Univo IRB is an independent committee that helps to protect the rights and welfare of research participants. If you have any questions about your rights and welfare as a research participant, or have concerns or complaints regarding this research study, please contact:
Univo IRB
(919) 910-7743 or via email at info@univo-group.com.
Univo IRB
4509 Creedmoor Road Suite 403
Raleigh, NC 27612
Additional questions and closing
Efforia and Univo have approved the information in this consent form and have given approval to publish 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.