The Problem

NIEHS is the Institute within NIH tasked with the mission of discovering how the environment affects people in order to promote healthier lives.

For NIH to receive accreditation for its human research protection program, each Institute that has an IRB must pass an onsite audit by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). NIEHS sought support for AAHRPP audit preparations.

The Solution

NIEHS turned to DIFZ because of our previous success streamlining and automating processes of the IRB Office at the National Institute of Allergies and Infectious Diseases (NIAID).

Working closely with NIEHS team members both onsite and remotely we:

  • Performed an audit of all pre-IRB and IRB activities and artifacts, from initial concept/proposal review through a Scientific Review Board to final IRB review.
  • Conducted Gap, Impact, and Sensitivity Analysis (GISA).
  • Worked with NIEHS staff to complete the AAHRPP self-audit process.
  • Worked with NIEHS staff to resolve issues identified through the GISA and self-audit.
  • Helped NIEHS prepare a formal self-assessment to be provided to AAHRPP, a required step in preparing for the AAHRPP onsite audit process.

The Benefits

Our work prepared NIEHS to successfully pass the audit process.

Other benefits accrued as well. As part of our comprehensive review and recommendations, we:

  • Helped NIEHS plan for the future by performing “as is” and “to be” business process modeling.
  • Identified change opportunities to streamline, reduce inefficiencies, and shorten the time approvals take.
  • Helped NIEHS establish the Office of Human Research Compliance (OHRC). To help the OHRC meet its mission of maintaining a Quality Assurance and Improvement Program, we developed SOPs, administrative procedures, and workflow diagrams necessary to audit, monitor and continually improve the quality of this new office’s human research protections.