Policy Statement

Mission
The Health Sciences Research Core provides core methodological, biostatistical, and epidemiologic consultation, collaboration, and support for health sciences research at the University of South Carolina, partner institutions, and research clients, while stimulating original methodological research.

The Health Sciences Research Core (HSRC) is a component of the Office of Research and Health Sciences, in collaboration with the schools and colleges that comprise the Division of Health Sciences.  It was developed to provide a central core of methodological, biostatistical, and epidemiologic research and support including, but not limited to, consultation, collaboration, research, and services in the areas of research design, implementation, analysis, interpretation, and data management. 

Structure and Staffing
HSRC is administratively under the Vice President for Research and Health Sciences, through the Associate Vice President for Health Sciences.  A Steering Committee composed of representatives of health science units will provide guidance on policy and services.  As shown in the diagram below, the HSRC will initially contain three units: 

• the Methodology and Biostatistics Collaborative Unit (BCU), formed by the Department of Epidemiology and Biostatistics and composed of faculty from that Department and methodological researchers from other departments, provides consultation and collaboration and conducts original methodological and biostatistical research; 
• the Data Support Services Unit (DaSS) provides biostatistical and methodological support, data entry and management, data analysis and interpretation, and assistance with preparation of standard data management and analysis sections of grants;
• the Data Portal and Repository (DaPR) archives data from research projects and other data available for use in research, maintains a library of public access data sets with documentation, and serves as liaison or access point for other sources of data such as the SC Data Warehouse in the Office of Research and Statistics.

The HSRC Director will be responsible for overall development, direction, and administration, and serves as Unit Director on an interim basis for any unit without a director.  Unit Directors oversee operations of each of the constituent Units (BCU, DaSS, DaPR).  The HSRC Director and Unit Directors coordinate the work of these units, and others that may be added in the future, so that services appear to be seamless to clients and constituents.

The BCU is composed primarily of faculty and staff from the Department of Epidemiology and Biostatistics, though other doctoral or masters level faculty and staff with appropriate training and expertise may also be affiliated.  HSRC provides administrative support for the BCU.  DaSS and DaPR will be composed primarily of bachelor’s and master’s level biostatisticians, epidemiologists, programmers, and other staff to support biostatistical, methodological, and data-related aspects of health sciences research.  They are supervised by persons with appropriate training and experience, typically a faculty member.

Organizational Chart with Current Personnel

Services
Pre-award Support:

• Assistance with formulating and clarifying research questions or hypotheses and measurement approaches. Variable identification based on your research questions, determine what variables are needed, how to code these variables and what the best data collection method is.
• Assistance with research study design, power and sample size calculation, appropriate analytic approach and implementation plan, and data sharing plan.
• Develop data management including data handling, data storage, data archiving, data security and IT plans, data sharing plan, and write related application sections
• Assist with the collection and analysis of preliminary data used in determining sample size and power considerations.
• Create scanable survey forms for data collection with TeleForms.
• Participate in writing methods and analysis sections of applications; collaborate in writing application
• Assistance with data coordination center for single and multisite studies
• Protocol development - as needed for pre-award submission

Post-award Support:

• Participate to develop protocols, manuals of operation, and data collection forms. Collaborate in the development, implementation, and monitoring of network protocols
• Set-up and maintain study sites IT infrastructure. Establish/manage secure computerized system to collect data. Set-up and maintain automatic transmission of data.
• Develop/manage secure computerized system to collect data. Provide data management and quality control and adverse event monitoring
• Data Entry, Cleaning, and Quality control - data entry services for non scannable forms and use of TeleForms software to scan data. Data cleaned of outliers and checked for response accuracy and quality control checks performed on data collected to ensure quality is being met.
• Develop needed databases and implement a web-based system to coordinate program activities and monitor performance of the study centers and other central units
• Provide coordination of DSMB, Steering Committee, and Research Site subcommittee teleconferences and meetings
• Prepare and distribute report (e.g., Monthly/Quarterly, adverse event report compilation and distribution, clinical center recruitment performance, Steering Committee, DSMB, and final report.)
• Design and implement state of the art analytic approaches and interpret results. Collaborate on joint presentations and joint publications
• Conduct original methodological research related to the analytical challenges posed by the project.
• Data analysis and interpretation

Other Services:

