Informed Consent to Participate in Research

and

Authorization to Use and Disclose Protected Health Information

Study Title

Effects of AI-Generated Chills-Eliciting Audio on Depression, Anxiety, and Early Maladaptive Schemas

Key Information

You are invited to participate in a research study conducted by the Institute for Advanced Consciousness Studies.
This study examines the effects of artificial intelligence (AI)-generated chills-eliciting audio on depression, anxiety, and early maladaptive schemas—negative belief patterns formed early in life.

• Purpose: Evaluate emotional and physiological responses to AI-generated audio and its potential mental health applications.
• Participants: About 3,300 total (3,000 online; 300 on-site).
• Risks: Possible transient emotional reactions.
• Benefits: No guaranteed medical benefit; contribution to research knowledge only.
• Voluntary Participation: You may withdraw at any time without penalty.

Purpose of the Study

This study aims to determine whether AI-generated chills-eliciting audio can reduce depressive and anxious symptoms and modify early maladaptive schemas.

Participants will be randomly assigned (like a coin flip) to one of two groups:

• Chills-Eliciting Audio
• Neutral Audio (Control)

Each session includes a 15-minute audio exposure surrounded by baseline and post-questionnaire periods.

Note: The "Chills Engine" is investigational, not FDA-approved, and not intended to diagnose, treat, or cure any condition.

Online Study Procedures

If you qualify through our screening survey, you will gain access to a secure web portal for data collection.

1. Consent: Sign electronically via a HIPAA-compliant e-signature platform.
2. Baseline Questionnaires: Assess depression, anxiety, and early maladaptive schemas via HIPAA-compliant Google Forms.
3. Random Assignment: You'll be assigned to either the Chills or Neutral Audio group.
4. Audio Experience:
   • Baseline (5 min): Sit quietly with eyes closed.
   • Audio (15 min): Listen to the assigned audio. Personalized AI-generated or machine-learning-enhanced content may be used.
   • Post (5 min): Rest quietly again.
5. Post-Session Surveys: Complete short questionnaires assessing immediate effects.
6. Duration: ~1 hour per session; extended programs may last up to 8 weeks.

Compensation: $15/hour via Prolific.

While this may feel therapeutic, the study is not a substitute for professional treatment. If distress occurs, contact study staff for referral to mental health resources.

Technology

• Personalized Clones: AI-created audio tailored to individual profiles.
• Machine Learning-Enhanced Audio: AI-adjusted sounds matched to your user data for increased relevance.
• AudioMotor Feedback: Movements produce real-time sound through sensors, linking physical motion to audio output.

Tasks

Some participants may complete a brief computerized task involving rapid identification of animal images to earn points. The task tests focus and decision-making speed.

On-Site Study Procedures

Eligible participants will attend sessions at:
2811 Wilshire Blvd, Suite 510, Santa Monica, CA 90403

1. Informed Consent: Review and sign the printed consent form.
2. Questionnaires: Complete pre-experience measures.
3. Setup: Attach bio-sensors (respiration, heart rate, EEG or Muse-S).
   • EEG: 64-channel cap (for first and last sessions).
   • Muse-S: Research-grade EEG headband (for other sessions).
4. Experience:
   • 5 min baseline silence
   • 15 min Chills or Neutral Audio
   • 5 min post-rest
5. Debrief: Remove sensors, complete post questionnaires.
6. Compensation: $30/hour (rounded to nearest 15 min); parking validated.

Total time: ~1.5 hours per visit; up to 42 sessions for extended programs.

Potential Benefits

• No direct medical benefit.
• May advance scientific understanding of AI-based emotional regulation.
• Any commercial benefits from findings will not be shared with participants.

Potential Risks

• Temporary emotional discomfort.
• Mild skin irritation from electrodes.
• Possible privacy risks if using shared or insecure personal devices for eConsent.
• Other unforeseen risks.

If you experience distress:

• Contact study staff immediately.
• In emergencies, call 911 or 988 (Suicide & Crisis Lifeline).

Participant Responsibilities

You must:

• Follow all study instructions.
• Complete sessions without interruption.

Do not participate if under the influence of substances, ill, or experiencing symptoms such as nausea, headache, or sleep deprivation.

Exclusion Criteria

Do not participate if you have or are experiencing:

• Epilepsy, seizures, or light/sound sensitivity.
• Eye conditions (cataracts, corneal injury, uveitis).
• Vertigo, claustrophobia, or motion sickness.
• Pregnancy or suspected pregnancy.
• Use of medications known to cause photosensitivity or hearing alteration.
• Hairstyles preventing scalp contact (e.g., braids, dreadlocks, extensions).

