Going pro: Research monitoring program keeps sites in compliance

Proactive and flexible enough to be applied to any institution

Research institutions and IRBs can keep trial sites in compliance through proactive measures that address regulatory issues before an IRB or federal audit reveal problems.

This strategy improves an institution's overall human subjects protection program and may prevent poor audit findings.

But how does an institution implement such a proactive program to obtain the best departmental and trial site buy-in?

The Office of Protocol Research at the University of Texas M.D. Anderson Cancer Center of Houston has an answer. The office recently launched a new compliance tool that's called ARMP, short for administrative research monitoring plan.

"We wanted to proactively address regulatory issues in departments before compliance problems occurred," says Wanda Quezada, CIP, research regulations manager of the Office of Protocol Research. Quezada and co-authors presented a poster about the ARMP at the 2009 PRIM&R Advancing Ethical Research Conference, held Nov. 15-16, 2009, in Nashville.

"Normally, an IRB will request that an investigator or department submit a corrective action plan in response to a bad report," Quezada explains. "We tried to create a proactive approach so that before a department or investigator has a regulatory issue, we help them develop a plan to address it."

The ARMP template was created last fall, says Martha Matza, MS, CIP, CIM, director of operations of the Office of Protocol Research.

"It's not a plan for each research protocol," Matza says. "It's a plan for the entire department, for an organization."

The goal is for research departments to develop their own ARMP with help from the template and use this as a foundation for the protection of research subjects, she adds.

"It's a guideline, a process-driven type of system," Matza says. "So when you have any type of problem you can go to your process and say, 'How do I deal with that problem? How do I report the problem?'"

For these plans to succeed, sites need to have institutional senior management support, she notes.

"That's critical to the success of this endeavor," Matza says. "You have to have resources to create and implement this, and if you don't allocate time then people won't take the time to focus on it."

It's too early for outcomes, but the IRB and research officials have given positive feedback about its use, she notes.

"It really helps the department be proactive instead of reactive," Matza says. "The ARMP helps to protect research patients, and it brings higher quality research to the institution."

From the IRB's perspective, the ARMP helps reduce the workload, Quezada says.

"When there are issues with the protocol, then the IRB will ask if there's an administrative research plan in place to address these issues," she says. "Often times there are regulatory issues with individual studies, so we go with the ARMP that's been created and have investigators follow the procedures in the departmental plan."

The Office of Protocol Research came up with the plan as a solution to one department's research compliance issues, says Marion Olson, CIP, research regulations supervisor.

"Wanda and I met with a department that was struggling with trying to be compliant," Olson says. "They were at a point where they had to submit a corrective action plan, and we went to them and suggested they may need a monitoring plan."

Working with the department, they sketched out a basic concept that eventually became the ARMP. It contains these six steps:

  • Step 1: Perform a department profile assessment;
  • Step 2: Perform an assessment of the department research resources;
  • Step 3: Develop a department monitoring plan;
  • Step 4: Define an implementation strategy;
  • Step 5: Regulatory monitoring of the ARMP;
  • Step 6: Outcome expectations.

Each department adapts to own plan

Each department uses these skeletal guidelines to develop its own plan, tailoring the plan to departmental goals and types of research conducted, says Evanna Thompson, MPH, CIP, research regulations supervisor.

"We have seen plans that are three-to-five pages, but they can be up to 20 pages," Thompson says.

"When we talk with different departments, we tell them to first do an assessment of which resources are available and of their studies and who has responsibilities for those studies," she adds. "The process for consenting patients, doing lab work and clinical work can be incorporated into that plan."

If a department has had past experience with particular compliance issues, then these also can be added to the plan.

"Then the IRB reviews their plan and acknowledges whether it is acceptable," Thompson says.

Often the IRB will request changes; the department will implement them, and then the ARMP will be approved.

ARMP participation is voluntary, but the Office of Protocol Research encourages it, Quezada says.

"There are times when an IRB may mandate an ARMP because of regulatory compliance issues with that particular department," she adds. "That has happened several times."

When Quezada and Olson met with the initial department that prompted their development of the ARMP, they gave the department leaders some specific points to follow, Olson notes.

"We required their department chair to do an assessment of their resources as far as FTEs, research nurses, physicians, and the type of research they do," she explains. "They needed to outline the educational process."

Each ARMP needs to address communication between the department chair and researchers and the IRB.

"They need to make certain everybody is on board with regard to how these research protocols are monitored," Olson says.

Also, the ARMPs should be included in the study design of high-risk protocols and can be used to report unanticipated problems or trends that might necessitate stopping a study.

The Office of Protocol Research staff has been educating researchers and others about the ARMP in brown-bag lunch sessions, Quezada notes.

"Education is part of our ongoing mission," she says.

The one-hour lunchtime education sessions are held every other Monday and have been well attended with 50 to 100 attendees each session, she adds.

"We also have an IRB help-email-line where people send in questions about implementing the plan," she says. "We provide guidance on the development of an ARMP."

There also have been departments that requested individual educational sessions as they work on completing an ARMP, Olson says.

"It's been a positive response as departments try to be proactive," she explains. "They recognize their shortcomings, and as they complete the ARMP they identify their shortcomings, change and their departmental procedures, and, anecdotally, they report seeing fewer protocol deviations."

One important aspect of the ARMP is that it's a continuous process, Olson says.

"It's a continuous cycle, and it's flexible enough to be applied to any institution that is doing human subjects research," Matza says.