Research Enterprise Management
Human Research Protection Program
Huron Consulting Group’s Human Research Protection Program (HRPP) represents a complete set of tools (Standard Operating Procedures, templates, worksheets, checklists, and databases) designed to help higher education institutions meet regulatory and accreditation requirements, including those of the:
- Food and Drug Administration (FDA)
- Department of Health and Human Services (DHHS)
- AAHRPP®
- Department of Energy
- Department of Education
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- Department of Defense
- Department of Justice
- Environmental Protection Agency
- Veterans Administration
- International Council on Harmonisation – Good Clinical Practice (ICH-GCP) E6 standard
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This HRPP toolkit incorporates maximum regulatory flexibility consistent with good compliance practice.
These Standard Operating Procedures are comprehensive, brief (<60 pages), easy to follow, non-redundant, easy to update and maintain, and readily adaptable to electronic IRB systems. Importantly:
- These documents have been used successfully by organizations applying for AAHRPP accreditation.
- They have successfully been incorporated into electronic IRB systems.
- Unlike most SOPs, these documents are organized by business process (e.g., pre-review, review, post-review) rather than by topic (e.g., continuing review, drugs, and protocol deviations).
- They reference checklists and worksheets, allowing users to efficiently and effectively document regulatory determinations.
Please contact us at hrppsops@huronconsultinggroup.com for additional information.