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Informed Consent

Consent to Participate in An Early Feasibility Study

 

TITLE:                                   E360 - A Social-Emotional Health Assessment

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PROTOCOL NO.:                HSM-006

                                              ASPIRE® Protocol #20193002

 

SPONSOR:                           Obidou Health Informatics

 

INVESTIGATOR:                  Antonio Ocana, MSc, MD, FCCFP, FABAM

                                               1968 S Coast Hwy  Suite 3664

                                               Laguna, Beach CA 02651 

                                               aocana@epiphany360.io

                                               604-803-8513 (24 Hour)

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This is a research study. You are being asked to take part in this study because you are a member of the community, not necessarily receiving mental health care. This study includes only individuals 18+ years of age, who voluntarily choose to participate. Please take your time to make your decision. Discuss it in confidence with your regular doctor, friends and family if you want. If there is anything you do not understand in this document, please email us at aoacana@epiphany360.io

 

WHAT IS THIS STUDY ABOUT?

The purpose of this study is to look at new technology, E360 as it applies to mental health. The screening, assessment and monitoring tool called E360 is investigational, which means that it is not yet approved by the Food and Drug Administration (FDA).

 

This research is being done to establish a baseline of the burden of mental health challenges in a diverse sample of the general public.

 

This is not a randomized clinical trial. It is a device feasibility study to demonstrate the safety and efficacy of a cloud-based community mental health assessment. There is no diagnosis or treatment included in this study. We will be conducting pre-screen assessment with a sub-set of participants to finalize the protocol.

 

HOW MANY OTHER PEOPLE WILL BE IN THIS STUDY? HOW LONG IS THIS STUDY?

Up to 500 people may take part in this study.  You will be in the study for about 12 months depending on whether you choose to be monitored.

 

WHAT IF NEW INFORMATION BECOMES AVAILABLE?

If new information becomes available, we will let you know. 

 

WHAT WILL HAPPEN DURING THE STUDY?

If you agree to take part in this research study, you will be required to sign this informed consent form.  

 

STUDY PROCEDURES

If you agree to participate, the following procedures will occur:  

  • You may use your mobile device to participate in this research

  • You will take a confidential cloud-based assessment of your mental health.

  • The assessment consists of 16 yes or no questions, some questions about your use of drugs and alcohol, and questions about your personality.

  • If you screen positive in any domain, a further series of 5-6 questions will be asked to determine the severity of the symptoms. 

 

Based on your answers, the counselor will make some recommendations or suggest a referral for further care; however, you will not receive treatment as part of this research.

 

  • If you accept to be monitored, you will get regular follow-up emails to monitor your progress.

  • We can send a copy of your results which you can share with your family or your care team. Or, you can login to our website to see your social-emotional wellness dashboard

  • An end-of study interview a report will be generated. You can share the report to inform your further care.

 

You may have additional assessments or tests at your care-team’s discretion.

 

Please tell any other health care providers that you are participating in this research study.

 

WHAT ARE THE RISKS OF PARTICIPATING IN THIS STUDY?

Screening can trigger some uncomfortable feelings. You may:

  • Worry about your privacy

  • e uncomfortable sharing your feelings

  • Not want to admit that you’re struggling

 

These are all normal feelings, they should pass. In some cases, these feelings may persist and you may want to withdraw. Feel free to schedule a follow appointment with us or your care team. 

 

For more information about risks and side effects, see our website or make an appointment with Dr. Ocana.

 

ARE THERE BENEFITS TO TAKING PART IN THE STUDY?

Subjects participating in this study will not derive any direct medical benefit. However, in previous similar studies subjects have benefitted in a number of ways:

 

  • Learned about their mental health in general

  • Explored their own mental health and got help

  • Helped others

  • Felt more involved in their care

  • Had better outcomes by being monitored

 

Your current participation constitutes a baseline measure of the impact of COVID-19 on your mental health. Your future participation will contribute to our understanding of the long-term effects of pandemics on mental health. You are also helping us gain further knowledge about the safety and efficacy of cloud-based mental health assessments like Ephiphany360.

 

WHAT ARE THE ALTERNATIVES TO PARTICIPATING IN THIS STUDY?

The web-based screening tool will give your care givers important information about you. It is not, by itself, designed to diagnose, treat or prevent any disease.

