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CEBU policy for provision of biostatistical and related support

Version 1.1: 22nd November 2007

Preamble

The Clinical Epidemiology and Biostatistics Unit (CEBU) has wide-ranging expertise in biostatistics and epidemiology, and its essential purpose is to provide expert advice, practical assistance, training, and collaborative engagement in the conduct of high quality research on the RCH campus. For this work it is funded by the MCRI and the University of Melbourne Department of Paediatrics (currently in a ratio of about 4:1) to the extent of 3-4 EFT academic/professional positions and one administrative position. Additional staffing is supported by funds raised by our teaching program and funds contributed for specific purposes, either directly related to projects (fee-for-service) or for general-purpose roles in the form of fractional salary contributions. A wide range of research on the RCH campus benefits from CEBU  input and there is considerable potential for extending the contribution further. It is important to make our system for rational allocation of limited core resources as explicit as possible.

Service provision policy

1. We provide an initial consultation (up to an hour) free of charge on any new project that is based primarily on this campus. As far as possible this consultation will be provided by an experienced CEBU researcher who will make recommendations for the statistical and related needs of the project, some of which may be met by having further CEBU involvement (as below). Project development may also be assisted by discussion with the Clinical Research Development Office (CRDO) and other on-campus research support groups, either before or after the initial CEBU discussion.
   
   
2. For projects that have no or limited external funding, the initial consultation will be followed by up to 5 additional hours of free support, generally provided by a more junior member of CEBU staff. This support will not include routine technical work such as data entry and data cleaning, although it may include providing guidance to investigators on how to organise this (possibly using our fee-for-service technical support) or how to carry it out for themselves. Although we endeavour to provide this for everyone, resources may not always allow it, and there may be a waiting time.
   
   
3. Research higher degree students should be aware that they are expected to perform the bulk of their own statistical work (since this will usually be an integral part of their results), and our role will generally be to act in an advisory capacity. For projects involving substantial statistical analysis or more advanced statistical methods it may be appropriate to discuss with us the possibility of CEBU providing a co-supervisor.
   
   
4. Beyond the above level of support, further unfunded engagement in a project will requirethat the project fits the strategic priorities of CEBU  as warranting additional longer-term investment, which currently encompass the following considerations:
   • Strong scientific basis, likely to lead to significant publication(s)
   • Contribution to research career development (especially research higher-degree students)
   • Contribution to MCRI strategic research priorities
   • Contribution to hospital clinical practice development priorities
   • Contribution to the evidence base for clinical practice, implying special priority given to randomised controlled trials
   • Assisting CEBU staff career development by providing opportunities for coauthorship of research publications
     
     
5.  CEBU places high priority on developing collaborative relationships under which more substantial funded engagement in research programs and projects may be developed, where the above criteria are met. In this regard it is very important that external funding applications involving collaboration with CEBU include an agreed budget allocation, and that this budget allocation is transferred to CEBU if the grant is awarded. In order to avoid mismatched expectations we prefer to be involved in the development of funding applications from the beginning. In addition to specific project-based funding, more open-ended funding arrangements, allowing allocation of a dedicated fraction of a CEBU staff member’s time to a group or Theme, can be negotiated.
   
   
6. CEBU also provides a range of technical services in data entry and data management, for which charges are made (see below), beyond the initial hour of scoping discussion.

Types of service provided and corresponding charges

The policy above applies to a wide range of scientific services provided by CEBU:

• Development of research question and project design
• Protocol development, including design of sampling/recruitment plans and analysis plans
• Questionnaire design
• Database design and setup
• Data analysis, including preparation of tables and figures
• Preparation of manuscripts for publication
• Advice on specific statistical issues, e.g. after project completion or manuscript review

Where we charge for these activities, the rate will be determined by the seniority of the individual(s) involved, and will generally be along the following lines:

 Note that these are indicative figures only, subject to change and to negotiation. They are for internal purposes only. In addition, arrangements for support of fractions of salary may be negotiated and will generally be charged at the actual payroll cost of the salary fraction.

Technical services attracting charges

In addition to the scientific services discussed above, CEBU offers a range of technical data services, for which charges are made, as follows:

Authorship & collaboration

Many of the services provided by CEBU involve the provision of intellectual input that warrants consideration of coauthorship on resulting research papers. Our policy is that this should be considered on a case-by-case basis and discussed as early as possible in the relationship with CEBU. Discussion of authorship should be kept separate from funding issues (except as noted above in relation to staff career development), since authorship should relate to scientific contribution and there is no necessary connection between this and the source of an individual’s or group’s income.

In deciding authorship issues, we are happy to adhere to standard guidelines such as those recently published by the NHMRC in the Australian Code for the Responsible Conduct of Research (2007). The NHMRC guidelines require a substantial contribution to the work in a combination of:

• conception and design of the project
• analysis and interpretation of research data
• drafting significant parts of the work or critically revising it so as to contribute to the interpretation.

Statisticians often meet these criteria when they have been involved early in a project and/or when they are active in drafting reports of results and their interpretation. (And a major contribution to the analysis would generally warrant authorship even if the statistician was not involved in the conception of the project.)

In a similar vein, CEBU scientific staff members generally prefer to be involved in projects on a collaborative basis, so that they participate in as many aspects of the research design and conduct as possible. In our experience this usually leads to better quality data and higher quality research output.