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.
*minimal risk means that “the probability or magnitude of harm or discomfort
anticipated in the research are not greater in and of themselves than those
ordinarily encountered in daily life or during the performance of routine physical or
psychological examinations or tests.” (45 CFR 46.102(i))
Categories for Expedited Review
In order to qualify for Expedited review, your research must not pose greater than
minimal risk to subjects, and all research activities must fit into one or more of the
nine categories below:
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?C
FRPart=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?C
FRPart=812] or the medical device is cleared/approved for marketing and
the medical device is being used in accordance with its cleared/approved
labeling
2. Collection of blood samples by finger stick, heel stick, ear stick, or
venipuncture. Collection may not occur more frequently than 2 times per
week and must proceed as follows:
a. Up to 550 ml (roughly 1 pint) in an 8 week period for healthy, nonpregnant adults; or
b. No more than 50 ml or 3ml per kg body weight in an 8 week period
for other adults and children.
3. Prospective collection of biological samples for research purposes by
noninvasive means (e.g., hair and nail clippings, sweat, urine, saliva samples,
cheek cells collected via swab, etc.)
4. Collection of data through noninvasive clinical procedures, excluding
procedures involving ionizing radiation (e.g., x-rays and microwaves).
Medical devices used must be cleared/approved for marketing. Examples
include motion sensors, ECG, EEG, MRI, galvanic skin response, strength
testing, body composition assessment, and flexibility assessment.
5. Research involving materials (data, documents, records, or specimens) that
have or will be collected solely for non-research purposes (e.g., medical
records, educational records, etc.)
6. Collection of data from voice, video, digital, or image recordings made for
research purposes
7. Research on individual or group characteristics or behavior or research
employing survey, interview, oral history focus group, program evaluation,
human factors evaluation, or quality assurance methodologies
8. Continuing review of research previously approved by the Full Board if :
a. The research is permanently closed to enrollment, all subjects have
completed research-related interventions, and the research remains
active only for long-term follow-up of subjects; or
b. No subjects have been enrolled and no additional risks have been
identified; or
c. The remaining research activities are limited to data analysis
9. Continuing review of research not conducted under an IND or IDE where
categories 2 through 8 above do not apply, but the Full Board has determined
and documented at a convened meeting that the research involves no greater
than minimal risk and no additional risks have been identified.
Expedited Submission Processing
When submissions are received by the Office of Research Compliance, they are
reviewed for completeness and risk. If the application is incomplete or any
supplemental documents are missing, the Office of Research Compliance will contact
the Principal Investigator with the requirements for a complete application package.
Once the application package is complete, the research will be preliminarily
reviewed for risk. If the research is judged not greater than minimal risk, and it does
not qualify for Exempt review [LINK TO: UHSRC Exempt Review Procedures
document], it will be sent to one or two UHSRC members for review. The UHSRC
members have 2 weeks to complete their reviews. The UHSRC Chair or Vice-Chair
then conducts their own review, compiles all reviews, and sends correspondence to
the Principal Investigator. If the reviewers do not issue an approval, the
correspondence will detail revisions required in order to secure approval. The
Principal Investigator must respond to all revisions in order to secure approval. The
response to the revision request letter will be processed by the UHSRC Chair or
Vice-Chair within 2 to 4 days upon receipt.
Expedited Review Process
All research reviewed under Expedited procedures must be compliant with Federal
Regulations outlined in 45 CFR 46 (LINK TO:
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html]. The UHSRC
reviews the application in accordance with 45 CFR 46 and EMU policy to ensure
protection of human subjects in research. Principal Investigators may be asked to
revise or make changes to their application or supporting documents accordingly
prior to approval.
The following determinations can be made under Expedited review:

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.

Approval with Conditions: Before your study can be formally approved,
you need to make some minor clarifications or changes to your application
and supplemental documents. These revisions will be sent to you via email
from IRBNet. You must respond to each point in your revision request email
in order for your study to be approved. Once your study is formally
approved, you will receive a separate approval letter.

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.

Referral to Full-Board Review: This happens in two situations:
o The Expedited reviewers feel that the original risk judgment made by
the Office of Research Compliance is not correct, that the study is
riskier than otherwise believed, and that the risks involved merit
Full-Board review; or
o Following considerable correspondence back-and-forth between the
Principal Investigator and the UHSRC Chair or Vice-Chair, all human
subject protection issues cannot be resolved and Expedited approval
cannot be secured. This option is rarely employed and suggests that
the study will be disapproved during Full-Board review if the
Principal Investigator does not make major changes. Studies can only
be disapproved at Full-Board meetings.
Post-Approval
Once you receive your approval letter, you are all set to begin your research. Along
with your approval letter, you will receive stamped copies of your consent and
recruitment documents. You must use the stamped versions of these documents
and actual stamped copies whenever possible (e.g., in-person consent, posting
recruitment fliers, etc.).
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.