A spoken memory exam is only meaningful if we know what a normal result looks like at every age. Building that requires volunteers, and this study is recruiting now.
Your consent form is below. Read it through, and if you are happy to take part you can give your consent at the end of it.
Research Participant Consent Form
Title: Establishment of Age-, Sex-, and Education-Stratified Normative Data for a Fully Digital Voice-Recognized Neurocognitive Testing Platform in Adults Aged 18-100 Years
- Protocol No.
- Intra001 - WCG IRB Protocol #: 20261020
- Sponsor
- Intraneuron, LLC
- Investigator
- Gregory Sahagian, MD
- Email
- research@intraneuron.com
Research Consent Summary
You are being asked for your consent to take part in a research study. This document provides a concise summary of this research. It describes the key information that we believe most people need to decide whether to take part in this research. Later sections of this document will provide all relevant details.
Your participation in this study is voluntary. You may decide not to participate or you may leave the study at any time. Your decision will not result in any penalty or loss of benefits to which you are otherwise entitled.
If you have questions, concerns, or complaints, or think this research has hurt you, talk to the research team at the phone number(s) listed above.
Dr. Gregory Sahagian owns private equity stock in the sponsor company. Please feel free to ask any further questions you might have about this matter.
How long will I be in this research?
About 20 to 30 minutes for one online session. Some participants may be invited to complete a second session 2 to 4 weeks later (about 25 to 35 minutes).
Why is this research being done?
To establish typical (normative) score ranges for a fully digital, voice-recognition-based set of cognitive tasks in adults ages 18 to 100 years. These norms will help interpret scores by age, sex, and education and support research and clinical use of the platform.
What happens to me if I agree to take part in this research?
You will (1) complete this electronic consent, (2) answer a brief online screening questionnaire about your background and health, and (3) complete a series of short, voice-based cognitive tasks (for example, generating words, naming images, repeating or recalling information, and other brief timed tasks). Your spoken responses will be recorded and analyzed by the platform. You may take breaks or stop at any time.
Could being in this research hurt me?
The most important risks or discomforts include mild fatigue, frustration, or feeling uncomfortable if you think you did not perform well. Some screening questions ask about mood and anxiety, which some people may find sensitive. There is also a small risk of loss of privacy if research data were accessed without permission, but we use safeguards to reduce this risk.
Will being in this research benefit me?
It is not expected that you will personally benefit from this research. Possible benefits to others include improved understanding of typical cognitive performance using digital voice-based testing and the development of better screening and monitoring tools.
What other choices do I have besides taking part in this research?
Your alternative is to not take part in the research.
What else should I know about this research?
This research is not designed to diagnose, treat, or prevent any disease, and you will not receive diagnostic feedback or medical advice from your results. You will need a quiet space and a device with internet access and a working microphone. You can choose whether your deidentified data may be used for future research.
There is a possibility that your deidentified information (including deidentified voice recordings and test results) may be used or shared for future research studies without asking you again. You will be given an option to allow or decline future use.
Detailed Research Consent
The purpose of this research is to create normative reference values for a fully digital, voice-recognition-based neurocognitive testing platform in adults ages 18 to 100 years. We will use your results, along with results from other adults, to understand typical ranges of performance by age, sex, and education. About 800 to 1,200 participants will take part in this research.
What happens to me if I agree to take part in this research?
This study is done through a secure web-based platform. If you agree to take part, you will be asked to:
- Provide electronic consent.
- Complete a brief online screening questionnaire (demographics, education, and health history; includes brief mood and anxiety questionnaires).
- Complete a series of short, voice-based cognitive tasks. Tasks may include speaking words that fit a rule (for example, words starting with a letter or belonging to a category), naming images, repeating sequences, and recalling information after a short delay.
- Allow the platform to record your spoken responses for automated scoring and quality review.
You may complete the study at home or another private location using a computer, tablet, or smartphone with a working microphone and internet connection.
What are my responsibilities if I take part in this research?
- Complete the questionnaires and tasks to the best of your ability.
- Use a quiet space and speak clearly so the voice-recognition system can capture your responses.
- Tell the study team if you experience significant distress during the study.
- Avoid having another person coach you or answer for you while you are completing the tasks.
Could being in this research hurt me?
This research is considered minimal risk. You can take breaks, skip any question you do not want to answer (unless it is needed to determine eligibility), or stop participating at any time. If any question makes you uncomfortable, you may stop and contact the study team. If you are in immediate danger, call 911.
Will it cost me money to take part in this research?
There is no cost to you. You are responsible for any usual costs of using your own device and internet connection.
What happens to the information collected for this research?
We will collect information you provide in questionnaires and your performance and voice recordings from the digital tasks. When possible, your research data will be labeled with a study ID rather than your name. Contact information (if collected for compensation or follow-up) will be stored separately from research data.
We may publish the results of this research. However, we will keep your name and other identifying information confidential. We protect your information from disclosure to others to the extent required by law. We cannot promise complete secrecy.
We plan to keep deidentified research data for up to 10 years for analysis, publication, and regulatory documentation.
Who can answer my questions about this research?
If you have questions, concerns, or complaints, talk to the research team at the phone number(s) listed at the top of this form. This research is being overseen by WCG IRB. You may contact them at 855-818-2289 or clientcare@wcgclinical.com.
Intraneuron, LLC can be contacted at research@intraneuron.com or 153 South Sierra Ave #1429, Solana Beach CA 92075, or (858) 230-8480
Will I be paid for taking part in this research?
For taking part in this research, you may be paid up to a total of $20 — up to $10 for the main session and up to an additional $10 for the optional second (test-retest) session.
Statement of Consent
By confirming below, you indicate that you have read this form, your questions have been answered, and you agree to take part in this research.