Overview of Policies
Mission
The mission of the Biostatistics Program is to provide outstanding statistical and informatics support to clinical, applied, translational, and biomedical researchers while advancing the reputation and research capacity of the Arkansas Children’s Research Institute (ACRI), Arkansas Children’s Hospital (ACH), the University of Arkansas for Medical Sciences (UAMS) Department of Pediatrics (DOP) and ACH-based UAMS faculty.
Protocol Development
The program provides assistance with protocol development. This support includes framing and refining of research questions and study design. This also includes creating a statistical analysis plan (SAP), developing a randomization plan, determining/justifying sample size, and developing a data management and data collection plan. A biostatistician should be involved early in the grant submission process.
Grant Development
The program provides grant planning for both intramural and extramural grant development. This includes research design development as well as creating a statistical analysis plan (SAP), developing a randomization plan, determining/justifying sample size, and developing a data management and data collection plan. A biostatistician should be involved early in the grant submission process.
Database Support
The program provides comprehensive database design and support to produce quality improvement, research and clinical databases and surveys. Various database systems, including REDCap, are available to fit the specific needs of your project. Visit the database support page for more information about database services and policies.
Data Retrieval
The program provides data retrieval from the MEDITECH system. If data retrieval is in the preparation of research, the Use of PHI in Activities Preparatory to Research form must be submitted to ACHRI Regulatory Compliance.
Statistical Data Analysis
The program provides statistical analysis and interpretation of results. Assistance in the preparation of results for grants, manuscripts, and presentations is also provided.
Manuscript Preparation
The program provides assistance with the preparation of statistical results for manuscripts.
Teaching & Journal Clubs
The program provides teaching and journal club support through seminars and courses on various statistical topics.
Funding
Project Funding
Project support from the Biostatistics Program can be funded through General Research Funds, Division/Section Funds, Discretionary Funds, Specialized Purpose Funds, Endowed Chair Funds, Intramural Grant Funding, Extramural Grant Funding, and other funds. There is no charge for the initial consultation. On a limited basis, projects can be funded by institutional support subsidized through the DOP, ACH, and ACRI. Grant development is usually provided through institutional support.
Institutional Support
Institutional support allows the program to offer comprehensive biostatistics and database support for all types of research activities and also supports growth and expanded expertise to enhance the Biostatistics Program.
Requests for subsidized assistance will only be considered after all other funding sources have been fully explored. All requests for institutional support are submitted through the Biostatistics Program and will be routed to the section chief and the appropriate administrative office for approval and signatures.
Percent Effort Cost Basis
Biostatistics Program personnel can be funded through grants and contracts for appropriate percent efforts (e.g. 5% Biostatistics Faculty, 10% Biostatistics Staff, and 10% Informatics Staff) based upon the defined work scope. This funding is usually the result of the Biostatistics Program support provided during grant development, which is provided through institutional support.
For extramural grants, the minimum percent effort for biostatistics faculty is generally 5% annually. The biostatistics staff needs are negotiated on a case by case basis with approval by the Biostatistics Program Director. Note: Pre-approval must be obtained from the director before including faculty or staff on a grant application submission.
Hourly Cost Basis
Support can be funded using an hourly cost basis. Cost estimates will be provided by the Program Manager after an initial project consultation with a biostatistics faculty supervisor. There is no charge for the initial consultation. The hours worked will be billed monthly at the following hourly rate:
- Biostatistics Faculty: $120 per hour
- Biostatistics Staff: $75 per hour
- Informatics Staff: $75 per hour
Other Policies/Guidelines
Authorship
Co-authorship is independent of funding and should be based on the level of participation. See below for more information. If the program’s faculty and/or staff make a contribution that warrants authorship based on the guidelines, they should be listed as co-author.
Guidelines for Determining Co-Authorship for Biostatisticians
Determining whether a statistical consultant should be a co-author can be a difficult issue and should be negotiated on a case-by-case basis. Generally speaking, authorship should be based on the level of participation and should not be influenced by whether or not the consultant was paid. The following guidelines should be seen as recommendations that may be helpful in determining co-authorship.
