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Change in Consent Form Expiration Dates

December 11, 2008

Dear Colleagues,

Beginning Jan. 1, 2009, the JHM IRB will issue consent documents that will include an approval date. The consent document will not have an expiration date. The approval for the consent document will last the life of the study, or until it is amended—whichever comes first.

It will be the responsibility of the principal investigator and the research study team to monitor the expiration date of the study for continuing review purposes. It will also be the responsibility of the principal investigator and the research study team to ensure that no participant is enrolled if the expiration date for the study’s JHM IRB continuing review has been exceeded.

Below is an explanation of this policy for new, amended and continuing review research studies.

New Research Study: The JHM IRB will issue the consent document with the initial approval date.  This consent document will be for the life of the study or until it is amended.

Change in Research with a revised consent document: The JHM IRB will issue a consent document with a Change in Research approval date. This approval date will last the life of the study, or until there is a further amendment with consent document revisions.

Continuing Review with no changes to consent document: Until such time that all consent documents are issued without an expiration date, the JHM IRB will continue to issue a consent document with the approval date of the continuing review. The document will not have an expiration date and no further consent document will be issued for the study, unless it is amended.

For questions please contact the Office of Human Subjects Research at 410-955-3008 or jhmirb@jhmi.edu.

Sincerely,

Daniel E. Ford, M.D., M.P.H.
Vice Dean for Clinical Investigation