HRP Services
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
OHRP Issues Single IRB Draft Guidance
On July 1, 2022, OHRP posted a draft guidance document for public comment entitled “Use of a Single Institutional Review Board for Cooperative Research.” The draft guidance will be open for public comment until August 30, 2022. The recently posted draft guidance...
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”:...