Focus on essential areas to help program thrive
Compliance Corner
Communicate clearly, efficiently
IRB managers sometimes are daunted by the prospect of streamlining their program. Starting a new quality improvement initiative might seem terribly time-consuming and labor intensive. But as one expert notes, an IRB office could make considerable improvements in efficiency and compliance by just focusing on these three areas: IRB review processes, education for IRB members, staff, and researchers, and quality assurance/quality improvement.
"The first goal is to have a robust human research protection program," says Cheryl A. Savini, CIP, principal and chief operating officer of HRP Consulting Group Inc. of Clifton Park, NY. Savini speaks about improving IRB operations at national conferences, including the annual Advancing Ethical Research Conference, sponsored by Public Responsibility In Medicine & Research (PRIM&R), to be held Nov. 7-9, 2013, in Boston.
"Unfortunately, there are times when submitting to an IRB is considered burdensome paperwork," Savini says. "When an IRB is functioning efficiently, it can facilitate research and have the utmost concern of those participating in research."
Savini offers these suggestions for how an IRB program might focus on the three chief areas for improved compliance:
• Supplement educational program. IRBs can use national educational programs, such as the Collaborative Institutional Training Initiative (CITI) program, for their initial and refresher training of staff and IRB members and for researcher training requirements. But then they should follow up CITI with continuous training initiatives, Savini suggests.
Such training could include in-house lectures, webinars, provision of guidance documents, and attendance at external conferences.
"This provides a solid base for researchers, IRB members, and staff in understanding the basic protections and everyone’s responsibilities for the protection of human subjects," Savini says. "It also provides researchers with the knowledge of what the IRB’s roles and responsibilities are in the process."
The goal is to help researchers understand why the IRB asks for certain additional information and to help investigators learn how to more clearly describe in protocol submissions what their research is about, how it’s going to be conducted, and what they are trying to accomplish, she adds.
• Provide efficient, effective protocol reviews. There are many tools available to assist IRBs with making the review process more timely and efficient without compromising human subject protections, Savini says.
"IRBs must be flexible and reasonable in their reviews and not impose unreasonable demands on the researcher," she says.
For example, a study might involve a benign survey, such as shopping or food preferences. In this case, IRBs that require a signed informed consent document for each participant are creating an unnecessary burden for the researcher, she explains.
"The regulations allow for waivers or alterations of informed consent or documentation of informed consent in such instances where the IRB determines that there is minimal risk to subjects and that the request satisfies the criteria for such waivers or alterations, outlined in the federal regulation," Savini says.
Instead of requiring a signed IC form, the IRB could require that the survey include a statement disclosing that the survey is for research and stating that returning the completed survey indicates consent to participate in the research, she adds.
Another strategy for streamlining the IRB review process would be to use a detailed protocol submission form, Savini suggests.
Although it will take investigators a little longer to complete the form initially, it will result in fewer questions by the IRB and a quicker turnaround time, she notes.
"A submission form that asks questions clearly rather than using broad, open-ended questions provides researchers with exactly the information the IRB is looking for and gives IRBs precisely the information they need," she says.
It’s very frustrating to investigators when IRBs send them repeated requests for additional information, and it’s frustrating to IRBs to have to send out these requests, she says.
"What is the IRB actually looking for? What is the researcher actually doing? They shouldn’t need to guess. IRBs should have complete and detailed information in order for the IRB to make their required determinations," Savini says.
IRBs should create their own detailed submission forms that are customized to their institutions’ specific needs and types of research. HRP has created its own detailed submission forms, which have been customized and successfully used by numerous organizations, including many that have become accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), she adds.
Even with the best submission forms, there might be occasions when IRBs have to ask for additional information. When this occurs, it’s best to be clear and concise about which information is needed by the IRB and why it’s needed, Savini says.
"You might even want to call the investigator to clarify something," she says. "It’s better than sending out an email."
The phone call can be followed up with documentation, but it at least provides an opportunity for discussion and clarification, she adds.
• Create a solid quality improvement/quality assurance program. The QI/QA program should provide continuous oversight in how the IRB is functioning and help to ensure researchers are conducting their research as approved by the IRB, Savini says.
Solid programs might include random researcher protocol audits, observing the consent process, obtaining IRB metrics, reviewing IRB meeting minutes, review of non-compliance issues, and others, she says.
Collecting data and auditing study sites gives IRBs the information they need to determine areas of concern and which should be highlighted for additional training and education, she adds.
"For example, if you find out that the IRB is continually asking the same questions of researchers, then maybe it’s time to ask that question in a more detailed and clearly written way in the submission form," she says.
Helpful metrics to collect might include the IRB’s protocol turnaround time, the time it takes researchers to respond to requests for additional information, and how long it takes for the IRB to review the additional information and provide final approval.
"When HRP conducts a program evaluation, we begin by reviewing documentation, such as IRB meeting minutes, standard operating procedures, IRB rosters, submission forms, reviewer checklists, a sample of protocol determinations, and we look at turnaround time," Savini says.
"We conduct audits on a sample of protocols, and we interview all the stakeholders, such as researchers, IRB members, IRB staff, and institutional officials," she says. "It is important that interviews occur not only with those directly involved in the IRB, but also within each of the departments that play a role within the process."
IRBs can use metrics to identify problem areas and to target education and training for researchers who are having repeated problems with the submission process.
"Researchers want to do the right thing, but they need to know what it is, and they need to know how to apply the regulations, as well," Savini says.
Effective communication between the researcher and the IRB is essential, Savini says.
"There are many times the IRB is seen as a black hole where a researcher submits an application and doesn’t hear anything for weeks," she explains. "That’s not to say the IRB is not doing its work, but the researcher has no clue what is happening."
One way to ensure better communication between the IRB and researchers is to provide an automatic email when the submission is received, Savini suggests.
This can be done electronically or by IRB staff.
"Let researchers know when a pre-review is conducted, saying, We looked over your application and we see that you forgot to submit your consent form,’ or that they didn’t clearly describe something, or whatever the case may be," she says. "The researcher then has the opportunity to provide the information or clarifications before it goes to the IRB for review."
"The goal is to consider the IRB a partner with the researcher rather than a hindrance," Savini says.
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