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.
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INFORMED CONSENT DOCUMENT AGREEMENT TO BE IN A RESEARCH STUDY
| Challenge/Study Title | Cold Exposure Mental Health Protocol |
|---|---|
| Challenge Coach (The Person in Charge of This Research Study) | Efforia Advanced Author |
| Sponsor | This study is made possible by your participation. |
| Challenge Cost | $0 |
| Included Products & Services | Guidance documents, online support sessions, and monitoring tools. |
| Outcome Measures | 36-Item Short Form Survey Instrument (SF-36), NIH Toolbox® Item Bank v3.0 – Positive Affect Survey (Ages 18+) Score. |
| Contact | help@efforia.com |
Hello! You are being asked to join a research study on the Efforia platform focusing on the Cold Exposure Mental Health Protocol. This document is here to help you understand what participation involves so you can make an informed decision. If at any point you have questions or uncertainties, please hold off on consenting and reach out to us at help@efforia.com.
The Purpose of This Study
This study aims to explore the effects of controlled cold exposure on mental health outcomes. By participating, you will contribute to research that could uncover new methods to enhance mental wellness through environmental stressors. The findings may provide insights into how routine cold exposure affects mood, stress levels, and overall mental health. Your participation will be instrumental in advancing our understanding of these dynamics.
Your Responsibilities as a Participant
As a participant, you should be in good general health and comfortable with experiencing cold temperatures in a controlled environment. You will be expected to follow the study guidelines, attend scheduled virtual sessions, and complete all required health surveys. Participation involves regular self-reporting of mood and well-being using provided digital tools. It is crucial that you provide honest and precise feedback throughout the study.
Your Rights as a Participant
Participation in this study is completely voluntary, and you can withdraw at any time without penalty. However, please note that the challenge fee is non-refundable as it supports the administrative costs of running this study. Your involvement is important to us, and we are committed to respecting your decision regarding participation at any stage.
How to Leave the Study
To leave the study, go to your Profile page, click "Your Challenges" and select "leave." Remember, your join fee is non-refundable. This payment helps maintain the quality of the study experience for other participants.
Risks and Benefits
Participating in this study may expose you to mild discomfort due to cold exposure. There are also potential emotional risks if you find some of the mental health questions unsettling. However, the study could provide valuable insights into your mental health and well-being. It's essential to consult a healthcare professional, such as a doctor or life coach, if you have any concerns. In case of feeling suicidal, please contact the National Suicide Prevention Hotline by dialing 988 immediately. Remember, this study is not designed to diagnose or treat any conditions, and there's a chance you might not experience direct benefits from participating.
What to do if you have an adverse event or medical emergency
If you experience any medical emergencies or adverse events during the study, seek immediate medical attention from local healthcare providers. After receiving care, please report the incident to us at help@efforia.com for documentation and follow-up.
Data Protections
Your personal data collected during this study will be used to track your progress and communicate with you via email, SMS, and push notifications. All collected data will be stored on secure servers and accessed only by authorized personnel with your consent. We encourage sharing your experiences within the community and with the public, enhancing the collaborative spirit of this study. Please review your communication preferences in your profile settings to ensure your comfort with the information sharing level. For detailed information, refer to Efforia's Terms & Conditions and Privacy Policy.
If you have questions
If you have any questions or need further clarification, feel free to engage with the community or directly contact us at help@efforia.com. We are here to assist you!
California Experiential Research Subject’s Bill of Rights
As a participant in California, you are entitled to certain rights under the California Experiential Research Subject's Bill of Rights. These rights ensure your voluntary participation, respect for your privacy, and access to information about the study. You have the right to receive answers to any questions regarding your participation and to withdraw from the study at any time without repercussion.
HIPAA Waiver
By agreeing to participate in this study, you provide a HIPAA waiver allowing the limited release of your health information as part of this research. This includes data necessary for the study's conduct and oversight. Rest assured, all personal health information will be handled with strict confidentiality and only shared as permitted by law.
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- Authorization and Consent for Diagnostic Testing
- 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:
- 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.
- 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.
- 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.
- 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.
- My health information and results may be shared with CWI employees and agents for the purpose of ordering, processing, and reporting my results.
- 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.
- I authorize CWI to contact me via text message to communicate with me regarding my test.
- Patient Rights and Privacy Practices
- 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.
- 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.
- Release
- 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.
- 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.