Accreditation experts say IRBs should not make too many changes when they first seek accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP). It’s better to focus on what has to be done and to not do everything.
“We didn’t follow that advice,” says Fanny K. Ennever, PhD, CIP, research compliance officer at Boston Medical Center.
In 2016 and 2017, the Boston Medical Center and Boston University Medical Campus human research protection program (HRPP) tackled both accreditation preparation and a policies and procedures (P&P) overhaul in anticipation of the revised Common Rule. The 15-month process, including the 800-page accreditation application, required Ennever’s full attention, as well as monthly meetings and action by the HRPP advisory committee that consists of IRB chairs, co-chairs, and ex-officio IRB members.
The organization had not sought accreditation previously out of concern that the process would be too resource-intensive, Ennever notes. “But we recognize that in this day and age, you have to be accredited to be a credible IRB.”
The IRB’s efforts were a success. Boston Medical Center received accreditation from AAHRPP in December 2017.
The purpose of the Common Rule changes is to realign regulations with the goals of human research protection. Changes reduce oversight on low-risk studies and put more scrutiny on higher-risk studies, she says.
“The flexibility coalition has been promoting this for more than a decade,” Ennever says.
Years ago, Boston Medical Center unchecked the federalwide assurance box, freeing its research program to have separate policies for federally funded and non-federally funded studies. But the institution never changed its P&Ps until it began preparing for accreditation, she says.
“One of the big questions people had was how difficult it was going to be to have two different kinds of research to specifically keep track of what was funded and what was unfunded,” she explains. “We had unchecked the box, but didn’t change the policies.”
With the Common Rule changes, the sought-after flexibility applies to federally funded research, so the IRB’s policy changes reflect that flexibility, Ennever says.
“We made changes almost monthly for a year and a half,” Ennever says. “We were making changes, broadly, for the purpose of accreditation, but also so that we could accomplish the things we wanted to — realigning our program to focus on where there was higher risk.”
The following is how the organization handled preparation for both accreditation and the revised Common Rule:
• Engage the HRPP committee. The committee and its 12-14 members meet for two hours every month.
The committee discusses changes, considers details, and decides on courses of action. Its motivation for change included the following:
- improve investigator experience;
- use board member time more efficiently;
- follow internal and external mandates;
- meet AAHRPP requirements.1
“They discuss flexibility changes, minor changes, and specific changes in policies and procedures,” Ennever says.
Ennever made the changes suggested by the committee. She spent more than a year working on the revised, 180-page P&P manual. For each item in the P&Ps, she listed the dates of when the policy first was approved and when its revisions were approved.
• Target inefficient policies and procedures. “The policy change that made people the happiest involved chart reviews,” Ennever says.
The chart review policy was revised in February 2018. It reads, “For chart review submissions, additional required information must be provided to determine whether or not the study is eligible for exempt category.”
Before the change, researchers could only perform exempt category chart reviews if the reviews were only of existing data. Any new information collected would have triggered an expedited IRB review, she says.
“That made it very difficult to do a chart review,” Ennever says. “The idea behind having an exempt category is you could walk into a records room, pull a chart, get information, and put it right back.”
But the exempt category did not cover many chart reviews. In the revised Common Rule, there is an additional exempt category for data that exist now and might exist in the future, she adds.
For low-risk chart reviews the expedited review process is burdensome, so the organization changed the policy to reflect the Common Rule changes.
“We took something in a category that required more work, which was expedited review, and moved it into a category that requires less work, which is exempt review,” Ennever says.
• Seek institutional approval of changes. Once the HRPP committee reached consensus about proposed changes in policies and procedures, the change was given to institutional officials — one for Boston Medical Center and one for Boston University Medical Campus — for review. If they approved it, the change was implemented.
“We were fortunate that both institutional officials were engaged in the process,” she says.
“I’d write a document explaining what the proposed changes were, the pros and cons, and there’d be discussion at the HRPP committee meeting about it,” she adds.
The committee would make suggestions, Ennever would incorporate those changes, and the rewritten policy would go first to the committee and then to the institutional officials for approval.
After a change was approved, it became part of the policies and procedures manual. Then, Ennever communicated the change to the research community through a monthly newsletter.
• Follow AAHRPP’s guidance. As the IRB prepared for an accreditation submission and visit, Ennever followed AAHRPP’s guidance to see where additional changes were needed.
“All the materials provided by AAHRPP were a good guide to the kind of changes we needed and pointed us into the direction of where we had inadequate policies,” Ennever says.
IRBs also should look at AAHRPP’s reviewer’s guide — but only after making changes according to the accreditation organization’s materials for sites, she suggests.
“If you look at the reviewer’s guide first, you’ll feel like there’s no way you can have everything done, so first look at their standards and compare those to your own policies and procedures,” Ennever says. “Then, prioritize the changes.”
Having only one set of P&Ps helped simplify the process. Ennever used Word to add hyperlink cross-references within the text. For instance, when a section listed requirements, each bullet point header had sections with hyperlinks to the pertinent sections.
“It was tedious to set up, but it came in handy for the AAHRPP application,” she says.
After nearly one-and-a-half years of making changes, preparing for accreditation, and revising the P&Ps, Ennever says the process was worth the effort.
“The document was unrecognizable after a year-and-a half process,” she says. “One of the great accomplishments is that now there’s a mindset that changing the policies and procedures is normal, and we developed a very transparent and robust process for making the changes.”
1. Ennever F, Feldman J. Case Study: Boston Medical Center and Boston University Medical Campus. Presented at the AAHRPP 2017 Annual Conference, May 9, 2017, Detroit.