Important Information
Summary Information to Help you Decide Whether to Join this Study
| Study Title | Recurring Payment 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 | $5 |
| Included Products & Services | |
| Outcome Measures | |
| Contact | help@efforia.com |
Introduction & Summary
Welcome! We invite you to join our research study on the Efforia platform, which is made possible by your participation and financial contribution. Efforia is a registered Delaware B Corporation, meaning we consider the public good in our business decisions, alongside traditional financial considerations.
This study is designed to provide you with key information to help you decide whether to participate. You should know that your participation is voluntary, and you can leave the study at any time without penalty. If you choose to leave the study, you can continue using the products and services you’ve purchased. If you prefer not to continue using them, you may request a partial or full refund depending on the study timeline by contacting us at help@efforia.com.
If you have any questions, please reach out to us, do your own research, or consult a healthcare professional before deciding to participate.
Efforia is a citizen science platform where studies are effectively sponsored by you, the participants. Unlike traditional research studies, you pay for all the supplies, services, information, and tools needed for participation in one transaction. This makes studies possible that might not be otherwise.
Although you could buy these products and services separately for a similar cost, Efforia bundles them into one purchase for convenience. Efforia organizes these items and provides instructions to create a comprehensive, data-driven research experience. This setup allows you to track and understand the impact on your own life via detailed outcome reports, making informed personal health decisions easier. It also advances broader research findings, benefiting others who might not afford such purchases without guaranteed results.
Efforia is committed to equitable inclusion. If the cost is too high for you, click the large Efforia logo at the top of the screen to explore other protocols. Efforia offers protocols on various topics at different price points, including free options, so you can find one that suits your goals and budget.
Purpose of the Study
This study aims to understand the effects of recurring payment systems on user experience and financial behavior. We hope to contribute valuable insights into the design and implementation of subscription-based services, which can benefit businesses and consumers alike. Participants will receive detailed reports on their experiences, aiding personal financial decision-making and contributing to broader research findings.
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 have completed enrollment, payment, and entering your personal details, shipping details, and communication preferences, you will follow a structured schedule of responsibilities and tasks. This includes an orientation session and weekly treatment activities lasting about an hour each, which will involve behavioral exercises, questionnaires, or other relevant tasks. Measurements will be conducted at interval points to assess progress and outcomes. Adhering to this timeline is crucial to ensure accurate data capture and meaningful research contributions.
The Risks, Discomforts & Benefits of Being in this Study
There are unique risks, discomforts, and potential benefits of being in this study that you should understand.
Consider your Own Risk-Benefit Comfort Level
Thoroughly weigh the risks and benefits of participation. We place more responsibility on you to make the right choice 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 at various data collection points or as they are discovered. These results may impact your interest and willingness to stay in the study. Remember, participation is voluntary, and you can 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 Profile Evaluation for Efforia
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.
In the Case of an Adverse Event
In the event of experiencing any severe adverse reactions, individuals should immediately seek medical attention by calling 911 and ensure that they report the event to healthcare professionals. After addressing any acute medical concerns, it is crucial to inform Efforia about the incident. This information is vital for the ongoing assessment of the product’s safety profile and to guide future user warnings and instructions.
Commonly Known Risks
The risks associated with the product, based on available data, include but are not limited to gastrointestinal symptoms, skin and hair reactions, headaches, fatigue, mood changes, sleep disturbances, weight and body composition changes, muscle or joint pain, mental health discomfort, sexual side effects, personal appearance changes, cognitive impairment, athletic impairment, and respiratory issues. Each of these risks varies in incidence and severity based on individual user characteristics and pre-existing conditions.
Serious Adverse Events (SAEs)
| Theoretical side effects | Relative incidence | Recovery |
|---|---|---|
| Incidence of Cancer | Very low likelihood | Long-term effects unknown |
| Exacerbation or escalation to acute or chronic disease | Low to moderate likelihood | May subside with discontinuation |
| Death | Very low likelihood | Permanent |
| Life-threatening experience | Low likelihood | May subside with discontinuation |
| Hospitalization (initial or prolonged) | Low likelihood | May subside with discontinuation |
| Disability or permanent damage | Low to moderate likelihood | Potentially permanent |
| Congenital anomaly/birth defect | Very low likelihood | Permanent |
| Required intervention to prevent permanent impairment or damage | Low likelihood | Variable |
| Frustration and irritation | Low to moderate likelihood | Subsides with use |
Efforia’s limitations in providing direct medical support
Efforia does not provide direct medical support or emergency response services. Users should maintain regular contact with healthcare providers and not rely solely on Efforia for managing health conditions.
