Institutional Review Board (IRB)/
Ethics Committee (EC)
Those who know us well know that our roots are in human research protections and IRB. HRP Consulting can provide expert assistance with practically any aspect of IRB development and management, including the following:
- Setting Up an IRB or Ethics Committee
- IRB Reliance Management
- IRB Process Evaluation and Enhancement
- IRB Compliance Evaluations
- Collaborative IRB Development
- Policies, Procedures, Forms and Checklists
- Training and Education
- IRB Review Consultations
- Temporary IRB Members
- Temporary IRB Staff
- Retainers for on-call guidance and support
FDA recently announced enforcement action taken due to noncompliance with ClinicalTrials.gov requirements. While the enforcement action noted in the FDA announcement was directed at an industry sponsor, FDA made clear that responsible parties of all types, including...
Institutional Review Board: Management and Function” is now available through the Jones & Bartlett Learning website. Ms. Savini, Ms. Christianson, and Ms. Matuk of HRP Consulting were honored to contribute content for this book, casually referred to as the “IRB...