Now the real work begins: Maintaining accreditation
IRBs describe how they plan to stay accredited
Preparing for an accreditation site visit is difficult enough, but the hard work doesn’t end after an IRB receives a letter announcing that it has been fully accredited, according to the first IRBs to receive full accreditation from the Association for the Accreditation of Human Research Protection Programs Inc. (AAHRPP) of Washington, DC.
"I would advise others to be aware that the accreditation is an ongoing process and that resources are needed for the implementation of new policies and procedures, and for educating members of the organizations of these new policies," says Erin Thacker, MS, CIP, lead administrator for the New England Institutional Review Board (NEIRB) of Wellesley, MA.
The hard work also doesn’t end with the site visit. The four-day visit typically has an exit interview and is followed by a letter sent to the IRB in which AAHRPP details suggestions for improvements in the IRB’s processes and policies.
Following the New England IRB’s site visit, AAHRPP wrote the IRB, detailing recommendations and findings that had first been discussed during the exit interview, Thacker says.
"None of the changes requested by AAHRPP were unexpected, and the exit interview had prepped NEIRB to begin to develop strategies to comply with AAHRPP’s recommendations," she says.
One change, for example, was recommendation that NEIRB address the reporting of unanticipated problems that may occur during a clinical trial, Thacker recalls.
"In order to address this, NEIRB created a definition of an unanticipated problem and developed examples of what might constitute an unanticipated problem," she says. "SOPs were developed for the reporting, tracking, and handling of these reports."
IRB staff also notified investigators, staff, and members about the new reporting requirement, she adds.
"AAHRPP’s recommendations also included suggestions that resulted in further development of our policy regarding exculpatory language in the consent form and for monitoring the consent process," she says.
For instance, NEIRB staff further developed the policy about exculpatory language to provide examples of language that is considered exculpatory and, therefore, would not be allowed in a consent document, Thacker says.
"NEIRB’s policy regarding monitoring or witnessing of the consent process was further developed to address situations in which NEIRB may decide to witness the process and the mechanisms for conducting the observation, as well as any corrective actions that might need to occur," she reports.
After AAHRPP site visitors spent four days at the University of Iowa in Iowa City, reviewing IRB records and interviewing IRB staff and members, AAHRPP sent the institution an initial report to which the IRB staff could respond within 30 days, says Trish Wasek, CIP, director of the human subjects office.
"They went through all of the criteria in that report, and they made comments and wanted us to correct any factual errors," she says. "And if there were any recommended changes, we could respond with our plans for implementing those changes."
Any changes the IRB made within those 30 days would be included in AAHRPP’s consideration for the final determination on accreditation, Wasek says. "Nothing in the draft report was a surprise because we had a detailed exit interview in which the leader of the accreditation team went through, point by point, all of the standards with us."
All of the suggestions were minor items, such as suggestions for adding more questions about the consent process to the protocol application form, she notes. "We did make a change in the way we conduct our continuing review."
"We felt we had a very strong program going into this, so the suggestions were not a problem for us," Wasek adds.
Once an institution receives full accreditation, the IRB must submit an annual report for each of the three years that the accreditation is valid, and at the renewal time, the IRB must submit an updated version of the initial application to AAHRPP and schedule another site visit, Thacker says.
"The most important program that NEIRB has implemented in order to remain prepared for the next survey is an expanded internal quality assurance and quality improvement program," she adds.
The program enables NEIRB to continuously examine its policies and procedures, improve areas of weakness, and fine-tune any areas that need improvement, Thacker says.
"In addition, NEIRB’s educational program for staff and members has been expanded," Thacker adds.
For instance, staff members who are particularly knowledgeable in certain areas have been encouraged to develop inservice programs for the rest of the staff, Thacker explains.
"In order to be prepared for our annual report, NEIRB continuously tracks areas in which new policies are being implemented and records the implementation of the new policies," Thacker says. "This compilation will allow NEIRB to have a solid framework for the submission of our annual report, requiring less resources to be utilized at the time of the submission of the annual report."
Preparing for an accreditation site visit is difficult enough, but the hard work doesnt end after an IRB receives a letter announcing that it has been fully accredited, according to the first IRBs to receive full accreditation from the Association for the Accreditation of Human Research Protection Programs Inc. (AAHRPP) of Washington, DC.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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