Ebbing the tide: PIs fight "mission creep"

Action plan has 8 recommendations

Review board mission creep: nearly every research organization experiences it, and most clinical trial sites resent it.

Still, in these days of more focused public attention on research and human subjects protection, mission creep among ethics review boards is inevitable.

Some institutions are making concerted efforts to improve definitions, policies and procedures to reduce mission creep whenever possible. One major institution, the University of Texas Health Science Center in Houston, TX, has devoted considerable time and resources to reducing regulatory burden and mission creep.

One of their chief strategies was to come up with eight regulatory and fundamental recommendations. Here's their action plan:

1. Define boundaries of regulating human subjects research. "In discussing the issue of mission creep, we felt a lot could be gained in terms of facilitating the process by having our university system define much more clearly the boundaries of regulatory human subjects research," says Peter Davies, MD, PhD, executive vice president for research at the University of Texas Health Science Center.

"We charged our university system with helping to put together a roster of areas and issues," Davies says. "We made a point that this would be a living document, and over time different issues would arise that would be considered under that process."

The goal is to create guidelines for research campuses to use when determining whether or not studies are appropriate for IRB review, Davies adds.

2. Encourage IRBs to be flexible.

"We received a lot of advice and had internal discussion about the idea of encouraging our IRBs to utilize the flexibility that already exists in current regulations and to promote ways to facilitate IRBs in utilizing this flexibility much more effectively," Davies says.

3. Reconsider applicability of Federal Wide Assurance (FWA).

"The choice is making informed decisions about whether to apply the common rule only to federally-sponsored research or to all research," Davies explains.

"There are arguments on both sides that need to be considered in terms of filing a limited FWA," he adds.

With a limited FWA, the institution would commit to apply the common rule only to federally-funded research, he says.

"The vast majority of UT campuses applied the FWA to all human subjects research on campuses, but there is increasing interest in limiting it to only federally-sponsored research," Davies says.

The idea of limiting the FWA is that there can be appropriate levels of protection for subjects without sites necessarily following all the elements of the common rule.

4. Adopt measures ensuring adequate scientific review.

"Institutions in our UT system were encouraged to adopt measures that would ensure adequate scientific and scholarly pre-review of human subjects research," Davies says.

Rather than relying on IRBs to provide all of the necessary review, research sites should have mechanisms for pre-review to address some of the scientific and literature questions about research projects, he adds.

5. Promote efficiency and reduce regulatory burden.

"The idea is to look carefully at applying the appropriate level of IRB review," Davies says. "Sometimes IRBs tend to be cautious and go beyond what is necessary."

There are mechanisms that can help IRBs and IRB staff more clearly decide what is appropriate for a particular type of study, he says.

"We have over a dozen different campuses, and some are major medical centers with very sophisticated IRBs," Davies explains. "Others are small, academic campuses in regions of the state that are not heavily populated."

What the campuses need are mechanisms coordinated at a central location for providing advice and consultation about which level of review is necessary, he adds.

6. Reduce number of IRB reviews per protocol.

Often there are several IRBs reviewing a single protocol, and that's a redundancy problem, Davies says.

"So we're creating a memorandum of understanding at a system-wide level that allows for reciprocity within our IRBs," Davies says. "This is becoming much easier as we go through more and more institutions receiving accreditation."

IRBs can defer to one another rather than duplicating the whole review process, he adds.

"This is something particularly important with the clinical and translational science award (CTSA) projects, where there is a lot of interest in creating multi-site trials across CTSAs," Davies says. "The UT system is creating templates for use as we streamline the process."

7. Reward IRB members and staff.

Research institutions need to do a better job of recruiting, retaining, and rewarding IRB members and staff, Davies says.

"We need to ensure people have access to appropriate levels of training and professional development," he says. "They need to be excellent at what they do."

UT has a point person overseeing this process and implementing activities to enhance recruitment, rewarding and retaining IRB staff and members.

8. Build culture of trust.

"This last one is the one we spent the most time on, and in some ways it's the most important," Davies says. "We need to build a culture of trust, building processes and conscience to create a foundation for ethical human subjects research."

This is the cornerstone of all the systems created to reduce mission creep and regulatory burden, and each research campus needs to be aware of and committed to the process, he adds.

This also suggests a policy of transparency in areas of conflicts of interest and providing leadership at every level of a university, Davies says.

"CTSAs have been remarkably important in setting up community engagement processes," he says. "In a variety of different ways, the research establishment and communities have facilitated open dialogues, and the research agenda is set by communities themselves."