Informed Consent to Participate in a Research Study for Grounding Innovations
Title of Research Project: Posttraumatic Stress Intervention Electronic System
PURPOSE AND BACKGROUND
Tikvah Ivri with Grounding Innovations is conducting research on the effectiveness of an electronic-based posttraumatic stress intervention system. The purpose of your participation in this
research is to help the researcher is to (1) identify the systems overall effectiveness, (2) determine system limitations, (3) Identify which activities are most effective in reducing posttraumatic stress symptoms. You were selected as a possible participant in this study because you exhibit 5 or more PTSD symptoms per the DCM-5 criteria and you agree to submit constructive feedback after each use. NOTE: If Researcher is not the Principal Investigator, add information regarding supervision of researcher.
If you agree to participate in this research study, the following will occur: The research study will take place via electronically. Feedback is provided at the close of the program. The amount of time it takes to use the system depends on symptom severity. In other words, the duration of the program hinges upon the persons willingness to rate their symptoms and submit a brief survey before closing the program. The time can range between 15 and 25 minutes.
The survey comprises the following questions.
- Question: My symptoms were ______ before using this app.
- Answers: Extremely High, Very High, High, Moderate, Mild
- My Symptoms were ______ after using this app.
- Answers: Extremely High, Very High, High, Moderate, Mild
- Were the activities helpful?
- Answers: Yes, No
See Liability Waiver
Grounding Innovations will not collect personal identifiable information. Individuals using this system will be assigned randomized identification numbers associated with devices, not a person. We ensure absolute privacy and confidentiality for individuals using or participating in this study. For individuals participating in Beta Testing are required to submit their email address to gain access. Once the device becomes public, no email address is required.
The study will rely heavily on survey analytics using SPSS and Google Analytics. All data collection, retention, trade secrets, analyses and summaries will be stored separately and secured at all times. Any statistical data will be used to improve the systems efficacy.
BENEFITS OF PARTICIPATION
There will be no direct benefit to you from participating in this research study. Any statistical data will be used for system reliability, effectiveness, and enhancement.
Your decision whether or not to participate in this study is voluntary and will not affect access to the intervention system.
If you have any questions about the study, please contact Tikvah Ivri by firstname.lastname@example.org
BY REGISTERRING TO BE A BETA TESTER AND DOWNLOADING THE APPLICATION TO YOUR ELECTRONIC DEVICE YOU AGREE TO PARTICIPATE IN THIS STUDY. BY CLICKING AGREE, YOU HAVE DECIDED TO PARTICIPATE IN THE STUDY AFTER READING ALL OF THE INFORMATION ABOVE AND YOU UNDERSTAND THE INFORMATION WRITTEN AND YOU MAY PRINT THIS PAGE AS YOUR COPY OF THE INFORMED CONSENT OR REFER TO OUR WEBISTE ANYTIME.
GROUNDING INNOVATIONS LIABILITY WAIVER
This waiver of liability includes any risk of engaging in posttraumatic stress intervention device (P.T.I.D.) activities or other services provided by the Grounding Innovations. Please read the below medical waiver and disclaimers carefully before using the Posttraumatic Stress Intervention Device (P.T.I.D) or accessing any material, information or services through the electronic systems.
WHAT TO EXPECT
Because our system serves as an earthing (grounding) tool, there will be significant visual, audio and tactile sensations. This is by design. Although we made every effort to prevent triggering events, this does not guarantee a person will not be triggered during system usage.
While program is running:
- Expect significant PHYSICAL SENSATIONS such as pulses, vibrations, tactile feedback and sound with your electronic device and paired wearable
- Expect significant visual imagery to include images, colors and frequent image and color changes.
- Expect frequent audio sounds that vary in duration, pitch and noise depth.
THIS SYSTEM COMPRISES VISUAL, AUDIO AND PHYSICAL SENSATIONS THAT MAY STARTLE OR CAUSE ALARM. THIS IS BY DESIGN AND IS INTENDED TO ENGAGE AND DISTRACT THE USER. THE PROGRAM GRADUALLY AND SYSTEMATICALLY REDUCES ANXIETY.
