Healthcare Lung Study Agreement

HEALTHCARE LUNG STUDY AGREEMENT

This Lung Study Agreement documents voluntary informed consent for participation in the research study identified below. Study Sponsor/Site: Study ID:

Participant Information

Participant Name: Date of Birth:

Insurance Information

Medical History

Chronic Conditions (check all that apply): Asthma COPD Lung cancer Heart disease Diabetes None

Study Procedures and Participation

Purpose and Procedures: The study will evaluate lung structure and function using diagnostic procedures which may include imaging (CT scan), pulmonary function testing (spirometry), blood sampling, symptom questionnaires, and brief clinical examinations. Estimated duration of participation: . Number of study visits: .

I consent to the following study procedures (check all that apply): Chest CT scan Spirometry / lung function testing Blood draw Bronchoscopy (if applicable) Questionnaires / interviews

Risks, Discomforts, and Benefits

Risks: Procedures may involve risks including radiation exposure from CT imaging, temporary shortness of breath or lightheadedness from spirometry, pain or bruising at blood draw sites, bleeding or infection with invasive procedures, and incidental findings requiring follow-up. There is a possibility of unforeseeable risks. If any procedure-specific risks apply, these have been explained to me.

Benefits: There may be no direct benefit. Potential benefits include information about lung health that may assist clinical care and contribution to medical knowledge that may benefit others.

Participant initials acknowledging review of risks: Radiation risk: Bleeding/infection risk: Discomfort/other risks:

Confidentiality, Use of Data and Specimens

Data and biological specimens collected for this study will be stored securely. Identifiable information will be accessible only to authorized study personnel. De-identified data and samples may be used for future research; such use does not require additional consent if identifiers are removed. I understand that my medical records may be reviewed by authorized monitors and regulatory bodies for verification purposes.

I authorize storage and future research use of my de-identified samples: Yes I authorize use of specimens for genetic analysis: Yes I authorize future research contact: Yes

Compensation and Costs

Compensation for participation, if any, and reimbursement for travel or parking will be provided as described below. I understand routine clinical care costs remain my responsibility unless otherwise stated.

Voluntary Participation and Withdrawal

Participation is voluntary. I may withdraw at any time without penalty or loss of benefits to which I am otherwise entitled. Withdrawal will not affect my right to future clinical care. If I withdraw, data collected prior to withdrawal may remain part of the study unless I request destruction where feasible.

HIPAA Authorization / Privacy Acknowledgment

I acknowledge that I have received an explanation of how my health information will be used and disclosed for the purposes of this research study and that my protected health information may be disclosed to the study sponsor, study monitors, and regulatory authorities as necessary for study conduct and oversight.

I acknowledge receipt of the privacy practices information: Yes

Questions and Contacts

For questions about study procedures or to report an adverse event, contact the study coordinator or principal investigator.

Certification and Consent

By signing below I certify that I have read (or been read) this agreement, my questions have been answered, I understand the risks and benefits described, and I voluntarily agree to participate in this lung study. I understand I may be contacted for additional information or follow-up as described above.

I confirm that study procedures, alternatives, and expected duration were explained to me: Yes

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