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    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 Porn Abstinence Impact Challenge: Nighttime Wood Test
    Study Author Matthew Amsden, Christos Konstantinidis, Jordan Tsanev
    Sponsor This study is made possible by your payment to join.
    Cost of Products, Services & Information to Participant $149
    Included Products & Services Adam Sensor – Nocturnal Erection Tracker
    Outcome Measures Weekly Porn Consumption Survey, Sexual Desire Inventory-2 (SDI-2) Survey for Men & Women, International Index of Erectile Function Survey, Adam Sensor: Nocturnal Penile Tumescence,
    Contact help@efforia.com

    Introduction & Summary

    Welcome to the "Porn Abstinence Impact Challenge: Nighttime Wood Test" research study on the Efforia platform. Your support makes this study possible, and we invite you to consider joining us. This document aims to help you understand the study’s purpose and procedures so you can make an informed decision about participating. Remember, participation is voluntary, and you can leave the study at any time without penalty. If you have any questions, please reach out before deciding.

    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 pornography abstinence on nocturnal erections, mental clarity, libido, mood, and energy levels. We use the Adam Sensor, a device that tracks nocturnal erections, to gather data. Participants will also complete surveys such as the Weekly Porn Consumption Survey, Sexual Desire Inventory-2 (SDI-2) Survey, and the International Index of Erectile Function Survey. The findings will contribute to scientific knowledge about the potential impacts of pornography consumption on personal health and well-being.

    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 entered your personal details, shipping details, and communication preferences, the study will involve:

    The study spans 40 days, divided into two main phases. The first week (Days 1-7) is the Baseline Observation period, where participants continue their regular porn usage to establish a baseline of their current state, including tracking nocturnal erections using the Adam Sensor. This phase involves completing surveys like the Weekly Porn Consumption Survey, the Sexual Desire Inventory, and the International Index of Erectile Function Survey.

    From Day 8 to Day 38, participants enter a 30-day Abstinence Period, aiming to refrain from pornography. During this period, participants are encouraged to track changes in nighttime erections, mental clarity, libido, mood, and energy levels. They are to use the Adam Sensor regularly, ideally for at least three consecutive nights, to monitor nocturnal erections, and check-in every seven days to record their progress and reflections via surveys.

    Participants are instructed to use tools like Google Calendar and Todoist to ensure consistency and are reminded that adherence to the timeline is crucial as it affects the integrity of the data collected. The study emphasizes the importance of understanding personal health indicators without judgment, aiming to enhance self-awareness and health insights.

    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

    We encourage you to thoroughly weigh the risks and benefits of participation. In this study, more responsibility is placed 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 as well as overall findings. These findings will be made available at various data collection points in your experience in the study 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 with an e-mail to 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

    Introduction and Summary of Known Risks

    The Adam Sensor – Nocturnal Erection Tracker is a wearable device designed to monitor nocturnal erections as a biomarker of male sexual health. While the device offers innovative benefits, it is important to discuss potential risks and side effects associated with its use.

    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 a severe adverse reaction while using the Adam Sensor, seek immediate medical care by calling 911. After addressing any acute medical needs, please inform Efforia about the incident. Reporting your experience can help improve the safety profile of the device and assist others in the community.

    Risks and Side Effects

    • Skin & Hair Reactions: Users may experience skin irritation or allergic reactions at the site of contact. These reactions are generally mild and resolve upon discontinuation of use.
    • Personal Appearance Change: Extended use may cause temporary marks or indentations on the skin due to pressure or tightness of the device.
    • Mood Changes: Frustration and irritation with the device or the data collection process are possible.
    • Cognitive Impairment: There is a theoretical risk of sleep disturbance due to wearing the device, which could affect cognitive functions like alertness and concentration temporarily.
    • Device Malfunction: Improper function of the sensor could lead to incorrect data which might influence medical decisions or personal insights inaccurately.

    Serious Adverse Events (SAEs)

    Theoretical Side Effects Relative Incidence Recovery
    Skin Allergy or Severe Irritation Low Likelihood Subsides after discontinuation
    Chronic Skin Damage Very Low Likelihood May have lasting effects if untreated
    Frustration and irritation Moderate Likelihood Subsides after discontinuation

    Efforia's Limitations in Providing Direct Medical Support

    It is important to note that while Efforia provides the platform for data collection, it does not offer direct medical advice or emergency response services. Users should maintain regular consultations with healthcare providers.

    Long-term Dependence

    No long-term dependence has been associated with the use of the Adam Sensor. Users can stop using the device at any time without adverse health consequences related to dependence.

    Legality and Compliance

    The use of the Adam Sensor does not violate any laws or regulations. However, users should be aware of privacy considerations when sharing personal health data. The device is compliant with general health device standards and is not restricted by organizations such as the World Anti-Doping Association or the National Collegiate Athletic Association.

    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.

    If you experience any problems, side effects, or injuries related to the study, you should seek local medical care first, if necessary. Efforia cannot provide emergency medical care or diagnosis. It's important to contact Efforia 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:

    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.

    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:

    Data will be collected, used, and protected in 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:

    Learn more about your rights by viewing 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.

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