Research Support Services | Apply for Services | What to Expect When Your Participate

What is Informed Consent? | Current Clinical Trials | Faculty & Staff

The Clinical Research Unit (CRU) at the Department of Pediatrics research facility in E. V. Williams Hall offers children and their families within the Hampton Roads community the opportunity to participate in national clinical trials for new and improved pharmaceuticals.  The unit offers research support services to faculty within the Department of Pediatrics and other departments throughout Eastern Virginia Medical School. See list of Clinical Research Unit faculty and staff below.

Research Support Services 

The Clinical Research Unit provides assistance to investigators of all research experience levels for all research support needs, whether your study is investigator-originated, part of a national protocol or an industry-sponsored research project.  Our research staff is expert in Good Clinical Practices, and has experience in conducting industry-sponsored Phase I, II, III, and IV clinical trials.  Our 15-year history includes conducting trials evaluating vaccines and infant formulas as well as assisting with projects in pediatric sub-specialties including allergy, neonatology, nephrology, otolaryngology, endocrinology, gastroenterology, genetics, infectious diseases, and sickle cell disease.  Our experience extends to assisting principle investigators with their grants from National Institutes of Health, Centers for Disease Control, and other federal and private funders, with a full scope of services from research design and measurement, to grant application, research assistance and manuscript editing.  We also assist residents in their research projects and are often successful in helping them find funding for their projects as well. 

Investigators within the Department of Pediatrics may request full study support, consisting of budget and contract negotiation, completion of regulatory documents, and full coordinator support.  Alternatively, the CRU has a service menu and fee schedule covering many support services on an as needed basis.  In addition, an MPH-trained epidemiologist provides study design, database development, data management, statistical analysis, and manuscript assistance.  Coordinator orientation and ongoing educational consultation is available to assist the investigator’s clinic staff who are new to research and are assuming some coordinator responsibilities. 

The Clinical Research Unit provides assistance to faculty, house staff, and other staff members from the inception of the research question through data collection, analysis, and manuscript submission.

Apply for Services

Click on the link below to access the Research Support Services Application Form and Price List for Available Services. For best results, we encourage investigators to contact Research Support Services prior to beginning a project regardless of the level of services you may anticipate requesting.

• Research Support Services Application Form AND Price List

   

  

WHAT TO EXPECT WHEN YOU PARTICIPATE

Children receive attentive, expert care from outstanding medical practitioners when parents enroll them in clinical studies offered by the Clinical Trials Unit of Eastern Virginia Medical School’s Department of Pediatrics Clinical Research Unit.  Parents feel good about their participation because their support allows doctors to gain important information to better protect all children from disease.  We also offer adult studies, providing the same caring attention to subjects of any age. 

Each clinical trial is different, but in all cases the health of the patient is of the utmost importance.  Clinical research experts carefully analyze information collected about study subjects.  The results enable investigators, drug and medical equipment manufacturers to produce the most effective medicine and treatments for childhood and adult illnesses.  Some results help doctors actually prevent diseases. 

Study subjects receive investigational treatments and medical care under close supervision by physicians and other research professionals.  Industry-sponsored trials have been developed by respected pharmaceutical and biotechnology companies, and are reviewed by the US Food and Drug Administration. 

When volunteers participate in a study, their health is carefully monitored throughout the trial.  It is important that subjects and pediatric subjects’ parents follow all instructions from the study staff, take all prescribed medicines, keep all scheduled appointments, and report any symptoms the subject may experience no matter how small they may seem.  Subject safety is our top priority.  So is privacy.  Medical records always remain confidential and trial results provided to the pharmaceutical company never include names of subjects or their families. 

Data Collected Contributes to Medical Knowledge 

After each study, information from all subjects is analyzed to determine if the investigational treatment is working.  Results are also analyzed to verify that the treatment is safe and to note any side effects.  The FDA closely reviews these results before approving any new drug for general public distribution.   

Even after approval, companies continue to study drugs and compare them to other treatments for effectiveness and safety.  Involvement as a study volunteer is extremely important in bringing this knowledge to the medical community and the benefits to people worldwide. 

Supported by Trusted Experts 

Staff and faculty from Eastern Virginia Medical School are closely involved in our research.  So are pediatricians at Children’s Hospital of The King’s Daughters and from around the region.  Over seventy local pediatricians participate in our pediatric trials.  These doctors appreciate the value of clinical studies and know how important the results are for all children. 

The Clinical Research Unit conducts from 20 to 25 clinical trials at any time.  Children of all ages can participate, and several adult studies are available.  Whether you participate in one or several of our trials, we thank you for your involvement. 

WHAT IS INFORMED CONSENT?

When individuals, or the parents of children, agree to participate in a clinical trial, they must sign a document giving consent to their participation.  Consent is not just a signed document; it is a process.  Study coordinators and study subjects should take time to sit down and discuss issues related to study subject participation in a clinical research trial.  To be better prepared for this step in participation in a clinical trial, a potential study subject should understand requirements of the process. 

Requirements for informed consent include that those involved in research (study subjects, or parents of children who will become study subjects) must have sufficient time to consider participation.  No improper enticements or coercion (for example, excessively large payments) may be used. The informed consent document must be in lay language with medical terminology explained in lay terms. 

When you review a consent document, look for the following information: 

• That the study is research oriented

• Any potential risks

• Any potential benefits

• Alternative treatments

• Extent of confidentiality (sponsor and FDA may inspect records)

• Compensation for injury; medical treatments for adverse effects and sources for additional information

• Contact for further information about the study or for information regarding injury

• That the study subject’s participation is voluntary and that the study subject may discontinue without prejudice.

 Other information that must be included, if applicable to the study protocol:

• Potential for unforeseeable risk to subject, embryo, or fetus

• Circumstances under which subject may be terminated from study without subject’s consent

• Additional costs to subject related to participation

• Consequences of study subject’s withdrawal from the study

• Provision for release of new information that may affect study subject’s decision to remain in the study

• Approximate number of study subjects to be included in the study

If you have any questions, your study coordinator or physician should be able to answer them to your satisfaction before you sign your consent to the study.

E.V.M.S. Department of Pediatrics – Clinical Research Unit

855 West Brambleton Avenue

Norfolk, Virginia  23510

(757) 688-6414

 Clinical  Studies

June 2007

You are invited to enroll your child in any of the following research studies at no cost to you.  If you are interested in finding out more about clinical trials research, or any of these studies, or if you would like to enroll your child, contact the study coordinator listed. 

FACULTY

• Christine Buescher, BS, CCRC (Division Director)

STAFF

• Lorrie Coggsdale, RN, Clinical Research Coordinator 

• Mary Beth Donner, RN, CCRC, Certified Clinical Research Coordinator 

• Rita Harvey, Administrative Assistant 

• Teresa Hedrick, BS, MT, CCRC, Laboratory Operations Supervisor, Contract and Accounts Manager,
  Certified Clinical Research Coordinator 

• Rebecca Sheeran, RN, MSN, CPNP Clinical Research Coordinator 

• Melody Skinner, RN, MSN, CPNP, Clinical Research Coordinator