Frequently Asked Questions About GCN
- How can I be involved in research and publication using this data?
- Who can participate?
- What are the costs of participation?
- What are the study procedures?
- How can my center obtain IRB approval?
- Are there additional risks to my patients?
- How does HIPAA apply to the GCN?
- How do I become a part of the Global Cardiomics Network™?
How can I be involved in research and publication using this data?
A scientific board will be assembled with representatives from participating institutions. This board will coordinate approval and execution of research endeavors. Opportunities for authorship will be shared broadly across the consortium.
Who can participate?
All cardiac catheterization sites with current or planned electronic data capture capabilities are encouraged to participate. Sites that are ACC-NCDR compliant will require minimal changes to data entry and submission procedures. Interested sites are asked to submit contact information to receive further information. These sites will then be contacted for further assessment of their available infrastructure and resources. After an initial assessment of each site's capabilities to collect, store, and ship the required data, participating sites will receive a "site kit" containing the necessary documents to initiate enrollment into the GCN. This kit will include a universal informed consent form, legal documentation establishing a relationship between the site and the GCN, a listing of the necessary data elements to be collected, and standardized protocols for sample collection, storage, and delivery as well as data submission. To be eligible to participate, a prospective site must commit to submit data on at least 500 new patients each year.
What are the costs of participation?
Duke will be funding all central core activities, including database development, annual follow-up of patients, sample storage, and site management. Sites are asked to donate the time necessary to obtain informed consent as well as collect, process, and ship blood samples. The GCN will offset these investments over time for all sites as well as for Duke through grant support and other revenue sources.
What are the study procedures?
Each participating site will also be asked to provide its own study coordinator, and will need to have access to a centrifuge and -80ºC freezer. 30 cc of blood will be collected at the time of catheterization into EDTA-lined tubes. These samples will be centrifuged and stored at the site in a -80ºC freezer. Samples will be shipped in batches every other week to a central repository at Duke. Data collection will begin as soon as the sites allocate necessary resources, receive IRB approval, and train site personnel.
How can my center obtain IRB approval?
Each site will be required to obtain IRB approval for participating in this multi-center initiative. A protocol summary will be provided for you along with a master IRB consent form. These materials will also be reviewed and approved by the Duke IRB.
Are there additional risks to my patients?
The nominal additional risks to your patients are a blood draw during the time of catheterization and protection of medical privacy. Every effort will be made to mitigate privacy concerns, and every patient's medical privacy will be protected through stringent adherence to de-identification procedures.
How does HIPAA apply to the GCN?
HIPAA (Health Insurance Portability and Accountability Act) is a legislative act that governs how an individual's protected health information (PHI) may be used and disclosed by health care providers. The GCN has strict policies and procedures in place to explicitly address and conform to all applicable HIPAA regulations.
How do I become a part of the Global Cardiomics Network™?
For further information please contact us.
P (919) 668-8805