August 2010

The Organization requires use of valid, approved consent forms in every research protocol for which the IRB determines that documented informed consent is required.  The Organization requires IRB review of research protocols, including 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.

I. JHM IRB approval expires after the continuing review application is    submitted to the JHM IRB, but before committee review.

OHRP and FDA place specific limitations on the conduct of research studies that have been submitted for IRB continuing review, but for which IRB approval expires during the review process.  In general, no research activity may occur until the IRB approves the continuing review application. It is the policy of the Organization that new enrollment must stop when IRB approval expires.  The IRB, however, may take an action permitting continuation of study activity with enrolled participants under certain limited circumstances. 

• OHRP “Guidance on Continuing Review” dated July, 2002: study activity may continue for a brief time if it is in the “best interest” of the study participants.
• FDA’s “Guidance for Institutional Review Boards and Clinical Investigators – 1998 Update” is slightly different, but expresses the same concept: if the investigator is actively pursuing renewal with the IRB and the IRB believes that an over-riding safety concern or ethical issue is involved, the Organization allows the IRB to permit the study to continue for the brief time required to complete the review process.

A.    The PI will be notified by the JHM IRB if it determines that the study activity with enrolled participants may continue once approval has expired, and the length of time the activity may continue.

B.     If JHM IRB approval of a study will expire after the continuing review application is submitted, but before the continuing review application will be discussed at a convened or expedited meeting, an IRB Chair may determine whether continued study activity is allowed.  The PI will be notified of the IRB’s decision. 

II.  JHM IRB approval expires before submission of a continuing review application to the JHM IRB.

A.    The study must terminate.  No study activity may occur after the expiration date.  The Organization does not grant to the IRB the authority to “extend” the approval period for a protocol, nor may it provide a “grace” period.  All activity for which JHM IRB approval expires before submission of a continuing renewal application must stop.

B.     A new research application must be submitted. A continuing review application will not be accepted once approval has expired. Submission of a new application is required to obtain JHM IRB approval.

C.     Limitations on use of data obtained through expired consent forms.  The Organization policy is that use of an expired consent form is a protocol violation.  If an expired consent form is used to enroll a new participant, the Organization requires notification to the IRB.  The Organization grants authority to the IRB to determine whether data obtained from new enrollments when an expired consent form was used may or may not be published or used in the data analysis phase of a project.