Healthcare Burger Study Form

HEALTHCARE BURGER STUDY FORM

Participant Information

Patient Name:

Date of Birth:    Gender: Male Female Other/Prefer not to say

Insurance and Responsible Party

Medical History

Study Description and Procedures

This clinical research study evaluates the acute metabolic, gastrointestinal, and subjective effects associated with consumption of a standardized burger prepared under controlled study conditions. Participation requires scheduled visits during which participants will consume the study burger, complete questionnaires, and provide biological samples as specified below.

Procedures that may be performed:

• Oral consumption of study-provided burger under observation.
• Blood draws (up to specified volumes per visit) for metabolic and safety testing — consent required below.
• Stool sample collection for microbiome analysis — consent required below.
• Completion of appetite, gastrointestinal symptom, and dietary recall questionnaires.
• Observation period for up to four hours following consumption at selected visits.

Voluntary Participation and Withdrawal: Participation is voluntary. You have the right to withdraw at any time without penalty or loss of benefits to which you are otherwise entitled. Withdrawal will not affect your access to standard medical care.

Risks, Benefits, and Alternatives

Risks: Known risks include transient gastrointestinal discomfort, nausea, allergic reaction if sensitive to ingredients, bruising or soreness at blood draw site, dizziness, and rare infection related to phlebotomy. There may be unforeseen risks. If you experience severe adverse effects, study staff will provide necessary medical referrals.

Benefits: You may not benefit directly. Study results may contribute to scientific understanding of dietary exposures. No guarantee of personal therapeutic benefit is made.

Authorizations and Consents

Please indicate consent for the specific procedures below by checking the corresponding box. If you do not consent to an optional procedure, leaving it unchecked will not automatically exclude you from other aspects of the study unless required by protocol.

I consent to consume the study-provided burger under supervision and to play an active role in study procedures as scheduled.

I consent to blood draws for metabolic and safety testing.

I consent to providing stool samples for microbiome analysis.

I consent to audio and/or video recording during study visits for data coding and protocol adherence checks.

Privacy and HIPAA Authorization

I authorize the study investigators and authorized personnel to use and disclose my protected health information (PHI) related to this research, including medical records, laboratory results, and questionnaire responses, for purposes of the study. Information disclosed may include identifiable health information necessary to achieve the research objectives.

I authorize use and disclosure of my protected health information for this research study and understand my rights described below.

Authorization Expiration: This authorization will expire on:

Compensation & Costs

Participants may receive compensation for time and travel as described in the study information sheet provided at enrollment. There will be no charge for study-specific procedures. Clinical care for any adverse events related to the study will be provided or arranged; you may be responsible for costs of unrelated medical care.

Participant Certification

By signing below I certify that:

• I have read and understood the information provided above and all my questions have been answered.
• I have disclosed all known medical conditions, medications, and allergies to the study team to the best of my knowledge.
• I understand that participation is voluntary and that I may withdraw at any time without penalty.
• I consent to the procedures I have indicated and authorize use of my PHI as specified above until the expiration date provided.

Additional Participant Declarations

Yes No Unsure

Acknowledgment and Signature

I acknowledge that I have read and understand this Healthcare Burger Study Form, that the study activities, risks, benefits, and my rights have been explained to me, and that I consent to participate as indicated by my signature below.

If signing as legal guardian or authorized representative, indicate relationship:

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