According to the International Committee of Medical Journal Editors (http://www.icmje.org): All persons designated as authors should qualify for authorship, and all those who qualify should be listed. Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content.
Authorship credit should be based only on:
- a. substantial contributions to conception and design or
b. acquisition of data or
c. analysis and interpretation of the data - a. drafting of the article or
b. revising it critically for important intellectual detail - final approval of the version to be published.
Conditions 1, 2, and 3 must all be met.
Recommendation: In keeping with the above guidelines, If the statistician participating in the study performs some activity in each of categories 1. and 2. above and then approves the final version of the manuscript prior to submission to a journal, he or she should be given co-authorship. The most common situation is that the statistician helps with the design of the study (including determining the appropriate sample size), analyzes the data once they have been collected, and explains the results to the principal investigator(s). The statistician then writes the statistical methods section of the manuscript (or edits a version written by one of the other investigators) and may write and/or edit some or all of the Results section. In addition, the statistical consultant usually makes significant contributions to the tables and figures in the manuscript. If the statistician then reads the final version of the manuscript prior to submission (which is always recommended) and offers his or her comments, these activities would qualify the statistician as a co-author under the above guidelines. Furthermore, some journals require that “Any part of an article essential to its main conclusions must be the responsibility of at least one author…” (Academic Medicine Complete 2006 Instructions for Authors http://www.academicmedicine.org). If the statistician is not listed as a co-author, then one or more of the authors would have to take responsibility for the statistical analysis. Generally speaking, clinician researchers in the health sciences probably would not be experienced enough statistically to do this.
IRB Application
Any biostatistics faculty collaborating on a research proposal requiring IRB approval should be considered as co-investigator or sub-investigator on the IRB application. All program personnel maintains current human subject research credentials with the IRB. Investigator status (e.g. co-investigator, sub-investigator, key personnel) should be determined based on the level of participation.
For projects involving research, please provide the protocol, approval letter, or determination form from the IRB or IACUC. Please note that if at any time during the course of your support IRB approval expires, all access and work on the project will be suspended until approval is reinstated.
Grant Application
Any biostatistics faculty collaborating on the development of a grant application should be considered as co-investigator on the application, regardless of funding source (e.g. intramural or extramural). When allowable and applicable, percent effort for faculty and staff should be included in the grant budget. Please let the Biostatistics Program Manager know the outcome of the grant application (e.g. awarded, not awarded) in a timely fashion.
Timeline
For anything with a deadline (grants, abstracts, etc.), the program recommends at least eight weeks of collaboration prior to the submission date. This allows the program to manage staffing levels and ensure that there is time to provide input on design and analysis issues.
Biostatisticians need sufficient time to develop a strong grant for submission. For R21 grant applications, it is best to contact the Biostatistics Program as soon as possible, but at least three months prior to the deadline is required. For R01 applications, contact the program six to eight months prior to the deadline. For Intramural applications, such as ABI applications, the program requires at least four weeks of collaboration prior to the deadline (e.g. contact by February 1 for a March 1 deadline).
Outside Biostatisticians
It is understood that existing projects may receive statistical support from other sources outside of the DOP/ACH/ACRI Biostatistics Program. However, it is expected that all future projects (new or extended) requiring biostatistical support on ACH’s campus collaborate with faculty and staff within the Biostatistics Program at DOP/ACH/ACRI. If there is a need to use an outside biostatistician (external to ACH’s campus), please discuss this with the Biostatistics Program Director, Dr. Mario Cleves.
Request Support
To request support from the Biostatistics Program, complete a Pediatric Biostatistics Project Registration Request.
After support is requested, an initial consultation will be set up by the Biostatistics Program. If the investigator requesting support is not the Principal Investigator (PI) of the project, the PI should be included in the initial meeting and on all future correspondence.
The Biostatistics Project Manager, Amber Sharp, can be contacted at 501-364-6631 or asharp@uams.edu.
The Biostatistics Program Director, Dr. Mario Cleves, can be contacted at 501-364-5033 or clevesmarioa@uams.edu.