INFORMED CONSENT DOCUMENT AGREEMENT TO BE IN A RESEARCH STUDY

Study Title	Tadalafil Impact on Male Body Image Study
Study Author	Matthew Amsden, Reviewer User
Sponsor	This study is made possible by your payment to join.
Cost of Products, Services & Information to Participant	$145
Included Products & Services	Product or Service Missing from Efforia Library
Outcome Measures	Men’s Body Image and Attractiveness Assessment, Hamilton Anxiety Rating Scale (HAM-A) Survey, Impacts of Erection Problems on Sex Life
Contact	help@efforia.com

Introduction

Welcome! We invite you to join the Tadalafil Impact on Male Body Image Study on the Efforia platform, made possible by your participation and financial contribution. This document will help you understand the study’s purpose, your role, the risks, and benefits, so you can decide if you want to take part. Please ask any questions you might have before proceeding.

Efforia is a citizen science platform. This study, like many on Efforia, is effectively sponsored by participants. This approach is unique because it requires a small payment. This makes the study possible when traditional research funding is limited or unavailable. Your payment covers all the supplies, services, information, and tools you need to participate.

While you could buy these products and services separately on the open market for a similar total cost, Efforia bundles them into one purchase for ease. Efforia also organizes these items and provides instructions to help create a thorough, data-driven research experience – something that would otherwise be difficult to do. This setup not only allows you to track and understand the impact on your own life, making it easier to make informed personal health decisions, but it also helps advance broader research findings. These findings can benefit others who might not be able to afford self-experimentation purchases without a strong guarantee of results.

Efforia is committed to equitable inclusion. If this cost is too much for you, please click the large Efforia logo at the top of this screen and review other protocols. Efforia hosts protocols on this and other topics at all price points, including free. You will be able to find other protocols that suit your goals and budget.

Purpose of the Study

The Tadalafil Impact on Male Body Image Study aims to understand how Tadalafil affects male body image, mental well-being, and sexual health. Tadalafil, commonly known by its brand name Cialis, is a medication used to treat erectile dysfunction. This study will use various measures, including the Men’s Body Image and Attractiveness Assessment, the Hamilton Anxiety Rating Scale (HAM-A), and the Erection Quality Scale, to gather comprehensive data on these effects.

What You Will Do as Part of this Study

Once you have completed enrollment, payment, and entering your personal details, shipping details (if included products and services), and communication preferences, you will participate in the following activities:

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.
• Tell 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.

The Risks & Benefits of Being in this Study

There are some unique responsibilities for participants in citizen science trials, including some risks that you should understand. Efforia does not endorse or sponsor this trial; it is simply hosted on the Efforia platform. This means Efforia provides the platform for the study but does not influence the study outcomes.

Consider Your Own Risk-Benefit Comfort Level

Participants are encouraged to thoroughly weigh the risks and benefits of participation. We are placing 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.

Possible Benefits of Participation

By joining this study, you may gain insights into how Tadalafil affects your body image, mental well-being, and sexual health. The study could also contribute to broader scientific knowledge that might help others in similar situations.

Possible Adverse Events & Side Effects

While Tadalafil is generally safe, it can have side effects, including headaches, indigestion, back pain, muscle aches, flushed skin, and stuffy or runny nose. Severe side effects may include an erection lasting more than four hours, sudden vision loss, or sudden hearing loss. Please consult your healthcare provider for a complete list of potential side effects and ensure you are comfortable with these risks before participating.

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/

What to Do if You Have a Study Related Injury

If you experience any problems, have any side effects, or have any study-related injury, it is important to contact Efforia. However, please seek local medical care immediately.

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. Medical services will be offered at the usual charge.

In the Case of Medical Emergency

In the face 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 is 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.

Privacy and Confidentiality

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 or conflicts of interest. We are not paid by the sponsor of this study. 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 or 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 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. Further, depending on the nature of the violation, additional legal proceedings may be initiated as warranted by law to address the breach adequately.

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 also be partners who have access to your data, such as 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

Provide a relevant summary for participants in California and a link to the privacy policy: 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

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 IntegReview. IntegReview is a group of people that have reviewed this research study. The main goal of this review is to protect the rights and well-being of the human subjects participating in research studies. IntegReview’s policy indicates that all concerns/complaints are to be submitted in writing for review at a convened IRB meeting to:

Chairperson

BRANY

123 Main Street

Suite 320

NY, NY 78704

email@BRANY.com

If you are unable to provide your concerns/complaints in writing or if this is an emergency situation regarding subject safety, contact our office at:

555-326-3001 or

toll free at 1-800-123-4567

between 8 a.m. and 5 p.m. Eastern Standard Time

Additional Questions and Closing

Efforia and BRANY have approved the information in this consent form and has 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.