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UHSRC Expedited Review Procedures
UHSRC Expedited Review Procedures
Introduction
Not all human subject research subject to Federal Regulation 45 CFR 46 requires
review at a UHSRC meeting. Research deemed not greater than minimal risk* and
that falls into at least one of nine categories can undergo Expedited review.
Expedited review does not necessarily mean “quick,” but rather the UHSRC burden
is alleviated in that the entire committee is not required to review the study.
Expedited reviews are conducted by one or two UHSRC members in lieu of the
entire committee. Expedited reviews also are conducted on an ongoing basis and
not at monthly meetings. As such, there is no submission deadline for Expedited
review. Turn-around time for Expedited research, from initial submission to
approval letter generally takes 3 to 4 weeks.
1. Clinical studies of drugs and medical devices only when the drug research
does not require an Investigational New Drug (IND) application [LINK TO:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?
CFRPart=312] and the medical device research does not require an
Investigational Device Exemption (IDE) application [LINK TO:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?
CFRPart=812] or the medical device is cleared/approved for marketing and
the medical device is being used in accordance with its cleared/approved
labeling
6. Collection of data from voice, video, digital, or image recordings made for
research purposes
Approval: Your study has been approved as-is, and you can begin your
research. Your research must be conducted exactly according to the
approved application and supplemental materials. Any subsequent changes
must be submitted to the UHSRC and approved prior to implementation.
Deferral: Your study cannot be approved as-is and requires some major
revisions or clarifications. You will receive a list of clarifications in a deferral
letter from IRBNet and must revise and resubmit your application and
supplemental materials accordingly.
Continuing Review: Your UHSRC approval will last for 365 days unless otherwise
indicated. Your study expiration date will be printed on the letter. If you plan to
continue your research beyond 365 days, you must submit a Continuing Review
Application in IRBNet 2 to 4 weeks before your expiration date to allow for timely
processing. If your study approval expires without renewal, you must cease and
desist all human subject research activities. It is against Federal Regulation 45
CFR 46 to conduct human subject research without valid UHSRC approval.
Expedited Continuing Reviews are typically approved within one week from the
submission date.
Changes to Approved Research: If you plan to make any changes to your study
during the course of your approval period, you must submit a Modification Request
Form and all relevant supplemental materials detailing these changes and obtain
UHSRC approval prior to implementation. Any changes made to already-approved
documents must be highlighted or tracked using Track Changes mode in Word.
Expedited Modification Requests are typically approved within one week from the
submission date.
If you have any questions about Expedited review, contact the Office of
Research Compliance at research.compliance@emich.edu or 734-487-3090.