Ethical regulations for the Swedish Intensive Care Registry agreed at the annual meeting in Saltsjöbaden of March 2010
- Registered data is identified by intensive care unit but not by patient.
- Membership of SIR entails that the intensive care unit permits the auditing of data in a format that allows each individual unit to be identified, i.e. such that the register is subject to complete transparency. This applies to data gathered concerning operations dating from 1/1/2005 onwards.
- Publication of aggregated data on SIR's website is carried out at the discretion of SIR's R&D group.
- Excerpts from the register for other purposes than publication on SIR's website may be permitted at the discretion of SIR's Board, following preparation by SIR's R&D group. If cases of doubt members may be consulted. All decisions subject to this paragraph must be audited at the following annual meeting.
- Supplementary registration may be permitted at the discretion of SIR's Board, following preparation by SIR's R&D group.
- The cost of excerpts from the register and supplementary registration will be determined by SIR's Board following preparation by SIR's working groups.
- Advertising and publication of links on SIR's website will be determined by SIR's Board following preparation by SIR's working groups. The same guidelines apply to other types of sponsorship.
- SIR is a nonprofit organization the majority of whose services are provided without financial compensation. Within the context of national quality control work it is a matter of urgency for SIR to openly declare all relationships which could be perceived as challengeable. The challengeable period is the preceding five calendar years. Matters of challengeability are addressed on a regular basis and typically published on SIR's website. (This item has been provisionally adopted by the Board as of 3/2009 and will be submitted to the annual meeting in March 2010)
Why the need for ethical regulations?
From its outset SIR identified a number of situations in which data from the register may be of interest to various stakeholders. In many cases the use of this information is potentially sensitive, and the purpose of using it may need to be analyzed and published. For this reason SIR has established a procedure for how a request for a data excerpt from SIR is to be handled in cases where this is more demanding than what can be handled via our open external data portal.
Requests can be submitted via email to email@example.com. Enquiries will be processed on an ongoing basis and responses provided at the earliest opportunity.
The ethical regulations also form the basis for granting opportunities for carrying out research on the register. There should be the facility for the website to reflect those projects which are repeatedly approved.