Producing best-practices in research compliance
A well-run program can alleviate PI burden
Academic researchers spend a large chunk of their time on paperwork. Regulatory and institutional burdens could seem overwhelming. However, a well-run compliance program could alleviate some their load and documentation responsibilities.
"A survey of researchers done a couple of years ago indicated the faculty are spending 42% of their research time on administrative duties rather than doing research, and these findings made a lot of people sit up and pay attention," says David L. Wynes, PhD, vice president for research at Emory University in Atlanta, GA.
"I'm always aware of the burden on researchers," he notes. "We can't cut corners, but that doesn't mean we can't do efficiencies and reduce the burden so researchers can spend more time doing research and less doing paperwork."
Wynes oversees a large research program with 175 employees. It encompasses these areas: an IRB office, research compliance office, conflicts of interest program, technology transfer program, environmental health and safety program, sponsored programs office, and animal care and use committee.
Despite its size and the potential for bureaucratic encumbrances, the research program has a strong and effective compliance program. The key is its cohesive and empathic framework. Wynes describes these elements of compliance program best practices:
Establish practices for how various research offices interact: "First and foremost you must recognize that none of these units operate in a vacuum," Wynes says. "You have to figure out how that office is going to interact with all the other offices, including some external constituencies."
Think of the research organization as a network that operates under a common framework that includes compliance standards. Ask these questions when creating the framework:
What are the compliance goals you are trying to achieve in the office?
What are the ethical goals, apart from research regulations?
Which ethical and safety goals match the various compliance requirements and regulations?
How will you meet the goals the laws were designed to accomplish?
The common framework has to make operational, as well as ethical sense, Wynes notes.
"It's easy to sit down and write a process for absolute compliance, but then you have to look at it and say, 'Will this really work?'" he explains. "Many times the answer is 'No.'"
For example, sequential committee reviews does not work operationally, Wynes says.
When a research site starts a new clinical trial the proposal needs to be reviewed and approved by the IRB, the research billing office, and other entities, including sponsored program negotiations, he explains.
"The easy way to do this would be to have one office review it at a time and then hand it off to the next office," he explains. "But by the time you finish that process, the trial will be closed to enrollment before having a single subject."
So what is the easy way does not work operationally.
Instead, the research organization needs to find a way to have concurrent reviews while keeping communication channels open between the different groups.
"We're constantly fighting a misperception investigators sometimes have that they have to do things in a sequential order when they can go on in a parallel process," Wynes says.
"We had to develop parallel processes and ensure there was cross-communication at the right points between the offices," Wynes says.
Improve communication within and outside of the organization: An efficient way to do this is to use an information technologies (IT) solution.
Research sites can have automatic notifications built-in to their systems.
"For example, a person might answer certain questions in an IRB application, and their answers will send a notification to the research billing office, saying there are clinical trial charges and bills for these procedures," Wynes says. "Then someone in the research billing office will see the email and ask if the office had received an application from the person and, if not, they can contact the person."
Another strategy is to keep research units physically near one another within a large organization.
At Emory, the various groups, including the IRB office, are located in the same building, Wynes says.
"They see each other at lunch in the cafeteria," he says. "The IRB office is down the hall from the billing group and one floor away from the contracting group."
Since employees working in one unit are neighbors with those working in another unit, they begin to get to know each other.
"They're not just people on the other end of the phone," Wynes adds. "You can't dodge them. You have to confront them face-to-face."
The research office can facilitate keeping the line of communication open by holding regular meetings and bringing different parties together to speak openly and frequently.
"We do staff recognition gatherings where everyone gets together and has lunch, and we identify new employees and people who've been here five years, 10 years, etc.," Wynes says. "I encourage people to find someone they don't know and talk with them, finding out what they do and how it might relate to what they do."
Obtain feedback from stakeholders: Emory has a survey questionnaire about customer service. The customers are faculty members and research coordinators. The various research units are encouraged to include a link to the survey in the emails they send to researchers, Wynes says.
"So we have feedback on individuals and whether they were customer friendly and helpful," he says.
It's particularly important to learn how the research community perceives the IRB office and the quality assurance (QA) people who work with investigators on research compliance, he notes.
The QA staff obtains indirect feedback about their performance when they work with investigators and review protocols and compliance issues. For instance, if there are patterns of problems among researchers, then that's a sign that the education process needs to be improved, Wynes says.
"If we find lots of people not doing things the right way, then I presume we're not educating them correctly," he adds.
Encourage research staff to document immediately: It's easy for busy research officials to let their documentation slip. The problem is that it's more difficult to recall details that might go into a documentation note once some time has passed, Wynes explains.
"If you don't keep on top of the paperwork that needs to be done and attempt to construct it a month later, then you will have problems and miss things," he says. "In some of our monitoring visits we've identified that as something we need to work on."
This is a point that should be continually reinforced until it becomes a habit. People have to be habituated to a new process, he notes.
"In part we use technology to help people along so information is captured automatically," he says. "You remind people of these expectations through workshops and monitoring visits, and you remind the entire team so it becomes a team issue."
So maybe at weekly research meetings, a principal investigator will say, "Let me see the records" or "Is everything here that needs to be here?" This builds group awareness, he adds.
After time, immediate documentation becomes a habit like brushing teeth.
But initially there needs to be pressure of some kind to get people to recognize why this is important.
Use information technologies solutions whenever feasible: "We have a great IT solution with our conflicts of interest (COI) program that we've developed over the last two years," Wynes says.
When researchers enter the Emory system, they list any outside consulting activities they do. Then they answer questions about their research projects. The IT system asks them if the projects are tied to any of the consulting work.
Then when investigators submit a new grant application, the system brings up their consulting activities, showing them the list they have created and asks if the grant would relate to any of these, he explains.
"We'd have close communication both verbally and through IT between the office of sponsored programs and the IRB office to make certain no one falls between the cracks," he says. "The system is tied into the school's annual reporting requirements of outside activities."
The system does require their personal knowledge of conflicts: "I need the investigator to say, 'Yes, one drug made in this study is made by this company and I'm on the scientific advisory board,'" Wynes explains.
"We provide investigators with integrated information and they don't have to give a lot of thought to it," he adds. "Anytime they enter a new consulting activity, the program gives them the list."
The conflict of interest affiliations are current and can be changed whenever an investigator begins a new consulting activity or study. The IT program also prompts them to update their list each year, as well.
"We have a very comprehensive process for identifying any kind of financial activity related to research and needs," he says.
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