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We are collecting your blood in order to create a permanent source (a bank) of DNA for genetic analysis for each individual. Creating this bank will enable us to research many possible candidate genes without having to draw more blood from patients in order to perform future tests. The blood will be used to extract DNA, the substance in your cells that contains genes, and to establish cell lines A gene is the unit of heredity which is received from each parent that determines a person's characteristics. A cell line is made from white blood cells, which are treated in a way that causes them to grow and allows researchers to create an unlimited supply of DNA on which to conduct tests. This DNA will be used solely for CF research.
This study employs a system for preserving anonymized, code-identified samples of your blood and tissues indefinitely at Johns Hopkins for use in future research for genetic variation in CF. If authorized CF researchers from sites other than Johns Hopkins ask to study factors that contribute to the variability of CF using these samples and your clinical data, they will receive samples and data that have been stripped of any information identifying you.
For more information about the collection and storage of blood samples, please continue.
Sample Handling and Blood/DNA Banking
Patient Identifiers/Confidentiality/Data Storage
For the protection of patient privacy, this is a coded study. As blood samples are received, technicians remove the name labels from the blood tubes and assign a Johns Hopkins Study ID (JHSID) number. From that point forward, the blood and the DNA is identified by the JHSID only. A DNA Bank using the JHSID number as identification is established and maintained in a separate and secure location.
At the time of collection, blood and forms containing data will be identified using the CFF identifier whenever possible. When the materials arrive, the CFF identifier will be reconciled and then replaced with a JHSID number. The anonymized data will be stored in password- and firewall-protected database.
When forms arrive, the first page containing identifying information is removed by administrative staff and placed in a locked filing cabinet in the office of the Principal Investigator. The code linking the JHSID to the forms is also stored in this locked filing cabinet. Clinical data is kept separate from identifying information in a secure area. It is important for the patient name and CFF ID # to be recorded on their blood samples and the first page of their data collection forms in order to:
- verify the patient names match the CFF ID # recorded in the CFF database.
- ensure that a participating subject is able to request that their clinical information and/or DNA be removed from this study at any time. In the experience of the investigators, most cystic fibrosis patients do not know their CFF ID #. Without a master list of names and corresponding CFF ID # as well as Study ID #, it would not be possible for the PI to fulfill this request.
- be able to determine that the correct data collection form and blood sample is recorded for the correct family member. Because of the unique nature of a family study (i.e. same birthday, same parents' names, same address), we must be able to verify this information.
- avoid duplication of study participants that have received care at more than one CF Center and may be reported from different institution-specific identification systems.
If the CFTR genotype for the patient is undetermined, genotype testing will be performed in the research laboratory of Dr. Garry Cutting, and if requested by the patient's physician the genotype will be verified by the DNA Diagnostic Lab at JHMI (a CLIA-approved facility). And results will be shared with the CF Care Center.
Blood Collection
We will provide the necessary materials for the collection and shipment of blood for the study. For each twin/sib over age 5 and each parent we provide two 8.5 mL yellow-topped tubes and two 10 mL purple-topped tubes. For small children (under 6 years of age), we provide one 6 mL yellow-topped tube and one 10 mL purple-topped tube. In these tubes we would like as much blood as is reasonable to take from the patient. However, in extreme circumstances, 3 mL in the yellow-topped tube is the absolute minimum we can accept for inclusion in the study.
Samples should be shipped overnight at room temperature. Please contact us if you need any additional information or supplies.
What about the DNA Bank? *
Who can deposit into the Bank?
The DNA Bank will only accept deposits from health care professionals representing CF patients/guardians who have agreed to participate in this study.
Who owns the DNA in the Bank?
The Johns Hopkins Core Facility will have custodial storage of the banked plasma and DNA for the duration of the research.
Policies of the DNA Bank:
- Services provided — Storage of lymphoblasts that provide an inexhaustible supply of DNA samples for research into the causes of disease variation in CF.
- Duration of storage — Permanent.
- Disposition of the DNA at the end of the agreed-upon term of storage or upon the death of the depositor — Sample remains in the Bank.
- Conditions of use — DNA is banked only for research into the causes of disease variation in CF and cannot be used for any other purpose.
- Risk — Although duplicate samples are maintained in different locations, there is a very small chance that a sample may be lost or misplaced. The process of creating immortalized blood cells that serve as the source of DNA does not work in about 1 in 200 cases. In either situation, the Bank may request a second sample from the depositor.
- Release of information — The Principal Investigator will inform depositors of the nature and progress of studies involving samples deposited into the DNA Bank through published papers in scientific journals.
Release of DNA Bank materials?
The DNA Bank may release samples to investigators performing studies of the causes of disease variation in CF as approved by their local IRB. Medical information corresponding to each sample may also be released following IRB approval. All samples and records will be anonymized prior to release.
What about Security?
The DNA Bank set up for the CF Twin/Sib study is located separately from the research laboratory, is monitored for quality assurance, and has secure storage.
Withdrawal?
Individuals wishing to withdraw from the study and desiring that their DNA be removed from the Bank can do so by notifying the Principal Investigator, Dr. Garry Cutting, in writing of their desire to withdraw and specifying that they would like the DNA in the DNA Bank to be destroyed. The PI will confirm this request in writing. Please go to the contact page for the address.
* Based upon the recommendations from the American Society of Human Genetics, National Institutes of Health, Office of Human Research Protection, the National Bioethics Advisory Commission.
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For Patients 
