Internal Review Board

David H. Strauss, M.D. Chairman

This is the first time the IRB has been included in PI’s Annual Report, and perhaps this local change mirrors the recent growth in prominence of human subjects protection on the national agenda. Clearly, we are all spending more time on IRB review. In response, the year 2001 witnessed important enhancements in IRB review mechanisms and a shift in our strategic plan. What remains unchanged is our central interest in the rights and welfare of those who participate in research studies and our commitment to a culture at PI which supports the ethical conduct of science.

The high quality of IRB review at PI is the result of the exceptional work of the scientists, non-scientists, clinicians, and community members who comprise the committee itself, and the skill and dedication of the PI-IRB’s administrative staff. The effectiveness of our IRB ultimately rests, of course, in the hands of the hundreds of investigators, project coordinators and research assistants at PI whose research—and this is not simply “compliance”—demonstrates the fact that the ethical conduct of research and excellence in clinical research go hand in hand.

In 2001, the IRB and the IRB staff faced an increased workload. This derives from increasing regulatory demands and expectations for IRB review, and from the increasing productivity of the community of investigators at PI.

In 2001, the IRB saw a 7% increase in new studies (and a 25% increase to date in 2002). Also in 2001, the number of approved modifications to existing studies increased by a dramatic 28% (to 785, or 65/month), perhaps in response to education, training and compliance monitoring. The number of continuation applications processed for review actually dropped 4% (to 626, or 52/month), a change which likely reflects our efforts this year to encourage investigators to close out of studies which are no longer active.

To keep apace of a trend toward increasing numbers of new studies and increasing expectations regarding content of review (especially continuing review), the IRB doubled the number of full board meetings to twice monthly, moved to a system of primary review for continuation applications, and significantly increased our contact with investigators and other members of the research team in order to enhance education and training.

At the subcommittee level, review and feedback to investigators has been enhanced, perhaps most easily appreciated by the increasing educational content of memos to investigators. To enhance review, we have assigned primary and secondary reviewers to each protocol and we are increasingly assigning complex minimal risk studies to subcommittee in lieu of alternative (often slower) approaches to expedited review. To pilot a novel hands-on educational approach, we have invited junior Faculty and Fellows to participate in IRB subcommittee meetings.

In 2001, the IRB began a collaboration with the Research Foundation Information Technology staff to enhance our database. We re-trained our staff and introduced a considerable number of efficiencies enabling us to manage the increasing work flow of amendments and continuing review applications. For example, the addition of database parameters to define and track study expiration dates now permits the automated creation of renewal reminder notices for investigators. In addition, the database generates a by-protocol list of all amendment approvals since the last continuing review cycle. This information is incorporated into the material distributed to board members for review at continuation.

The IRB created a Web site and posted a downloadable (and revisable) protocol summary and continuation forms, description of IRB review processes, guidance for investigators IRB review, the list of subcommittee and full board meeting dates, up-to-date consent form guidelines, and a guide to the informed consent process for subjects (http//:irb.nyspi.org).

E-mail now helps speed many aspects of the review process. Although all formal approval notices are all still prepared in hard copy, we write and edit our memos using GroupWise and e-mail them to investigators to reduce delay. This ultimately reduces time to approval, especially important for time sensitive sponsored studies and grants. A significant number of investigator queries concern the sequence and status of protocol review, and we have begun to facilitate access to this information through automation. IRBmail is now the preferred method of contacting the IRB for routine communications and the number of queries received documents the need for additional investigator support.

Going forward, we have identified three fundamental and related areas for improvement; technology and development, investigator support, and program evaluation. To preserve quality in the face of an increasing workload, we will increase IRB staffing and increase the efficiency of IRB review, in part by moving toward paperless systems. We can better educate investigators as to IRB expectations and requirements through use of web-based forms, guidance, and examples. With technology, the IRB can improve its abilities to measure and improve its performance.

The quality of review depends on the committee members, and we will work to maintain the diversity of background and expertise that is the central to fulfilling the IRB’s mission. By including senior scientists from each of the Institute’s clinical research divisions, we can promote practical IRB-related education of other scientists within each division and enhance discipline specific scientific education of the IRB itself. We hope to recruit new members from the community and additional members who represent patients and patient family groups.

Any rational institution-based research ethics review process must recognize that the increasing demands of human subject protection affect both the IRB office and the community of investigators whose work is reviewed. Effective and efficient IRB Review will directly and indirectly enhance human research protections and researcher productivity. The key to improved effectiveness in review involves a collaborative effort with investigators and enhanced methods of communicating compliance requirements, expectations as well as increased efficiency in protocol processing.