Overall Purpose: Establishing & Maintaining Robust HRPPs

An effective and practical Human Research Protections Program is central to all research institutions. Providing the bridge between the regulations that require human subjects protection and the research staff who interact with human subjects, a robust HRPP encourages the growth of research.

UNI-CORN’s HRPP consulting services include the following areas:

Policies and Procedures

For both HRPPs and FFPs (Fabrication, Falsification, and Plagiarism), UNI-CORN reviews current policies, procedures, and SOPs for completeness and regulatory accuracy.

As needed, recommendations for achieving and maintaining compliance are provided.

Governance Structures

  • Review of Program structures to assess consistency with Best Practices and Conflict of Interest requirements.
  • Analysis of resourcing and recommendations for maintaining compliance.
  • On-site advice for establishing and maintaining a QA/QI program.

Training

We offer a proprietary and tested instrument for evaluating Training Needs. Separate domains of the UNI-CORN instrument address the
specific needs of Board members, the IRB staff, and institutional officials.

Following the needs assessment, UNI-CORN provides tailored, on-site training designed to quickly and effectively bring all members of the research enterprise into compliance.

Inspections

We support both prospective and “For Cause” inspection needs. Before an inspection, we can:

  • Review existing compliance activities, specific components of HRPP (e.g., meeting minutes) or randomly selected protocols or PIs, providing recommendations as needed.
  • Support an institution’s risk management program by providing formal, external reviews.

Following “For Cause Inspections, we conduct focused reviews of alleged violations and provide a path to compliance.

AAHRPP Accreditation

We support institutions throughout the Accreditation process.

  • Audit the HRPP to provide an internal Needs Assessment.
  • Assist in the preparation of submissions.
  • Support AccreditStation Document management
  • Support during the Site Visit and in preparing responses.