Preparing for a Certification Assessment

Client Situation

The mission of the National Institute of Environmental Health Sciences (NIEHS) is to discover how the environment affects people in order to promote healthier lives.

For NIH to receive accreditation for its human research protection program, each of its Institutes that have an IRB must individually pass an onsite audit by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP).

To prepare for the AAHRPP audit, NIEHS turned to Digital Infuzion – chosen for its success streamlining and automating processes of the IRB Office at the National Institute of Allergies and Infectious Diseases (NIAID). Digital Infuzion staff worked onsite and remotely with NIEHS team members to review the processes and artifacts used by the Institute, as well as help to prepare a formal self-assessment to be provided to AAHRPP, the first step in preparing for the AAHRPP onsite audit process.

The Digital Infuzion Solution

Digital Infuzion:

  • Performed an audit of all pre-IRB activities, from initial concept/proposal review through approval by a Scientific Review Board
  • Performed an audit of all IRB activities
  • Conducted Gap, Impact, and Sensitivity Analysis (GISA)
  • Worked with NIEHS stuff to complete the AAHRPP self-audit process
  • Worked with NIEHS staff to resolve issues identified through the Gap analysis and self-audit

As part of its comprehensive review and recommendations, Digital Infuzion:

  • Performed “as is” and “to be” modeling;
  • Identified processes that could be streamlined, and others that could be added to reduce inefficiencies and shorten the time it takes to get approvals; and,
  • Assisted NIEHS in establishing the Office of Human Research Compliance (OHRC).


To help the OHRC meet its mission of maintaining a Quality Assurance and Improvement Program, Digital Infuzion developed developed SOPs, administrative procedures, and workflow diagrams necessary to audit, monitor and continually improve the quality of this new office’s human research protections.