ELSO Data Policy
The purpose of the registry is to provide member institutions data to improve quality of care to patients. Data are submitted by member institutions to the registry as a "Limited Data Set" (LDS). The "Limited Data Set" includes gender, race, nature and severity of illness, technical details of extracorporeal support used, complications and outcome. The data have been de-identified except for date of birth and dates of services used in calculations within the database. The registry issues quality assurance reports on a semi-annual basis to active ELSO members. In addition, members can query the registry for support in clinical decision making. Data are not released to non members. Queries to the registry of LDS information for purposes of research for presentation or publication, including posters, will be permitted with approval from the IRB of the individual member\'s institution, and the ELSO Protocol and Registry chairs, assuming ELSO has a Data Use Agreement (DUA) on file from that institution. Data requests for completely de-identified information (no dates of service or birth dates) still requires an active DUA, but does not require an individual IRB approval. All information is stored on password protected computers.
- All data submitted to the ELSO Registry contains no patient identifiers except for what is allowed in a "Limited Data Set". The Center ID is used only for quality assurance reports. Data is only given out either in aggregate or without the Center identifier.
- Registry information will be available to active participating Centers. An active Center registers at least one patient (neonatal, pediatric, or adult) per quarter. A center not registering a patient for 12 consecutive months will be queried. A Center registering no patient for 18 consecutive months will be considered inactive.
- Only Centers whose ELSO dues are paid in full will be considered active. Data requests from Centers with more than six months in arrears will not be honored.
- Non-ELSO data requests will be given the current ECLS Registry Report International Summary face sheet only and be referred to data in the public record.
- Special requests (NIH, industry, etc.), will be reviewed by the registry committee chairman and forwarded to the steering committee chairman for final approval.
- Data requests must be in writing or e-mail. Telephone requests will not be honored except when a patient is currently on or is about to be placed on ECMO, and the information is for patient care, not for presentation or publication. All requests must detail the following:
- Who wants the data?
- What is the question to be answered?
- What patient population is to be queried (i.e. neonatal, cardiac, pediatric, etc.)?
- Diagnosis and/or Procedure code(s) to be included (either ICD-9 / CPT, or ELSO cardiac codes)
- What time frame to search (i.e. 1995 onwards, last 5 years, entire registry)?
- Purpose of data request? (i.e. publication, internal use, patient care, etc.)?
- Data requests must be signed (or e-mailed) by either the ECMO Director or the ECMO Coordinator.
- The Registry Committee maintains confidentiality of Center identifiers. Center names can be released for patient care issues. Requests for information available only by decoding will be considered on an ad hoc basis and only if each center included in the data request gives permission for its data to be used in such a manner. Requests for data deemed politically charged will not be honored.
- After a request is received, it is reviewed by either the Registry or Protocol Chairman for approval. Once approval is granted the data request will be honored. Approval is not necessary for requests concerning a patient currently on or about to be placed on ECMO.
- Clinical Data requested that is currently not in the registry and is completely de-identified may be requested of ELSO centers only for specific clinical questions of quality improvement and patient care, and will be approved and coordinated through the Protocols Chairperson. Individual centers should not request patient data from other ELSO centers as it lies outside the DUA\'s.
Any publication based on Registry data must acknowledge the ELSO Registry as the data source. Registry face sheet can be published with acknowledgment only, and does not require prior approval. Publication of more detailed Registry data requires approval by the Protocol and Registry Committee chairmen. Local IRB approval is not required by ELSO when only de-identified data is requested; however the requester should be familiar with his or her institution\'s policies to see if their IRB requires internal review of such requests. If a limited data set is required then local IRB approval will then be required by ELSO.
Data requests for publication which are a duplication of an earlier request by another investigator may be honored at the discretion of the Protocols Chairperson. In these cases, attempts to arrange collaboration will be made. After 12 months a duplicate request may be honored.
Follow-up on Registry data that is used for publication must be reported to the Registry. If none is forthcoming, the ECMO Director will be contacted one year after the data request for follow-up.
The Registry should be cited as:
ECMO Registry of the Extracorporeal Life Support Organization (ELSO), Ann Arbor, Michigan, (Month), (Year).