CPP Fall 2014 IRB Training Session
Version 10/7/14
eIRB Instructions
• To access the full eIRB instructions, please visit our website
http://www.csupomona.edu/~research/irb/index.shtml
• Click on the “Getting Started With a Protocol” tab.
• Click on “How to Create an eIRB Protocol.”
Communicating With Your Assigned Reviewer
Administrative Reviewer
• When communicating via email,
always include your protocol
number in the subject line and
only use one email threat.
• Be sure to address comments
made by the administrative
reviewer in full detail.
Designated IRB Reviewer (DIR)
• DIR appreciate clarity, detailed
information and grammar
among other things.
• It is always best to write your
protocol in a way that a person
outside of your discipline or
campus, can understand exactly
what your study is about.
*When revising your protocol according to the reviewers comments, please
indicate the changes in BOLD OR RED.
Viewing and Responding to Comments
1. Click on the “Review” option
from the protocol form.
2. This window will pop-up
and under each or some tabs
you will find comments made
by the admin reviewer of DIR.
Note: Make sure that you make the appropriate changes indicated my the
reviewers comments to your protocol in BOLD or Red.
3. To respond, simply click on
the comment and enter your
respond in the “Response”
box. To save your response
click “Respond.”
Approved Protocol
1. Email Notification:
The investigators will receive an email when
their protocol has been approved.
3. Finding the Approval Memo on the E-IRB
Portal:
Right click on the
paper clip
then on the drop
down menu select
edit attachment. