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

• IRB 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 related to human diet and nutrition studies.

Fees

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