Tag Archive: Clinical Research Unit

ICTR in the News: Recordings Reveal Deep Credibility Gap When Doctors And Parents Discuss Outcomes For Critically Ill Infants


The following article profiles work performed by ICTR researcher Renee Denise Boss, M.D., associate professor of pediatrics at the Johns Hopkins University School of Medicine. An analysis of 16 audiotaped conversations between parents of infants in a neonatal intensive care unit (NICU) and clinicians found that medical staff routinely downplay quality of life issues and leave families more optimistic about their babies’ prognoses than the clinicians intended. A report of the analysis, published in the Nov. issue of the Journal of Perinatology, highlights a persistent gap between family and clinician understanding of infant outcomes, and the need for clearer communications … Continue reading

Service Request: Clinical Research Unit (CRU) Online


All investigators must submit an application to a Johns Hopkins Institutional Review Board (IRB) before beginning their ICTR Clinical Research Units (CRUs) application. There are two ways to submit an application to the ICTR Clinical Research Units (CRUs)– one method applies if you are using the School of Medicine eIRB system, while the second applies if you have submitted to another Johns Hopkins IRB. Please read through the materials below. If you need assistance with your budget before you apply, please contact Shernice Madison (smadison@jhu.edu, 410-550-7033) or Nicole Cooper (ncooper2@jhmi.edu, 410-550-1880).   First Method: For investigators who apply to the … Continue reading

Charges For Clinical Research Unit Services


Effective May 2018, Clinical Research Units are now operating using a service center model. The National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH), which supports the ICTR Clinical Research Units (CRUs) through its Clinical and Translational Science Award (CTSA) program, announced in 2014 that direct support of the CRUs will not be allowed for any new or re-competing CTSA awards. Our CRUS have been a major source of support for investigators throughout Johns Hopkins and this change in policy will have a significant impact on our future ICTR operations. This NCATS policy has already been … Continue reading

Pediatric Neuropsychological Testing


Neuropsychological testing, includes achievement tests, behavior checklists, measures of personality, developmental status, intelligence, executive function, language, visual spatial skills, and memory, are available to ICTR CRU investigators. Skilled psychologists are available to provide a broad range of testing, including assessments of children who are cognitively very limited; those less severely impaired; and learning disabled children and adults; and control groups.

Operant Performance Measures


State-of-the-art Operant Performance Measures are available to investigators through the NBRU at Kennedy Krieger Institute. Direct observation of behavior, conducted in areas that simulate naturalistic settings, is accomplished by the use of computers with accompanying customized software that allows for the simultaneous recording of up to twenty behaviors for real time analysis, including conditional probability calculations.

Research Participant Advocacy


The Research Participant Advocacy Program offers consulting expertise on human subjects and regulatory issues, IRB applications, the informed consent process, study feasibility and good clinical practice (GCP). Our advocates serve as a resource to research teams and research participants by reviewing applications to the Clinical Research Unit to assure high standards for human subjects protections. Contact our team to review consent forms, protocol or data and safety monitoring plans. Advocates are available to provide: Information on how to administer the best consent Help with Good Clinical Practice (GCP’s) Assistance on how to report an unanticipated study event Guidance with assembling … Continue reading

Research Participant Advocacy Program


The Research Participant Advocacy Program offers consulting expertise on human subjects and regulatory issues, IRB applications, the informed consent process, study feasibility and good clinical practice (GCP). Our advocates serve as a resource to research teams and research participants by reviewing applications to the Clinical Research Unit to assure high standards for human subjects protections. Contact our team to review consent forms, protocol or data and safety monitoring plans. Advocates are available to provide: Information on how to administer the best consent Help with Good Clinical Practice (GCP’s) Assistance on how to report an unanticipated study event Guidance with assembling … Continue reading

Exercise Physiology and Body Composition


The Exercise Physiology and Body Composition Core’s laboratory provides DEXA measurements for body fat, muscle and bone composition, metabolic stress testing, and also supports exercise-training protocols. The facilities are located at the Bayview Clinical Research Unit. DEXA scanning is also available on the Broadway campus through the Adult Outpatient Unit. Supported studies address issues like exercise testing and training and body composition of patients with chronic health conditions. The Core also provides coronary risk factor assessment and modification for approved users and works closely with CRU Research Nursing, Research Nutrition, and the Research Core Laboratory for sample collection and processing. … Continue reading

Research Nutrition


ICTR Research Nutrition was established to support CRU investigators in developing and implementing the best nutritional plans for their research protocols for both pediatrics and adults. Services are located in the clinical research units at both the Johns Hopkins Bayview Campus and the Broadway (main medical) Campus. Research Nutrition staff includes a diverse nutrition team comprised of a research nutrition manager, research nutritionists, a kitchen supervisor, and research nutrition technicians. The ICTR Research Nutrition staff can perform: In-depth nutrition assessments Diet intake analysis for both macro- and micro-nutrients Nutrition counseling Anthropometric and body composition measurements, Energy expenditure assessments Design and … Continue reading

We analyze the 24-hour recalls and food records using Nutrition Data System for Research (NDSR).

Nutrition Education

We provide diet counseling and nutrition education for numerous protocols that involve weight loss, food allergies, chronic diseases including diabetes and cardiovascular disease, and a wide range of rare metabolic disorders for both pediatrics and adults.

Anthropometrics and Body Composition

We offer several non-invasive techniques to measure body composition, including:

  • Height and weight,
  • Circumference measurements like waist, hip, head, thigh, and mid-arm,
  • Skinfold measurements to estimate percentage of body fat, arm muscle area, and arm fat area,
  • Bioelectrical Impedance Analysis (BIA): A small current is passed through the body to estimate body fat mass (weight and percent), fat-free or lean body mass (weight and percent), and body water.

Energy Assessment

  • Indirect Calorimetry– The metabolic cart calculates energy expenditure (REE), which accounts for 75-95% of total energy expenditure. The remaining 5-25% is highly variable depending on age, sex, size, disease state, and daily activity.
  • Predictive Equations– —These equations calculate energy requirements based on height, weight, age, and activity factor. Examples are the Mifflin St. Jeor equation, the Harris-Benedict equation, DRIs, etc.

Visit Meals and Diets

We can provide standard or protocol-specific meals snacks, and formula.

 

  • Research Nutrition Presentations
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    Cardiovascular Imaging Laboratory


    The Cardiovascular Imaging Laboratory provides echocardiographic and carotid imaging for approved CRU protocols, as well as measurement of endothelial function and arterial stiffness.   Echocardiogram Echocardiograms are performed on a Toshiba Artida ultrasound system. All cardiac studies are stored digitally and analyzed using the Philips Excelera System. Image acquisition and analysis protocols can be customized to meet the unique needs of the investigator. Carotid IMT Carotid imaging is performed on a Toshiba Aplio ultrasound system. Using commercially available state of the art equipment that includes automated border detection, the core lab can accurately measure carotid intima-medial thickness and distensibility. Brachial … Continue reading

    Clinical Research Units


    The Clinical Research Units (CRUs) provide resources at 3 locations throughout the medical campuses–Johns Hopkins Hospital, the Charlotte R. Bloomberg Children’s Center and the 301 Building on the Johns Hopkins Bayview Medical campus. The CRUs are the safest, most efficient way to perform clinical and translational research and offer an indispensable resource that is widely used and required by our NIH funded investigators. Through protocol review, investigator mentoring, trained nursing staff, protocols performed on the CRUs are planned, vetted, monitored and performed under a similar safety standard to clinical care. All protocols are reviewed for scientific rigor, appropriateness of resources … Continue reading