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
Study Title | Topical Antifungal Treatment and Marathon Training |
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Study Author | Matthew Amsden |
Sponsor | This study is made possible by your payment to join. |
Cost of Products, Services & Information to Participant | $0 |
Included Products & Services | |
Outcome Measures | Self-Entry VO2 Max |
Contact | help@efforia.com |
Introduction & Summary
Welcome to the Topical Antifungal Treatment and Marathon Training research study on the Efforia platform. This study is made possible by your support through participation. The primary goal is to enhance toenail health and marathon performance over a 12-week period. Your participation is entirely voluntary, and you can withdraw at any time without penalty. This document is designed to help you understand the study and decide whether you want to participate. Please ensure all your questions are answered before proceeding.
Purpose of the Study
This study aims to assess how topical antifungal treatments can improve toenail health and marathon performance. By integrating a structured marathon training regimen with topical treatments, this study seeks to provide insights into dermatological health and athletic performance. Participants will apply a topical antifungal treatment and follow a marathon training plan over 12 weeks. The study will measure improvements using the Dermatology Life Quality Index (DLQI) and Self-Entry VO2 Max.
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."
Welcome to the Topical Antifungal Treatment and Marathon Training Challenge, a comprehensive 12-week program designed to enhance toenail health and marathon performance. Participants are required to integrate both topical antifungal treatments and a structured marathon training regimen into their daily routines.
Overall Schedule and Timeline: The program spans 12 weeks, during which participants will engage in specific activities and assessments to track progress. The timeline is crucial for the success of the treatment and training, and participants are expected to adhere strictly to it.
Treatment Activities:
- Morning Application: Apply the topical antifungal treatment each morning.
- Evening Application: Apply the topical antifungal treatment each evening.
Training Activities:
- Weekly Long Run: Engage in a long-distance run once a week to build endurance.
- Speed Workouts: Participate in speed training sessions designed to improve pace and agility.
- Rest and Recovery: Allocate time for rest and recovery to prevent injury and promote healing.
Assessments and Measurements:
- Baseline Assessments: Complete the Dermatology Life Quality Index (DLQI) and Self-Entry VO2 Max assessments at the beginning of the program.
- Follow-Up Assessments: Repeat the DLQI and VO2 Max assessments at the end of the program to evaluate progress.
Participants are encouraged to link their Google Calendar and Todoist, set communication preferences, and prioritize Efforia emails to ensure they remain on track. Maintaining adherence to the timeline and protocol is essential for achieving the desired outcomes of improved toenail health and enhanced marathon performance.
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
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. 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.
Personal and Overall Findings
Efforia will provide you with both personal outcomes and overall findings. These findings will be made available at various data collection points in your experience or as they are discovered by Efforia. The results and findings may impact your interest and willingness to be involved 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
Risk Assessment and Safety Profile for Topical Antifungal Treatment and Marathon Training Challenge
Introduction
The Topical Antifungal Treatment and Marathon Training Challenge is a 12-week program designed to treat fungal infections of the toenails while simultaneously enhancing marathon performance through a structured training regimen. This report outlines the potential risks, side effects, allergies, and adverse reactions associated with the components of this program, including the topical antifungal treatments and physical exercise demands of marathon training.
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
If you experience any severe or unexpected symptoms such as difficulty breathing, severe skin reactions, or significant physical discomfort, it is crucial to seek immediate medical attention by calling 911. After addressing any acute situations, please inform Efforia about the incident to help improve safety monitoring and program adjustments.
Common Risks and Side Effects
Topical Antifungal Treatment
- Skin Irritation and Allergies: Common reactions include redness, itching, or burning at the application site. These reactions are generally mild and resolve with continued use.
- Chemical Sensitivity: Some individuals may develop sensitivity to active ingredients or preservatives, which can cause dermatitis.
Marathon Training
- Musculoskeletal Injuries: Including sprains, strains, and stress fractures, commonly reported in rigorous training schedules.
- Cardiovascular Strain: Intense exercise can lead to heart-related issues, especially in participants with underlying conditions.
Serious Adverse Events (SAEs)
Theoretical Side Effects | Relative Incidence | Recovery |
---|---|---|
Frustration and irritation | Medium likelihood | Symptoms subside with use |
Anaphylactic reactions (Topical Antifungal) | Very low likelihood | Immediate medical intervention required; may have lasting effects without treatment |
Severe musculoskeletal injuries (Marathon Training) | Low to medium likelihood | May have lasting effects; depends on injury severity |
Efforia's limitations in providing direct medical support
Efforia does not offer direct medical interventions. Participants are advised to have access to local medical services and should maintain regular contact with their healthcare providers throughout the duration of the program.
Long-Term Dependence Issues
Long-term dependence is not typically associated with the use of topical antifungal treatments. However, the psychological aspect of continuous physical training may create a dependency or compulsion towards excessive exercise, which needs to be monitored.
Legality and Compliance
The components of this program, including topical antifungals and physical training, do not conflict with general legal standards. However, participants should verify the compliance of any medication or supplements with the World Anti-Doping Association, National Collegiate Athletic Association, and workplace policies to avoid potential conflicts.
It is essential for participants to adhere to recommended guidelines and consult healthcare providers to tailor the program according to individual health conditions and needs.
Privacy & Security Risks
We are doing everything we can think of 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 very 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 agency, or Institutional Review boards may review records that have 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, it is important to contact Efforia if you experience any problems, have any side effects, or have any study-related injury after you've received any 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 cace 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 in the upper portion of the page and find a different study that may be more appropriate.
Your Rights as a Participant
Ethical Considerations: 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.
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
Describe how data will be collected, used, and protected, ensuring compliance with data protection laws.
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, you should make sure your phone or desktop computer and your e-mail accounts are protected by a password, pin, or other form of “access control.” You should also avoid sharing your accounts with others or sharing your account passwords. As this study is hosted in Efforia, it is governed by a set of privacy and confidentiality standards that put you, as a participant, in control. You can 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. There may be partners who also have access to your data (like labs and connected health devices).
What will we do with your data
We will use the data to show you your own 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.
California Experiential Research Subject’s Bill of Rights
Tell participants about the California Experiential Research Subject Bill of Rights. Give participants a link to the 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 (646) 679-2479 OR CLICK THE CHAT BUTTON ON YOUR SCREEN If you are unable to reach anyone at the number(s) listed above and you require immediate (life-threatening) medical attention, please 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 at (919) 910-7743 or via email at info@univo-group.com. Univo IRB 4509 Creedmoor Road Suite 403 Raleigh, NC 27612 info@univo-group.com (919) 910-7743
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 Univo 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.