HRPP is ready for growth, including compliance changes
Work smarter, more efficiently
Human research protection programs (HRPPs) are poised for the next level of evolution as today’s controversies push research ethics in new directions.
IRBs and HRPP leaders need to look at their programs from a 50,000-foot altitude, suggests Eric Allen, CIP, CPIA, associate director of consulting services at HRP Consulting Group, Inc., in New York City. Allen is based in Riverview, FL.
"That’s the view you need for a strategic plan," Allen says. "Most research organizations have an overarching strategic plan."
Strategic plans should include oversight and the goal of improving efficiency, he adds.
They could be divided into four main areas: research compliance, institutional compliance, public responsibility, and financial compliance.
"Research protection programs need to work smarter so they can be more efficient," Allen says.
Allen outlines what a HRPP’s strategic plan should include and how IRBs might make changes to adapt to 21st century realities.
Address IRB resources and needs. HRPPs and IRBs need policies and procedures for research oversight with the goal of assessing problems before they grow into something catastrophic, Allen says.
The big issue for more organizations is understaffing, he says.
"A lot of IRBs do their jobs well, while they are understaffed," Allen says. "No one knows how much effort and manpower it takes because it’s just me and this other person, and we get the job done.’"
Someone needs to let a research institution’s leadership know when resources are a problem because this can contribute to noncompliance issues, he says.
IRBs should make sure all resource issues are identified, managed, and reported to organizational leaders so they can see what needs to be done financially, Allen says.
When an IRB truly needs a funding increase, the argument could be about what it would cost if there is a serious research program violation that results in media reports, legal trouble, or bad publicity.
"If things go south and the institution has a problem that needs to be reported to regulators, how will that affect the organization?" Allen says. "In the worst-case scenario, money could be restricted, and the problem could cost the organization millions of dollars."
Perhaps resources could be shifted and an IRB’s workload could be handled within existing infrastructure, Allen says.
"The concept is to make it smarter, to use everyone in the organization to mitigate, manage, and contain the good things and get rid of the bad," he adds.
IRBs also should consider what they’re lacking on their board when it comes to handling 21st century studies.
For instance, when regulations were written about IRBs, technology was not an issue. Now it is. So IRBs could have a technology professional on their board to assist with research in the virtual realm, Allen suggests.
"If you don’t have an expert, then it’s in the best interest of your organization to have a member with some information technology (IT) skills to guide you," he adds.
Assess HRPPs’ short- and long-term needs. Research organizations should conduct consistent and routine assessments of their IRBs and HRPPs. They need to know what’s going well and what’s not working while aiming for efficiency and overall improvement, Allen says.
"Some organizations send surveys to everyone who worked with the HRPP office," he says. "We might think we’re doing wonderful things, but the people we’re working with have a different point of view, and their perspective is important."
Research organizations also need to plan for major changes, such as starting a medical program or merging IRBs, he says.
If a research institution is adding a new program, the IRB’s submission volume will change, and the institution will need a plan for how to ramp up efforts and get new resources in place, Allen explains.
"Someone at the institutional level has to have a strategic plan to show where the organization is going and how the HRPP and IRB fit into institutional goals and what they want to do to improve," he adds.
Improve auditing efficiency. Large research organizations have resources for audits and post-approval monitoring, but this can be a problem for smaller HRPPs, Allen says.
"If I were to look at strategies for doing post-approval monitoring with limited resources, I’d first modify the continuing review form," Allen says. "I’d incorporate additional questions for investigators."
A few questions about the research site’s staff, participant withdrawals, study modifications, and changes to the research question could give an IRB insight into any potential compliance problems.
For instance, Allen says, the same questions that might be asked in a post-approval monitoring visit could be included on a continuing review form, including these:
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Where do you keep your files?
Are your activities consistent with your application?
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Have you changed your password since last year?
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Have you had any changes in study personnel?
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Did you remove any old staff’s access to study data?
Do you have control over the study medications?
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Are you monitoring study medications according to Food and Drug Administration (FDA) guidelines?
Have you reported all adverse events?
"These are the things you want to evaluate, as well as any problems that come up," Allen says.
An investigator might have made a change that affects risks and benefits, and the IRB could learn of this through the continuing review form, Allen says.
"A lot of safety monitoring is assuring they’re doing everything they said they want to do," Allen says. "Make sure they’re following up on the study’s confidentiality, monitoring the number of people with access to the files — these are easy questions for investigators to answer."
Improve internal communication. IRBs and HRPPs should communicate with institutional leaders before there’s an emergency.
"The message usually is communicated loudest when it’s a negative message, but the positive things of having an IRB person who works 80 hours a week doesn’t get recognized," Allen says.
IRBs need to work with senior level administrators to form mitigation strategies, figuring out how to prevent problems, he adds.
For example, when there’s an institutional expansion or a sudden increase in federal research funding, the IRB and institution should prepare for an influx of money and studies.
"Foresee potential impact changes on your IRB and HRPP and work on them before they erupt," Allen says.
Another example could be when an institution is blindsided by outside criticism of a particular study. This happened a decade ago with some researchers studying HIV/AIDS behavioral interventions to identify ways to reduce transmission among specific high risk groups. Special interest groups targeted some of these studies, basing their objections on the study’s focus on risk factors, such as sexual behavior. They claimed the studies were a waste of taxpayer money.
Many institutions and researchers would have stopped their studies in the light of harsh media and national attention. But some kept the lines of communication open with institutional officials and with the public and managed to survive the media storm, Allen recalls.
"Communication is key," he says.
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