Department of
Pediatrics

WVU Medicine Children’s Research Consortium (CHRC)

Who we are

The WVU Medicine CHRC represents individuals who help coordinate and support pediatric research within WVU Medicine and the Health Sciences Center.

The team includes

  • certified coordinators,
  • regulatory staff or individuals trained in monitoring and ensuring ethical steps are taken,
  • nurses,
  • administrative assistants for clinical and data entry and
  • faculty who provide statistics and writing.

The idea is to support clinical research from the beginning to the end when the findings are in.

What we do

  • Provide grant writing assistance for grants and other external funding
  • Assist with writing trainee scholarships and support documents
  • Collaborate with other university units to activate contracts with various sponsors
  • Assist with Institutional Review Board protocol development, monitoring and reporting obligations
  • Assist with coordinating the project to meet milestones
  • Develop and implement project budget
  • Coordinate data sharing plan with partners
  • Ensure good clinical practice in research and quality improvement are maintained
  • Provide investigator mentorship and guidance

Projects we monitor

Non-Clinical Trial: This research involves more than minimal risk or involves protected populations such as children, prisoners or disabled individuals. Research that is not eligible for exempt or expedited review also falls under this category.

Clinical Trial: Voluntary research studies conducted on human participants designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments are considered clinical trials.

Quality improvement or any research project that Includes WVU Medicine Children’s, plus at least one additional site.

Any projects that examines a topic of particular concern to WVU Medicine in regard to COVID-19 or opioid use.

How is participant eligibility determined?

 

Some research projects are specific to a condition, or many of them are general pediatrics that they may hear about it from their pediatrician.

How do we communicate with families?

 

Parents will be told the purpose of the study, what is involved which the consent form will lay out. The research project investigator will walk the parent through what will be needed from the parent and child. The investigator will honestly lay out the risks and benefits for parents to determine whether they want to participate.

Why participate in research studies?

This research will bring more opportunities to improve care and outcomes for West Virginia families.

What research projects/opportunities exist?

 

  • Complete a survey - Participant can complete a survey.
  • Review medical records- When inpatient or outpatient care has already been given, the CHRC can review any patterns that exist or if things were effective so previous medical records are reviewed. This does not require anything of families, but it improves care.
  • Randomized controlled projects - prospective studies that measure the effectiveness of a new intervention or treatment.
  • Pharmaceutical studies - Testing a new drug, device, or new process. Investigators must obtain the appropriate human subjects and FDA approvals for each step. Our investigators are completing trials in the following phase groups:
    • Step 1: Discovery and Development;
    • Step 2: Preclinical Research;
    • Step 3: Clinical Research;
    • Step 4: FDA Drug Review; and
    • Step 5: FDA Post-Market Drug Safety Monitoring.

Pharmaceutical studies are only open to children if the drugs are shown not to place the patient at any increased risk. The CHRC can assist investigators with identifying the process and certain approvals needed as well as navigate them through that process.

What ages are eligible to participate in research?

 

General pediatrics includes newborns to age 17 years-old. There are occasions when care is provided to individuals as old as 26 years-old.

Part of a larger network

WVU Medicine Children’s belongs to the Children’s Oncology Group (COG), a global network of more than 200 leading children’s hospitals, universities and cancer centers.

Globally, pediatric cancer research has resulted in improved survival rates from only about 50% in the 1975 to better than 80%.

 

WVU Pediatrics coordinates, and/or contributes to, several multi-site clinical trials. Currently, there are over 80 trials in progress within the areas of Cystic Fibrosis, Neonatal Intensive Care, and Hematology/Oncology.

WVU’s pediatric oncology team offers COG protocols for various types of leukemias and lymphomas, brain, bone, and soft tissue tumors. Through WVU’s Children’s Oncology Group COG affiliation, patients have access to the treatments used at prominent cancer treatment centers worldwide.

The WVU CHRC is charged with tracking all quality improvement and research efforts as they relate to

  • the number of “more than minimal risk” projects conducted using hospital data of any type.
  • the number of multi-site projects.
  • the number of data sharing agreements.
  • the status of the project, challenges experienced and solutions identified.
  • investigator training needs and completion rates.