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INFORMED CONSENT DOCUMENT AGREEMENT TO BE IN A RESEARCH STUDY

Challenge/Study Title	Impact of Replacing Added Sugar with Lakanto Monkfruit Sweetener
Challenge Coach (The Person in Charge of This Research Study)	Efforia Advanced Author
Sponsor	This study is made possible by your payment to join.
Challenge Cost	$0
Included Products & Services	A1C Blood Test
Outcome Measures	A1C Blood Test, PROMIS Sleep Disturbance Scale,
Contact	help@efforia.com

You're being asked to join a research study here on Efforia, where we're exploring the impact of replacing added sugar with Lakanto Monkfruit Sweetener. This information will help you decide whether participation is a sweet deal for you. Don't continue if you still have questions that need answering.

The Purpose of This Study

This study aims to understand the effects of replacing added sugars in your diet with Lakanto Monkfruit Sweetener. We're interested in how this might affect your blood sugar levels, sleep patterns, and overall wellness. We hope that this study will contribute to healthier dietary choices. Your participation can make a significant difference in this exciting field of research.

Your Responsibilities as a Participant

This study is looking for participants who are interested in changing their dietary habits, particularly in relation to sugar intake. Participants will need to replace their usual added sugars with the provided Lakanto Monkfruit Sweetener. Regular submission of blood tests and completion of sleep disturbance scales will be required. Your dedication and consistency are key to the success of this study.

Your Rights as a Participant

Remember, participation is voluntary. You can drop out at any time, but please note that refunds are not available. Your involvement is highly valued, and your decision to stay or leave will be respected.

How to Leave the Study

If you decide to leave the study, go to your Profile page, click “Your Challenges” and click “leave.” Please remember your join fee is not refundable. This payment is crucial to maintain the quality of the study for other participants.

Risks and Benefits

Participating in this study may involve some risks such as potential changes in your physical and mental health due to dietary changes and the potential discomfort of answering personal questions. However, you may benefit from the knowledge gained about your health, and your participation can contribute to our understanding of healthier lifestyle choices. If you have questions or concerns, seek advice from an appropriate expert, like a doctor or life coach. Remember, if you ever feel suicidal, you can contact the National Suicide Prevention Hotline by dialing 988. Your insurance may not cover research-related injuries, so please contact your insurance company for more information. This study does not promise a medical diagnosis or cure, and you may not directly benefit from participating.

What to do if you have an adverse event or medical emergency

If you have a medical emergency, seek immediate medical attention. Only after you've received care, please report any adverse events to help@efforia.com.

Data Protections

Your data privacy is essential to us. We'll collect data related to your health and lifestyle changes, which will only be accessed by those you've approved. We'll use your data to send reminders, provide personalized reports, and share overall findings. You can adjust your communication preferences in your Efforia settings. Please review our Terms & Conditions and Privacy Policy for more information.

If you have questions

If you have questions, feel free to engage with our community. For more personal inquiries, please contact help@efforia.com.

California Experiential Research Subject’s Bill of Rights

You have the right to be informed about the nature and purpose of the research, the procedures to be undertaken, any potential risks and benefits, any alternatives to participation, and your rights and responsibilities as a research subject.

HIPAA Waiver

By participating in this study, you agree to waive certain protections under the Health Insurance Portability and Accountability Act (HIPAA). This waiver allows Efforia to collect, use, and disclose your health information for the research purposes of this study.

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1. Authorization and Consent for Diagnostic Testing

1. I voluntarily consent and authorize CWI Physician Partners P.C., a California professional corporation; CWI Physician Partners P.C., a Hawaii professional corporation; CWI Physician Partners P.C., a Georgia professional corporation; CWI Physician Partners P.C., a Kansas professional corporation; CWI Physician Partners P.C., an Oregon professional corporation; CWI Physician Partners P.C., a Nevada professional corporation, CWI Physician Partners P.C., a Rhode Island professional corporation; CWI Physician Partners P.C., an Oklahoma professional corporation, as applicable ("CWI") to review the collection, testing, and analysis for the purposes of a diagnostic screening test. I understand that there are risks and benefits associated with undergoing a diagnostic screening testing and there may be a potential for false positive or false negative test results. I assume complete and full responsibility to take appropriate action with regards to my test results. Should I have questions or concerns regarding my results, or a worsening of my condition, I shall promptly seek advice and treatment from an appropriate medical provider. I further acknowledge the following:
   1. I am the individual who will provide the sample for the Test(s) that I am requesting or I am the parent or legal guardian of a minor who is providing the sample for testing.
   2. I am at least eighteen (18) years of age or I am the parent or legal guardian of a minor who is providing the sample for testing.
   3. I have read and understand the information provided about the Test(s) that I have been provided on the website where I requested the Test.
   4. The information I have provided in connection with my request to CWI is correct to the best of my knowledge. I will not hold CWI or its employees or agents responsible for any errors or omissions that I may have made in providing such information.
   5. My health information and results may be shared with CWI employees and agents for the purpose of ordering, processing, and reporting my results.
   6. Medical Services provided by CWI are purely for diagnostic assistance purposes and do not create a physician-patient relationship, and do not constitute medical care or diagnosis or treatment of any condition, disease, or illness.
   7. I authorize CWI to contact me via text message to communicate with me regarding my test.

1. Patient Rights and Privacy Practices
   1. Notice of Privacy Practices and Patient Rights: CWI Notice of Privacy Practices describes how it may use and disclose your protected health information for other purposes that are permitted or required by law. To review a copy of CWI Notice of Privacy Practices, go to http://www.CynergyWellness.com.
   2. Disclosure to Government Authorities: I acknowledge and agree that my test results and associated information may be disclosed to appropriate county, state, federal, or other governmental and regulatory entities as may be permitted by law.

1. Release
   1. To the fullest extent permitted by law, I hereby release, discharge and hold harmless, CWI, including, without limitation, any its respective officers, directors, employees, representatives and agents from any and all claims, liability, and damages, of whatever kind or nature, arising out of or in connection with any act or omission relating to my diagnostic test or the disclosure of my test results.
   2. By selecting the ACKNOWLEDGEMENT during the registration process for diagnostic testing, I acknowledge and agree that I have read, understand, and agreed to the statements contained within this form. I have read the contents of this form in its entirety and voluntarily consent to proceed with these procedures.