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Expired Protocols and Consent Forms in Human Subject Research

December 2003

It is the Principal Investigator's responsibility to make certain that valid, approved consent forms are used in every research protocol, and that research protocols are submitted for IRB continuing review on a timely basis.

It is the Principal Investigator's responsibility to submit to the Institutional Review Board (IRB) a continuing review application for active protocols. This application should be in the JHM-IRB Office six weeks prior to expiration of the protocol, regardless of whether or not a renewal reminder letter was mailed by the IRB.

Enrollment of new participants may not occur once the consent form has expired.

No new participants may be enrolled once the consent form has expired. After approval has lapsed data collection from participants already enrolled can continue only if the IRB has explicitly notified the Principal Investigator that the continuing review application for the protocol is under review. If the Principal Investigator feels that it is in the best interest of study participants for data collection to proceed, they must request permission to do so from the IRB.

As of November 1, 2002, data obtained from new enrollments and/or from participants already enrolled during a period of time when approval had lapsed and an expired consent form was used to enroll subjects may not be published or used in the data analysis phase of a project. As always, such lapses must be reported to the IRB.