RESEARCH PARTICIPANT INFORMATION AND CONSENT FORM

Please ask the study staff to explain any information in this consent document that is not clear to you. If you have questions, you cannot ask your physician directly. Please consult the Frequently Asked Questions resource or contact Dr. Mike Davis at the contact information listed above. You may review this consent form or discuss with family or friends before making your decision to participate.

In this consent form, “you” always refers to the research participant. If you are a parent or legally authorized representative, please remember that “you” refers to the study participant (the person with plastic bronchitis).

PURPOSE OF THE STUDY

The purpose of the International Plastic Bronchitis Registry is to understand the natural course and long term health outcomes of patients diagnosed with plastic bronchitis. This can provide essential data for identifying possible causes of this disease and potential treatments. The secondary aim is to understand the structure of casts and how they form.

We are asking you to donate your airway cast for research and for access to your medical history.

Plastic bronchitis patients have casts removed during bronchoscopy as part of their routine care or they are able to expectorate (cough out) casts. The casts are normally discarded. If you agree to participate in the registry your airway casts and medical history will be sent to Dr. Bruce Rubin’s Research Laboratory at Virginia Commonwealth University (VCU).

Your de-identified International Plastic Bronchitis Registry information will also be shared with other databases such as the Global Rare Disease Patient Registry Data Repository (GRDR). This will allow more researchers to use the information to do research across all rare diseases and to develop novel diagnostics and therapeutics for patient benefit. VCU is responsible only for the management of the International Plastic Bronchitis Registry.

We may also share your de-identified casts with other researchers.

PROCEDURES

If you decide to be in this research study, you will be asked to sign this consent form after you have had all your questions answered.

In this study we ask you and/or your referring physician for your complete health record, history and physical exam, laboratory test results, photographs, videotapes, diagnosis and treatment codes, consultation reports, X-ray reports, discharge summary, progress notes, X-ray films/ images, and/or casts.

We will also ask you or your referring physician to ship casts to Dr. Rubin’s laboratory. Casts should be placed in normal saline and shipped overnight on dry ice.

You may also be contacted for various reasons after you join the International Plastic Bronchitis Registry. If you provide additional casts, you may be asked to update your registry information. Registry staff may contact you each year to remind you to update your data or to fax/upload test results and any other relevant reports. You may also be contacted about participating in a clinical trial, based on your data within the International Plastic Bronchitis Registry or GRDR.

Your registry account can be updated whenever there is a change in your health, change in medication, or new symptom. If the registry tries but is unable to contact you, your account may become inactive.

GENETIC TESTING

At this time, your samples will not undergo genetic testing. However, the research team may wish to explore genetic components in the future. The research team will contact you with additional information and obtain your permission before any genetic tests are performed.

RISKS AND DISCOMFORTS

The main risk that should be considered is potential loss of privacy. However, all reasonable efforts will be made to protect the confidential information that can in any way be connected to you.

Although we will make every effort to keep your information confidential, no system for protecting your confidentiality can be completely secure. Government or University staff sometimes reviews studies such as this one to make sure they are being done safely and legally. If a review of this study takes place, your records may be examined. The reviewers will protect your privacy. The study records will not be used to put you at legal risk of harm.

USE AND DISCLOSURE OF PROTECTED HEALTH INFORMATION

Authority to Request Protected Health Information

The following people and/or groups may request my Protected Health Information:

• Principal Investigator and Research Staff
• Research Collaborators
• Institutional Review Boards
• Government/Health Agencies
• Others as Required by Law

My physician treating my plastic bronchitis and the VCU Health System (VCUHS) may release the information identified in this authorization from my medical records and provide this information to:

• Health Care Providers at Virginia Commonwealth University Health System
• Principal Investigator and Research Staff
• Research Collaborators
• Institutional Review Boards
• Government/Health Agencies
• Others as Required by Law

Once your health information has been disclosed to anyone outside of this study, the information may no longer be protected under this authorization.

