June 11, 2004

Dear Colleagues:

I am writing to inform you of changes in triage of human subject protocols to WIRB, effective July 1, 2004. As of that date:

• All new federally-funded protocols (whether multicenter or single center) will be reviewed by JHM IRB. As you know, such protocols should be submitted to the IRB when the Principal Investigator has received notification that funding is likely, not before.

• Commercially-funded protocols will continue to be reviewed by WIRB. There are important exceptions to review of commercially-funded protocols by WIRB:

• Protocols that involve gene therapy or for which there is review by the Conflict of Interest Committee will be reviewed by JHM IRB.
  
• Investigator-initiated studies in which the protocol is written by the investigator and the company does not accept responsibility for the protocol will be reviewed by JHM IRB.
  
• Commercially-funded protocols that the investigator believes qualify for an expedited review or waiver of consent may be submitted to the JHM IRB, if the investigator wishes to do so. The investigator should include a cover letter listing the criteria that he/she believes support use of an expedited review process. For guidance see the IRB Web site (http://irb.jhmi.edu/Guidelines/expeditedreview.html). Regardless of which IRB reviews the application, sole-sponsor commercially-funded studies receiving cash support in excess of $10,000. will be charged an IRB review fee. Please see http://irb.jhmi.edu/GeneralInformation/westirb.html for a list of the IRB review fees.

These new procedures apply only to newly submitted protocols. WIRB will conduct continuing review of protocols originally reviewed by WIRB. Our ability to review more protocols at the JHM IRBs reflects the substantial improvement in our processes over the last year. This improvement is due to the hard work of Judith Carrithers, the Director of the Office of Human Subjects Research, and Barbara Starklauf, the Assistant Dean for Human Subjects Research Compliance, and their staff. Please let them know (phone 410-955-3008; e-mail ohsceb@jhmi.edu) if you have any comments or questions.

Sincerely,

Michael J. Klag, M.D., M.P.H.
Vice Dean for Clinical Investigation