Expedited Review
Materials submitted for expedited review may be new studies, qualifying continuing reviews, revision requests that present no more than minor risk to participants (see below for further details). The administrator shall review all submitted materials to assure that they are in compliance with the applicable portions of He-M 206.00. If materials are not complete, the administrator will contact the PI to request the missing materials.
When an investigator is certain that their study meets the criteria for an expedited review, then the form is filled out and the items under "Expedited Review Submission Requirements" must be included. A completed Expedited Review Form must be completed, signed, and submitted. Rolling submissions of Expedited Reviews are acceptable and standard.
Submission Deadline: Expedited request can be submitted anytime for review.
Submission Requirements: For Expedited Review / Work Preparatory to Research / Research with PHI Only:
- Copy of either the Expedited Review Study Form (a.k.a. summary protocol) or The Dartmouth/NH CPHS Medical Record/Chart Review Form.
- Copy of any grant application or protocol for the same study submitted to the U. S. Department of Health and Human Services or FDA, if applicable.
- Copy of the investigator brochure(s), if applicable.
- Copy of the consent form or waiver of consent.
- Letters of support from all sites under jurisdiction of the NH CPHS.
- Copies of written materials used in the study and to which subjects might be exposed, such as assessment tools that are not standard, scripts, treatment manuals that are not standard, advertisements; Web-based postings, or handouts.
Sample Forms & Documents: All necessary documents with instructions can be downloaded from the www.irbnet.org in the "State of New Hampshire DHHS CPHS, Manchester, NH" Library.
Please note that studies that previously qualified for expedited review can change now require full board review.
For multi-center trials/studies:
- The criteria "no subjects have been enrolled" is recognized by OHRP to mean "no subjects have ever been enrolled at a particular site,"
- "No additional risks have been identified" is recognized by OHRP "to mean that neither the investigator nor the IRB at a particular site has identified any additional risks from any site or other relevant source."
When Can Expedited Review Procedures Be Used for Continuing Review?
If review of the study did not previously qualify for expedited review, then the rule of thumb is that continuing review will not, EXCEPT:
- "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 OR
- Where no subjects have been enrolled and no additional risks have been identified; OR
- Where the remaining research activities are limited to data analysis.
How do I determine if my review is suitable for a Full Committee Review or an Expedited Review?
The CPHS office will review all submissions and will determined whether or not a study is suitable for expedited review. See the outline above for submissions meeting criteria for an Expedited Review. Please see the above information for further details on what qualifies as an Expedited Review.