Sometimes best practices emerge from an experienced and dedicated leader taking over a struggling program and turning it into an efficient, well-organized enterprise.

At least that’s what happened when Enid A. Virago, PhD, CIP, CCRP, became the QI/QA program administrator in the office of research and innovation at Virginia Commonwealth University (VCU) in Richmond.

When Virago started the job, the quality improvement (QI) office was building so slowly that only three site visits had been conducted. QI was delegated to human protection professionals who could shuffle around some part-time hours.

By contrast, now the office has an experienced full time administrator/monitor, who aims to conduct 24 visits a year and has the goal of building more rapport and trust between principal investigators (PIs) and the office of research subject protections.

“When I started, there wasn’t really much in the way of developed policy, and there was no standardized process,” Virago says. “It probably took me two years to feel like I was educated enough to find good examples of programs I could modify and change in such a way that it would work in our system.”

Virago started her self-learning process by asking other QI directors for advice and then shadowing a QI peer, Josy Lyons, DEd, MEd, assistant director of quality management at Penn State University in University Park.

What she learned was that a QI program run by one person would have some limitations, but could accomplish a great deal with the right processes and efficiency measures in place.

“You’re only going to be able to do so many QI visits,” Virago notes. “We have 700-800 PIs and multiple studies.”

Once she made it her goal to have the office become a resource that would help PIs improve their human research protection and avoid problems, she found that she could make a huge difference: “I have people calling me and saying, ‘I’m writing something and need to know more about the consent process,’” Virago says. “It’s important to create that good will so PIs will come to you.”

Virago builds rapport with investigators: “I try to explain by saying that when you send something in to the full IRB board, you have 15 great minds looking it over and trying to help you make it a little bit better,” she explains.

Since revamping the QI program, which is called the Post Approval Monitoring and Quality Improvement Program (PAMQuIP), Virago has received feedback that principal investigators now are more confident with their IRB submissions and human subject protection.

“There is one investigator who has come back to me several times for advice about his studies,” she notes. “He’ll contact me and say, ‘I’m about to put this in the informed consent, and I’m worried about this one thing, and I can’t remember what you’ve said about it, so will you look this over?’” she says.

The program’s goal of prevention and education works well enough that investigators and study coordinators increasingly are requesting the visits to help them with protocol issues of concern, Virago adds.

The following are best practices Virago employed to develop PAMQuIP:

Research QI programs. For nearly a year, Virago spoke with QI experts and took a post-approval workshop from Public Responsibility in Medicine & Research (PRIM&R). The research program’s executive director at VCU also attended the workshop.

Virago’s research included looking at QI program and post-approval monitoring program tools. She gained permission to use various institutions’ tools, and borrowed and adapted some items.

“The post-approval monitoring community is so fantastic about sharing ideas, templates, and things like that,” Virago says. “There’s a real camaraderie within this hidden group.”

Another resource was VCU’s data security chief, who met with Virago and assisted with issues related to keeping data HIPAA compliant and secure, she adds.

Develop policies, letters and tools. PAMQuIP’s policy describes the primary objectives as the following:

- conduct post approval monitoring and quality improvement study visits,

- perform quality assurance reviews of the IRB process and documentation,

- serve as liaison between investigators and IRB panels,

- provide educational resources for the human research community, and

- research, develop, and evaluate quality improvement initiatives to foster efficiencies in human subject protections.

Virago developed a letter template for notifying investigators of a post-approval monitoring visit, and she pulled together resources for investigators on data destruction and data storage policies.

PAMQuIP has a four-page service request form that identifies the level of concern, the study’s risk level, the nature of the risk, and whether the request is for a quality assurance or quality improvement, as well as other items, she says.

Virago also amended the institution’s self-evaluation tool for principal investigators and made completing it a requirement, as it was rarely used previously.

The self-evaluation tool provides important QI data about PIs’ educational deficits, she says.

Provide PIs with a policy table. Searching through online tools created by other research institutions, Virago developed a tool kit that includes risk assessment and documentation information. She also pulled together many other research policies, including policies on data destruction and closing a study. Each policy incorporates all institutional rules, as well as federal and state regulations.

Virago created a policy table to make it easier for PIs to find a particular data security, maintenance and destruction policy — especially those that they didn’t know existed.

In general, policies are available on the department’s website.

Categorize QI site visits. “One of the first things that happens is when I say, ‘I’d like to schedule a visit with you,’ is that people get panicky and say, ‘Why are you picking me for a visit?’” Virago says. “I go ahead and respond to them that this is an educational visit or this is a focused visit, etc.”

Categorizing site visits also makes it simpler for Virago to collect metrics with visit information. She easily can see which visits had educational issues, which had general problems, and other themes might emerge.

In all, there are six categories of visits. They are as follows:

- For cause: These are visits requested by the IRB, office of research subject protection staff, institutional officials, and department chairs. They generally are in response to a concern about study conduct, compliance, or the research participant’s rights and welfare. IRB administrators sometimes will contact Virago to say, “The IRB had a really long discussion about this particular study, so you may want to put this one on your list,” she says.

- Routine: Routine visits are not initiated by any cause or concern. Studies are selected based on criteria, which include risk level, enrollment of vulnerable populations, use of investigational new drugs or devices, and involvement of complex procedures. They also include random selection from active studies.

- Focused: These are narrow reviews of research activities and concentrate on a particular aspect of study conduct, such as informed consent, recruitment, or treatment outcomes. This type of review, which is rarely done, may not be prompted by a specific issue or concern, and it’s similar to the routine review.

- Preventive/educational or consult reports: PIs, study staff, IRBs, and others can request visits to address an educational need related to study conduct. These reports often are requested when there are new study staff and PIs.

- Targeted: Such reviews take a look at a particular category of research, including studies reviewed by an external IRB, expedited research, or IRB review of studies involving a vulnerable population.

- Preparatory review: PIs or research staff request this visit when they need assistance with preparation for an audit or before the start of recruitment for a new study.

Educate and analyze. Virago meets with the executive director of the research subject protections office in biweekly meetings.

“The information shared there is helpful because I can tell people when policies are changing,” Virago says. “And our department has just hired an education person, so I hope deficits found through visits will be incorporated into educational sessions.”

Virago reviews PAMQuIP data each year to identify possible trends, educational needs, and problem areas. She also writes a year-end report that is reviewed by the department and available to the IRB.