The best organizations create value by providing beneficial products or services and by cultivating trust with their stakeholders. To do that requires consistent, rigorous review of the processes, materials, and outcomes associated with the work. The same is true for Northwestern’s research enterprise, where quality assurance is a vital component of how we create new knowledge that benefits society.
When pursuing research excellence, Northwestern considers the welfare of its human research participants paramount, and so our methods must remain aligned with the highest ethical considerations that inform the University’s values. This is clearly the right thing to do.
One of the ways the University achieves research eminence responsibly is by continuously monitoring its research activities. Northwestern’s Institutional Review Board (IRB) has a regulatory mandate to oversee human research and is a valuable partner to members of our research community who are working with those research volunteers. (You can read provisions pertaining to human research participants here. Clinical investigations that are regulated by the Food and Drug Administration are subject to the same review, and those provisions appear here, while research with animals is overseen by the University’s IACUC and must comply with guidance here.) First and foremost, the IRB’s mission is to protect the rights and welfare of these participants. In doing so, the IRB, in conjunction with the IRB Office, also serves the best interests of our investigators and helps the University’s research enterprise to thrive.
The IRB Office provides investigators with resources, education, and expertise. Post-approval monitoring — one of the mechanisms for such oversight that is managed by the IRB Office — is a routine compliance review of the study documents and/or the observation of the consent process. This review’s goal is to ensure that research is conducted in alignment with the terms of the protocol for that research; to promote ethical research conduct; and to support scientific credibility. The process features key components, such as in-person visits from IRB Office personnel as well as self-assessment tools that help investigators remain in compliance. About 3 to 5 percent of Northwestern researchers are randomly selected for self-assessment each year and are given a detailed checklist, recently revised to be more tailored to subject areas and to help increase turnaround time.
The assessment reviews important areas, such as regulatory documentation, protocol adherence, document retention, and participant informed consent and recruitment procedures. While such oversight requires additional effort by both our investigators and our administrative team, the effort helps to create a culture of compliance that serves the interest of the investigators and the University, safeguards the welfare of research participants, and enhances public trust. Post-approval monitoring tools also afford a great teaching resource when setting up protocols or onboarding research staff and so can be an important proactive tool for investigators to perform a self-check even when not undergoing formal review. (It’s a good idea to do this self-check every two years.)
The IRB Office team approaches its work with a spirit of genuine partnership, and with a desire to serve investigators as a resource for training and education. Rather than focusing on a punitive framework to address situations only after they become problematic, the IRB Office and investigators can collaborate proactively, reducing the need for corrective action that can result in costly research delays and complications.
Frankly, no one wants a research participant to experience harm, or see a study get shut down due to an oversight or misstep. That’s why I regard auditing and monitoring as a win-win for our research community and for the University overall. I encourage those in our community who are conducting human research to contact the IRB Office team with any questions and to regard these colleagues as essential partners in the journey for exemplary discovery.