Improve compliance processes with audit

Committee provides continuous oversight

Developing a thorough self-audit process is one-way research institutions can improve research and clinical trial compliance and prevent small problems from becoming regulatory nightmares, according to a research compliance expert.

"We have a well-established compliance office within the health system, and over the past year we’ve developed a campuswide research compliance program that includes a research compliance committee," says Lynne Chronister, MPA, associate vice chancellor of research for the University of California-Davis.

"What’s important is to promote a culture of integrity, and while that sounds so easy to do, it’s difficult to define and implement," she says. "But you can have wonderful compliance policies and internal controls and programs and forms to fill out, but if the culture doesn’t promote a culture of compliance, then those are just processes and are not as meaningful as they should be."

This is why a good way to improve a compliance program is through the development of an audit that provides a status report of every compliance area that needs improvement, she suggests.

"We went through the entire campus and medical center and looked at what we have done and where we are," Chronister says.

The audit report gave them a good idea of where the institution’s gaps and where additional policies, processes, and resources are needed, she adds.

Through this extensive process, which took about a year, research officials identified three important areas for improvements, including IRB, conflict of interest, and financial accountability, Chronister says.

Here’s how the auditing process worked:

1. Identify priorities:

Several key compliance people worked on the audit boilerplate over a three-month period, and then a compliance committee carried out the audit, Chronister says.

"First we had to go through and identify every area that’s critical to the broad area of research compliance, and then we had to go back and fill in the critical components of those areas of research compliance," she explains.

The next step was to identify the people responsible for each of those areas and find out what the compliance requirements were and whether they were being met, Chronister notes.

"Then, we prioritized those areas where we needed to improve, and we’re in the stage of requesting resources for those areas," she says.

2. Establish a continuous improvement process:

"What we plan to do annually is have an ongoing committee with continuous oversight look at those areas where we thought we needed improvement," Chronister says.

For instance, the oversight committee will view the audit chart and updates and see what has been accomplished over the year, she says.

"We will use the results of our audit and do a self-assessment on an annual basis, prioritizing those areas we felt needed attention first and those will be the ones where we’ll spend most of our resources in the coming year," Chronister explains. "We have high-risk, medium-risk, and low-risk areas."

The committee, which also conducted the audit, meets every two weeks, but soon will switch to a one-a-month meeting schedule, she says.

Update, update, update

3. Make changes where needed:

As a result of the audit, the institution’s staff are rewriting the policy on conflict of interest and have already rewritten the scientific integrity policy, Chronister notes.

"It’s important to come up with a process that works for a particular institution because federal policy says we have to manage, reduce, or eliminate the conflict of interest in research or in any study," she says.

For most institutions, it’s probably best to keep the policy somewhat flexible, Chronister adds.

For example, a policy that is prohibits all conflicts of interest in which a researcher has an overlap with his or her research and some company in which he or she has a personal interest could be too restrictive, she notes.

"Some campuses will say, You can’t work on that project on campus or have ownership in that company,’" Chronister explains.

And with clinical trial research perhaps it’s best to have a strict conflict of interest policy, but an option for other types of research is to have a policy in which some of these types of conflicts of interest are permitted, so long as they are managed with oversight, she says.

"At our institution generally, we would not allow conflicts like that in clinical trials," says Chronister. "But suppose you have a surgeon who develops a new process for thoracic surgery and he has started a company using that process, and the doctor is an expert but has a vested interest — so do you want that surgeon to do surgery or to have someone else do it?"

With animal studies, the institution typically tries to manage conflict of interest with oversight, she says.

Another area that the compliance program found in need of some changes involves the IRB, Chronister says.

New research issues arise regularly and require some adjustment to policies involving IRBs, she notes.

For example, research institutions in California now have to deal with the issue of embryonic stem cell research since voters approved the state’s Proposition 71 in November 2004. The state now will invest $300 million a year in human embryonic stem cell research, which could create new research opportunities statewide, but also requires additional policies and rules, Chronister explains.

The new law requires that all human stem cell research be approved by an IRB, and this means that IRBs will need to obtain appropriate expertise to deal with this new area of review, she notes.

"So who do you consent, and at what level is IRB approval needed?" Chronister asks. "We emphasize high ethical standards and some other IRB issues that are important are the selection of subjects and ensuring that appropriate subject populations are used."