How to write response after AAHRPP visits

Improve accreditation process

When a human research protection office seeking accreditation finally has the site visit, the hard work that went into the process is not over. Now it's time to prepare the best possible response to the draft site visit report.

"This process is very institution-dependent," says Moira A. Keane, MA, CIP, executive director in the human research protection program at the University of Minnesota of Minneapolis-St. Paul, MN. Keane also is the chair of the Council for Accreditation for the Association for the Accreditation of Human Research Protection Programs (AAHRPP) of Washington, DC.

After AAHRPP visits a site, the accreditation organization sends the site a draft report that describes the findings. Each human research protection program has the opportunity to respond to this report. Sites will want to make this response as comprehensive and thorough as they can, as it is an opportunity to show commitment to making the necessary system changes.

"There are a couple of different kinds of reports that AAHRPP counsel would expect institutions to provide after a site visit," Keane says. "The organization has an opportunity to provide a response or make changes in the program or correct an error in the draft report. The report is not final until the organization has an opportunity to respond."

The response to the site visit report is due within 30 days of the receipt of the draft report. AAHRPP does not dictate who writes the response or how it's prepared.

"There's not a single right way to prepare the response," Keane says. "Some have office staff preparing responses; others have senior leadership or IRB chairs preparing responses. AAHRPP is very flexible and neutral on who prepares the responses."

However, human research protection programs should keep in mind that it's both their response and AAHRPP's draft report that go to the AAHRPP council for consideration of the organization's accreditation status.

"So it's important in the response for the organization to demonstrate it has made changes and to show documentation of those changes, whether this includes a revised policy or documentation of monitoring that has occurred," Keane says. "It's important to be as precise or detailed as possible so the organization can demonstrate that they meet the standard."

AAHRPP also might ask a research organization to provide additional follow-up in the form of a status report. This report would describe the organization's efforts to monitor a specific situation and include examples of how the organization and staff have implemented the changes. The AAHRPP council reviews the status report and will accept it when it is adequate.

"The status report is a demonstration that the initiative we took immediately following the site visit actually took hold, and that it's enduring," Keane explains.

Keane offers these additional tips on how to write a great response to a draft site visit report that details some common types of findings:

Draft report says researchers were unfamiliar with certain requirements: "The organization might respond by providing an intervention for researchers and indicating dates on which it occurred," Keane suggests.

"Provide copies of the syllabus, materials for the intervention, and indicate who attended," she adds. "For example, it might say that 20 researchers of social-behavioral sciences attended the session on Nov. 28, and then you show materials so AAHRPP can be confident the organization has met the standard."

It's also a good idea to indicate there will be continuing monitoring, so if researchers were unfamiliar with what they were expected to report to the IRB, then the organization might do some spot-checking on the reports to ensure researchers are increasing the number of reports or making the proper kind of reports, Keane says.

"The idea is to take quality assurance steps and do some kind of intervention to measure what the deficiency is, and then to do quality improvement to intervene and to demonstrate that change has occurred," she explains.

Contracts with sponsors lack required language: "In our institution at our last site visit, we had some contracts with sponsors that apparently did not contain all the required language to meet the standards," Keane says.

The institution took several steps to correct this deficiency.

"First, we had an educational session with the staff that process contracts at the university," she says. "Then we had an educational session with the research coordinators who are often the first point of contact for a sponsor to ensure they know what we expect to see in contracts."

Then, they worked with contract staff to develop additional checklists they could use to make certain human protection standards were present in their current contracts, Keane adds.

"And we developed a process for communicating with sponsors if the sponsor is unwilling to put in some of the required language in the contract or if the contract language deviates from what we expect to see," Keane says. "We had a consultation with the contract staff about what the IRB would expect to see."

The final step is declining the study if the sponsor refuses to include the language the IRB expects to see, she adds.

The response to the draft report talked about the educational interventions and indicated when those sessions occurred and who attended, Keane says.

"We provided documentation on the materials, and we provided copies of revised policies and checklists for the contract staff," she adds. "We described the procedure for the consultation when there's a deviation."

The final and most critical piece was that they provided copies of very recent contracts that included all of the required language.

"This was so we could demonstrate the education and policies and procedure revisions that actually have taken effect," Keane says.

Some people find it challenging to demonstrate with documentation, Keane says.

"In our example with contracts, if we just said we did training and education and didn't document when this occurred, then we would have started to satisfy the requirements, but they'd need to see the whole picture to make sure the standard was met," she explains. "Provide details, such as dates training occurred, documentation in the form of a syllabus or slides that show there is some substance to the training."

AAHRPP is flexible on how organizations conduct the education and training, but the accreditation organization wants research sites to demonstrate that training took effect and changed behavior, she adds.

"So we had to do some kind of exercise in terms of monitoring the contracts to make sure the contract staff was negotiating for that information from the sponsor," Keane says.