By Melinda Young, Author

Research institutions seeking first-time accreditation or reaccreditation can always expect challenges. These hurdles are a little higher now as rules and regulations will change in 2019 under the new Common Rule.

But the basic process of preparing for accreditation remains the same, and any IRB can fast-track its preparation with organization and willingness to adapt.

“IRBs are used to doing things the way they were,” says Michael Mahoney, director of research operations and services, human research protection program (HRPP) administrator, at the University of Florida in Gainesville.

When IRBs seek accreditation, they have to adapt to doing things differently, he adds.

For instance, the Association for the Accreditation of Human Research Protection Programs (AAHRPP) of Washington, DC, has high expectations for research institutions, Mahoney says.

Successfully obtaining AAHRPP accreditation depends on having strong institutional leadership and having all staff engaged in the process, he says.

“We held ourselves to high standards and we wanted to get it done on the first pass, so everyone knew they had to be engaged on it,” he explains. “We were shooting for full accreditation, our No. 1 goal, and we accomplished that.”

The University of Florida’s HRPP underwent a fast-track accreditation preparation process, spending a total of 18 months from its AAHRPP application to its approval in March 2018.

“Most institutions take two to three years to get accredited,” says Gailine McCaslin, MS, HRPP coordinator at the University of Florida.

“At the University of Florida, we had a more aggressive timeline, partially tied to funding we had received — and, more importantly, it also was something our vice president for research mandated,” McCaslin says.

McCaslin and Mahoney describe how the program achieved accreditation fairly quickly, following these strategies:

1. Hire someone to handle the accreditation preparation workload.

The first step was hiring a dedicated professional with experience in the accreditation process.

“We knew we needed a full-time employee to serve as project manager in coordinating all the gap analyses, policy changes, and coordinating changes, and we were very fortunate that Gailine was fabulous,” Mahoney says.

“Prior to my role here, I had worked in the college of pharmacy and was familiar with the accreditation process,” McCaslin says. “I was not intricately familiar with the IRB, but that served me in terms of giving the process a new set of eyes.”

Just having McCaslin dedicated to the accreditation role was a big commitment for the institution.

“Most institutions use some in-house manpower, designated staff in other IRB positions, and they tack on the AAHRPP accreditation responsibilities,” McCaslin notes.

Since the institution wanted a fast track to accreditation, it made sense to dedicate a full-time position to this job.

However, due to limited resources, some IRBs might still choose to put accreditation duties on another employee’s plate as half or three-quarters of their duties, she notes.

2. Review policies and procedures.

McCaslin spent several months reviewing all of the HRPP’s policies, procedures, and practices, and speaking with stakeholders.

“Then we looked at AAHRPP standards and regulatory guidance and mapped everything together,” she says.

AAHRPP’s Evaluation Instrument for Accreditation helped: “It allowed us to complete a thorough assessment, and we benefited quite a bit,” McCaslin says. “Then we saw where our gaps were in terms of areas we needed to work on.”

“Using AAHRPP standards, including required policies and procedures, I identified a series of potential gaps,” she adds. “Even if one IRB met a standard, but another didn’t, I listed that as a gap because all three of the IRBs had to be on the same page.”

As policies were reviewed and revised, newly created investigator guideline documents were developed. They were in a question-and-answer format that makes it easy for investigators and others to understand regulatory requirements. For example, one guideline involved enrolling and overenrolling study subjects. It asks the question, “When does the IRB consider a study subject to be enrolled?” and answers it with three bullet points:

An enrolled subject is someone:

  • who has signed an informed consent form, or
  • whose data you have collected, or
  • whose medical record you have reviewed (in the cases where consent is not required). Every record you look at is an enrolled subject. (See samples of revised IRB policies in this issue.)

3. Compare HRPP’s policies and processes with those of other institutions.

“I sent out cold emails, made connections at the AAHRPP conference, and leaned on those connections,” McCaslin says. “I started looking at people’s HRPP pages and looked at their policies and how they addressed gaps like the ones we had.” Some IRBs use toolkits and make other helpful information available online.

“After presenting that information to our various boards, we tailored our policies and procedures [P&Ps] to fit our current practices,” she says. (See story on aligning P&Ps of multiple boards in this issue.)

4. Fix gaps.

Gaps were closed wherever possible. For instance, there was one gap involving the lack of specific AAHRPP-required language in sponsored study agreements/contracts.

McCaslin shared this information with contract office leadership and key IRB administrators. It included nuts-and-bolts details about the identified gap.

“I provided the skeleton in terms of AAHRPP requirements, and the key stakeholders added muscle with revised P&Ps,” she says. “The gap was procedural and related to the ways we negotiate contracts and the language we include in contracts, which needed to be AAHRPP-specific.”

One of the more significant gaps involved how IRBs documented the handling of protocols that had extra requirements from specific funding agencies. These policies needed to be documented, and the line of documentation was not often clear.

“So while sitting down with applicable IRB administrators, they’d walk me through the practice, and I’d follow up with Michael and the IRB chairs to discuss the best ways to document our practices in order to be in line with AAHRPP’s standards,” she says. “We needed a little bit more.”

The result was the IRBs needed to change how they reviewed studies with additional funding agency requirements, she explains.

IRBs were still doing a great job in review of such studies, but they had not been documenting their processes. “It was about documentation. That was the theme of the process changes: Clear documentation was key,” she says.

5. Conduct program evaluation plan of action.

“We set up work groups and had weekly meetings,” McCaslin says. “I worked with IRB staff and chairs and various other components of the HRPP. From July through October, we completed a thorough program evaluation and consulted with in-the-works groups to review identified gaps.”

They focused on policy and practice revisions, based on the gap analysis.

“The director of research operations and services, Michael Mahoney, provided periodic updates to key stakeholders and institutional leadership on the accreditation process, addressing any issues or concerns that needed to be tackled, and elicit feedback,” McCaslin says.

Additionally, the main point emphasized to IRB chairs and administrators was that the organization needed one set of P&P documents for all IRBs, and policies and practices needed to match. If a policy was written down, then the practice had to match it.

“We would be essentially setting ourselves up for failure if we have all of these great, newly created and/or revised policies and procedures, but couldn’t realistically put those policies into practice,” she says. “We had to make sure that while aligning ourselves with AAHRPP’s accreditation standards, in written documentation, that our internal business practices also reflected those standards.”