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February 12, 2002

Dear Colleagues,

I am writing to inform you that a new consent form template has been posted on the IRB Web site. The upcoming implementation of the HIPAA privacy regulations will require use of specific patient authorization to release identifiable data as part of research projects. In hopes of minimizing the burden on research participants and investigators, we have decided to add the HIPAA privacy authorization language to the informed consent documents that are reviewed by the IRBs. In addition to incorporating HIPAA language, we took this opportunity to revise the consent document format extensively to improve its readability for participants. The new format includes required paragraph headings and required institutional language.

Effective March 1, 2003, new submissions to the IRBs, protocol amendments that require changes in the consent form, and continuing review applications must include a consent form developed with the new template. The new Combined Informed Consent/Authorization Template and Fill-In Form, (HIPAA IRB Form 2) and instructions may be found at the IRB Web site at http://www.hopkinsmedicine.org/irb/jhmirb/. We are developing training sessions on use of the consent form template and will send out an announcement when the sessions are available.

For existing studies, there is no need to revise the existing consent form using the new template. Protocols with an already approved consent form may use a separate HIPAA privacy authorization form (HIPAA IRB Form 1: Authorization for Use and Disclosure of Health Information for Research), available at the JHM IRB Web site at http://www.hopkinsmedicine.org/irb/jhmirb/.

If you plan to request a waiver of consent/authorization for research, use HIPAA IRB Form 4: Application for Privacy Waiver of Authorization for Research Protocol. It also may be found at the JHM IRB web site at http://www.hopkinsmedicine.org/irb/jhmirb/.

Please send questions regarding the new format and template to the IRB e-mail addresses at ohsceb@jhmi.edu or ohscbay@jhmi.edu. Questions regarding HIPAA requirements should be sent to the Central HIPAA Office at HIPAA@jhmi.edu.

Thank you for your help and cooperation in implementing this change.

Sincerely,

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

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