 

You can explore your mental health in other ways:

  • Take other screening assessments

  • See your counselor or physician of your own accord

 

Or you can choose not to participate.  

 

CONFIDENTIALITY

By signing this document, you agree to allow us to collect this information through your mobile device, but any further participation is at your discretion. We will not collect any personal information. Your de-identified information will be encrypted, transmitted by SSL and stored in your home state. We only use HIPAA compliant cloud partners. Our security protocols meet the highest standards in Canada, the US and the EU. We cannot guarantee absolute confidentiality. With your permission, we  may share your de-identified information for research, teaching or to improve the mental health system. 

 

Other third parties, under confidentiality agreements, may inspect and copy your de-identified information for research, teaching, quality assurance, data analysis or to improve the mental health system, including:

  • The study staff and other researchers involved in the study

  • HealthSmith Medical (Sponsor of this study) or those who work for or represent the Sponsor

  • The U.S. Food and Drug Administration (FDA); the Canadian Health Protection Branch or other regulatory agencies

  • Aspire Independent Review Board (IRB)

 

The results from the study, may be published for scientific purposes.

 

There are rare situations that may dictate that your personal information is required to be disclosed by law to another entity. For example, if we become aware that you may present a danger to yourself or others, but that is part of the usual care-giver – patient relationship and would be outside the bounds of this study.

 

WHAT ARE THE COSTS?

There are no additional costs associated with being in this study.  You will not have to pay for the screen, secondary assessment, recommendations, referral or monitoring during this study. You are responsible for your regular health care while in this study.  

 

INVESTIGATOR PAYMENT                                       

Obidou Health Informatics and Dr. Ocana are conducting this study at their expense.

 

WILL YOU BE COMPENSATED DURING THE STUDY?

You will not be compensated for participating in and completing this research study

 

WHAT HAPPENS IF YOU HAVE COMPLICATIONS OR ARE INJURED?

If you have serious side effects, complications or are injured because of participating in this study, please contact the study doctor promptly.  The study doctor will provide any necessary treatment to help you promptly recover, but our liability is limited.  Your insurance will be billed for the medical treatment and the study Sponsor will pay for the costs not covered by your insurance or by third party governmental programs.  Such reimbursement will be offered only for reasonable costs and only if the injury is a direct result of the study. 

 

WHAT ARE YOUR RIGHTS AS A RESEARCH SUBJECT?

Taking part in this study is voluntary.  You may choose not to take part or may leave the study at any time. Choosing not to participate or leaving the study will not result in any penalty or loss of benefits to which you are otherwise entitled.  However, if you decide to stop participating in the study, we encourage you to talk to the study doctor and your regular doctor first.  

 

WHAT ARE YOUR RESPONSIBILITIES AS A RESEARCH SUBJECT?

You will be asked to follow the instructions issued by the study staff, but this is voluntary. For the best results, it is recommended that you answer all questions truthfully. 

 

Your study doctor may also exclude you from this trial if he/she deems it beneficial for your health, or if you do not meet the study requirements.   Your participation in this study may be ended if the Sponsor stops the study for any reason.  

 

WHOM TO CALL IF YOU HAVE QUESTIONS

For questions, concerns or complaints or information about the study or a research-related injury, contact the study doctor at the number on page 1.

 

This research is being overseen by Aspire Independent Review Board (“IRB”). An IRB is a group of people who perform independent review of research studies. You may talk to them at 1-877-366-5414 (toll free) if: 

 

  • You have questions, concerns, or complaints are not being answered by the research team.

  • You are not getting answers from the research team.

  • You cannot reach the research team.

  • You want to talk to someone else about the research

  • You have questions about your rights as a research subject

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Informed Consent

Your signature below means that you have read the information above and you are aware and understand what you are being asked, and that any questions you had were answered. You are also aware that you can change your mind, any decision you make will not affect your care, and by signing this consent form, you are not giving up any of your legal rights.  You can download a signed and dated copy of this agreement.

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Copyright. No words or images from this website may be copied.This website is intended for general guidance only, not as a substitute for detailed research or the exercise of professional  judgment. The information herein provided is on an “as is” basis and Obidou makes no representations or warranties, express or implied. This information is not meant to diagnose, treat or manage any mental health condition. If you are concerned about your mental health, please see your primary care provider or go to the nearest hospital emergency service.

© 2025 by Epiphany360

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