Accreditation requires teamwork and time
Give yourself a year to get ready
One of the keys to successful surveys is to spend time, sometimes as much as a year, preparing for the process. Here are some tips from IRB officials who have either been through the process or who have begun it, as well as from other experts, on how to best prepare for an accreditation survey:
• Conduct an internal review: IRBs and institutions should first conduct an extensive internal review, including a full description of the organization’s human research protection program, suggests Jeffrey Cooper, MD, MMM, deputy director of the Accreditation of Human Research Protection Programs (AAHRPP) of Washington, DC.
The New England Institutional Review Board of Wellesley, MA, in the summer of 2002 reviewed its standard operating procedures and conducted an internal operational evaluation in preparation for a fall survey, says Carol Saunders, RN, executive director of the IRB. Saunders also is the president and chief executive officer of the Center for Clinical Research Practice in Wellesley.
"We had just completed our yearly review and update to our SOPs [standard operating procedures] and felt that our policies and procedures were congruent with our daily operations and effectively applied the federal and state regulations and guidance," Saunders says.
In preparation for an AAHRPP survey, the University of South Dakota IRB in Vermillion decided to revamp its policies and procedures, beginning with the SOPs, says Lisa Korcuska, CCRC, CCRP, IRB accreditation and human subject education officer.
"We started to write them and then we found out that there is software out there where you can buy SOPs and tweak them for your IRB," she adds.
The IRB decided to use the SOPs developed by the Center for Clinical Research Practice, Korcuska says. A sample is available at www.ccrp.com.
CCRP’s standard operating procedures have been validated and proven in compliance with regulations through a number of Food and Drug Administration, sponsor, and internal audits, Saunders says.
"Without well-written and implemented SOPs that are regularly reviewed and updated, a program cannot function optimally and will be ill-prepared for the rigors of accreditation review and inspection," Saunders says.
• Study accreditation organization’s standards: The New England IRB carefully reviewed the AAHRPP’s standards and program elements outlined in the application, Saunders says.
"We established a writing committee that prepared the documents and highlighted any perceived deficiencies," Saunders says. "SOPs were expanded upon or written to document those activities being conducted but not necessarily incorporated into the SOP document."
It took three staff members about two months to complete the 900-page application, including a program description assessment with documentation and SOPs, Saunders says.
The application process also required:
— a quality assurance program that focuses on self-evaluation and ongoing improvement;
— education and training for members, staff, and investigators;
— participant outreach.
"During the process, we had biweekly meetings," Saunders adds.
Once the IRB had completed the application, a regulatory affairs consultant was hired to review the application for accuracy and consistency, Saunders says.
The IRB at McGuire Veteran’s Hospital in Richmond, VA, worked closely with the National Committee for Quality Assurance (NCQA) to obtain information, says Alison Faulk, IRB coordinator.
"We had time to prepare, but there was additional information needed almost daily," she says.
• On-site survey: The New England IRB had four months after submitting the accreditation application to prepare for the site visit, Saunders says.
"Any initial clarification/revisions requested by the reviewer were submitted and discussed prior to the scheduled site visit," she adds.
As a final survey preparation step, the IRB carefully reviewed the site visitor evaluation tool, identifying those documents that site inspectors need to validate the program, Saunders says.
"The goal is for the site visit team to have a clear sense of the IRB’s mission and operations," she adds.
AAHRPP has a team of experts to review a site’s self-assessment materials before scheduling an on-site visit, Cooper says. Surveyors will evaluate a program’s performance with respect to AAHRPP’s accreditation standards, he adds.
McGuire Veteran’s Hospital’s NCQA survey involved fewer questions than what Faulk expected after having undergone an FDA audit.
"If NCQA couldn’t find something, they didn’t ask for it. They just marked a zero," she says.
But Faulk says she’s been told that future surveys will be more user-friendly and less of a "gotcha" approach.
Although the University of South Dakota IRB has not yet had its survey, the IRB is preparing for questions from AAHRPP surveyors regarding protocol applications Korcuska says.
For instance, if the surveyor was to ask what would happen if a particular protocol is not complete when it’s received by the IRB, she can point to the IRB’s new SOPs, which state that once a protocol application is submitted, it’s reviewed for completeness. And if it is not complete, then it’s sent back to the investigator. If it is complete, it is submitted for IRB review, she explains.
• Council review: After surveyors submit their reports to the accreditation organization, the next step is for a council, such as AAHRPP’s Council on Accreditation, to review the report, deliberate on the team’s finding, and determine the organization’s accreditation status, Cooper says.
One of the keys to successful surveys is to spend time, sometimes as much as a year, preparing for the process. Here are some tips from IRB officials who have either been through the process or who have begun it, as well as from other experts, on how to best prepare for an accreditation survey.
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