Expert tips for restructuring compliance

Research councils, education are key

Across university systems and individual campuses, research programs rely on compliance programs to ensure federal regulations are followed and research is conducted ethically. A few years ago, officials with the University of Texas System saw that the systemwide compliance program needed expand to improve efficiency and effectiveness of the research programs in all its institutes.

"What I like about a systemwide compliance approach is the idea that we’re working with the institutional programs to help support their processes to address compliance requirements," says Wesley Byerly, PharmD, assistant systemwide compliance officer for research at the University of Texas System. "Compliance is the quality control point of ongoing activities. Audits show how successful you are with compliance programs."

Early evaluations of the UT System found research compliance activities often widely distributed throughout institutions, without a clearly identified organizational structure and ultimate leadership responsibility. The need to focus on specific areas such as research led to developing a system-level research compliance program to support and assist the nine universities and six health institutions of the University of Texas System in managing and mitigating research compliance risk.

The systemwide research compliance program was developed based on the essential elements of compliance programs:

Compliance leadership: There should be someone in place, such as a compliance officer, to make sure the components of the program are there and working, Byerly says. The role should be supported by other groups.

Clear definition of roles and responsibilities: Is there any direct operational oversight? Who is supposed to do what? There should be policies in place to follow the guidelines, and the policies need to be known and understood by members of the organizations.

Training: Develop training programs to ensure there is an understanding of what it means to be compliant.

Communication: Make sure there are effective lines of communication and everyone feels free to talk about concerns.

Monitoring: This includes establishing processes to make sure compliance activities are occurring as they should, such as monitoring, quality review, and auditing.

Enforcement: Consequences that will result if regulations aren’t followed need to be known, and mechanisms in place to execute those consequences if needed.

Corrective response: Respond promptly to detected problems, undertake corrective action, and report to appropriate agencies.

Institutional visits and outreach are also an important part of the program. "We used these to help the member institutions develop and maintain robust programs," Byerly says. "A lot of what we do is based on going out, visiting, and working directly with those individuals in the institutions who have boots on the ground."

The UT System compliance program is led by the chief compliance officer, and assistant compliance officers for information security, healthcare, and research.

"The idea is to have identified individuals with responsibility for our major compliance areas," he says. "These individuals bring the experience and expertise to support efforts on the campuses and to coordinate system initiatives." The assistant systemwide compliance officer works with the heads of the compliance programs and research administrative units at each of the University of Texas campuses to facilitate and coordinate communication on research-related issues; develop and implement research compliance standards, policies and procedures; assist with education and training; ensure mechanisms are in place to monitor and enforce research compliance standards; and to collaborate on investigations of noncompliance. They also advise the UT System Executive Offices on research compliance issues and act as a liaison between the institutional compliance programs and the Board of Regents to ensure that the board has sufficient information to provide effective oversight.

The UT System also developed a research compliance council, chartered by the System Executive Compliance Committee. The council is comprised of representatives appointed by the vice presidents of research from each of the system’s institutions. The council provides insight into current issues with the compliance programs at the members’ various institutions. "The council evaluates issues that arise both locally and nationally and generates recommendations on how to reduce compliance risk," Byerly says. It also identifies and provides assistance for specific projects, establishes best practice solutions for compliance issues throughout the system, develops training and education modules, ensures uniformity and consistency across programs, and is collaborating on a research compliance work plan.

Another key element of the program is having a comprehensive education program to ensure everyone knows the ins and outs of compliance, understands the regulations, and to have an opportunity to share best practices. The UT System developed a compliance academy that includes webinars for various compliance issues across the university system. The compliance academy is a collaborative program with the University of California System, with both systems sharing education responsibilities. "Education is key to what makes a strong compliance program," Byerly says. "I think that is a key function that we’re able to bring in from the system level." The research compliance education ranges from human subjects to animals to lab safety and fiscal compliance. "There is a full range of things for everyone to be aware of for what makes a robust program," he says.

Feedback from the program has been mostly positive, Byerly says. "Campuses don’t feel like they’re working in isolation — they feel the UT System is bringing them together to share best practices and engage in dialogue and pull together work groups. They have the community to fall back on," he says.

For institutions looking to improve compliance programs, "If you’re thinking of dealing with systemwide compliance, the first place to start is to see what you are doing for compliance in general at a system level," Byerly says. "Associated with that is, what is the focus for providing oversight for research at that level? Define and leverage off of that to build the program." The key, he says, is to develop a council or committee and work with them to define what their needs are. "Think about compliance programs at the institutional level — what are your compliance roles from your officers to the research office? Look at that, and consider how to keep all the components of the research program and specific risks or concerns to generate synergy when revamping it," he says.