
Informed Consent Policy
Informed Consent to Participate in An Early Feasibility Study

Title: Remote Monitoring Mental Health in Police and Public Safety Personnel using a Mobile Application
Sponsor: HealthSmith Medical Inc
Contract Research Organization Obidou Health Informatics
Protocol Number: HSM-005
Principal Investigator: Dr. Antonio Ocana MD
Sub-Investigator: Dr. Mitch Javidi, PhD
24-Hour Phone 604-803-8513
WHAT IS THIS STUDY ABOUT?
-
Police and Public Safety Personnel (PSP), which include first-responders such as fire, ambulance and correctional facility employees, experience much higher rates of physical and psychological trauma than the general population.
-
Not surprisingly, the prevalence of PTSD is 2-3 times higher in PSP than in people employed in other industries.
-
This is a research study of PTSD in PSP.
-
The first phase of the study is to determine the safety and feasibility of the technology as it is applied in collecting and disseminating the data.
-
The technology is a digital health application (App) called Epiphany360. Many police agencies have commissioned similar apps to help manage social-emotional health risks in their members.
-
The data gathered in this 12 week study will be submitted to the US Food and Drug administration (FDA) in order that this app may be recognized as ‘software as a medical device’, to be available in multiple languages, and shared with PSP world-wide.
-
This study includes only individuals who voluntarily choose to participate.
-
Feel free to ask questions about anything you do not understand in this document, or in the study in general.
-
Epiphany360 includes screening, assessment, wellness resources, recommendations and longitudinal follow-up of social-emotional health metrics.
-
This is not a randomized study. Anyone can participate.
HOW LONG IS THIS STUDY? HOW MANY OTHER PEOPLE WILL BE IN THIS STUDY?
The study is for 12 weeks. About 1000 PSP will take part in Phase 1.
WHAT IF NEW INFORMATION BECOMES AVAILABLE?
If new information regarding the safety of digital health platform becomes available, we will let you know.
WHAT WILL HAPPEN DURING THE STUDY?
STUDY PROCEDURES:
Seminar
Onboarding for the study will be preceded by a health and wellness seminar available through your professional organization. The seminar content and resources may be provided live or virtually.
Informed Consent
Before you participate, you will be required to sign a form that says that you understand the risks, benefits and reason for the research.
Preliminary Assessment
If you agree to participate, the following procedures will occur:
-
You will take a confidential web-based assessment on a secure platform from your mobile device.
-
The preliminary assessment consists of 20-30 screening questions in the following categories:
-
Leadership skills
-
Officer wellness
-
Interpersonal skills
-
Mental health resilience
-
Emotional variability
-
Suicide prevention
-
Post-Traumatic Stress Injury
-
Head injury
-
Metabolic heath
-
Based on your answers to the screening questions, you will receive a preliminary report which includes:
-
Your scores represented graphically
-
Interpretation
-
Recommendations
Secondary Assessment
The secondary assessment will invite you to provide more details, to get a more precise view of your social-emotional strengths and challenges, the results of which will form the basis for the secondary report.
Follow your Progress
The answers to your secondary assessment represent your ‘neuro-biological footprint’, a baseline measure of your social-emotional characteristics, retrospectively, over the span of your life. Follow your Progressallows you to see the change in these metrics as you move forward in your life, longitudinally. This allows you to see how any self-management, organizational initiatives, social-emotional or medical interventions affect your scores over the long-term. This is a real innovation which has only become feasible recently as the security of digital health and virtual care have improved and the costs decreased.
Reports
You can receive your reports by email as a pdf, or see them on your personalized dashboard when you log into our secure platform.
WHAT ARE THE POSSIBLE RISKS AND DISCOMFORTS OF PARTICIPATING
Social-emotional assessment can trigger some uncomfortable feelings. You may:
-
Worry about your privacy
-
Be 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. That’s OK too. Feel free to schedule a follow appointment with Dr. Ocana, or your care team.
For more information about risks and side effects, ask the study doctor, Dr. Ocana.
HOW ARE WE MINIMIZING THE RISKS?
The Investigators, seminar, consent document, protocol, assessments, reports and follow-up questions and financial disclosure will already have been reviewed, approved and a certificate of action issued by an independent ethics review board, WCG IRB, Puyallup, WA, USA.
WHAT ARE THE BENEFITS?
Your participation in this study is not meant to prevent, diagnose or treat any disorders, conditions or disease. This is a non-medical initiative. Subjects participating in this study may or may not derive any direct benefit. However, in previous similar studies subjects have benefitted in a number of ways:
-
Learned about their social-emotional health in general
-
Used the results to connect with their care team
-
Helped others with similar challenges
-
Felt more involved in their care
-
Had better outcomes
WHAT, IF ANY, ARE THE ALTERNATIVES TO PARTICIPATION?
You can explore your mental health in other ways:
-
Take other screening assessments
-
Connect with your care team, even without participating in the study.
Or you can choose to not address your social emotional health at this time.