Participants must be 21+ years old and employed (full or part-time).

Alternatives to Participation

The only alternative is not to participate in this study.

New Findings

If new information arises that could affect your decision to continue, you will be notified by email prior to your next session.

Payment

• On-site: $30/hour (rounded up by 15 minutes), payable by cash or Venmo.
• Online: $15/hour via Prolific.
  No participation costs.

Privacy and Confidentiality

Only authorized research staff will have access to your identity.
Data will be:

• Coded with subject ID numbers.
• Stored securely on local encrypted servers.
• Anonymized before analysis or publication.

Regulatory authorities (FDA, IRB, etc.) may inspect records for compliance.

Intended Use of Data

Data will be analyzed to assess the effects of AI-generated audio on depression, anxiety, and schemas.
De-identified results may be used for:

• Scientific publications or conference presentations.
• Future grant applications.
• Educational or public outreach (e.g., blog posts).

Voluntary Participation

Your participation is entirely voluntary.
You may withdraw anytime without penalty or loss of benefits.

The study may also stop your participation if:

• Continuing poses risk to you,
• You fail to comply with procedures,
• You become ineligible,
• The study is canceled.

All data collected prior to withdrawal may still be used.

Compensation for Injury

If injured, seek medical attention immediately.
There are no funds reserved for treatment costs.
You retain full legal rights to pursue compensation through appropriate channels.

Bill of Rights

You have been provided with a copy of the California Experimental Research Subject's Bill of Rights, summarizing your protections as a participant in medical research.

Agreement to Participate

Agreement to Participate

Please read the statement below carefully before proceeding.

By clicking "I Accept" at the bottom of this page, you acknowledge that:

1. You have read and understood the information provided in this consent form.
2. You have had the opportunity to ask questions about the study and received satisfactory answers.
3. You voluntarily agree to participate in this research study, without any coercion or undue influence.
4. You understand that your participation is entirely voluntary, and you may withdraw at any time without penalty or loss of benefits.
5. You confirm that you meet the eligibility criteria (e.g., no history of epilepsy, seizures, or sensitivity to light/sound, and not currently pregnant).
6. You understand that the Chills Engine and related audio interventions are investigational and not intended to diagnose, treat, or cure any condition.
7. You understand that any information you provide will be handled confidentially and in accordance with HIPAA and IRB standards.

By selecting "I Accept", you give your informed consent to participate in the study:
"Effects of AI-Generated Chills-Eliciting Audio on Depression, Anxiety, and Early Maladaptive Schemas."

Whom to Contact

For any study-related questions, concerns, or emergencies, contact:
Principal Investigator: (310) 907-9216

For questions about your rights as a research participant, contact:

Advarra IRB Study Subject Adviser

• Address: 6100 Merriweather Dr., Suite 600, Columbia, MD 21044
• Phone: 877-992-4724
• Email: adviser@advarra.com
• Reference Number: Pro00081190

Or contact:
California Committee for the Protection of Human Subjects

• Phone: (916) 326-3661
• Email: cphs-mail@oshpd.ca.gov
• Address: 2020 West El Camino Avenue, Suite 1000, Sacramento, CA 95833

Authorization to Use and Disclose Protected Health Information

If you participate, the study team will use and share certain health data about you, including:

• Name, contact information, and date of birth
• Medical history
• Study records and test results

This information may be shared with:

• IACS representatives
• Advarra IRB
• FDA and other government agencies
• Data safety monitoring boards (if applicable)
• Research collaborators and vendors assisting in data storage or analysis

Your health data will be used to conduct and oversee the study. Once shared, it may no longer be protected under federal law.

Your permission to share data expires 50 years after signing unless revoked sooner by written request.

If revoked:

• You will be withdrawn from the study.
• Previously collected data may still be used as outlined.

You may not access your health data during the study, but access will be restored after it concludes.

California Experimental Research Subject's Bill of Rights

Under California Health & Safety Code Section 24172, you are entitled to:

1. Be informed of the nature and purpose of the experiment.
2. Receive an explanation of all procedures, drugs, or devices involved.
3. Be informed of any potential risks or discomforts.
4. Receive an explanation of expected benefits.
5. Be informed of available alternatives and their risks/benefits.
6. Be informed of available medical treatment if complications arise.
7. Ask questions freely at any time.
8. Withdraw consent at any time without penalty.
9. Receive a copy of the signed consent form.

Statement of Authorization

I have read this authorization and understand its contents.
I voluntarily consent to the collection, use, and sharing of my health data for this study.
I have read and understand the information above.
I have had the opportunity to ask questions, which were answered to my satisfaction.
I voluntarily agree to participate in this study.