Philip A. Cola, PhD, Case Western Reserve University
Adrienne Dumke, MBA, University of Louisville
It has been our collective experience that aligning Institutional Review Board (IRB) and Conflict of Interest (COI) processes can be challenging. Variations in policies, procedures, federal regulations and guidelines and other compliance statutes force research institutions to manage a delicate balance of ensuring compliance while limiting investigator burden in carrying out their research. As research managers, we find that a breakdown or interruption of information flow between the IRB and COI offices or committees adds to the complexity and challenges of maintaining that balance.
Why is it challenging and potentially confusing to investigators? Investigators are asked to submit information on conflicts of interest to both the institution (through a COI or compliance office) and to the IRB for review. However, the information requested for institutional disclosure and project disclosure likely vary and not all information provided at an institutional level is necessarily available to be released to the IRB if it is not relevant to a specific research project. Therefore, the institutional level management plans implemented through COI committees are shared with the IRB to ensure human subject research protections and disclosure requirements are upheld for the project. If there are breakdowns in communication or flow then additional risks may be overlooked.
From our experience, delays in completing disclosure forms, management plan creation and sharing, and IRB interpretations cause frustration for multiple parties. This includes those of 1) IRB and COI committee research managers or compliance monitors, 2) accrediting bodies such as the Association for the Accreditation of Human Research Protection Programs (AAHRPP), 3) investigators submitting research protocols and 4) regulatory agents attempting to support investigators with submissions to the US Food and Drug Administration (FDA).
In conjunction with efforts to improve the COI process and communication flow at her own institution, Adrienne prepared a presentation for the 2016 annual meeting of the Society of Research Administrators International (SRAI) in San Antonio titled, “Monitoring Financial Conflicts of Interest in Research.” In this session, Adrienne not only shared her experiences but also attempted to collect real-time audience responses on factors influencing the COI process at institutions while also identifying weaknesses in those processes with the intent of driving process improvement.
Phil, as a former IRB member and institutional official, attended the session and recognized that a main recurring weakness emerging in the real-time data collection was challenges in constant communication and shared vision between the COI offices and other research administration and grant offices, including the IRB and its committee. This was a common issue at various institutions across the country. From this experience, the two seasoned research administrators teamed up to present a session on this topic together for the Midwest/Southern Sections of SRAI in May 2017 in Nashville titled, “Connecting the Dots of COI Management and IRB Administration in Clinical Research.” This session collected real-time audience responses on the identification of key overlapping factors in managing both COI and IRB, as well as organizational approaches to improve communication and management of these two key inter-related processes. What they found can be summarized as follows:
1) COI and IRB committees have similar roles in addressing risk factors that potential COIs could have, or appear to have, on research conduct (including human subjects’ protection). The two groups must find a common platform and work together to simplify and de-mystify the process for investigators in an effort to reduce any real or perceived bias due to financial or related interests of the investigator. Clear standards and shared processes, that focus on research participants first and foremost, are the recommended strategies; and
2) Variations in organizational approaches related to monitoring and communication between the offices and staff members can be addressed with continued technology growth and adoption within the compliance context. However, although we are saying that communication is a key, and that computers and electronic systems enable speedier results, we are predominantly advocating for maintaining open lines of communication and relationships among centralized research administration offices as essential in ensuring compliance and further integration of office functions.
It was interesting to us, and sometimes even amazing, to hear of research functions in organizations de-centralizing instead of centralizing. It is our belief that this will only confuse and cloud investigator perspectives of the process(es). Additionally, barriers to technology adoption in organizations still exist and make it increasingly more difficult to provide efficient and effective solutions to the increased risks caused by breakdowns in communication. Finally, our failure to recognize, organizationally and individually, that we tend to try to solve complex problems in a linear fashion still inhibits efficient processes.
The problems we encounter in research administration in the 21st century are complex and we need to begin to think of them in a non-linear fashion where we are “no longer just connecting the dots,” but rather building continuous feedback loops to improve communication, shared vision and relational capacity among all stakeholders.