Meet our Leadership Team

Vice Chair, Pediatrics Research

Janice Sullivan, MD, FAAP, FCCM, CPI
Research Bio

As Vice Chair for Research in the Department of Pediatrics, Dr. Sullivan supports the Department of Pediatrics mission and vision to be a national leader in pediatric research in the following areas: clinical and translational research, basic science research, health services research, and education research through her leadership and guidance to faculty, fellows, and students. She leads the Pediatric Innovation and Research Advisory Team and works closely with the leadership of the Norton Children’s Research Institute to develop and implement strategies to advance research and improve care for children in our region.

Research Leaders

Kyle Brothers, MD, PhD
Division Chief and Endowed Chair of Pediatric Clinical & Translational Research
Chief Scientific Officer, Norton Children's Research Institute affiliated with the University of Louisville School of Medicine
Research Bio

As Division Chief for the Division of Pediatric Clinical and Translational Research, Dr. Brothers leads pediatric faculty members who work primarily in clinical and translational research. In his role as Chief Scientific Officer, Dr. Brothers leads the scientific work of the Norton Children's Research Institute, with a focus on developing successful research programs and ensuring pediatric investigators have the resources they need to succeed.

Lu Cai, MD, PhD
Division Chief, Pediatrics Research Institute
Research Bio

As Division Chief for the Pediatrics Research Institute, Dr. Cai leads faculty, learners, and staff to be substantial contributors with basic science knowledge in childhood diabetes and neurosciences.

Deborah Winders Davis, PhD
Director, Child & Adolescent Health Research Design & Support Unit
Research Bio

As Director of the Child and Adolescent Research Design and Support Unit, Dr. Davis supports faculty, staff, and trainees in planning, implementing and disseminating Pediatric health services research and supports the development of the Department’s research infrastructure.

Matthew Hawthorne, JD, MBA
Administrative Director, Norton Children's Research Institute

Sara Watson, MD, MS
Medical Director, Kentucky Pediatric IDeA States Research Center

As Medical Director, Dr. Watson oversees the clinical research aspects of the Division of Clinical and Translational Research and the Pediatric Clinical Research Unit. In collaboration with clinical teams, she provides strategic leadership and medical guidance. She coordinates the clinical research teams to achieve daily goals that support the overall mission for pediatric research.

Staff Leaders

Jen Comings, RN, BSN
Director, System Research Program
Norton Children's Research Institute

Kristen Gossett, BS, CCRC
Inpatient Clinical Research Manager
Norton Children's Research Institute

Sarah King, BSBA, ACRP-CP
Manager, Norton Children's Research Institute Operations
Norton Children's Research Institute

Kendra Sikes, MSc, CCRP, CCRR
Manager, Research Development and Support
Child & Adolescent Health Research Design and Support (CAHRDS) Unit

Research Units

Norton Children's Research Institute affiliated with the University of Louisville School of Medicine

• Pediatric Clinical Research Unit (PCRU)
  
• Child and Adolescent Health Research Design and Support (CAHRDS) Unit

Pediatrics Research Institute (PRI)for basic science research

Contact Us

Resources for Medical Professionals and Investigators

Access thePediatrics Research Internal Resources           and Requests

• Click the link "Pediatrics Research Internal Resources and Requests" to access resources and forms for faculty, staff, learners, and collaborators.  Use the ULink ID and password to log in.

• Access the Norton Healthcare Research Office

• University of Louisville Research Offices:
• Office of Research and Innovation
• Human Subjects Protection Program (IRB) Office
• Office of Sponsored Programs Administration: Grants and Contracts
• Office of Research Integrity

Frequently Asked Questions

How do I connect my patient with one of your studies?

Please call the Pediatric Clinical Research Unit (502) 629-5820 and select option 1 to be connected with the appropriate Research Coordinator or ask your patients to complete the Patient Interest Form.

I am a Sponsor. What is the fee schedule?

• Level 1
• Level 2
• Level 3

I need help funding, designing, or conducting my project.  How can I access services and find resources? 

