Research Compliance Network:  Join the conversation on postapproval monitoring

The Research Compliance Network (RCN) is a national consortium of representatives from academic medical centers, universities, and hospitals who are interested in postapproval monitoring and quality assurance and quality improvement activities (QA/QI). The group serves as a communication forum that allows members to exchange best practices, share strategies and resources, and collaborate to develop new tools.

Integral to most human research protection programs (HRPPs), post approval-monitoring and QA/QI components identify risks and areas for improvement, and provide assurances about the quality of human subject protections. The implementation of QA/QI functions varies widely depending on the size and structure of the organization and the research portfolio. Thus, there is a great need among individuals responsible for QA/QI activities to network with colleagues from peer institutions to benchmark and discuss routine practices as well as more challenging and unique issues.

Recognizing this need, a group of QA/QI professionals came together several years ago and established the RCN. The first RCN conference call occurred in 2014 and included five members from four different institutions. Today, the RCN includes over 100 members from 40 institutions, big and small. Utilizing a system that allows screen-sharing, the group meets bi-monthly to discuss questions submitted by members and to listen to guest speakers. The RCN also utilizes a group email distribution list for online discussions and shares resources through a secure cloud storage space that all members have access to.

In addition to the bi-monthly conference calls, members of the consortium meet annually at the PRIM&R Advancing Ethical Research (AER) Conference, which has been vital for strengthening connections within the group and offering an opportunity to brainstorm ideas for potential collaborations and working groups. Following AER18, a small working group was established to develop a metrics survey to collect data on postapproval monitoring resources, organizational structures, and QA/QI scope and procedures at participating institutions.

As founding and participating members of the RCN, University of Michigan and the University of Minnesota QA/QI team members can attest that the consortium has been a great opportunity to engage in conversations on QA/QI and learn from the collective knowledge of and resources shared by members. With the changing landscape of human research, the need for collaboration to identify best practices is greater than ever.

The RCN continues to grow and welcomes new members. If you are interested in joining please contact Together we can learn from one another to facilitate safe, ethical and high-quality research at our institutions.

Bethany Hansen, MA, is the Senior Quality Analyst at the University of Minnesota. Bethany’s work in human research protections is informed by her 20+ years of experience providing direct service and leadership in programs and organizations serving individuals experiencing significant life stressors, including chronic illness and mental health challenges. Bethany’s primary areas of responsibility include responding to participant complaints and concerns, quality assurance audits, and the development and implementation of participant-facing resources. In addition, she serves as the liaison between the institution and the Community Oversight Board, a committee of volunteers formed to help protect community interests and ensure community benefit from research conducted at the university.

Sana Khoury-Shakour, PhD, is the Director of the Office of Research Compliance Review at the University of Michigan. In this capacity, she is responsible for the day-to-day operations, strategic planning, and collaboration with IRB and other compliance units. She also serves on different committees and working groups at the university and has coordinated the AAHRPP re-accreditation effort in 2016. Sana is an epidemiologist by training with experience in public health and clinical research. She received her master’s in Epidemiology from Michigan State University, Ph.D from the Technion in Israel, and completed a post doctorate research fellowship at the University of Michigan.