Applications for New Studies
Without the active participation of clinical staff, UKOSS will not be able to provide useful information. The system clearly depends on reliable and complete case identification and data collection by clinicians to provide accurate information. In return we undertake to report promptly the results of studies to provide information to assist in patient management and service planning. The collaboration of clinicians is also vitally important to identify studies which will answer questions of clinical importance. In this we would encourage all researchers, no matter how inexperienced, to contact the UKOSS team if they have identified a question which could usefully be answered through a UKOSS study. We will undertake to provide support in generating an appropriate research proposal.
Criteria for inclusion of studies in the UKOSS programme
Studies are expected to fulfil three or more of the following criteria:
- The condition is an important cause of maternal or perinatal morbidity and mortality.
- The condition is an uncommon disorder of pregnancy, thus inclusion within the study programme of UKOSS will not impose too great a burden on reporting clinicians (usually no more than one case per 2000 births annually in the UK).
- The research questions posed by the study can be suitably addressed using the UKOSS methodology (prospective descriptive, cohort or case-control studies).
- Other sources of information exist to enhance and/or assess completeness of data collection.
Application process
Applications are invited from clinicians and other researchers for inclusion of suitable studies into the surveillance system. Preliminary applications are considered for suitability against the criteria for inclusion in the surveillance programme by the UKOSS Management Group. Applicants whose projects fulfil the criteria for inclusion will be invited to submit a full application. UKOSS staff will provide advice and support for preliminary applicants to complete a full project proposal. Full applications are considered by the UKOSS Steering Committee which meets every four months. Applicants whose studies are accepted into the UKOSS programme will then be expected to obtain funding before the study can be included in the monthly report requests. The University of Oxford has obtained Research Ethics Committee (REC) approval for UKOSS (10/H0717/20) and a substantial amendment will be made to this to include any new study.
Each UKOSS study will have an initial bespoke costing. The cost of each study will be determined by individual study requirements (for example whether any data analysis is required by the UKOSS team) and will also depend on the study funder. UKOSS reserves the right to charge a higher amount for labour-intensive studies. In return, UKOSS will undertake all data collection in relation to the study and at the completion of the study will provide the investigator with a complete database of cases ready for analysis. UKOSS will function only as a data gathering and validation service and under usual circumstances will not undertake any data analysis.
Investigators whose studies are included on the monthly reports are expected to fulfil certain undertakings. This reporting system is dependent entirely on the time and effort of reporting clinicians. It is extremely important, therefore, that information obtained from UKOSS studies is fed back to clinical staff in a timely manner in order that it may be used to make practical improvements in prevention and treatment of these uncommon conditions and allow for more effective service planning. Each study must therefore nominate a researcher to act as study guarantor who will undertake to make certain that the study results are published within two years of completion of data collection. Outside of this time limit, UKOSS staff reserve the right to analyse and publish the data themselves.
Following final acceptance of the application and before commencement the investigator and study guarantor will be asked to sign a letter indicating agreed responsibilities in relation to the project.
UKOSS Study Application Guide
The UKOSS Study Application Guide includes the Preliminary and Full Application Forms and the Letter of Understanding.
