Rehabilitation Sciences Doctoral Program

Clinical Translational Sciences

Curriculum Program

 

Background

 

      The University of Kentucky is engaged in the process of establishing a Center for Clinical and Translational Science (CCTS). Financial support for this Center has been requested via a grant application to the National Institutes of Health in response to a request for applications to establish academic units to support clinical and translational science (PI: C. William Balke, MD, Senior Associate Dean for Clinical Research). Among the key elements required of the academic units of the CCTS is the development of programs to support research education, training, and career development.   

      The Graduate Certificate in Clinical and Translational Science is proposed to serve as the entry point for graduate-level training in clinical and translational science. The curriculum is designed to establish knowledge-based and skill-based competencies in communication, professionalism, critical thinking and synthesis of knowledge, planning, management and assessment; and leadership in five areas: CTS methods and technologies, scientific knowledge, measurement and statistics, research integrity (research ethics and responsible conduct of research), and collaboration and team building. These competencies are required of all CTS scholars, regardless of level of training or academic concentration. The Certificate curriculum will also serve as an emulsifying agent by integrating scholars with diverse backgrounds and training into a common training environment with group assignments and shared professional socialization experiences.

 

Goals and Objectives of the Certificate Curriculum

 

      The Certificate curriculum is intended to offer participants the necessary coursework, informational sessions, and mentored clinical research opportunities necessary to provide them with a strong background in the competencies necessary to participate in clinical and translational research. The knowledge and skills obtained are designed to support participants’ ability to attract research funding and to publish the results of that work in appropriate peer-reviewed journals. The Department of Behavioral Science in the College of Medicine will be the organizational unit responsible for the Certificate. The hours earned toward the Certificate may be used by students who wish to continue their study and earn an additional degree, such as the Master’s degree in Medical Sciences. 

      Completion of Graduate Certificate coursework will include assessment of the competencies needed to participate effectively in clinical and translational research. After completing coursework and the research practicum, certificate scholars should be prepared to step into ongoing clinical and translational protocols with minimal training, and serve valuable roles in supporting these protocols.

 

Certificate Requirements

 

To be awarded the Certificate, participants must complete the following coursework (currently a total of 12 credit hours) with an overall GPA of at least 3.0.  An overview of the program curriculum is outlined below.  A general description of each course is provided by clicking on the title of the course.

 

Course Section and Number

Title

Credits

BSC 731

Methods & Technologies in CTS

3 Credits

BSC 732

Interdisciplinary Protocol Development

3 Credits

BSC 733

Seminar in CTS

1 Credit

CPH 665

Ethical Issues in Clinical Research

3 Credits

STA 580

Biostatistics I (or equivalent)

3 Credits

 

Research Practicum

 

 

Certificate Curriculum Faculty and Graduate Faculty Status

 

Name

Department(s)

Graduate Faculty Status

Thomas H. Kelly, PhD (Director)

Behavioral Science, Psychiatry, Psychology, Nutritional Science

Full

Jane S. Harrison, PhD (Co-Director)

College of Medicine Dean’s Office

N/A

Richard J. Kryscio, PhD (Biostatistician)

Statistics, Public Health

Full

C. William Balke, MD

Physiology

Full

Thomas Foster, PharmD

Pharmacy

Full

Jimmi Hatton, PharmD

Pharmacy

Full

Carl G. Leukefeld, PhD

Behavioral Science, Communications, Sociology

Full

Ada Sue Selwitz, MA

Behavioral Science

N/A

Steve Shedlofsky, MD

Toxicology

Full

Susan S. Smyth, MD, PhD

Internal Medicine, Cardiology, Physiology

Pending

Mary E. Vore, PhD

Toxicology

Full

Mitzi Schumacher, PhD

Behavioral Science

Full

Brian Stevenson, PhD

Microbiology, Immunology & Molecular Genetics

Full

 

Detailed Descriptions of the Individual Courses

 

BSC 731 Methods and Technologies in CTS

(Currently offered in the spring semester and during the summer)

This overview course is designed to introduce students to the major CTS methods and technologies, enable students to interpret and evaluate research findings using these methods and technologies, enhance appreciation for multidisciplinary approaches to CTS; and enhance interdisciplinary vocabulary. The course will consist of presentations followed by open discussion. Topics include experimental, survey and qualitative research methods, community engagement/participatory research, cultural sensitivity, proteomics, genomics, imaging, bench bedside translation, clinical trials, epidemiology, health behavior models, bedside community translation, and health services utilization. Homework assignments will include readings and experiential opportunities to work with these CTS methods and technologies.