TACTILE SENSATIONS, SOUNDS AND IMAGES MAY BE DISTURBING AND STARTLING. USE OF THIS SYSTEM AND ENGAGEING IN ACTIVITIES THEREIN MAY CAUSE UNWANTED SIDE EFFECTS TO INCLUDE, TRIGGER UNWANTED PHYSIOLOGICAL RESPONSES AND OR INCREASING PSYCHOLOGICAL AND EMOTIONAL STRESS, OR INCREASE UNWANTED SYMPTOMS FROM OTHER MENTAL DISORDERS.
DISCONTINUE USE IF YOUR SYMPTOMS OR CONDITION WORSENS DURING ACTIVITIES.
If you are experiencing mental health issues, neurological issues, addictions, eating disorders, or suicidal thoughts you should seek the assistance of appropriate mental health and care professionals. If you feel psychologically stressed to the point that it is interfering with your ability to function, please seek the help from your doctor or a mental health professional.
LIABILITY WAIVER TERMS AND CONDITIONS
By downloading, using or engaging in activities in the application you agree to the following terms:
- I understand that using the Posttraumatic Stress Intervention Device (PTID) to include downloading the application, launching the system, engaging in activities therein, and utilize resources on our company website and any other service provided by Grounding Innovation, services do NOT substitute for clinical mental health care or medical care and DO NOT assess, diagnose, treat or cure any mental health or medical conditions.
- I understand that this system is not recommended by a therapist or medical professional.
- I understand that this system is not a substitute for mental health or medical or coach is not acting as a medical professional.
- I understand that this system does not assess, diagnose, treat or cure any mental health condition or medical condition.
- I understand and authorize the use of my camera, alerts, and microphone and authorize the application to use.
- I understand the camera and microphone is only active during activities and will NOT record images or sounds, or store images or audio clips during activities on any system.
- I understand that we will NOT collect any personal identifying information.
- I understand the system will collect usage statistical data to include duration of system use, activities use, duration of activities, activity response times, and system crashes.
- I understand that the use of technology is not always secure and accept the risks of confidentiality in the use of email, text, phone, and other technology.
- I understand and agree that I am fully responsible for my own well-being during my use of system, and subsequently, my choices to continue or discontinue usage.
- I understand that downloading, activating and engaging in activities in the system are my choice and my own free will.
- I also understand that for all legal purposes, the services provided by this system will be considered to be under State of Colorado revised statutes.
- I understand that Grounding Innovations and its staff, members or any other affiliates, reserve the right to refuse access to our services.
- In consideration of being permitted to participate in the calls, I, for myself, my heirs, next of kin, personal representatives or assigns, do hereby covenant not to sue the Grounding Innovations, its associates, members, and release, waive, and discharge all parties from all liability for injury, death, accidents, illness, loss of income, property damage or any other loss sustained by me as a result of my participation in activities related to Grounding Innovations, it’s technology and systems due to any cause whatsoever, including, without limiting the generality of the foregoing, breach of contract, negligence, or breach of any statutory or other duty of care by the Grounding Innovations, partners, creators, associates, and members.
- I also agree to indemnify and hold harmless Grounding Innovations, its members, system creators, and associates from any and all claims, actions, suits, procedures, costs, expenses, damages, and liabilities, including legal costs and fees brought as a result of my involvement and participation in any service provided by Grounding Innovations and to reimburse any such expenses incurred.
- I hereby release, waive, acquit and forever discharge Grounding Innovations, any agents, staff member, successors, assigns, personal representatives, executors, heirs and employees from every claim, suit action, demand or right to compensation for damages I may claim to have or that I may have arising out of downloading, launching, engaging, using that otherwise resulting from the coaching relationship contemplated by this agreement. I further declare and represent that no promise, inducement or agreement not expressed in this agreement has been made to me to sign this agreement. This agreement shall bind my heirs, executors, personal representatives, successors, assigns, and agents.
- Acknowledgment of Understanding: I have read this agreement, fully understand its terms, and understand that I am giving up substantial rights, including my right to sue. I acknowledge that I am signing this agreement freely and voluntarily, and intend by my signature to be a complete and unconditional release of all liability to the greatest extent allowed by law.
By submitting my email, I agree to the terms written in the Liability Waiver Agreement and Informed Consent in order to be an applicant for the Android BETA Test Program.