Achieving accreditation through tough times
Seek help early and often
Every human subjects research protection program seeking accreditation expects the road to be long and difficult. Just add a few more years and unforeseen obstacles, and the experience might parallel what WellSpan Health in York, PA, dealt with before receiving an accreditation plaque in July 2013.
"We started the process seven years ago, and there have been many challenges in those seven years," says Melissa Schlenker, MS, CCRC, CIP, the IRB and clinical trials manager at WellSpan Health.
WellSpan Health’s leaders decided to pursue accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) so the organization would be more attractive to pharmaceutical and device sponsors of clinical trials, she says.
"It would show our local community that we had their best interest in mind, and it would help us standardize our programs," Schlenker says.
Achieving these goals was not easy.
The IRB office’s leadership changed twice; the organization downsized its overall staffing from 10 employees to four and its IRB staffing from four to two positions. The organization changed the office structure to merge quality improvement with the IRB office, which now is the population health management and research office, Schlenker says.
Despite having a smaller staff, the office had to create new standard operating procedures (SOPs), develop numerous tools including checklists, and prepare staff for accreditation survey interviews. Then two weeks before the survey was scheduled, Schlenker broke her ankle and was forced to remain homebound for three months.
The accident occurred right before the IRB office was going to hold mock accreditation interviews, notes Tara Moore, quality assurance (QA) specialist at WellSpan Health.
"AAHRPP had provided us with a list of people they would like to interview, including IRB members, researchers, research staff, and leadership," Moore says. "We had scheduled the mock interview for right before the site visit of Feb. 15. Then Melissa fell and broke her ankle the Monday before the mock interviews were going to start."
With help from others at WellSpan, Moore went ahead with the mock interviews.
"We work closely with research managers in other departments," Schlenker says. "And everyone rallied and said, Whatever you need to make it happen, we’ll help.’ Everyone understands the importance of accreditation, and they felt they were invested in our achieving accreditation."
Schlenker and Moore provide these descriptions of their institution’s accreditation process, including how obstacles were overcome:
• Improving SOPs. When they started the accreditation process, the human subjects protection program had five standard operating procedures (SOPs). When they were done about five years later, there were 45 SOPs, Schlenker and Moore say.
The original SOPs were all-encompassing and general policies tied closely to federal regulations. These were enhanced and made more useful with definitions of words, references to regulations, and references to AAHRPP standards. The idea was to provide context, answering any questions about why a particular policy or procedure was necessary, Schlenker explains.
They reviewed SOPs other institutions were willing to share and adapted what would work and meet their own SOP goals.
"We sometimes pull out our policies and procedures to see if we’re doing something right because rules and practices change over time," Schlenker says. "The SOPs need to stay current with changing regulations."
A core group reviewed the SOPs, providing feedback. Also, the IRB had access to a medical writer who reviewed the work for clarity and grammar, she adds.
• Work with AAHRPP early on. "At some point in your preparation you have to contact AAHRPP and tell them you’re getting ready to submit an application," Schlenker says.
Schlenker and Moore took advantage of AAHRPP’s consultation services and advice in the many months leading up to their scheduling a site visit.
"They read our SOPs and gave us critical feedback that was helpful in making sure we met AAHRPP’s expectations for that standard," Schlenker notes. "As time got closer to finalizing the application, I had more direct communication with them."
As the submission date drew near, Schlenker asked AAHRPP consultants to review all of the SOPs and checklists.
"I’d encourage people to take advantage of the access they have to an accreditation director because the information is quite helpful," she adds. "I would have reached out to AAHRPP a lot sooner, in hindsight."
• Find outside help and resources. Moore sought help from other institutions through the IRB Forum website.
"I asked if they would be willing to share tools and checklists, and then I’d adapt them to our needs and ask our biggest customers if these would work for them," Moore says.
"Just reach out to people and ask for information and guidance from others," Schlenker says. "People shouldn’t be afraid to look to colleagues at other institutions for help."
Plus, there are resources available on AAHRPP’s website, and AAHRPP staff are very friendly and accommodating, Schlenker says.
"They want to see you succeed, so don’t be afraid to ask for help," she adds.
• Use the self-assessment tool. AAHRPP provides a self-assessment tool that institutions can use once they have revised SOPs and developed checklists and other tools, Schlenker notes.
"You take this self-evaluation form and go through it step by step, writing down SOPs and reference and where you address a specific standard, and that was very helpful," she adds. "It took us two days to go through all of our documents, and at the end we knew where we had holes in our policies and procedures."
With this information, they were able to add information to the SOPs or develop another checklist or reporting form, Schlenker adds.
Although Schlenker and Moore did not think to use the self-assessment tool early in the process, they say they now wish they had. "In hindsight, when we started writing SOPs, we should have referred to that self-assessment tool much sooner," Schlenker says. "We could have used the self-assessment tool to drive the writing of the SOPs."
The self-assessment tool explains the AAHRPP standards and the expectation for each standard.
"If we could have started with that as a reference, it probably would have made it easier to focus our SOPs and saved us a lot of time," Schlenker says.
• Conduct mock interviews. "I was given the list of possible questions that could be asked, including questions specifically to the institution officials, specific to research staff, and specific to IRB members," Moore says.
Moore gave the people who would be interviewed by accreditation surveyors an idea of what they would be asked, and then she reviewed answers and important information with them. As part of mock interviews, she asked them questions pertaining to their role at the institution.
"If they didn’t know the answer, they would ask for help," she says. "I would help guide them."
Moore also advised staff and others who would be interviewed to be honest with the surveyor about any issues they had with the IRB.
"I told them if they don’t feel comfortable telling me anything, then they can take it to that official," Moore says. "And they did: One of the suggestions from the surveyor’s interview with researchers caused a change in our policy."
WellSpan Health has two IRBs, one that specializes in cancer studies and one for medical-surgical studies, she notes.
"Historically, that’s how it’s been," Moore says. "Occasionally there has been a need or request to have a cancer study reviewed by the med-surg board and vice-versa."
But investigators told AAHRPP officials that they would like to go to any IRB at any time, Moore says.
So the institution made a policy change in July 2013 that permits any study to be submitted to either IRB. While the two IRBs still specialize, there can be a consultant available to assist if they review a study outside of their specialty area, she adds.
• Make lemonade out of problems that arise. Several obstacles arose as the IRB office prepared for accreditation. Research directors and other staff came and went. The office was downsized even as the workload, because of accreditation preparation, increased.
Then Schlenker, who had been preparing for accreditation for several years, broke her ankle and had surgery two weeks before the scheduled site visit.
"I was out of the office for three months, but was available by telephone, and I spoke with site visitors over the phone," Schlenker says. "I worked four hours a day from home; I made the changes AAHRPP requested while I was on medical leave, so we met their deadline."
Soon after Schlenker returned to the office in May 2013, AAHRPP reviewed the application. By the end of June, WellSpan Health received word that it had achieved full accreditation.
"They requested that we monitor or audit some of the changes we had made as a result of the site visits," Schlenker says. "We need to follow-up on those items for seven months, doing some audits, and writing reports."