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Town Meeting Showcases IRB Process

By Eddy Ball
November 2007

“We hope that what we present today,” Johnson-Thompson observed, “will convince you that we are really working for you.” She also encouraged investigators to suggest ways to improve further the approval process.
“We hope that what we present today,” Johnson-Thompson observed, “will convince you that we are really working for you.” She also encouraged investigators to suggest ways to improve further the approval process. (Photo courtesy of Steve McCaw)
With his extensive experience in clinical research, Zeldin understands how time-consuming the preliminary and IRB approval processes can be. “It can take weeks to months to get the initial buy-in for a study,” he said.
With his extensive experience in clinical research, Zeldin understands how time-consuming the preliminary and IRB approval processes can be. “It can take weeks to months to get the initial buy-in for a study,” he said. (Photo courtesy of Steve McCaw)
Packenham discussed the Stakeholder Committee’s “simplified” flow chart, which she distributed in the form of an eight-page handout.
Packenham discussed the Stakeholder Committee’s “simplified” flow chart, which she distributed in the form of an eight-page handout. (Photo courtesy of Steve McCaw)
A former high school teacher, Blackmon looks for language that can be understood by someone with a seventh-grade reading level by red-flagging acronyms, technical jargon and culturally insensitive phrasing.
A former high school teacher, Blackmon looks for language that can be understood by someone with a seventh-grade reading level by red-flagging acronyms, technical jargon and culturally insensitive phrasing. (Photo courtesy of Steve McCaw)
As a bioethicist, David Resnik, J.D., Ph.D., is an active member of the IRB Committee.
As a bioethicist, David Resnik, J.D., Ph.D., is an active member of the IRB Committee.(Photo courtesy of Steve McCaw)
Protocol Specialist Darlene Switalski works with IRB Administrator Jane Lambert in support of investigators negotiating the IRB process.
Protocol Specialist Darlene Switalski works with IRB Administrator Jane Lambert in support of investigators negotiating the IRB process. (Photo courtesy of Steve McCaw)

Scientists and other interested members of the NIEHS research community attended a Town Meeting in Rodbell Auditorium on October 1 to learn more about how to facilitate Institutional Review Board (IRB) approval of their research involving human subjects. Billed as “A Conversation between the Institutional Review Board and Clinical Investigators and Staff,” the meeting featured presentations by key players in the IRB process, including an overview of efforts to fully automate the process.

With ample time reserved for questions and concerns, the meeting provided a forum for the growing number of NIEHS researchers required to seek approval for their studies. Among the speakers was Joan Packenham, Ph.D., program director in the Office of the Scientific Director and key person for development of the electronic management system, who traced the IRB process step by step for the audience.

In his opening remarks, Acting Director Sam Wilson, M.D., noted that the meeting was one of the Institute’s responses to a “friendly audit” of the IRB in 2006, which recommended increased communication between the IRB and the NIEHS research community. He also underscored the importance of the IRB and the Board’s continuing efforts to make the process more efficient.

Acting Scientific Director Perry Blackshear, M.D., D.Phil., presented a short history of measures to protect human subjects of research following the introduction of congressionally mandated regulations in 1974. The regulations initially were of limited concern to researchers at NIEHS, which had only five “active protocols,” studies using humans and subject to approval, during the 1980s. At the current time, however, there are 49 active protocols, with even more anticipated as NIEHS begins research at its new Clinical Research Unit in 2008.

According to the meeting’s keynote speaker, Marian Johnson-Thompson, Ph.D., chair of the NIEHS Institutional Review Board, the purpose of the IRB is “to protect the rights and safeguard the welfare of human subjects.” Anyone working with human subjects and identifiable human specimens must seek IRB approval for a study before it can proceed — or obtain a formal waiver from the NIH Office of Human Subjects Research.

Johnson-Thompson outlined other measures NIEHS has taken in response to the 2006 audit, including the first-ever day-long IRB retreat and increased training for principal investigators. The IRB is developing its new Electronic Management System. In addition, Johnson-Thompson and Packenham have visited other NIH institutes and centers in search of ways to streamline the IRB process at NIEHS.

“We’ve also entered into discussions with intramural researchers about how the scientific review process could be enhanced,” she added. “We are working now to resolve issues on a new component in the process, the conflict of interest element.” Because consent form issues have been the leading reason for delays, “we want to develop a consent-form template… to prompt you to answer specific questions.”

Senior Investigator Darryl Zeldin, M.D., addressed the overarching concern of researchers in his presentation, “Investigator Perspective: Why Is It Taking So Long?” Zeldin opened by noting “that the IRB approval process, while a significant component…, is only one of many processes and approvals an investigator needs to go through in order to be successful.”

At any point in the process, an investigator may be required to revise the protocol and the many documents that are part of the study manual. In some cases, a study may also need approval by one or more external IRBs and, if contractors are involved, exemption from the Office of Management and Budget Review Board, in itself a nine- to twelve-month long process.

The meeting’s final presenter was Community Member Betty Blackmon, who discussed her role as a non-affiliated lay member of the IRB. Blackmon acts as a non-scientific gatekeeper and scrutinizes the wording used in protocols, consent forms, surveys and other documents for subjects. “I want to be sure… [the written material] fully explains the study, risks and other information that they may need to determine whether or not they want to be a volunteer.”


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