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By Melinda Young
Post-approval monitoring (PAM) is one method that IRBs could employ when keeping tabs on minimal-risk studies or studies that no longer have to go through the continuing review process. It also can be a way for a small IRB to improve office efficiency and enhance relationships with investigators.
The new Common Rule says that continuing review no longer is required if:
• the research is eligible for expedited review;
• the research is subject to limited IRB review;
• the research was approved by the full board, but has progressed to where it only involves data analysis, even if the information or biospecimens are identifiable,
• the research was approved by the IRB, completed, and now only includes accessing follow-up clinical data from clinical care procedures.
IRBs that would like additional information from studies, after continuing review ends, could use PAM to obtain that information.
For example, one small IRB began providing PAM of minimal-risk studies that underwent expedited review. A larger research institution’s IRB used PAM as an alternative to continuing review, says Cecilia Brooke Cholka, MA, CIP, IRB specialist at the University of Nevada, Reno. Cholka is scheduled to speak about PAM at the Social, Behavioral, and Educational Research (SBER) Conference at the 2019 Advancing Ethical Research Conference, Nov. 17-20, 2019, in Boston.
Once an IRB develops PAM tools, including an initial email sent at the first of the month, IRB staff might realize how helpful PAM is in terms of education, Cholka says.
As part of PAM, an initial email to investigators, such as the one Cholka has noted, could include some simple “yes” and “no” questions, including these examples:
• Did any protocols deviate during the project?
• Has the funding source changed?
• Were there any unanticipated problems? Were these reported to the IRB?
• Have any participants complained about the study?
• Are all research team members trained? Have they met conflicts of interest requirements?
Many institutions are not comfortable with eliminating all post-approval review of expedited studies. Starting a PAM program provides a middle ground, says Andrea Rossing McDowell, PhD, IRB administrator and business communication lecturer at Seattle University. McDowell also is scheduled to speak at the SBER conference in Boston.
“What we do now for all expedited studies is write to them and ask investigators, before the year is up, to answer a few questions,” she says. “The email asks if they have concluded the research project and if they have concluded data collection and are just doing analysis, and then we will downgrade those to exempt status — if they are not dealing with human subjects.”
The email references federal regulations and explains that the questions are in lieu of a formal continuing review process. It says, “We are checking in briefly to determine the current status of your study,” according to a sample email Seattle University shared with IRB Advisor.
The email also asks five questions about the study, including whether the research project has concluded or concluded all data collection. Here are two sample questions:
• “If your study is ongoing, approximately when do you anticipate concluding data collection?”
• “For student studies, please indicate whether any data remain identifiable, and if so, whether raw data were transferred to the faculty advisor.”
The email also reminds investigators to fill out the modification request form if they wish to make any significant changes to an ongoing study.
Seattle University received far more expedited review and exempt studies than full board review studies, she notes. “We didn’t have any full board reviews last year, and we typically have two to five full board reviews, so last year was unusual,” McDowell says.
“For full board protocols, where there’s a slightly higher risk level, we do a continuing review with those and have a brief continuing review application that asks about the status of the project,” McDowell explains. “Any project, previous to last year, that’s still ongoing and was a full board review, still needs to have a continuing review.”
But since the new Common Rule was implemented, the IRB has seen more expedited reviews, she notes. Prior to the Common Rule change, expedited, minimal-risk studies were awarded a two-year approval period.
“They wouldn’t have to keep checking with us every year if there were no adverse events or problems that occurred,” McDowell says. “Most of our researchers concluded their studies before that two-year period ended.”
For larger IRBs, post-approval monitoring can employ a variety of tools and models. Cholka, until her recent IRB role at the University of Nevada, worked for an IRB that had conducted for-cause audits before the new Common Rule eliminated continuing review for many studies. “We were flustered because it felt like a really important thing that was taken away,” Cholka says.
IRB members were uncomfortable losing sight of projects and wanted to ensure appropriate conduct of ongoing research. They researched models that would work in this new environment, she adds.
“The criticism of continuing review is that it’s just filling out paperwork, it’s an administrative burden, and it’s not needed anymore,” Cholka says. “But without it, you don’t know what’s going on.”
That is why the IRB decided to create a PAM program with several different parts, varying in depth. (See list of potential PAM models in this issue.)
PAM provides a good opportunity for IRBs to engage with researchers through outreach and ongoing education about regulations and requirements, she notes. “It helps increase an IRB’s visibility and builds its reputation as a collaborative worker, instead of casting the IRB as adversaries,” Cholka says. “It broadens our mission to one of saying, ‘Here are the different tools to help you do it right, and we’re here to help you.’”
For example, IRBs could develop a minimal PAM model that involves giving researchers a self-assessment tool that serves as a reminder of their patient recruitment, screening, recordkeeping, and informed consent responsibilities. Sample questions might include the following:
• “Are all IRB records, including consent forms, correspondence, protocol, signed applications, and an approval letter, stored in an accessible location for at least three years after the project is closed?”
• “Do you have documented approval of advertising and recruitment materials?”
• “Did you use IRB-approved script/text to enroll participants?”
The Seattle University IRB’s PAM model asks investigators for brief answers to its email questions about the study’s status: “We ask, ‘If your study is ongoing, please tell us in no more than one sentence what the current status is,’” McDowell says. “They can answer ‘yes’ and ‘no’ to most questions and then give a brief update that we’ll save to their protocol file.”
Using a brief check-in email has helped improve compliance, resulting in 100% of people responding. Under the continuing review process for minimal risk studies, the IRB would have to pester researchers to fill out the required form and submit it to the IRB, McDowell says.
“Even though it is a short form, people get busy doing other things,” she explains. “But in the first two weeks of using the email system, we were able to close out 20 studies because investigators could just respond by email.”
It’s also a big plus from a recordkeeping perspective, she adds. “It takes very little effort on our part and on their part, and our records are far more accurate now,” McDowell says.
The email PAM process works especially well with studies involving student researchers, she adds. When students are the lead investigators of a study, all PAM ends with the student’s graduation date. “Once they are alumni, we cannot provide oversight because they’re not our students anymore,” McDowell explains. “In the past, we’d never hear back from student researchers, and we’d have to track down their faculty advisors to find out what was going on,” she adds. “Now, we send the email prior to their graduating, and we get feedback from them, saying, ‘Yes, I’m done, and I’m graduating,’ and we close the student files.”
If a student wants to continue a study after graduation, the IRB works with the faculty advisor, who becomes the study’s lead researcher and the student is an affiliate, she says.
“For us, the post-approval monitoring, brief email system has made things much easier and has also improved our recordkeeping,” McDowell says. “It’s even improved our relationships with researchers because when they get an email of ‘Hey, what’s the status?’ they’re much more likely to respond, and we can say, ‘OK, let’s close this file.’”
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jonathan Springston, Editorial Group Manager Leslie Coplin, and Physician Editor Lindsay McNair, MD, MPH, MSBioethics, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Nurse Planner Kay Ball, PhD, RN, CNOR, CMLSO, FAAN, is a consultant for Ethicon USA and Mobile Instrument Service and Repair.