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.
Summary Information to Help you Decide Whether to Join this Study
| Study Title | Repeating – Email Test |
|---|---|
| Study Author | Reviewer User |
| 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 | Sense of Agency Scale |
| Contact | help@efforia.com |
Introduction & Summary
Welcome to the "Repeating – Email Test" research study hosted on the Efforia platform! Efforia is a registered Delaware B Corporation, which means we consider the public good alongside traditional financial goals. This study is made possible by your participation and support. This document is here to help you understand the key reasons to join or not join this study. The purpose of the study is to explore the effects of specific tasks on the Sense of Agency, which refers to the feeling of control over actions and their outcomes. Your participation is entirely voluntary, and you're free to leave at any time without any penalties. You'll still have access to the products and services you've purchased, and if you prefer not to continue using them, partial or full refunds may be possible. Just reach out to Efforia by email. Before deciding, make sure to ask any questions you have by contacting Efforia, doing your own research, and speaking with any health professionals familiar with your circumstances.Purpose of the Study
This study aims to evaluate the impact of daily tasks on participants’ Sense of Agency, which is an individual's perception of having control over their actions and the outcomes of those actions. The Sense of Agency Scale will be used to measure these effects. Through your participation, we hope to contribute valuable insights to the scientific community and potentially improve personal health decisions.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've completed enrollment and entered your personal details and communication preferences, you will participate in a daily task titled "Repeating — Task Daily." This involves a series of activities designed to assess specific outcomes. Consistent daily performance of these tasks is crucial for reliable data collection and analysis. You will need to follow a set protocol for each session, including specific treatment activities and measurement procedures, and record your observations as directed.The Risks, Discomforts & Benefits of Being in this Study
There are some unique risks, discomforts, and potential benefits of being in this study that you should understand.Consider your Own Risk-Benefit Comfort Level
It is important to weigh the risks and benefits of participation. This study places 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. These findings will be available at various data collection points or as they are discovered. The results may impact 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
In the Case of an Adverse Event
If you experience any adverse reactions or medical emergencies while participating in the "Repeating — Task Daily" regimen, it is imperative to seek immediate medical attention by calling 911, especially if the symptoms are severe. After addressing any acute medical concerns, please inform Efforia about the incident. This will help us monitor the safety and effectiveness of our interventions and provide necessary support.
Introduction and Summary of Known Risks
The "Repeating — Task Daily" regimen, despite its seemingly benign nature, could potentially lead to a range of side effects and adverse reactions. These reactions can vary from mild to severe, depending on individual health status, pre-existing conditions, and other factors.
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)
Potential Serious Adverse Events associated with the "Repeating — Task Daily" regimen may include, but are not limited to:
| Theoretical side effects | Relative incidence | Recovery |
|---|---|---|
| Frustration and irritation | Medium likelihood | Subsides with use |
| Cognitive impairment, intoxication, or loss of control | Low likelihood | Corrects after discontinuation |
| Mental Health Discomfort | Low to medium likelihood | Subsides with use |
Risks
Risks associated with the treatment may include, but are not limited to:
- Gastrointestinal Symptoms: The repetitive nature of the task may induce stress, potentially leading to mild gastrointestinal issues such as nausea or discomfort. These are usually anecdotal and subside as the participant adapts to the regimen.
- Mental Health Discomfort: Prolonged engagement in monotonous tasks might exacerbate or contribute to stress, anxiety, or depressive symptoms, particularly in susceptible individuals.
- Cognitive Impairment: There is a theoretical risk of decreased cognitive function due to the repetitive nature of the task, which might lead to reduced mental flexibility or creativity.
Efforia's limitations in providing direct medical support
Efforia is not equipped to provide direct medical support or emergency services. Participants are advised to contact their healthcare provider or local emergency services in the event of serious health issues.
Long-term Dependence Issues
No long-term dependence has been definitively linked with the "Repeating — Task Daily" regimen. However, psychological dependence on routine or fear of missing daily tasks could potentially develop, especially in individuals with a predisposition for obsessive-compulsive behaviors.
Legality for Use
The "Repeating — Task Daily" regimen does not involve any prohibited substances or methods under current regulations by the World Anti-Doping Association, National Collegiate Athletic Association, or general corporate workplace standards. However, participants should consider the mental health implications and personal performance impacts that could indirectly affect their compliance with institutional or professional standards.
Inappropriate Participants Inclusion/Exclusion
Under the Efforia minimal risk protocol, within which this study is reviewed for safety and human subjects ethics, all individuals over the age of consent are eligible, however, it is the responsibility of participants to determine if their unique circumstances make participation inappropriate.
Based on the risks informed consent, intervention, and outcome measures, here is a table identifying the kinds of people who should avoid being part of this trial:
| Category of Individual | Contraindications | Reason |
|---|---|---|
| Pregnant or breastfeeding women | Potential unknown effects on fetus/infant | The intervention may pose risks to fetal or infant health and development. |
| Individuals with severe allergies | Potential for allergic reactions | The intervention may contain allergens or trigger severe allergic responses. |
| Immunocompromised individuals | Increased risk of infection or complications | The intervention may affect immune responses or pose a risk of infections. |
| People with chronic illnesses | Potential interference with current treatment | The intervention could interact negatively with existing medications or treatments. |
| Individuals with mental health disorders | Potential exacerbation of symptoms | The intervention may have psychological side effects or worsen mental health conditions. |
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, available here: https://efforia.com/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 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 necessary, seek local medical care first. Efforia cannot provide emergency medical care or diagnosis. It is important to contact Efforia if you experience any problems, side effects, or a study-related injury after receiving necessary treatment. We want to make sure 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 does not seem quite right, or too expensive for your specific purposes, Efforia is dedicated to making other studies available. You may 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. 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:
Participants have a role in reducing conflicts of interest as well. It is crucial that 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 significantly compromise the study's integrity and the validity of its results.Consequences of Conflict of Interest Non-Compliance:
Should you fail to disclose such 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.