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110.1 Organization Policy on Expedited Review of Proposed Research

November 2010

It is the policy of the Organization that any IRB designated to conduct review of research may use an expedited review process.  An expedited review process may be used only in accord with DHHS and FDA regulations; therefore, only research that meets the regulatory definition of research involving no more than minimal risk, meets all applicability criteria in the document “Categories Of Research That May Be Reviewed By The Institutional Review Board (IRB) Through An Expedited Review Procedure” published by DHHS and FDA in the Federal Register and that involves procedures that are listed in one or more of the categories in this document are eligible for an expedited review process.  An expedited review process may be conducted for initial new applications, continuing review applications, or proposed minor changes in previously approved research.  OHSR shall provide examples to researchers and IRB members regarding proposed changes in research that would qualify as a minor change eligible for expedited review.  (See Guidance: “Changes in Research”).

An expedited review may be conducted by any member on the designated IRB reviewer list, with the exception of research involving a drug, biologic, or CAM, which must be reviewed by the P&T member.  Members will be added to the designated member list when the IRB Chair determines the member has sufficient experience and training to conduct such reviews.  See Organization Policy No. 107.3. “Training and Evaluation of IRB Members and Chairs.” The Organization grants the primary reviewer conducting the expedited review process the authority to take action on a protocol is accord with Policy 109.5.  A primary reviewer conducting an expedited review is not authorized to disapprove an application per Policy No. 109.6(a).  New applications, continuing review applications, or proposed changes in already approved research that a reviewer finds at expedited review may not be approvable must be referred for discussion at a convened meeting. 

Research approved initially through a convened process may reach a stage which qualifies for an expedited review process.  This may occur when any of the following are true:

  • A reviewer using the expedited procedure determines that the research is permanently closed to the enrollment of new subjects, all subjects have completed all research-related interventions; and the research remains active only for long-term follow-up of subjects. Such determinations of the review will be documented on the expedited review form;
  • A reviewer using the expedited procedure determines that the remaining research activities are limited to data analysis. Such determinations of the review will be documented on the expedited review form;
  • The convened IRB determines that the research involves no greater than minimal risk and no additional risks have been identified. Such determinations of the IRB will be documented in meeting minutes.

A list of all actions taken through an expedited review process will be provided to the IRB at a convened meeting.  Any member of the IRB may request re-review of research approved using an expedited process.  If such a request is made, the project will be scheduled for convened meeting discussion.


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