Biolife Advance NF Informed Consent
Biolife Health Research
Informed Consent Form for Participant
This Informed Consent Form is for adult men and women who are invited to participate in a research study on a health App trial called Biolife Advance NF - Remotely Guided Integrated Behavioral Health.
The title of our research project is: Testing of Biolife Advance NF to Evaluate the Performance, Effectiveness, and Usability of the App. The App is designed to help in conditions such as anxiety, stress, ADHD, depression, mood, peak performance, drug addiction, PTSD, and other conditions.
Name of Principal Investigator: David Priede, Ph.D.
Name of Organization: Biolife Health Research
This Informed Consent Form has two parts:
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Information Sheet
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Certificate of Consent
You will be given a copy of the full Informed Consent Form.
PART I: Information Sheet
Introduction
Biolife Health Center, LLC is researching a health App designed by NewroFlow and to be implemented in a proprietary health system called Biolife Advance NF. This system uses a multitude of modalities, and this test is part of one of such.
There may be some areas of this document that you do not understand. Please feel free to ask us any questions you may have by calling the Principal Investigator at 954-655-9539 or by emailing admin@biolifeHCresearch.com.
Purpose of the research
The purpose of this research is to obtain your feedback on the following areas of the App:
1. Ease of use and design (qualitative data).
2. Content (questionnaires, multimedia, exercises, and reading material).
3. Get data on your results (quantitative data).
Type of Research
This research evaluates the Biolife Advance with the Neuroflow modality only. Biolife Advance NF comprises multiple modules, and this research is only a part of the overall program. We are interested in your observations and what you like and dislike about our services. And the effectiveness of the health improvement programs.
Participant selection
We are inviting adults (male, female, non-binary) who are willing to participate as users of the health program.
Voluntary Participation
Your participation in this research is entirely voluntary. It is your choice whether to participate or not. You may change your mind later and withdraw your participation, even if you agreed earlier.
Procedures and Protocol
This research will involve completing an online health questionnaire, downloading the App to your phone or tablet (Apple or Android), and using the App 3-5 days per week. The App will send you a notification when it’s time to do a session. Each session lasts 5-15 minutes and can be conducted at any time of day.
The App includes a journal section. After every session, we would like to write down your observations. We will have access to your valuable observations after every session and include them in the research documentation.
Duration
The research was conducted over a period of one month.
Risks
We do not foresee any risks, as this is an evaluation research study of an App.
Benefits
If you participate in this research, you will have the following benefits: the Biolife Advance NF is a health improvement program. During the process, you may benefit from the health improvement features it provides. Your participation will help improve Biolife Advance NF, ultimately enhancing the overall health of future participants.
Reimbursements
Your participation is free. You will not be given any other money or gifts to take part in this research.
Confidentiality
It is possible that if others in the community are aware that you are participating, they may ask you questions. We will not disclose the identities of those participating in the research.
The information collected from this research project will be kept confidential. Information about you that will be collected during the research will be encrypted and stored on our servers by the Information Security Management System (ISMS) standard, ISO/IEC 27001 and 27002.
Only the researchers will have access to it. Any information about you will have a number instead of your name. Only the researchers will have access to your number, and we will keep that information secure. Your information will not be shared with or given to anyone except Biolife Health Center Research Division researchers.
Sharing the Results
The knowledge gained from this research will be shared with you through the App and in personal or online sessions via video conferencing. Confidential information will not be shared after the results are analyzed and tabulated. After the research is completed, the results will be used to improve the App, intake, evaluations, and other procedures.
Right to Refuse or Withdraw
You do not have to take part in this research if you do not wish to do so. You may also stop participating in the research at any time you choose. It is your choice, and all of your rights will still be respected.
Who to Contact
If you have any questions, you may ask them now or later, even after the study has started. If you wish to ask questions, you may contact David Priede, Ph.D., at (954) 655-9539 or via email at admin@biolifeHCresearch.com.
PART II: Certificate of Consent
I have read the foregoing information, or it has been read to me. I have had the opportunity to ask questions about it, and any questions that I have asked have been answered to my satisfaction. I voluntarily consent to participate in this research.