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May2019

I could never have guessed just how large and life changing a venture creating a two-way, system-wide IRB infrastructure would be when one of my former bosses announced I would receive exactly that project in late 2010. We were in the midst of forming a compliance office for clinical research at our academic medical center for the first time, and I honestly had no clue where the role might take my career. The work was interesting, the people amazing, and I was finding a professional rhythm (finally!). Little did I know, this project was one I’d spend the next four years heavily immersed in, and one I’d still be discussing almost a decade later.

So what in the world was this project? And what makes it even remotely as special as I’ve built it up to be? Both great questions, and frankly ones I myself asked in the beginning. Because of our AMC partnership with the largest health system in the state, one of the roles of our newly created office was to oversee projects related to that partnership and the clinical research environment. The health system needed to evaluate the current research infrastructure in each facility and region, and wanted to encourage more research across the state with less regulatory burden.

Sites throughout the system already performed research and had their own separate HRPPs, but the health system wanted a centralized model that would tap into the AMC’s HRPP as well. That motivation was borne out of a realization that our catchment area had such broad demographics that, once each health system site was added to the AMC sites, we felt we could attract more clinical research to our state if we could lower the number of IRB applications required for multi-site research. The idea was aggressive, novel, and it blew my nerd mind.

As I came to understand the motivations, stakeholders, scope, and value of this project, I will never forget sitting at my desk contemplating where to even start. No manual or guidance documents, let alone regulations, addressed how to form such a mutual-deferral-based IRB system. A colleague suggested I attempt to formulate a workplan at a high level first, then, dive deeper, but I was otherwise overwhelmed by the blinking cursor on the screen as I tried to develop a plan.

And, please allow me to be clear here, this work was absolutely not performed in a vacuum or solely by me—this was a massive collaboration, and the work of my colleagues was a huge contributor to the success of the project. But, it was certainly my responsibility to move the project forward with measurable progress. In the end, I opted to create a core vetting process that would serve as the central workplan for each site we were to evaluate, then we could tailor the individual plans to each site. It kept the model reproducible and consistent across sites, even if edits had to be made to each plan.

You may be thinking, why is this actually valuable for me Edye? What can I do with this story? I believe what we were able to achieve in this project lays the foundation for more health systems and states to attempt similar projects. Further, with the single IRB mandate per the NIH, knowing where and how to begin is vital in the clinical research industry currently. And the benefits of a system like this are many: expanded access to clinical trials; streamlined regulatory and administrative processes; and the leveraging of an entire health system’s resources, subject matter experts, and existing quality standards. The health system and AMC clearly understood and embraced these benefits, but they couldn’t be fully realized without significant operational efforts (thus the workplans), which is what I see as the ultimate takeaway for this audience: an operational plan for creating a two-way, system-wide IRB infrastructure. I certainly am not positing that my way (below) is the only means to this end, merely that it worked well enough for me and others might find value in it. So, here it is…

Start by identifying the scope in your given endeavor, and ensure you know what questions to ask. Asking exactly who your stakeholders will be, and which model truly fits their goals, is critical to success in coordinating such a large venture. Remember, you have several models to choose from, and you can always create your own, especially if you’re able to perform a certain amount of evaluation before you finalize the scope and model. As you’re working to determine who your stakeholders are for the centralized system, ensure you’ll be interacting with a consistent team of individuals at that level for approval and system-wide review of each step. Your work can easily be wasted if all of your stakeholders aren’t synergistic about the goals, model, and steps to be taken, as well as continuously updated and approving each proposed next step.

When forming a work plan, ensure you’re accounting for the initial communication and site visits for each location, as well as the assessment, strategy, application, training, and ongoing maintenance required to attain your goals. You’ll first be identifying risks, setting benchmarks, and fully explaining the goals of the venture to each site, and; as such, be prepared to encounter potential concerns, fears, and even resistance, as you become the face of such an initiative. You’ll also need to:

  • Assess all the regulations involved and exactly what research areas will be included
  • Complete a gap analysis of the current policies and procedures; and, of course,
  • Identify any immediate efficiency measures so you can have a transitional infrastructure and potentially begin offering reduced IRB applications before your project is wholly complete.

The strategy you develop will then be based on your evaluations at each location, which should be formalized to report all your findings, recommendations, and each tailored work plan. Then, you’ll need to revisit your progress with your stakeholders to finalize decisions on which model to employ, and you can proceed with application of each work plan to the respective site.

As you announce the plans to each location, you’ll be tasked with providing the requisite training and moving the individualized steps of the work plan forward along the projected timelines for that site. This is no small feat, and will likely take two to three times as long as the initial site visit, assessment, and strategy components. Last, but not least, you must be forward thinking when it comes to how your newly placed infrastructure will be maintained and what resources are needed for that final, but essential step.

By 2012, we were successfully pursuing these steps with results that warranted sharing with the clinical research community in several venues, including a poster presentation at PRIM&R’s 2012 Advancing Ethical Research Conference. In December 2014, the NIH made the request for comments as it shared a proposed draft single IRB policy in a Notice in the NIH Guide for Grants and Contracts. And, as quickly as it began, by 2015, the project was transitioned to another office as I assumed new responsibilities again to adapt with AMC needs. Less than one year later, the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research was initially released and the need to reproduce these efforts became clear.

As the effective date of the policy was delayed, I began to realize the need to share the efforts I was so fortunate to lead and participate in for the benefit of all the organizations not only contemplating this step, but being required to implement it at this juncture. I can only hope this brief effort to capitulate our successes and failures will lead you and your organization to even grander aspirations and achievements than my own.

Edye Edens, JD, MA, CIP, CCRP  is a licensed attorney with an international human rights, ethics, and healthlaw background who is a Senior Research Compliance Consultant with First Class Solutions providing a new line of consulting services focused on research compliance and life sciences. Legal consulting services include but are not limited to: research administration, healthcare compliance, grants/contracts to IRB, COI, education, privacy, HIPAA, FDA, AAHRPP, misconduct and site-level compliance work as it relates to QA, monitoring, and auditing (particularly oncology). Services are provided as education and training, program creation and management, organizational change management, or even as a complete outsourcing solution.

Previously, while in-house for a decade at Indiana University, she focused on the role of human rights in health and worked at the Human Subject Offices on both the Bloomington and Indianapolis campuses, the Indianapolis Grant Services office, Clinical Research Compliance Office and the Research Integrity Office aiding in quality assurance and compliance matters including managing accreditations, internal auditing, education and managing consultation projects involving outside entities. In 2016, she became the first Quality and Compliance Manager for the IU Simon Cancer Center over all aspects of compliance related to all clinical trials performed at IUSCC, before departing for the consulting world.

Educationally, she completed her MA in International Research Ethics in 2012, and was the program manager for a NIH grant to aid in creating a joint international institutional review board (IRB) in conjunction with IU’s existing Moi University medical school partnership in Kenya and the IU Center for Bioethics, which expanded her ability to consult in compliance matters globally. Additionally, she teaches at IU’s McKinney School of Law and Fairbanks School of Public Health in Indianapolis, and oversees the Hall Center for Law and Health’s Externship Program.


Guest contributors to PRIM&R's blog are valued members of our community willing to share their insights. The views expressed in their posts do not necessarily reflect those of PRIM&R or its employees.

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