Human Subject Research Core

The Human Subject Research Core will assist with protocol development for PenNSAM studies. It will manage regulatory compliance and implement inpatient and outpatient PenNSAM protocols including recruitment and screening of participants, implementation of study visits and procedures, as well as the collection and management of study data.

Services offered

    • IBR protocol and FDA IND applications
    • Stool Collection Methods/Materials
    • Dietary history instruments
    • Study participant payment
    • Case report forms
    • Staffing
    • Budgeting
    • Assistance with grant preparation: The core can provide assistance with
      grant preparation through consultation on study design, statistical analysis
      design, power calculations, and assisting in drafting text for analyses
      and translational study designs.

Fees

    • Research Coordinator Time – $40 / hour
    • Senior Coordinator Time – $75 / hour
    • Senior Project Manager Time – $125 / hour
    • Core Director Time – $150 / hour

Director

James D. Lewis, MD, MSCE

Professor of Epidemiology in Biostatistics,
Epidemiology and Informatics
Professor of Medicine
Director, Human Intervention Core,
PennCHOP Microbiome Program and
Penn Center for Nutritional Science and Medicine
lewisjd@pennmedicine.upenn.edu

Clinical Research Staff

Lisa Nessel, MSS, MLSP
Senior Project Manager
nessel@pennmedicine.upenn.edu

Brittaney Bonhomme
Clinical Research Coordinator
bobrit@pennmedicine.upenn.edu