Subscriber Spotlight: Confessions of a Research Compliance Professional

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Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, Legal Experts, and Investigators!

330+ subscribers and counting!

Written by Kelsey Miller

Reviewed by Tasha Mohseni

We’ve made it to November folks! I bet you’re ready for a much needed holiday break at the end of the month (aka Thanksgiving).

I always love using that week/weekend for family time and connecting with loved ones. However, it’s just as important to recharge your OWN batteries. I can’t stress enough how important it is to practice self care. Life in itself can be difficult. Even if life is going smoothly, our profession can be burdensome. Whether you’re in IRB, IACUC, or any other compliance area, you might feel that we have a heavy burden. And by burden, I don’t mean feeling weighed down. I mean our burden (and responsibility) to protect those who choose to participate in research.

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If you feel overwhelmed or unsure your daily tasks, this article is for you: Top Career Hacks for Compliance Professionals.

For today, first, I’d like to welcome you back to the Subscriber Spotlight blog series!

For these posts, you can expect to read:

  • An introduction of the valued subscriber,
  • How long the individual has been a subscriber,
  • Relevant social media and/or publications, and
  • A brief description of today’s topic.
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Who is Kelsey Miller?

Kelsey Miller is compliance program manager with a focus on collaborative approaches to enhance the research enterprise who has been a CREST subscriber since.

  • She has experience working in the laboratory research industry in a cross functional research management and compliance role.
  • She’s highly skilled in areas of human subjects research, animal research, committee coordination, internal and external communication, and protocol development.
  • She’s adept in team leadership, facilitation, project management, training, and presentation of scientific concepts.
  • Lastly, Kelsey’s passionate about human health and research-driven solutions.

Kelsey will share her perspective as a research compliance professional and the importance of building community in this space.

Without further ado, let’s get started! As a general reminder, any legal information discussed within this post should be discussed with your institution. The views in this post are of the authors alone and not their employers.

Table of Contents:


Research compliance found me

I hear this kind of sentiment regularly around the field. Most of us arrive in our first IRB, IACUC, or other compliance role without having known it existed previously. This field isnโ€™t on a list of careers in high school or college. It isn’t something typically โ€œfallen intoโ€ based on interest in research or general administrative ability. What Iโ€™ve found in my first decade in this field is a profession that deserves to be defined.

This is community that I could not be more proud to count myself among.

We have an opportunity, perhaps a responsibility, to continue the growth of this community by:

  • Defining our professional identity and core skill sets,
  • Supporting the continued development and standardization of best practices, and
  • Finding our communal voice as a cohesive field.

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Our professional identity is difficult to define

Sometimes we are defined by the term โ€œcomplianceโ€ as playing the hall monitor or security guard role, catching bad behavior.

Letโ€™s all agree here, catching bad behavior is NOT why we came to this field!

If youโ€™re like me, you connect most with the vision of finding the best way to harmonize the requirements, research, and reality (aka constraints) with the larger mission of helping humankind through ethical scientific discovery! Our shared identity may then be better defined by:

  • The communities we bring together,
  • The regulatory complexities we navigate, and
  • The ethical values we are charged to prioritize within our roles.

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The ability to bridge

The foundational competency of a successful Research Compliance Professional, I believe, is best defined as the ability to bridge.

Bridging the gap between science and the realities of people impacted, between the complexity of the requirements and the chaos of the research environment, between whatโ€™s most ethical and whatโ€™s actually possible, between what the researcher wants to do and what they actually wrote in a protocol๐Ÿ˜‰. This competency is much more than simply memorizing regulations, it is rooted in an understanding of both people and language, blossoming through collaborative facilitation of interconnected yet fragmented systems. I believe our professionโ€™s defining characteristic is as complexity navigators!

Our certifications, professional communities, and career development focus should therefore reflect this foundation as a collection of many more skills and abilities than regulatory knowledge. Todayโ€™s drivers of change are many (e.g., AI, regulatory uncertainty, changes to research systems, etc), but the research compliance profession is founded in this ability to navigate complex perspectives and fragmented systems. By supporting these professionals more holistically, our untapped capacity to navigate and connect systems can drive the research environment of the future.

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We must prioritize connection and collaboration

As the field takes this defining next step in recreating our professional identity, we must prioritize creating spaces for connection and sharing.

Communities are a necessity to establish innovative best practices designed to take on our future challenges. I have had the privilege of talking with many in this community, and each individual voice brings a different experience. From the small institution where a weary one-person office juggles five compliance roles to the manager of two dozen staff focused only on the huge workload of a human subjects research program.

Our shared knowledge has the potential to create significant advances and define the next generation of our professional identity, but we must bring these voices together.

In celebrating the diverse experiences of our field and the complex skillset we develop, it should not be lost that sharing and cocreation requires many different forums. By supporting networking and information sharing both within and across regional groups and regulatory areas, our communal identity can begin to shape the development of the field as a whole. The complexity of these fragmented systems necessitates wider connections between institutions for standardization and specialization as needed in organizations both large and small, health-centered and academic, for-profit and public, etc. 

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Share your voice with the community

If thereโ€™s one message I hope to convey, it is to encourage readers to add their voice as well as learn from the wider community.

There are so many opportunities to engage! For the last three years, Iโ€™ve had the honor of facilitating a group of professionals from small human subject programs, the Small HRPP Community. In this community we:

  • Focus on keeping up-to-date on regulatory changes (thanks for your help CREST!) and
  • Open discussion of local challenges within our programs.

We are able to focus on solutions that are specific to small programs with 1 or 2 staff members, provide support for particular challenges we face in lack of resources or historical precedent, and come together to share innovations and best practices. This year, Iโ€™ve begun a new initiative to create a similar community for animal research programs. If you havenโ€™t found the community that fits your needs, start one! The more opportunities we take to share, the stronger our identity grows.

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Final thoughts

We are in a foundational moment as our profession matures, and our regulatory and research environments change.

Our strength is in our diverse experience and shared knowledge, our ability to bridge across complexities and perspectives. By supporting each other through community, we have the opportunity to emerge as a unified voice for reasonable, ethical research practices in an environment desperate for complexity navigators!

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I hope you enjoyed reading this post from Kelsey Miller!

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