QI program identifies deficiencies, educates

Program smoothes process with investigators

A well-run human research quality improvement (QI) program can be an IRB's best friend, working with investigators to help them prevent common mistakes and to communicate better with the IRB, while avoiding the back-and-forth questioning that can drag out the review process.

At Partners HealthCare System in Boston, the Human Research Quality Improvement Program utilizes a combination of investigator-friendly onsite review and targeted educational sessions to bring investigators up to speed regarding regulatory and institutional requirements, clarifying what is needed and how to provide it, says Delia Y. Wolf, MD, JD, director of the Partners QI program and assistant professor of radiology at Harvard Medical School.

In fact, the IRB often refers investigators to the QI program when study submissions, particularly continuing review applications, need clarification, she says.

"The IRB is appreciative of our existence and our expertise," says Wolf, who for six years was one of the chairs of various Partners IRBs. "They advocate our program [to investigators] because they know we can help both parties by expediting the review and approval process. Once the investigator gets the green light from the IRB to begin his/her research, we provide a valuable resource throughout the life of the study."

Partners' Human Research QI program recently received an Award for Excellence in Human Research Protection — Best Practice from the Health Improvement Institute.

Program starts small

According to Wolf, the program was established in 1999 as a part of an overhaul of the Partners human research protection system in the wake of highly publicized problems with human subjects protection at other institutions.

Wolf says Partners chose to be proactive to ensure compliance with federal and state regulations governing human research, and to promote an environment in which research would meet the highest human protections standards.

"We realized no matter how hard we worked at the IRB end, if the investigators are not following what the IRB required them to do, it was still a wasted effort," Wolf says. "For example, you can revise the consent form with multiple back-and-forth correspondences, and investigators could still later use the wrong version.

"Situations like these prompted us to establish a program that would work with investigators and help them, making sure they were doing what the IRB required and expected them to do."

Although she was QI program's only member at first, Wolf gradually built the program, adding staff as its size and scope increased.

The program initially was focused on conducting onsite reviews to determine what investigators were doing and to identify common deficiencies. Those onsite reviews still are an important part of the QI program; staff conduct up to two to three such reviews a week.

"We review study records and we interview study staff and investigators," Wolf says. "We also review the IRB file before we go on site, so we know what the study is about and what documents should be on file."

Wolf says the goal of the onsite review is to offer assistance to the investigators in a friendly manner, rather than functioning as auditors who may be viewed with resentment.

"People have a conventional concept that 'quality assurance,' means 'audit,'" she says. "Right away they're on the defensive, making it hard to do our job. The improvement approach is a better one because it gives the message to investigators that 'We're not here to audit you — we want to provide more resources to you, to offer services.'"

In fact, Wolf's staff do not report back to the IRB with their findings, unless the IRB had specifically requested the review.

"We are independent from the IRB, and that is a very attractive feature for the investigator," she says. "If we conduct our routine onsite review and identify deficiencies, we follow up with investigators, explaining how to correct and avoid deficiencies and how to report violations to the IRB, if necessary."

Wolf says one of the important accomplishments of the QI program is that it teaches investigators how to properly correct errors in documentation when they discover them in the future.

"There are so many mistakes that can be made," she says. "Everybody tries their best to avoid them, but you still make mistakes. It's part of being human.

"The good news here is that we've taught people how to correct mistakes they've already made — for example, writing a note to file, instead of back-dating and trying to 'fix' the mistake," Wolf says. "We tell people, 'Don't be afraid to report your violations. It's not the end of the world if you have to document a mistake, but it may get you into trouble if you try to hide them or correct them in your own, inappropriate way.'"

Wolf says the number of deficiencies identified in onsite reviews has substantially decreased over the life of the QI program. She says that while it's impossible to review every study conducted at the institution, she's made an effort to work with as many investigators as possible, so that they can learn from the process and make improvements with future studies.

Adding education to the mix

The second prong of the QI program, its educational component, was developed in recent years, after Wolf's staff had a chance to work with more than 500 investigators and had learned what the most common problems were with meeting regulatory requirements.

They began a series of education sessions, but kept them small and specifically targeted to particular study groups. "For example, when we realized there's a lot of investigator-initiated IND studies, we had a session addressing sponsor-investigator responsibilities," Wolf says. "In the smaller setting, people start to talk more freely and share their experience."

Wolf says that larger, more generalized educational sessions often don't provide as much substantive information to participants.

"With small, group-focused education, we provide more intensive information to the people who really need it and want it," she says.

The QI staff conduct about two to four such sessions monthly, on topics such as good clinical practice guidelines, data and safety monitoring plans, writing standard operating procedures for a study site, and continuing review submissions to the IRB.

Wolf works with the staff to develop the sessions, analyzing the findings from recent onsite reviews and utilizing case studies and hypothetical situations to illustrate the points.

While Wolf currently has six QI program staff members, she says smaller institutions with fewer resources shouldn't be scared away from attempting similar programs themselves. "When I talk with people from other organizations, they say, 'Oh, you have a huge organization,'" she notes. "Yes, right now I have six people, but I started with one. The majority of onsite reviews in the first three years were conducted by three people."

What's important, Wolf says, is that the staff be well qualified. She says most of her staff have graduate degrees — masters and PhDs — and direct experience in the field of clinical research.

"Some institutions tend to think this is an administrative role — they're auditors, looking at paper, so they don't need specialized background and training," she says. "I wouldn't agree. If you have very knowledgeable, qualified people, with terrific interpersonal skills, you really don't need to hire a lot of them. It is quality, not quantity."

Wolf also suggests using templates and checklists to help facilitate consistency and more efficient reviews.

While she currently doesn't see the QI program branching out into new activities, she does have a goal of working with all the institution's investigators, including those who may have been reluctant to participate in earlier years when the program was newly developed and working toward establishing a reputation.

"There's always a group of people who are very diligent, they have good records and they usually are the first ones to sign up for QI services," Wolf says. "There are others who say they're doing fine, but actually, they could use some help from us. These are the investigators we would like to find and work with.

"All of our education and services are offered on a voluntary basis. Our program's challenge is to attract those investigators who haven't volunteered to get help from us. Because based on our experience, after investigators have worked with us, they like us, and want us to be their regular resource."