v. Expedited Review

Federal regulations recognize certain kinds of research that may be reviewed and approved by an IRB Chair (or designee) rather than by the full board.  Expedited review does not mean that the review occurs more quickly than full board review.

The expedited review procedure cannot be used for projects where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless the investigator has documented that reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

The IRB Chair or designee is responsible for determining whether the research meets the expedited criteria, based on review and approval of the investigator's application to the IRB.  However, it is at the IRB Chair’s or designee’s discretion to require full board review, even when the project appears to meet the criteria for expedited review.

A listing of all protocols that have been reviewed and approved through the expedited process or determined to be exempt is e-mailed to all University of Iowa IRB members on a monthly basis.  These reports include initial reviews, continuing reviews and reviews of modifications to previously approved research.

When an application is submitted to the IRB, the application undergoes an initial administrative pre-screening process to ensure that the application is complete.  Once the application is complete, the staff member who conducts administrative pre-screen sends the application to the appropriate person based on a pre-defined path of review and list of reviewers that includes IRB Chairs and Chair-designees for expedited review and application analysts to prepare for full board review.

The expedited review process may be used for the initial review of projects involving no more than minimal risk, and only those procedures listed in one or more of the following categories.  The activities listed are not deemed to be of minimal risk simply because they are included on the list.  Inclusion on the list means that the activity is eligible for expedited review when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.  If the research project as a whole involves more than minimal risk, it is reviewed by the full board, even if the activities are limited to those listed.

Modifications to previously approved research projects may be expedited if the modification involves only a minor modification to the approved project during the (one year or less) period of approval.

The continuing review of research may be expedited in certain instances as designated by federal regulations:

1. If the project was previously reviewed and approved using the expedited procedure and conditions have not changed such that the research would no longer be eligible for expedited review (e.g. protocol change or experience shows the research to be of greater than minimal risk).
2. If continuing review of the research was  previously approved by the convened IRB and conditions have changed to make the research eligible for expedited review (e.g. research is within those categories and experience confirms the research to be of no greater than minimal risk)
3. If continuing review of the research was previously approved by the convened IRB and the research is permanently closed to the enrollment of new subjects, and all subjects have completed all research-related interventions, and the research remains active only for long-term follow-up of subjects; or
4. no subjects have been enrolled and no additional risks have been identified; or
5. the remaining research activities are limited to data analysis.
6. If continuing review of the research was previously approved by the convened IRB and
7. the research is not conducted under an investigational new drug application or an investigational device exemption, and
8. the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk, and
9. no additional risks have been identified since IRB review at a convened meeting.

The expedited review procedure is not used for the continuing review of research where the research involves more than minimal risk except as described above.

Studies involving prisoners may not be reviewed under expedited procedures regardless of whether they meet the criteria above except for (1) new studies limited in scope to retrospective review of prisoners’ records and (2) minor modifications to already approved research.  In the case of these exceptions, approval of the research can only be granted after review of and comment on the protocol by the prisoner advocate member of the IRB.