                                                                                                           

BSC 732/CPH 670: Interdisciplinary Protocol Development

(Offered in fall 2007 as BSC 772-003; currently offered in the fall semester)

This course is designed to orient students to leadership and teamwork processes involved in clinical and translational research and to train students to function effectively in team settings. Teams will be composed of students from different disciplines with a designated principal investigator. Each team will develop a conceptual model for an integrated multidisciplinary research proposal, in response to an existing NIH Request For Application. Each team member will be responsible for developing one component of the protocol. The course objectives are to understand the role of leadership and teamwork in multidisciplinary clinical and translational research; contribute effectively to a multidisciplinary team engaged in clinical research protocol development; apply knowledge of the responsible conduct of research, statistics, and CTS methodologies and technologies to protocol development; and model professional clinical and translational teamwork through effective interaction and communication with leadership and team members.

 

BSC 733/CPH 671: Seminar in Clinical & Translational Science

(Offered in fall 2007 as BSC 772-002; currently offered during the fall and spring semesters)

TEAM sponsors a continuously running ni-monthly seminar series that serves as a training and career development resource for all CTS faculty and scholars. This seminar series includes cutting-edge CTS research presentations by faculty, ‘work-in-progress’ presentations by scholars designed specifically to offer constructive peer-review support and feedback from the CTS community, and professional development presentations. Depending on a scholar’s stage of development, presentations may consist of project updates, reviews of papers or grants, or practice sessions for podium talks at national meetings. Discussion/critiques will be lead by a review panel consisting of the scholar’s mentors and additional reviewers with relevant research experience and other program scholars. Relevant papers and grants in-preparation will be distributed several weeks in advance to provide sufficient time to prepare critiques. This series will also provide career enhancement seminars led by faculty from across the university on such topics as “Getting the most from your mentored training experience,” “Grantsmanship 101: selecting the right funding mechanism,” “Facilitating neutrality in studying special populations diverse from the backgrounds of the research team,” and “Effective time management strategies”. This seminar course is designed to engage certificate scholars in critical review of clinical and translational research at University of Kentucky & to train students to incorporate a multidisciplinary cooperative approach to clinical and translational research. The course objectives are to understand and contribute to the development of clinical & translational research; develop effective interdisciplinary scientific communication skills; apply knowledge of and responsible conduct of research and CTS methodologies and technologies in oral, written communication; model professional clinical & translational demeanor through effective interaction and communication; and demonstrate respect for diverse CTS methodologies and technologies.

 

CPH 665: Ethical Issues in Clinical Research

(Next offering tentatively scheduled for fall 2008)

Based on NIH guidelines for responsible conduct of research, this course will present ethical and regulatory guidelines for conducting clinical research. Topics include institutional protection, regulation of human & animal research, subject recruitment/retention, vulnerable populations, research ethics, placebo & washout issues in clinical trials, ethics and genetic research, tissue/DNA banking, data ownership/sharing, misconduct, mentoring, and conflict of interest.

 

STA 580: Biostatistics

(Currently offered during the fall and spring semesters)

This course will present descriptive statistics, hypothesis testing, paired and unpaired t- tests, ANOVA, contingency tables, log rank test, and regression with biostatistics applications.

Note: STA 570 or equivalent course can be substituted.

 

Research Practicum

In addition to formal coursework, a six-month clinical and translational research practicum is required for certificate completion. Completion of Graduate Certificate coursework will include certification of the competencies needed to participate effectively in clinical and translational research. As such, Certificate scholars will be prepared to step into ongoing clinical and translational protocols with minimal training, and serve valuable roles in supporting these protocols. Prior to entering the research practicum, the certificate scholar, in collaboration with his/her mentor, must submit a detailed research training plan that includes a description of the research project, a list of objectives and expected outcomes for the scholar in relation to the project, a detailed plan for measuring objectives and monitoring progress, a proposed timeline of scholar activities, and description of the mentoring plan. The research practicum must contribute to original research and peer-reviewed publications. This plan will constitute a ‘contract’ signed by scholar and mentor. This plan will be submitted to the Certificate Curriculum Faculty for review, approval, and research funding consideration.