Self-assessment can point to needed changes 

Full accreditation end reward for one organization

Copernicus Group IRB of Cary, NC, sought accreditation to validate that the 8-year-old, independent IRB and human research protection program was on the right track with its human research protection program.

The organization has grown from a two-person office to a support staff of 35. Its IRB meets twice a week, reviewing 200-500 studies each year, reports Sharon Hill Price, BSN, MS, CIP, chief executive officer.

"I think the main reason we wanted to seek accreditation was to get validation that we’re doing the right thing and protecting human subjects in the best way possible," Price says. "We learned a lot, and we obviously thought we were doing the right thing, but during the self-assessment process we picked out potential areas that needed improvement, and we built on those areas."

Copernicus Group IRB began the process of seeking accreditation in May 2003 and, by the end of July 2004, the organization received full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP) Inc. of Washington, DC.

"The main area we needed to improve or adjust our focus about was unanticipated problems involving risk to research subjects and others," says Tammy Sayers Lesko, CIM, director of quality assurance and regulatory compliance.

"We were primarily looking at serious adverse events and significant protocol deviations and not at the whole unanticipated problem umbrella," she says. "And after talking with representatives at AAHRPP, it was made clear to us what exactly is involved with unanticipated problems involving research subjects and others."

Initially, the organization formed a subcommittee to assist in conducting the self-assessment, Lesko says.

The subcommittee included Lesko, Price, the director of IRB services, IRB chairperson, and other staff and IRB members.

Within four months, the subcommittee had come up with a working draft of the organization’s self-assessment, but it lacked consistency, Lesko says. "I had divided up tasks into five domains, and I assigned different groups of people to work on those and get their comments back to me," she says. "I found people had a lot of different writing styles, and even though I had given a lot of direction about what product I needed to have returned to me, people have different ways of doing things."

The five domains evaluated for accreditation were the organization, research review unit, the investigator, the sponsor, and research participants, Lesko says.

After incorporating the varied styles into one working draft, she and Price attended a three-day workshop held by AAHRPP.

Lesko came away from the workshop with the idea that eliminating the subcommittee process and instead working with one expert within the organization at a time could improve the draft. "So if I needed something about a vulnerable population, I contacted the IRB chairperson who had experience in that," she explains. "If I needed IRB meeting minutes, I’d talk to the director of IRB services who helps with meeting minutes."

Lesko and Price discovered that the self-assessment process was more than an opportunity for an organization to take a closer look at policies and procedures.

"It’s also a way to explain to an outside group exactly what we do and how we do it," Price says. "After the self-assessment was completed, we sent it to AAHRPP to determine if our processes met federal regulations."

Then AAHRPP conducts the site visit and interviews are held to see if the organization is doing what it said it was doing, Price adds.

Keeping it short and sweet

One of the changes Lesko and Price made to the self-assessment document was reducing each section to what was most succinct.

"Where we might have taken a standard and described it in four or five paragraphs, what they wanted was short and sweet," Price says. "They wouldn’t mind if you said, This element is addressed in SOP [standard operating procedures] 10,’ for example, so we could cut out a lot of stuff that we’d put in it."

Basically, they replaced their initial paragraph form with brief, concise sentences, Lesko notes.

"It took 2½ months to revise the self-assessment," she says. "Part of that time was spent revising our SOPs and reissuing new SOPs, making revisions for a majority of forms and updating the web site."

Their goal was to update and revise everything necessary before submitting the self-assessment to AAHRPP, Lesko notes.

When the self-assessment was complete, it numbered nearly 1,000 pages, most of which involved reference material such as the entire list of SOPs and a list of active protocols and investigators, she says.

"Our self-assessment with the five domains was 35 pages, but the references were 919 pages," Lesko adds.

Any checklists and resource materials normally provided to IRB members were included in the packet sent to AAHRPP, Price notes.

The accrediting organization required the IRB to submit an electronic PDF file document on disk along with hard copies for site visitors to review, she says.

A long and arduous journey

Reaching the point to submit the material took seven months, longer than Price had anticipated. "Any organization involved in ethical review of research thinks they’ve got all their ducks in a row, and we’ve got SOPs, and it won’t be a big deal," she says.

But when the organization became involved in the process, it became clear that considerable work and changes would be needed to make the document as clear as possible, Price adds.

Once the self-assessment was submitted, the IRB waited for a site visit, but the work didn’t stop here, Lesko says. "We were training staff and IRB members on the revised SOPs and new forms, and we were making use of that time with interactive sessions."

One of the major changes involved bringing the IRB’s focus back to unanticipated problems through determining a process in which investigators would inform the IRB of their situation and whether a problem was unanticipated, Price says."We had to educate investigators to have them feel comfortable making that assessment. It required sending out information to investigator sites, including additional information about unanticipated problems."

Also, the IRB updated its web site with information about unanticipated problems, providing specific details for investigators, Price says.

"We developed a better form for obtaining the information we needed as an IRB," she adds.

Another major change was in beefing up documentation of meeting minutes, Price reports.

"We thought we had very good minutes, but we’ve improved them through our interactions with AAHRPP and site visitors," she says.

For example, the minutes now include more detail regarding controverted issues.

The term "controverted" always has been confusing, Price says. "It means issues that are discussed for a while."

An AAHRPP site visitor suggested that any issue discussed by the IRB for more than two minutes could be a controverted issue and should be documented as such, Price says.

The IRB also needed to improve on how information is captured about principal investigator qualifications and research experience, Price says.

The investigator site questionnaire was improved with more questions about the informed consent process, including these:

  • How long does it take an investigator to conduct an informed consent process?
  • Do they understand privacy vs. confidentiality?
  • Does the research involve a vulnerable population?
  • What types of populations are enrolled in the study?

"We’ve added information about these on our web site, and our investigator site questionnaire points investigators to our web site if they need more information in any of these areas," Price says.

If investigators indicate that they’ve enrolled subjects who are economically disadvantaged or who have limited English-speaking skills, then the IRB will ask investigators to describe how they will protect that population with additional safeguards, Lesko says.

Finally, the IRB received an accreditation site visit in April. Interviews with study coordinators, sponsors, contract research organizations, IRB staff and members, and investigators had been scheduled in advance, and everyone knew what to expect, she explains.

After the three accreditation officials met with the IRB for three days, they provided detailed verbal feedback, Lesko adds.

AAHRPP had a deadline of 30 days in which to provide the written feedback, and then the IRB would have 30 days to address and solve any problems that were noted in the report. But the verbal feedback gave the IRB some extra time to prepare, she explains. "We had the benefit of a detailed, closeout meeting."

Price, Lesko, the IRB chair, and the director of IRB services met with the site visitors, while an administrative assistant took notes.

"The notes turned out to be crucial for us," Lesko says. "We could start working on some of the things that were identified instead of waiting a few weeks to get the report, and we needed the extra time."

When the written report arrived there were no surprises, and the IRB was able to complete all improvements by the 30-day deadline, she says.

"We weren’t working in a vacuum with our response," Lesko says. "Every single element we were responding to in our report, we ran past our draft answers with AAHRPP, and they reviewed each item before we submitted the final draft."

Fewer than two months after the final draft was submitted in June 2004, Copernicus Group IRB received its full accreditation, she reports.