Data Sharing

The IMPACT investigators are strong believers in international collaboration. In fact, the entire project is only possible by virtue of data sharing and mutual collaboration between research teams. The expanded IMPACT database on TBI which we will be creating is an invaluable resource for further research which we would wish to encourage. We note however that we are not the principal owners of the datasets which will be included in our studies. Only two (TCDB and NABIS Hypothermia) out of the 16 datasets derive from NIH funded studies. The remaining studies were funded by industry or other sources. As a condition of obtaining access to these databases we pledged to respect the confidentiality and ownership of the databases and access to the datasets was, in most instances, explicitly restricted to the research purposes as defined in the specific aims. We must respect the confidentiality aspects and the trust which the principal stakeholders awarded us in providing access to their datasets for the purposes of our proposed studies. For this reason the IMPACT database on TBI can not as yet be made fully accessible in the public domain.

Recognizing the scientific importance of maximizing the potential benefit of the IMPACT database we plan to act as "clearing house" for access to the data. We have, in collaboration with the advisory board, agreed on procedures consistent with the concept of a "data enclave" as outlined in NIH policy. We have established a data sharing committee, consisting of the principal investigator (A.I.R. Maas), the lead statistical investigators (A. Marmarou, G. Murray, E. Steyerberg) and three members of the advisory board (G. Teasdale, L.F. Marshall, D. Yates).

Research questions and proposals for analysis will be addressed to the data sharing committee. The proposals will be screened for scientific merit and to ensure that there is no obvious conflict with the rights of the data owners (e.g. a request to data dredging using the actual randomized treatment allocation will be refused). Where appropriate, the data sharing committee will discuss the research proposal and the level of access with the relevant stakeholders.

Access to the IMPACT database will be limited to use via on site facilities in the participating institutes in order to guarantee confidentiality to the original stakeholders. Relatively simple analyses, requested by other investigators, will be run by our research staff. For more complex analyses, we will provide on site access to the database and will provide appropriate support where required. Full documentation on the content and structure of the IMPACT database will be made available. If significant time and effort is required from our research staff, costs will have to be charged to investigators requesting analyses with the IMPACT database.

These procedures will become operational following completion of the expanded IMPACT database on TBI, which is foreseen by the end of 2008. The procedures outlined above are consistent with the NIH-concept of a data enclave, and are in our opinion, best suited for encouraging and facilitating further scientific work, whilst maintaining appropriate confidentiality for the original stakeholders. All data contained within the IMPACT database on TBI are anonymized, and thus aspects of patient confidentiality are maintained.