Instructions for Primary and Secondary Reviewers
Completing Expedited Reviews
All expedited review of IRB protocols are to be completed in accordance with the provisions
of 45CFR46.110. In order for a protocol to be reviewed under an expedited procedure, it
must present no more than minimal risk to subjects.
A primary and secondary reviewer system will be used for the expedited review process.
After an initial administrative review has been completed by the Research Compliance
Coordinator, the IRB Chair will assign a primary and secondary reviewer to each protocol
undergoing an expedited review procedure based on the topic of the research and the subject
matter expertise of board members, experience level, and a determination that there is no
conflict of interest present.
Once assigned, the protocol should be reviewed within five working days. As part of the
review process, each reviewer should use the following checklists as a guide in determining
whether to approve a protocol: Criteria for IRB Approval of Research, Expedited Review
Checklist, Informed Consent Checklist. If an investigator is requesting a Waiver of Informed
Consent or a Waiver of Documentation of Informed Consent, then the protocol is to be
referred to the full board for review. If, during the conduct of the review, it is determined
that a protocol presents more than minimal risk to subjects, it must be referred to the full
board for review.
Once checklists have been completed, they are to be uploaded into IRBNet. Be sure to enter
review comments on both the checklists and into the comments section of IRBNet. Select the
appropriate protocol status (i.e. approved, request for information, modifications required,
etc) and mark your review complete (even if information is requested or modifications are
required). Conditional approvals are not used for the expedited review process.
Special Note for Continuing Reviews completed using an expedited review procedure:
Continuing review is designed to ensure that risks to subjects continue to be minimized and
that research is being conducted in accordance with IRB approval of the initial protocol and
any subsequently approved modifications. Therefore, when a protocol undergoes continuing
review, the following statement is to be included in the comments section of the review checklist:
“This protocol was evaluated to ensure risks to subjects continue to be minimized and remain
reasonable in relation to any anticipated benefits and the knowledge expected to result. The
information provided by the investigator is consistent with the research protocol.”
Suffolk University Instructions for Primary and Secondary Reviewers Completing Expedited Reviews
Version 6.18.13
If information or modifications are required, the IRB Chair will consolidate the comments
from any administrative reviews with those of both primary and secondary reviewers, and
send a project email to the investigator requesting information and/or modifications.
When a response is received from the investigator, the primary and secondary reviewer
should review again to ensure all issues noted in their respective reviews have been
adequately addressed. At this time, reviewers can revise their comments entered into IRB
Net and if the investigator has sufficiently responded to concerns, mark the protocol as
approved.
The primary reviewer must send a project email through IRB Net to the Research
Compliance Coordinator and copy the IRB Chair and Administrative Assistant with the
following review information for the minutes: the protocol IRBNet ID, the title of the
protocol, type of review (i.e. new, continuing review, modification, etc), the category under
which the expedited review was approved (list all that may apply), and a brief summary of
the protocol. The format and content example of what the project email should include is
provided below:
IRBNet ID – Title of Protocol – Type of Review (i.e. New) – Approved under category (determine
category of review) of the expedited review process by Name of Primary Reviewer and Name of
Secondary Reviewer
Submitted by: Investigator Name
Protocol Summary: (e.g.) This study consists of a household survey which includes
demographic and consumption data to determine the impact of participation in the
microcredit organization Zidisha. Zidisha is an online peer-to-peer micro-lender that offers
loans in various African countries, the majority of lending occurs in Kenya. Individuals
voluntarily apply for Zidisha loans through its website to improve their small businesses.
Human Subjects include both borrowers and non-borrowers of Zidisha to compare the
impact of Zidisha borrowing on the economic, nutritional, and self-reported “happiness”
levels of those surveyed. Four-hundred to 800 participants aged 20+ will be recruited in
person. Participants will be interviewed about their satisfaction regarding particular types
of loans. The data will be used for program evaluation, as well as an assessment of microloans as opposed to other types of loans. This is a minimal risk study that involves no
deception. Request for a waiver of consent is appropriate due to cultural sensitivities
involved.
This information will be entered by ORSP into the comments section of IRB Net for what will
appear in the minutes.
Suffolk University Instructions for Primary and Secondary Reviewers Completing Expedited Reviews
Version 6.18.13
ORSP will complete and upload all protocol approval letters and make assignments to the
IRB Meeting agenda. Please note: protocols cannot be assigned to a meeting agenda until the
primary reviewer sends a project email through IRBNet with his or her protocol summary to
ORSP for upload into the minutes.
Suffolk University Instructions for Primary and Secondary Reviewers Completing Expedited Reviews
Version 6.18.13