Collaboration in the Research Process
It is important to contact us as early as possible when you are planning a study (see Grant/Protocol Development). Once the study protocol is approved by the IRB (and SRC and GCRC as necessary), we can begin to help you implement your study plan.
- IRB/HIPAA approval
- Protocol - Although we were likely involved in the protocol/grant development, we need to continue to be involved since there are often decisions made in finalizing the protocol that affect the data management and analysis.
- Data collection plans and forms
Financial Arrangements for Biostatistical Support
The Department of Biostatistics operates as a recharge center, an entity whose primary goal is to provide a service for the convenience of Indiana University. Due to this classification the department receives a limited amount of financial support from the School of Medicine. Therefore, it is necessary that investigators (or their departments/units) provide funding for all services and support costs, including data management, data entry, statistical analysis, and manuscript preparation. Funding for collaborative research projects is received by Biostatistics primarily through three mechanisms:direct support for named individuals on grants with NIH and other agencies, Biostatistics Services Support for smaller amounts of effort budgeted on grants and contracts, and fee-for-service billing for unbudgeted internal projects and outside agreements that are billed hourly.
Project Design and Grant Development
The limited amount of funding provided by the School of Medicine is used for grant development and study design. The Department is happy to accommodate investigators, within the School of Medicine, requiring help in study design, sample size estimation, and proposal writing free of charge. Researchers from other schools should discuss financial arrangement for grant development during their initial meeting since those efforts may be supported through other agreements (e.g. IU Cancer Center).
Investigators are encouraged to work with biostatisticians during the preparation of their proposals and to include adequate biostatistical support in their budgets. Discussions with the primary biostatistician regarding budget items and the proper method of inclusion of these costs on the project should be made prior to grant submission.
Direct Support for Named Individuals on Grants
Projects that contain substantial biostatistical support are submitted for outside funding with Department faculty and staff specifically listed in the personnel section of the grant. Substantial support is defined as at least 10% of a Department faculty or 20% of a staff member in any of the funded years. The Biostatistics portion of all budgets is prepared and approved by Shari Stanbery, the Department's Director of Finance, before they are submitted for outside funding. New rates have been calculated as of July 1, 2013.
The budgets for all projects represent our best estimates for the proposed research, based on past experience with similar projects. We recognize that research projects do not always go exactly as planned. There are frequently changes in the timeline and even occasional changes in the scope of the work. Therefore, we will monitor the effort of Biostatistics personnel biannualy to assure that it matches support received, within the variance allowed by the NIH or awarding organization. No funding changes will be made without first consulting the Principal Investigator of the project. Although the level of support may vary from the original budget in a particular time period to match effort, the total budget for biostatistical support will not exceed the budgeted amount over the entire granting period.
Biostatistics Services Support
Biostatistics faculty salaries are individually specified on a grant budget only when their percentages of effort are 10% or more for at least one year. Staff salaries are individually specified on a grant budget only when their percentages of effort for at least one year of the grant period are 20% or greater. Biostatistics Services for projects that fall below both of these criteria represent hourly biostatistical support as required by the proposed scope of the work. This may entail any or all of the following: study design, data entry, data management, statistical analysis, interpretation of results, and manuscript preparation. The number of hours for each task is estimated and budgeted based on the Department of Biostatistics fee schedule. Shari Stansbery, the Department's Director of Finance, prepares the Biostatistics portion on all budgets.
The budgeted amount represents our best estimate for the proposed research, based on past experience with similar projects. If the project is funded, the principal investigator needs to fill out a collaborative agreement and return the agreement to the Biostatistics collaborator on the project. All effort associated with biostatistical activities is then consolidated and billed by the Department of Biostatistics on a quarterly basis, to the account provided by the investigator. This represents actual effort in the previous three months and may be larger or smaller than the budgeted amount. Thus, it is important that the required work remain within the original scope in order to minimize variation from the estimated budget.
Research projects that do not have Biostatistics funding in their budget and unfunded projects, will be supported by the Department on a fee-for-service basis. After the initial meeting with the researcher, the primary biostatistician on the project will prepare a detailed estimate of the funding needed and the proposed time-line to complete the project based on the Department of Biostatistics fee schedule . Once the project terms are agreed upon, a collaborative agreement should be filled out and returned to the primary biostatistician. During the course of the project, all effort associated with biostatistical activities is consolidated and billed by the Department of Biostatistics on a quarterly basis to the account* provided on the collaborative agreement. The Department is responsible for monitoring this effort and informing the investigator if the original estimate appears to be incorrect.
*Account number and title required for internal (IU account) billing only