INFORMED CONSENT
By electronically signing this consent document, on your mobile device, you will be given 3 choices regarding your participation:
1. Agree to allow us to collect this information, participate in the 12 weeks study and allow us to publish your anonymous responses in a scientific journal
2. Agree to participate in the study, but not use your anonymous responses for any further purpose
3. Choose not to participate
CONFIDENTIALITY
This level of confidentiality is unprecedented. It has also only recently become affordable. Thus allowing us to include organizations that are geographically dispersed and people of all cultures and orientations.
-
Your administrative information and your health information are kept in two separate databases and can only be joined by two factor identification and a unique identifier, so that we can send your report to you and ensure that it is not misdirected.
-
We will not connect any name or organization with the study results to begin with.
-
Your study results will then be further de-identified by removing the date and your IP address. They will be truly anonymous, and therefore confidential.
-
Any personal identifying information you inadvertently provide, will be electronically deleted.
-
Your de-identified information will then be encrypted, transmitted securely and stored in your home state with two encryption keys stored separately. If anyone were to hack either database, all they would find would be gibberish.
-
Only you can connect your name and your health information.
-
Only you can access, update or share your information. You can share your report with members of your care team, or keep it to yourself. It’s your choice.
Aggregate (combined), and de-identified data of groups (not individuals) of PSP may be made available to your or other police organizations in order to improve 1) the health and wellness of their employees and 2) the financial viability of the organization.
We use your data in compliance with all state, national and international laws, most applicable in this case would be HIPAA (Health Information Portability and Accountability Act). A good summary of the main elements of HIPAA rules can be found at https://www.hipaaexams.com
We only use HIPAA compliant data processing partners. Our security protocols meet the highest standards in Canada, the US and the EU.
With your consent (see above) we may share your de-identified information for research, teaching, publication or to improve the mental health system.
Other third parties, under confidentiality agreements, may view your de-identified information including:
-
The study staff and other researchers involved in the study
-
HealthSmith Medical Inc, the Contract Research Organization (CRO), Epiphany Digital Health Solutions (The Sponsor) or those who work for or represent them
-
The researchers of any academic institution with which we may partner.
-
The U.S. Food and Drug Administration (FDA), The Canadian Health Protection Branch or other scientific regulatory bodies
-
WCG, the independent review board and any of their staff
-
The staff of any scientific publication to whom we may submit this data for review
The results from the study, may be published for scientific purposes.
There are some very rare situations (outside the bounds of this study) 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.
WHAT ARE THE COSTS?
There is no cost to you associated with participating in any part this study. You are responsible for your regular health care while in this study.
INVESTIGATOR CONFLICTS OF INTEREST
Neither the Principal Investigator or the Sub-investigator will be paid for or directly involved in data collection or analysis. They may benefit indirectly from the outcome of the study. Any potential conflicts have been reported in a Financial Interest Disclosure Report available on request from WCG IRB.
The research organization conducting this study may be paid from research funds allocated by a third party for cost recovery.
COMPENSATION
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 as a direct result of participating in this study, please contact the study doctor promptly. The study doctor will contact your provider or make any referral necessary to help you promptly recover, but our liability is limited. Your insurance will be billed for any medical treatment. The study Sponsor will not be responsible for costs not covered by your insurance or by third party payors.
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. Leaving the study will not result in any penalty, negative consequence or loss of benefits to which you are entitled. However, if you are considering ending your participation in the study, please let the study doctor know.
YOUR RESPONSIBILITIES AS A RESEARCH SUBJECT
You will be asked to follow the instructions issued by the study staff, but this is voluntary. This study and the associated interventions are for your benefit directly and for your organization indirectly.
Previously, it was operationally impossible to completely protect your confidentiality. Therefore, is understandable that you should want to avoid divulging certain elements of your social emotional health. But technology has dramatically improved the security and confidentiality of your data. Therefore, to optimize the benefits, it is recommended that you answer the study questions as truthfully as you can.
Your study doctor may also exclude you from this trial for your benefit, to protect 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 for information about the study or a research-related injury, contact the study doctor at the number on page 1.
SIGNATURE AND CONSENT
Your validated electronic signature below means that:
-
You have read and understood the above information.
-
You have had a chance to ask questions, and those questions were answered to your satisfaction.
-
You are aware that you can change your mind, to participate or nor participate, at any time.
-
You agree that your rights to compensation for damages have limits.
A copy of this agreement can be sent to you by e-mail, or you may choose to print it from your device.
________________________________________________ _________/________
SIGNATURE OF SUBJECT DATE
________________________________________________
PRINTED NAME OF SUBJECT
________________________________________________ _________/________
LEGALLY AUTHORIZED REPRESENTATIVE (if applicable) DATE
________________________________________________
PRINTED NAME OF LEGALLY AUTHORIZED REPRESENTATIVE (if applicable)
I confirm that a copy of this consent form has been made available to me or my representative to read and consider at a later date.
_______________________________________________ __________/________
SIGNATURE OF PERSON OBTAINING CONSENT DATE
Dr. Antonio Ocana MD
_______________________________________________
PRINTED NAME OF PERSON OBTAINING CONSENT