• Biostatistics Consulting
• Scanning and data entry, creation of datasets
• Provide support for meetings and teleconferences, including support for travel arrangements.
• Provide logistical support necessary to run an efficient and productive network.
• Periodic report preparation.
• Training: Short courses offered in the past (SAS, Stata, Epidata, and National Data sets).
• Data Portal Services
• National Dataset library - Maintain library of national public access datasets with documentation such as Vital Records data and National health survey data
• Local Dataset library - Maintain archives of research projects that may be used by other researchers with limitations.
• Dataset Acquisition Liaison - Serve as liaison to other agencies owning data that USC and other researchers want to use.
• Service offered:
• Archives data from completed projects and maintain a library of National and State level public access data such as vital records and national health surveys from the National Center for Health Statistics. Makes this data readily available to the USC students and researchers.
• Maintains a documentation of web access health related data websites.
• Assists researchers and students in accessing data from other sources such as the SC Central Cancer Registry, SC office of Research or other agencies, organizations and institutions. 
• Maintains a library of documentation for any data entrusted to it or obtained by it.
• Data file conversion & Storage - data can be stored or converted to any of the following formats: SAS, Stata, SPSS, CSV & other.
• Archiving - HSRC offers permanent storage for electronic data as well as paper survey forms.

Access to Services
Consultation and services may be requested by completing a Request for Services form, which can be downloaded from the HSRC web site. Requests will, so far as possible, be fulfilled in the order in which they are received except that priority for consultation and services will be given to faculty members from participating units.  Participating units are the health science schools and colleges who contribute to the base support of HSRC and any other departments, centers, institutes or other units of the University of South Carolina and its official partners who elect to participate by providing base support.  Persons or entities from outside the University and faculty from non-participating units may also request consultation and services, but will be billed for all services as noted below. 

Adequate notice must be provided for consultation or assistance on projects except routine questions.  For major projects with deadlines, such as grant applications or abstracts for meetings, requests should be made well in advance, ideally 60 days prior to the submission date whenever possible.  This allows us to manage staffing levels and ensure that there is time to provide input on the study design.  For requests without a deadline (papers, analysis, etc.), requests should be made as soon as the need is known, and staff will work with requesting faculty to determine a time line that is feasible and acceptable. 

No-cost and Billable Services
A basic level of statistical assistance with grant development and answers to methodological or analytical questions is provided for free for faculty from participating units. Very brief consultations or responses to simple questions may be provided to other faculty on a pro bono basis, as resources allow. Greater assistance can be provided when HSRC, including BCU or DaSS, is included in the grant budget.  Grant budgets will be developed in consultation with the Principal Investigator to reflect expected actual time and effort and expense.  All post-award work for grants that do not include HSRC and work that goes beyond the original plan will be billed at an hourly rate, as shown below.  This includes consultation, meetings, data entry, data management, data analysis, programming, writing, editing, paper revisions, etc.

Budgets for grant-related work will be created in a collaborative manner.  HSRC faculty and staff will work with the investigator to establish a scope of work and budget appropriate to the proposed project.  If the level of funding is fixed or limited, the budget and scope of work will outline what can be accomplished within the limitations. 

The HSRC will provide a budget for its services for grant proposals as well as a description for the resources section that contains biographical information and qualifications of HSRC personnel.  NIH biosketches will be provided only when there are named key personnel from the BCU or DaSS providing time and effort based on a percent of FTE.  Either unit may be included as a named entity in the grant. 

Time and Effort for Collaboration Compared to Standard Billable Hours
The HSRC does not replace collaborative research conducted in the Department of Epidemiology and Biostatistics or other Departments, but provides a means, through the BCU, to organize requests, provide continuing services that do not require faculty for completion, and facilitate matching requests to expertise.  It is expected that projects with more limited involvement of Department faculty and staff will be billed on an hourly basis, while projects that require extensive faculty-level consultation and collaboration and methodological research will be contracted through the BCU on a Time and Effort basis (percent FTE) and budgeted in the grant with the faculty member(s) listed as key personnel.  In all cases of grant-funded work, whether based on billable hours, a projected budget, or percent of FTE, the HSRC and its units will retain their share of indirect cost recovery, based on the direct expenditures associated with their work.  Whether an individual project should be handled through the HSRC as billable hours, a set budget, or percent FTE of faculty in the BCU, will be discussed during the application preparation process.  Factors to be considered include project size and duration and whether a BCU faculty member is available for an FTE-based collaboration.

