A result of the new rational about human research protections that has taken place over the past decade is an increased attention on post-approval monitoring. Previously, after an IRB had approved a protocol, it conducted continuing review at least once a year and reviewed changes and unanticipated problems throughout the course of the research. This was the extent of its post-approval monitoring. Essentially, no one was evaluating what was actually occurring in the conduct of approved research studies. Now, an important component of a human research protections program is an effective quality assurance/quality improvement (QA/QI) program. The purpose of a QA/QI program is to measure and improve human research protection effectiveness, quality, and compliance with organizational policies and procedures and applicable regulations. A QA program assesses 1) investigator compliance with regulations, IRB determinations and organization policies and 2) the effectiveness of the organization’s human research protections program. A QI program evaluates the results of QA assessments to determine if systemic changes are required in the HRPP to prevent re-occurrence.

Aside from being best practice, why should an organization invest its resources in a QA/QI program? The primary reason is to ensure that research is being conducted in a manner that protects the rights and welfare of human subjects. The fact alone that an investigator submitted an acceptable protocol and then submits continuing review reports does not necessarily mean that the research is being conducted according to the protocol. Without a QA program an organization cannot guarantee that subjects are being adequately protected. An effective QA/QI program will minimize the likelihood that an untoward event affecting the rights and welfare of human subjects will occur.

Another reason to have a QA/QI program is to ensure that the organization is “audit ready.” Human research programs are subject to audits by sponsors and federal regulatory agencies. Such audits can happen at any time and focus mainly on subject safety and the review of documentation such as IRB policy and procedures, IRB records, IRB minutes, and investigator files. An effective QA/QI program helps to safeguard that appropriate documentation is being maintained by investigators and the IRB. As a result, it is more likely that any audit by an outside agency will have a positive outcome for an organization.

Lastly, it is always better for an organization to discover non-compliance itself and then self-report to sponsors and regulatory agencies, rather than an outside agency discovering the non-compliance. Self-reporting of non-compliance, along with a corrective action to prevent re-occurrence will most likely result in the outside agency accepting the report without any further action. Discovery of non-compliance by an outside agency will be more apt to result in negative consequences for an organization.

Thus, finding out “what is really going on out there” is similar to insurance – resources are being invested to help an organization fulfill its responsibilities and prevent negative consequences for the organization.

HRP Consulting Group can assist organizations in developing a QA/QI program and can assist in conducting both investigator and HRPP audits.