HRP Services
Human Research Protection Programs (HRPP)
The core concept of a HRPP is to engage all stakeholders in ensuring the protection of human subjects in research. With increasing reliance on external IRBs, a highly functioning HRPP has become even more essential to ensure that organizations fulfill their responsibilities to oversee research, protect local subjects, and support regulatory compliance and best practices.
HRP Consulting can provide expert assistance with practically any aspect of HRPP evaluation, development, or management, including the following:
- Program Evaluation
- Process Assessments
- Establishing or Refining a HRPP
- Accreditation Support
- Policies and Procedures, associated materials
- IRB Evaluation and Support
- IRB or Investigator Audits
- Training and Education
- Interactions with or Responding to Federal Agencies
- Temporary 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OHRP Issues Single IRB Draft Guidance
On July 1, 2022, OHRP posted a draft guidance document for public comment entitled “Use of a Single Institutional Review Board for Cooperative Research.” The draft guidance will be open for public comment until August 30, 2022. The recently posted draft guidance...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”:...