Access the Pediatrics Research Internal Resources and Requests page to access the request form for all services and to answer questions such as:

• How do I get help with a grant application?
• How do I get help with an IRB application?
• How do I get help from a statistician?
• How do I write a new research protocol?
• A sponsor reached out to me about a new industry sponsored study.  What do I do now?
• I want to become a study site for a consortium I work with.  What do I do now?
• Can I get research personnel or learners to help me with my study?
• How do I get help navigating research at outside institutions and local partners?
  

I am unsure what types of approval my project needs. How can I get help?

• Study Types with IRB Requirements Chart
• Description of Study Types
• IRB Requirements
  
• Flow diagram including outside institutions (coming soon..)
• IRB Flow diagram (coming soon...)
• Still need help?  Access thePediatrics Research Internal Resources and Requestspage.

After IRB and Norton Research Office approval, how do request data for projects in EPIC?

     Please log into the Pediatrics Research Internal Resources and Requests page to access instructions.

I am on a research study. How do I complete my training?   

Institutional requirements:

• Before you begin Training - Study Personnel Requirements
• Additional trainings and forms:
• Bloodborne Pathogens Training must be completed annually by all faculty members.  Once you log in with your UofL credentials, go to Training - Course Directory- Bloodborne Pathogens Training - Launch Course.
• Attestation and Disclosure Form - Instructions for completing the online ADF are here.  Must be completed annually by faculty.
• CITI (human subjects) and HIPAA Research Fundamentals visit CITI Program website

• Sponsor requirements:
• Individual clinical trials or sponsored studies may have specific training requirements beyond institutional training.
• Check with your sponsor for more details.

I am the PI on a study, what are my responsibilities?

• Provide link to online training module (Coming Soon...)
• PI responsibilities and/or a document to verify PI training(Coming Soon...)
• Access the Pediatrics Research Internal Resources and Requests page for more information

I need help finding additional training related to conducting research. Where can I go?

• Visit Faculty Development resources
• Access the Pediatrics Research Internal Resources and Requests page for more information

Contact Us

Division of Clinical & Translational Research
Phone: 502.629.5820
Fax: 502.629.5285
Email: ncri@louisville.edu

Make a donation to Pediatrics Clinical & Translational Research

Pediatrics Research Institute

(Click the link above to learn more about the Pediatrics Research Institute)

Working under the leadership of Lu Cai, M.D., Ph.D., the Pediatrics Research Institute's mission is to improve children's health, development and well-being through high-quality research. At present, support is directed toward providing infrastructure support for promising pediatric scientists and pioneering new research directions. We intend to achieve maximum return on what constitutes a currently small but growing investment in pediatric research, while implementing a "bench to bedside" philosophy.

We currently house excellent research programs in  Sleep Neurobiology and Juvenile Diabetes. We are expanding our scope to include tumor biology and outcomes research. Moreover, all of the programs housed here have the potential for expansion through collaborative research.

We are located in the Baxter Research Building on the University of Louisville Health Sciences Center campus. Our facility aids research by providing state-of-the-art equipment and a laboratory design that maximizes efficiency and supports innovation. Through common areas like informal lounges, we also provide the means for collaboration among researchers from various disciplines. The 30,000 square foot research floors feature three core laboratories and 18 laboratories measuring 880 square feet each. Annual support for Pediatric Research Institute investigators totals more than $5 million, with a substantial amount of the funding coming from the National Institutes of Health.

We are dedicated to the discovery of fundamental problems associated with pediatric disease. It is a core departmental function that will only grow in importance. Each year, our faculty produces significant peer-reviewed publications, abstracts, scientific presentations, books, and book chapters—43 in 2013. We have four endowed chairs of pediatric research.

Contact Us

Pediatrics Research Institute
Office: 502.852.2669

Pediatric Clinical and Translational Research

Click to Join
a Pediatric Research Study

Clinical research is research that is conducted in close collaboration with healthcare providers, such as in a clinic or a hospital, and is focused on improving care for patients. One example of a clinical research study is a clinical trial designed to test whether a new medication is safe and effective for children.

