We have a clear process for moving from Phase 1 to Phase 2 applications, which takes proposals from a summary of the aims and objectives of the study to a full study protocol to a final acceptance by the steering group.
Phase 1 application
The first step is to submit a Phase 1 application form. This is a short outline proposal (up to two sides of A4), which should summarise the aims and objectives of the study and detail its suitability for inclusion on the card. The BOSU will review all phase 1 applications positively and even if the initial proposal is not suitable we will endeavour to help applicants amend their proposal to one that will fit in with our considerations.
Essential considerations
- Rarity: The condition of interest must be rare enough to require ascertainment of cases on a national scale in order to generate sufficient numbers for study. This will usually be considered as an estimated annual UK population incidence of less than 350 cases.
- Case identification: The study must be of a condition or complication that can be clearly defined and identified by reporting ophthalmologists.
- Quality of proposal: It is expected that all studies will by the time they start, be of high quality in terms of clear and achievable objectives, robust methodology, and confidentiality of patient information. However, the BOSU is also committed to assisting potential investigators, especially those less experienced in research methodology, in improving potentially good studies.
- Public health importance or scientific importance: Proposals with clear implications of public health importance or of specific scientific interest to the ophthalmological community are prioritised.
Moving from Phase 1 to Phase 2
All accepted phase 1 applications are then moved to Phase 2. This is in effect the full study protocol, will include the full methodology, and provides copies of any questionnaires and covering letters that will be sent to reporting ophthalmologists.
This application is also subject to a peer review process involving two ophthalmologists and an ophthalmic epidemiologist, who then report to the full steering committee for assessment. All questionnaires are assessed for size and content, BOSU also requires that a suitable piloting process has been undertaken.
Phase 2 application
To complete the second stage of the application process, applicants have to provide evidence that their study has sufficient funding arrangements, and has gained permission from a research ethics committee. However, because surveillance is nation-wide it is the individual researchers responsibility to obtain further ethics committee approval where required.
Once Phase 2 has been completed the applicant is then invited to attend a BOSU Steering Committee meeting to present the project to the committee for final acceptance. This allows the committee to meet the applicant and answer any outstanding queries that members may have.
Supporting the applications process
The unit is always happy to offer assistance to help with questionnaire design, or methodological issues. Contact [email protected] for further advice.