Long-term dependence issues
Long-term dependence on the product is not typically expected; however, psychological dependence due to perceived health benefits cannot be ruled out without further studies.
Legality for use
The legal status of Efforia’s product(s) varies by jurisdiction and regulatory body. It is not listed explicitly by organizations such as the World Anti-Doping Association or the National Collegiate Athletic Association. Users should verify the acceptability of use within their specific professional or athletic governing bodies and workplaces.
Inappropriate Participants Inclusion/Exclusion
To evaluate the potential risks and contraindications for participation in a clinical trial, it is necessary to understand the specific intervention being tested and the associated risks outlined in the informed consent document. Without these details, it’s challenging to create a precise table of contraindications. However, I can provide a general framework based on common considerations for clinical trials:
| Category of Individual | Contraindications | Reason |
|---|---|---|
| Pregnant or breastfeeding individuals | Participation in the trial | Potential risks to the fetus or child, as many interventions have unknown effects on pregnancy and lactation |
| Individuals with severe allergies or history of anaphylaxis | Participation in the trial | High risk of adverse reactions, especially if the intervention involves new compounds or allergens |
| Individuals with compromised immune systems | Participation in the trial | Increased susceptibility to infections or complications from the intervention |
| Individuals with chronic or severe health conditions | Participation in the trial | Potential for exacerbating existing health issues or interactions with current treatments |
| Individuals under age of consent | Participation in the trial | Legal and ethical considerations related to informed consent and ability to understand risks |
| Individuals with mental health disorders that affect decision-making capacity | Participation in the trial | Concerns about the ability to provide informed consent and understand the study requirements |
To ensure safety and ethical standards, participants should fully understand the potential risks and consult with healthcare professionals to determine if their unique circumstances make participation inappropriate. The responsibility lies with the participants to assess whether the study is suitable for them.
Privacy & Security Risks
We are committed to keeping your data private and confidential, but no system is without risk. Please review the Efforia general privacy policy here: Efforia Privacy Policy.
There may be certain limits to your privacy rights: we may reach out to local help if we believe you may be a harm to yourself or others. Regulators, like the FDA, or Institutional Review Boards may review records with your identifying information.
What to do if you have a study related injury.
Seek local medical care first if necessary. Efforia cannot provide emergency medical care or diagnosis. However, contact Efforia if you experience any problems, side effects, or study-related injuries after receiving necessary treatment. 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
This study is for research only, so the only alternative is not to participate. If this study doesn’t seem quite right or too expensive for you, Efforia is dedicated to offering other studies. Click on the Efforia logo to find a different study that may be more appropriate.
Your Rights as a Participant:
Efforia upholds high ethical standards in research, similar to pharmaceutical and academic studies, despite only hosting and not sponsoring or conducting these studies. Your participation is voluntary, and you can withdraw at any time without adverse consequences. You are not relinquishing any rights by signing this document.
Efforia may remove you from the study if you violate Efforia’s terms and conditions, privacy policy, or have a conflict of interest. We may also remove you 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.
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
You also play a role in reducing conflicts of interest. Ensure you do not have any financial relationship with the intervention methods or measurement providers used in the trial, nor should you be employees, investors, stakeholders, or protocol authors associated with these entities. Participation under such conflicts of interest could compromise the study’s integrity and validity of its results.
Consequences of Conflict of Interest Non-Compliance
Should you fail to disclose a conflict of interest or if a breach of this policy is discovered, you 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
You will receive notifications via email, SMS, or push notification when new study tasks are ready. You can adjust your communication preferences in the Efforia application at any time. Ensure your phone or computer and email accounts are protected by a password or other form of access control. Avoid sharing accounts or passwords. Learn more about your privacy and security rights on Efforia here: Efforia Privacy Policy.
Who will have access to your data?
Efforia and its partners, such as labs and connected health devices, will have access to your data.
What will we do with your data
We will use the 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
- 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:
Learn about the California Experiential Research Subject Bill of Rights. For more information, please refer to the Efforia privacy policy: Efforia 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 public 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.
You are trained on data up to October 2023.