Translational research is focused on learning how to take better care of patients. Translational research is done by gathering insights from laboratory research or by observing what happens in clinics, hospitals, or communities. We are doing translational research, for example, when we collect information about whether children being admitted to a hospital are receiving all of the services that are recommended for children with their condition.

Clinical research and translational research are closely related. In fact, they somewhat overlap with one another. The key feature of both, however, is that they involve doctors and scientists learning more so that children and families can stay healthier and receive better healthcare. These types of research are typically reviewed by an ethics committee to ensure that the risks of participating are kept to a minimum. The ethics committee also makes sure that families invited to participate in clinical or translational research will be able to make a completely voluntary choice about whether they want to participate.

 Clinical and Translational Research is conducted by:

Norton Children's Research Institute affiliated with the University of Louisville School of Medicine

• Child & Adolescent Health Research & Design Services
• Pediatric Clinical Research Unit  (Coming Soon...

 Why join a clinical research study?

There are frequent questions asked about conducting research in children. Children and Clinical Studies is a website that provides parents and children with the information they need to understand clinical research and make informed decisions about participating in a study. It can also assist primary caregivers in answering patients' questions about research as it provided key concepts of pediatric clinical research. The NIH has also created a video about Children and Clinical Studies that you can view here.

If you want to learn more about current or past clinical trials across the United States, please visit  www.ClinicalTrials.gov.

And if you want to learn more about pediatric trials, please visit the Pediatric Trials Network  or NIH Clinical Research Trials and You. 

Contact Us

Division of Clinical & Translational Research
Phone: 502.629.5820
Fax: 502.629.5285
Email:  ncri@louisville.edu

Make a donation to Pediatrics Clinical & Translational Research

Patients and Families

Click to join a
Pediatrics Research
Study

The Pediatrics Clinical Research Unit (PCRU) is a team of dedicated and experienced clinical research coordinators, nurses, and other staff. Our team members work together to coordinate patient-oriented research to improve healthcare and the safety of medicines and devices in children from birth to adulthood and includes all races and genders.

The PCRU faculty and staff work together with doctors, nurses and pharmacists at Norton Children’s Hospital, pediatric outpatient clinics and doctors across the Kentuckiana area to conduct current studies and share results.

 Did you know? 

• 70-80% of prescribed medicines given to children are not approved for use in children by the US Food and Drug Administration (FDA). Most have only been tested in adults. 
• The PCRU works with drug companies and federal agencies to make sure medications and medical treatments are safe for your child. 
• The research team works closely with your child’s physician throughout the study to ensure that your child received the best and safest care possible. 
• Some of our studies have already made positive changes in the way that we prescribe medications and provide care to children. 
• We have a research nurse on call 24 hours a day, 7 days a week. In clinical trials, patient safety is always our first priority.  
• It is often thought that clinical trials are mainly for people who have no other option. In fact, clinical trials can be an additional option to help you and your child through their medical care.

Frequently Asked Questions

Click here to access a list of Frequently Asked Questions

Why join a clinical research study?

We understand your hesitancy and questions about investigational treatments. Please always feel free to speak to a member of our staff about any questions or concerns you may have. If they don’t have the answer, they will be happy to find out an answer for you. If you would feel more comfortable reading more before joining, Children and Clinical Studies is a website that provides parents and children with the information they need to understand clinical research and make informed decisions about participating in a study. It can also assist primary caregivers in answering patients' questions about research as it provided key concepts of pediatric clinical research. The NIH has also created a video about Children and Clinical Studies that you can view here.

If you want to learn more about current or past clinical trials across the United States, please visit ClinicalTrials.gov.

And if you want to learn more about pediatric trials, please visit the Pediatric Trials Network or NIH Clinical Research Trials and You.

Contact Us

Division of Clinical & Translational Research
Phone: 502.629.5820
Fax: 502.629.5285
Email: ncri@louisville.edu

Make a donation to Pediatrics Clinical & Translational Research