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
HRP recently engaged in extensive correspondence with the FDA regarding the following statements that appeared in one of the later iteration’s of the FDA’s guidance document “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”:...
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...