HRP Services
Institutional Biosafety Committee (IBC)
HRP Consulting can also provide expert assistance with practically any aspect of IBC development, operations and management, including the following:
- Setting Up an IBC
- Development of IBC Policies, Procedures, Forms and Checklists
- Development of Information for Principal Investigators on:
- the preparation submission of rDNA and biohazard protocols
- documentation of researcher training (hands on practices and techniques)
- Development of Bio-Safety Procedures
- procedures for treating research-related biological wastes
- biosafety inspections
- IBC Process Evaluation and Enhancement
- IBC Self-Assessment and Compliance Evaluations
- Training and Education on:
- Dual Use Research of Concern
- Federal Toxin Due Diligence
- Blood Bourne Pathogens
- Providing Temporary IBC Members
- Providing Temporary IBC Staff
IND Safety Reports and IRBs
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 Announces ClinicalTrials.Gov Enforcement Action
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...