This is a minimal risk study without direct patient contact. The goals of this study are primarily descriptive of the CPRN patient population. All data will be collected from pre-existing sources. Because of this we are requesting a waiver of informed consent and assent. Waiver of informed consent is being requested for two reasons. First, the analyses are aimed at description of the entire network. Accrual numerators and denominators for event rates are very important. Exclusion of any patients will limit the scientific validity of these analyses. Second, the study poses no clinical risk or harm to the subjects included in the Registry and any additional risks are limited to those of privacy and confidentiality which are minimal.
Data will be acquired from hospital computer systems and medical records and the primary potential risk to subjects is improper disclosure of medical information. Data collected in this project do not include names, but do include sufficient identifying information (such as date of birth, gender, hospital admission dates) that project investigators must protect the confidentiality of the research data in accordance with privacy regulations such as HIPAA. This will be accomplished with the following actions:
- All data will be maintained in secure locations in locked offices.
- The patient log containing the patient’s identifying information and unique identifying number will be stored in a secure locked location. It is recommended that two copies of this record be retained in two different formats in two different physical locations.
- All data transmissions will be encrypted, as described in the Data Management section.
- The PI and Research Coordinator at the Clinical Centers and the DCC will provide documentation of human subject protection and research ethics prior to enrolling any subjects.
- All DCC staff work under strict confidentiality agreements.
- All analyses and reports will be presented in aggregate fashion.
- No identifiable data, either patient, surgeon, or site-specific, will be released by the CPRN through the DCC at any time. Requests for data will go through the CPRN and all aggregate data will be de-identified for site, subject, and surgeon.
No collection or submission data will occur at any specific Clinical Center until IRB review has been completed at that site.