Fees for Services
After the first year, annual support for participating units will be determined by the HSRC Steering Committee, based on prior year usage.  Internal and external hourly rates for billable services for the 2006-2007 fiscal year are shown in the following table.  These rates cover salary, fringe, computing, administrative, and operating expenses.  The internal rates do not include indirect costs but the external rates do include indirect costs.  Rates will be adjusted annually, and projects will be charged the current rates in effect when work is performed. 

If the charges are made to an internal USC account or an external participating partner, then internal rates will apply; all others will be charged the external rates.  HSRC will record hours on a weekly basis with each week starting on a Monday.  Bills will be generated on a monthly basis.  Bills for internal clients will be submitted to the person requesting the work or a designated business manager.   External clients will be billed according to the agreement that initiated the work, generally to the contact person for that institution or a designated business office. We will evaluate rates on an annual basis and will change them if necessary at the start of each fiscal year (July 1).  We will bill at the current rates.

Preparation for Working with the HSRC
If you request that HSRC assist with a grant, you should be prepared to provide a draft of the specific aims and research questions / hypotheses, a description of all available pilot data, proposed study design, a general description of the type of data to be collected and the methods or instruments, an idea of the feasible sample size, and any other relevant information.  If HSRC will be assisting with preliminary data analysis, you will need to provide the data in a readable and organized format, such as a database or spreadsheet.  If the data are in written form only, there may be additional delay or charges to allow for data entry and, in periods of high grant preparation activity, HSRC staff may not be able to accommodate the request.  HSRC staff will be happy to discuss how best to provide data. 

Post-award Rebudgeting
HSRC faculty and staff are well aware of the current funding climate and understand that entire grant budgets are routinely cut.  If HSRC has been written into a grant, it is expected that the percent reduction in the HSRC budget, if any, will be no greater than the overall grant reduction percent.  HSRC Directors and faculty will discuss with the PI how budget cuts will affect the work that can be performed.

Because the HSRC depends on funded projects to sustain its work, including the pro bono pre-award services provided to participating units, we must rely on researchers to maintain the implicit agreement entered into with the initial request and the provision of assistance in preparation of the grant.  Further, if HSRC faculty and staff are removed from grants that they have participated in preparing, they lose the opportunity to conduct the research they helped to plan and to receive the academic and intellectual, as well as the financial, rewards of participating in the funded research, analyzing the data, and disseminating the results.  The collaborative nature of our work, as well as our mutual trust as members of a community of scholars require that we all uphold the commitments we make: to perform the work as agreed on the part of the HSRC and to provide support and collaboration on the part of the funded investigators.  To do otherwise is a threat to collegiality and collaboration, and perhaps to the existence of the HSRC as a resource for researchers.

Authorship Status for HSRC Faculty and Staff
Current policies and ethical guidelines concerning authorship emphasize that authorship is independent of funding and data ownership.  Any HSRC faculty or staff member who makes a contribution that warrants authorship should be listed as an author(s), and not merely mentioned in acknowledgements.  The International Committee of Medical Journal Editors (ICMJE) (1) states
Authorship credit should be based on 1) substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3.
There is no discussion of payment as exclusion for authorship.  The JAMA policy on authorship is very similar (2).  The HSRC will operate under the ICMJE policy in matters of authorship.

Contact Information
Please contact the HSRC Director or the appropriate Unit Director (BCU, BDaSS, or DaPR)
Health Science Research Core
730 Devine Street Suite 114
Columbia, SC  29208
(803) 777-6203 office
(803) 777-4289 fax

Robert McKeown, Director HSRC, Interim Director DaPR
rmckeown@mailbox.sc.edu
(803) 777-6220 office
(803) 777-2524 fax

James Hardin, Director BCU
Jhardin@mailbox.sc.edu
(803) 777-0388 office
(803) 777-0391 fax

Robert Moran, Director DaSS
rrmoran@mailbox.sc.edu
(803) 777-6203
(803) 777-4289 fax
(803) 251-7876 Nutrition Center
(803) 251-7873 fax Nutrition Center
(803) 665-6741 cell

References:

1. The International Committee of Medical Journal Editors, Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication, http://www.icmje.org/, updated February 2006 (accessed December 13, 2006).
2. JAMA Instructions for Authors, The Journal of the American Medical Association, http://jama.ama-assn.org/misc/ifora.dtl , (accessed December 13, 2006).

Acknowledgement:  This policy draws heavily on documents from the Wake Forest University Data Analysis Unit.  We are grateful to Dr. Mark Espland for his advice and providing us with these materials.