Type of Information that may be Released

The following types of information may be used for the conduct of this research:

• Complete health record
• Hisotry and Physical Exam
• Laboratory test results
• Photographs, videotapes
• Diagnosis and treatment codes
• Consultation reports
• X-ray reports
• Discharge summary
• Progress notes
• X-ray films/images
• Other: Plastic Bronchitis casts

Expiration of This Authorization

This research study involves the use of a Data or Tissue Repository (bank) and will never expire.

Right to Revoke Authorization and Re-disclosure

You may change your mind and revoke (take back) the right to use your protected health information at any time. Even if you revoke this Authorization, the researchers may still use or disclose health information they have already collected about you for this study. If you revoke this Authorization you may no longer be allowed to participate in the research study. To revoke this Authorization, you must write to the Principal Investigator.

Participants cannot request their data/samples be destroyed/removed from the registry/repository after they have been de-identified. Also, information that has already been shared with the GRDR or sent to a researcher for a specific study prior to a subjects request for removal cannot be retrieved or removed.

BENEFITS TO YOU AND OTHERS

This is not a treatment study, and you are not expected to receive any direct medical benefits from your participation in the study. However, the information we learn from this research may be helpful in better understanding plastic bronchitis and in developing new treatments.

COSTS

There are no costs for participating in this study if your referring physician and/or hospital will agree to ship the specimens. The Rubin Laboratory will provide shippers and instructions on how to ship casts, and will pay for shipping costs if you have to ship the cast yourself.

ALTERNATIVES

Your alternative is not to participate in this study.

CONFIDENTIALITY

Potentially identifiable information about you will consist of complete health record, history and physical exam, laboratory test results, photographs, videotapes, diagnosis and treatment codes, consultation reports, X-ray reports, discharge summary, progress notes, X-ray films/images, and/or casts.

Data are being collected only for research purposes and steps will be taken to protect your privacy. Study records that identify you will be kept confidential as required by law.

We will store your specimens and data with a unique study identifier, with a key only accessible to limited senior research staff. Study data will be collected and managed using REDCap (Research Electronic Data Capture), a secure, password protected, web-based application designed to support data capture for research studies, hosted at Virginia Commonwealth University. Any paper documents will be maintained in a locked office with access to senior research staff only.

We will not disclose the answers you give us except in the registry. However, information from the study and information from your medical record and the consent form signed by you may be looked at or copied for research or legal purposes by Virginia Commonwealth University.

Although results of this research may be presented at meetings or in publications, identifiable personal information pertaining to participants will not be disclosed.

VOLUNTARY PARTICIPATION AND WITHDRAWAL

Your participation in this study is voluntary. You may decide to not participate in this study. Your decision not to take part will involve no penalty or loss of benefits to which you are otherwise entitled. If you do participate, you may freely withdraw from the study at any time. To withdraw you must write to Dr. Davis, whose information is listed at the beginning of the consent document. Your decision to withdraw will involve no penalty or loss of benefits to which you are otherwise entitled. If you withdraw, the investigators will destroy all your samples and data to the best of their ability. If your samples or information have been shared with other researchers, these will not be withdrawn.

Your participation in this study may be stopped at any time by the study doctor or the sponsor without your consent. The reasons might include:

• you have not followed study instructions;
• administrative reasons require your withdrawal.

QUESTIONS

If you have any questions or concerns about your participation in this research, please contact Dr. Michael Davis using the contact information listed at beginning of the consent document.

If you have general questions about your rights as a participant in this or any other research, you may contact the Office of Research at Virginia Commonwealth University via phone at 804-827-2157. Contact this number to ask general questions, to obtain information or offer input, and to express concerns or complaints about research. You may also call this number if you cannot reach the research team or if you wish to talk to someone else. General information about participation in research studies can also be found at https://research.vcu.edu/human_research/volunteers.htm.

Do not sign this consent form unless you have had a chance to ask questions and have received satisfactory answers to all of your questions.

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