ELSO Data Policy

Overview:

The purpose of the ELSO Registry (“Registry”) is to provide member institutions (“Centers”) with data to improve quality of care to patients. Data submitted by Centers to the Registry includes personally identifiable information: gender, race, nature and severity of illness, technical details of extracorporeal support used, dates of service, complications, and outcomes. All collected data is listed in the ELSO ECLS registry forms completed by Centers when they submit data.

Prior to any distribution or release personally identifiable data elements are removed except for coded date of birth and dates of services that are used in calculations within the database. ELSO issues Registry quality assurance reports on a semi-annual basis to active ELSO Centers. In addition, Centers can query the Registry for support in clinical decision-making, for institutional quality assurance, bench marking, and clinical research according to procedures described in this policy. The codes or computations enabling identification are not released. ELSO may allow queries to the Registry of de-identified data by regulatory bodies and industry for the purpose of advancing the care and safety of patients requiring Extra-Corporeal Life Support. Approval of the ELSO Registry Committee is required for all requests. All Registry data is stored on secure password protected computers.

  • All data submitted to the ELSO Registry contains no patient identifiers except for what is allowed by applicable law of the depositing Center.
  • The Center ID that connects the data to the providing Center is used only for quality assurance reports submitted to the Center.
  • Data is only given to requestors other than the depositing Center either in aggregate form or without the Centers’ names or identifiers.
  • Registry data is 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.
  • A signed DUA must be on file before any data requests will be granted.
  • Special requests from persons or organizations that are not part of an ELSO Center (NIH, industry, etc.), will be reviewed by the ELSO Registry Committee.
  • Data requests must be submitted using the ELSO Registry Data Request Form.
  • Requests for data that is not to be used for publication may be submitted using the Internal Use Only - Not for Publication Request Form.
  • Data requests from a Center must be signed by either the ECMO Director or the ECMO Coordinator of the Center.
  • The ELSO Registry Committee does not disclose the submitting Center’s name in conjunction with data provided by that Center. Some research studies may benefit from analyses accounting for clustering of patients from the same Centers. These requests will be adjudicated by the ELSO Registry Data Request Committee as required, and if approved, an anonymized Center identifier will be provided. Requests for data deemed politically charged will not be honored.
  • Data requests for projects intended for publication are reviewed once a month by the ELSO Registry Committee. Once approval is granted the data request will be honored.

Email completed data requests forms to ELSODataRequest@elso.org

Publication Policy:

Any publication based on Registry data must acknowledge the ELSO Registry as the data source. The 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 ELSO Registry Data Requests Committee. Local IRB approval is not required to be provided to ELSO when only de-identified data is requested; however, the requester should be familiar with his or her institution's IRB policies. Data requests for publication which are a duplication of an earlier request by another investigator may be honored at the discretion of the ELSO Registry Committee. In these cases, attempts to contact the earlier investigators or arrange collaboration will be made

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.

All academic product resulting from investigation of ELSO Registry data must include reference to ‘the ELSO Registry’. Publications in the scientific literature should reference the ELSO Registry as ‘the ELSO Registry’ or the Extracorporeal Life Support Organization Registry’ in the published abstract.

 

The Registry should be cited as:
ECMO Registry of the Extracorporeal Life Support Organization (ELSO), Ann Arbor, Michigan, (Month), (Year).

Revised: Oct 2018