January 14, 2002

Dear Colleagues:

I am writing to bring you up to date regarding submission of new protocols to the institutional review boards (IRBs). Over the last several months, the chairs and members of the IRB’s have worked incredibly hard to review all previously approved protocols. Concurrently they, along with Chi Dang, Barbara Starklauf and Joanne Pollak, have developed standardized procedures for review of new protocols that are consistent with federal regulations regarding human subject research. We owe them all considerable thanks.

The JCCI on the East Baltimore campus and the IRB at Bayview will begin accepting new applications in the newly revised format as of January 14, 2002.

Important aspects of this new process are as follows:

• Commercially-funded and federally-funded applications, except gene therapy protocols, will be reviewed by Western Institutional Review Board (WIRB). NIH applications do not need to be reviewed until there is a high likelihood of funding, in which case the WIRB fee will be covered by Hopkins. Likewise, WIRB fees for commercial studies are paid for by Hopkins, which in turn charges the Hopkins IRB fee to the sponsor or study budget.
  
  
• All other submissions, including gene therapy protocols, will be reviewed by the JCCI or Bayview IRB. This category will include applications to disease-specific organizations and foundations which require IRB approval as part of the grant application process.
  
  
• Applications which were under review in July when the review of new protocols was put on hold, and which have been stored in the JCCI office, will be reviewed by the JCCI prior to beginning review of new submissions.
  
  
• The revised forms and detailed directions for submission of protocols will be available on the Web as of January 14. Old forms will not be accepted.

We recognize that there is substantial pent-up demand for review of new protocols and want to do our best to meet this demand. We also know that the members of the research community who have been most hurt by the moratorium on review of new proposals have been junior faculty and trainees who could not afford the fees. On the other hand, we need to avoid overburdening our committees and maintain flexibility as these new procedures are implemented and we prepare for the OHRP site visit in February. This triage system will provide this flexibility and serve the needs of junior investigators. We envision that, after we have honed our procedures over a period of months, we will broaden the type of applications that will be reviewed by the Hopkins and Bayview committees. We also envision that Hopkins will continue to have a collaborative relationship with WIRB over the long term.

I greatly appreciate everyone’s patience and collegiality during the last several months. It has been especially frustrating, I know, because the policies and procedures of the IRB’s have been a moving target as they have evolved. Although our methods will continue to change as we strive to do the best possible job in the most efficient way, we promise to do our best to keep you informed of such changes. Thank you again.

Michael J. Klag M.D., MPH
Vice Dean for Clinical Investigation
Johns Hopkins Medicine

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