Successful accreditation process requires close attention to details

Small committee and IRB chairs' cooperation are key

The very first step to becoming accredited is to collect all of your institution's policies and procedures related to the human research protection program in a searchable electronic format, an expert advises.

"I highly recommend taking that first step because it makes it easier to see which policies apply to which elements in the AAHRPP Evaluation Instrument," says Lisa R. Ballance, MA, a special assistant to the vice president for research at Virginia Commonwealth University in Richmond, VA. Ballance helped steer her institution through a research accreditation process, and she's spoken on this topic at national conferences.

Virginia Commonwealth began the accreditation process with the Association for the Accreditation of Human Research Protection Programs (AAHRPP) of Washington, DC, in early 2005 by initiating a self-assessment process. The institution submitted the full application for accreditation in December, 2006, and received full accreditation in June, 2007, Ballance says.

"We had a core team of three people working on accreditation, with each of us taking the lead on one or more of the five AAHRPP domains — the organization, the research review unit, investigators, sponsored research, and participant outreach," Ballance says.

"Each of the domains is divided into standards and then elements," she notes. "We each had elements that we took the lead on for evaluation against AAHRPP standards."

The team then developed a matrix or map of the AAHRPP elements and standards, by domain. This was cross referenced with applicable policies, procedures, guidance, and forms, Ballance says.

"We noted where standards had been met, where clarifications were needed, and what our priorities were as we planned to implement changes," she says. "You need a point person who keeps track of the progress along the way."

Ballance suggests organizations also take these steps to improve their accreditation process:

1. Identify priority areas or concerns.

An accreditation committee can identify the areas that will need the most attention or involve institutional approvals or educational efforts, Ballance says.

"You need to identify those issues that will be protracted or require an additional layer of approval," she adds. "And you should get those projects started first."

For Virginia Commonwealth University, one such issue involved an institutional conflict of interest policy.

"We didn't have a written policy on the institutional side," Ballance says. "The IRB had a policy, but the institution didn't, so we needed to bring that to the attention of the upper administration to initiate that process."

2. Look for changes that won't need decisions from the top.

There are some policies that might be changed through simple wording changes or by adding references, Ballance says.

"So what kind of changes can you make without having to go through a large committee or process?" she says. "You should streamline the pathway to change, where possible."

For instance, Ballance noted that their committee negotiated approval to make procedural changes to written policies and to add clarifying information early in the process.

"This greatly reduces the 'noise' that can be created with change after change, and allowed us to focus our attention on changes that impacted how we carried out our human research protection program, in a more direct way.

"That saved us a lot of time," Ballance says. "Streamlining the pathway to change is very important when you're getting started in this process.

"The AAHRPP was instrumental in assisting us with defining our processes and procedures," Ballance says.

3. Work with IRBs.

"Our IRB is set up in five different panels," Ballance says. "So we needed to take procedural changes to all chairpersons so they could discuss these with us."

For instance, if there would be a change in the adverse event or unanticipated problems language in policies, the chairs would take a look at what was proposed, and their input would be incorporated into the changes.

"We'd take changes to the chairperson's committee that meets once a month," Ballance says. "It was always beneficial to us to be present during the discussion."

This was an efficient use of time for both the accreditation committee and the IRB chairs, she notes.

"We knew this process would put us in the direction we needed to be," Ballance says.

Since not everyone agreed on each suggested change and revision, it meant discussion and revision before the changes were finalized, Ballance notes.

"Don't be afraid to make small changes even if these are not exactly what you think you'd like it to be or where you'd like it to be if you were accredited," she suggests. "Making change toward progress might be what you need to do in order to clarify concerns and focus on the real issues."

Plus, the AAHRPP supports and assists with even small changes in the right direction, she adds.

4. Show accrediting organization a mock-up of changes.

"We found that AAHRPP was very receptive to seeing a mock-up of materials, as long as we had identified it as a mock-up and noted timelines for planned education or implementation," Ballance says.

Although VCU's policies are not saved in an MS Word format, the mock-up was created in MS Word so that the program's track change and text highlight features could be used, she notes.

"It helped greatly to use highlight or track changes, as needed, to reference the specific area of a policy where an element was addressed," Ballance explains. "In fact, this helped us as well."

The application itself is sent in a pdf format, she adds.

"I found that submitting a pdf version to AAHRPP was useful for us," Ballance says. "We were able to use the same pdf version we sent to review their comments and plan for our next steps for implementation of changes."

5. Ask for help when needed.

"There were a couple of areas where we felt we needed clarity on the best way to approach a particular change," Ballance says. "It is possible to adopt a procedure that doesn't work for your program and which would possibly lead you into noncompliance."

So a change should not be made haphazardly, she adds.

When in doubt, Ballance recommends sending an e-mail to AAHRPP and asking questions.

"We'd say, 'We have some questions about this policy,' and then we'd review the specific area in question and outline the issues," Ballance says. "From the AAHRPP we always received very thorough responses and insightful comments or suggestions for developing procedures that were not only compliant, but also flexible, functional, and efficient."