February 15, 2002

Dear Colleagues:

The Hopkins JCCI’s and the Bayview IRB’s, especially Barbara Starklauf and her staff, have been working hard to improve both the review process and the quality of service that we deliver to faculty. Here is a brief summary of what is happening:

New filing system - We are in the process of evaluating new methods of organizing and storing files. The new method, once in place, will be more space efficient and will help to prevent loss and misfiling.

Improved information technology - Working with Mike Amey and Barbara Starklauf, an outside consultant has improved the efficiency and usability of the IRB’s data system. This improvement has allowed us to find material that was previously not easily located. We will also be developing a new information system to track paper that better integrates with the filing system.

Web based data access - We are developing a system to allow PI’s access, through the intranet, to the IRBs’ database. This program will allow the PI’s to review where their protocols are in the review process. It will be very similar to web sites that many journals have regarding manuscript review.

More staff - We are implementing the plan developed by Chi Dang, with the strong support of Ed Miller, to improve staff support for the IRB process. Beth Moran started this week as the assistant IRB administrator. In addition, two associate IRB managers have come on board (Barbara Scherer for JCCI 2 and JCCI 3 and Ellen Taylor for JCCI 1 and JCCI 4). A search is underway to fill the parallel position at Bayview.

Increased staff efficiency - We are evaluating how paper flows within the IRB offices and are working with the IRB chairs to assess whether an electronic paperless system is feasible.

We appreciate your patience and understanding as we work to improve the infrastructure for review of research. Feel free to contact Barbara Starklauf or me with comments or concerns.

Sincerely,

Michael J. Klag, M.D., M.P.H.

Vice Dean for Clinical Investigation

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