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Building a new research compliance program: Where do I begin?

Tracy L. Popp (tpopp@askclover.com) is an Advisor at A Clover Group in Charlestown, IN, and Lynn E. Smith (lynnsmith@tgh.org) is Director, Research Compliance Officer, at Tampa General Hospital, Tampa, FL.

One of the hallmarks of a high-performing clinical research program is a robust research compliance partner. If you have the opportunity to build a new clinical research program, be sure to include a research compliance office in the design to work hand in hand with the clinical research staff. If you manage a clinical research program that lacks a research compliance partner, or a clinical research program with an ineffective or incomplete research compliance component, it is time to make a case to senior leadership of the importance of having this valuable partner.

The culture of the research compliance office is also of great importance. Research compliance could present itself with a culture of judgment with punitive outcomes, or it could present itself with a culture of collaboration and education. Hopefully, you will agree after reading this article that the latter is the best way to go.

Setting the stage for a new program or enhancing an existing one is the paramount point for a successful research program. The announcement to research team members, physicians, medical staff, and others of an upcoming change to the research program to include updating or building a research compliance program can send a panic through the halls of clinical research. Our daily lives contain a high level of stress; therefore, the steps you take to mitigate a full-out panic are of utmost importance. Many people have limited daily exposure to compliance individuals, the lack of knowledge on the role that compliance plays in research, or may recall a dreadful experience when compliance came to visit them. It is important to recognize this is a very real stress to individuals triggered by an announcement. How does operations fit into the compliance program? Our successful programs depend on compliance being embedded in all that we do each and every day for our patients. The operation leader is responsible to ensure that they set the stage for the success of the new or enhanced research compliance program. The team will look to the operation leader for guidance and assurance.

Let’s examine the critical conversations that need to occur with the teams. The panic of the team members or others will likely induce the following types of questions or comments for the operation leader. By preparing for these comments and questions up front, the operation leader will be able to mitigate the fears proactively.

Research teams ask:

  • What does compliance actually do?

  • Should I be worried that I will lose my job?

  • What did we do wrong?

Research teams may say:

  • Well, we never have had any problems before…

  • Isn’t this what the institutional review board does?

  • Who wanted this program changed or created?

  • I am too busy for this new layer of review.

Addressing the comments and questions will help build a successful foundation for the clinical research program. The building of a research compliance program remains a critical element for any research program regardless of the size of the program. Each site should maintain a level of compliance within the program. The research compliance team can start out as one individual dedicated to compliance review and build the program from there based on the site’s volume, risk, etc. When starting a program, consider the elements needed for a healthy program.

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