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
INFORMED CONSENT DOCUMENT
AGREEMENT TO BE IN A RESEARCH STUDY
| Field | Information |
|---|---|
| Study Title | Can EmeraldLED reshape your body with continued use? |
| Study Author | Ryan Junk |
| Sponsor | This study is made possible by your payment to join. |
| Cost of Products, Services & Information to Participant | $599 to $799 USD (Depending on location. You may have already paid for some or all of this amount.) |
| Included Products & Services | EmeraldLED service, 30 days of guided Green Light Therapy sessions, access to all study surveys and assessments |
| Outcome Measures | Body Composition Measurement Form; Quality of Life and Health Survey; Body Image and Self-Perception Survey |
| Contact | help@efforia.com |
👍 The table above provides a summary. You may sign now and continue, or read more detail below.
Introduction & Summary
Welcome to the “Can EmeraldLED reshape your body with continued use?” study. This study is designed to help us learn whether ongoing usage of green light therapy by active users of the EmeraldLED service can support positive changes in body composition and overall well-being.
In this study, you will use the EmeraldLED service for 15 minutes, two times a week, for 30 days. We will ask you to complete simple surveys and measurements at the beginning, middle, and end of the study.
You may wish to participate if you are curious about how ongoing green light therapy could impact your wellness, enjoy tracking your own health data, and want to contribute to new scientific knowledge.
You may not wish to participate if you are uncomfortable with light therapy, do not wish to pay the participation fee, or are unable to commit to the schedule.
Because the cost to participate ranges from $599 to $799 (depending on location. You may have already paid some or all of this amount), we want to be very clear:
- This study is experimental and may or may not benefit you personally.
- You are paying to receive the service, access to the structured study, and your own results.
- You should only participate if you feel comfortable with the risks, costs, and time commitment.
Purpose of the Study
The purpose of this study is to explore whether ongoing green light therapy, using the EmeraldLED service, may have measurable effects on body composition, body image, and quality of life over a 30-day period.
You will receive the EmeraldLED service and follow a specific schedule of use, along with completing health and wellness surveys and body composition measurements. These will help us see if any changes occur during the study period.
To measure prior usage, we will receive data from Beem Light Sauna's internal client management & scheduling system to identify prior usage of EmeraldLED.
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 contacting help@efforia.com or via chat.
Study procedures after enrollment:
- Baseline – Complete Body Composition Measurement, Quality of Life Survey, and Body Image and Self-Perception Survey.
- Intervention – Use the EmeraldLED service for 15 minutes, twice a week, for 30 days.
- Midpoint – Repeat measurements and surveys.
- Final – Complete final measurements and surveys.
The Risks, Discomforts & Benefits of Being in this Study
Possible Serious Adverse Events & Side Effects
| Risk Name | Likelihood | Summary |
|---|---|---|
| Eye strain or discomfort | Low | Possible temporary discomfort from light exposure. |
| Mild skin irritation | Low | Rare redness or itching in treated areas. |
Some People May be at Increased Risk
| Who Should Avoid the Study | Why |
|---|---|
| Pregnant, thinking of becoming pregnant, or breastfeeding | Safety for you and your baby has not been established |
| People with certain eye conditions | Potential worsening due to light exposure |
Consider Your Own Risk-Benefit Comfort Level
Not all risks and benefits are known. Please consult your healthcare provider before enrolling.
Privacy & Security Risks
Your data will be stored securely. However, any time personal information is collected, there is a small risk of accidental disclosure.
The Possible Benefits of Participating — Personal and Overall Findings
You may learn more about your body composition, mood, and quality of life changes over the study period. Your participation will also help expand knowledge about green light therapy.
What to Do if You Have a Study-Related Injury
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.
In the Case of Medical Emergency
After contacting emergency services, notify the study team at help@efforia.com. Our support team is available Monday–Friday, 9 AM–6 PM and aims to respond within 24 hours. Outside these hours, please seek urgent care first and inform us as soon as possible
Alternatives to Participating in the Study
You may choose not to participate. Green light therapy services may be available for personal purchase without joining a research study.
Your Rights as a Participant
Participant Rights
Your participation in this research study is voluntary. Refusing to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are entitled. If you decide to join the study, you may withdraw at any time and for any reason without penalty or loss of benefits.
New Information and study results
If information generated from this study is published or presented, your identity will not be revealed. In the event new information becomes available that may affect the risk or benefit associated with this study or your willingness to participate in it, you will be notified so that you can decided whether or not to continue participating.
Confidentiality & Privacy
The researchers will only use and share information that is needed for the study.
The researchers will protect your information, as required by law.
Absolute confidentiality cannot be guaranteed because persons outside the study team may need to look at your study records.
The Efforia Institutional Review Board may review your study records, and other agencies, committees, and offices that review and monitor research studies. The purpose for using and sharing your information is to make sure the study is done properly.
By signing this consent form, you are giving permission for Efforia to use and share your health information. If you decide not to sign the form, you cannot be in the study.
Rights to Request
Person of the gender of your choosing to assist with taking measurements.
Conflict of Interest Statement
Ryan Junk, is the Chief Executive Officer of Beem, the company offering the green light therapy service being studied. Beem provides the service to participants who purchase it, and the study's device is manufactured by Summus Laser. This relationship could be considered a potential conflict of interest because Ryan’s employment at Beem may influence, or be perceived to influence, how the study is conducted or reported.
Efforia, the organization overseeing the study, does not own any intellectual property related to the EmeraldLED service or Summus device, does not receive payments from Summus Laser, and does not benefit financially from the study’s results. To protect participants, the study is reviewed by an independent ethics review board (IRB) and will follow established research ethics guidelines. Your participation is completely voluntary, and choosing not to participate will not affect your access to services or products from Beem, Efforia, or Summus Laser.
We affirm that the study is being conducted to gather data, not solely to promote sales.
Data Protections
What You Can Do to Improve Privacy and Security
Use strong passwords and keep your account information private.
Who Will Have Access to Your Data
Only the research team and authorized Efforia staff.
What Will We Do With Your Data
We will use it to assess study outcomes and may publish anonymized, combined results.
California Experiential Research Subject’s Bill of Rights
As a participant, you have the right to be treated with respect, to know the risks and benefits, and to withdraw at any time. You may request a full copy of your rights by contacting help@efforia.com.
Questions or Concerns
This study has been reviewed by the Efforia Institutional Review Board (IRB).
Independent experts who help protect the rights, safety, and well-being of research participants.
If you have questions about your rights as a participant or would like to speak with someone outside the research team, you can contact the IRB at ethics@efforia.com
Efforia and Efforia IRB have approved the information in this consent form and have given approval to publish this study. This does not mean Efforia or Efforia IRB 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.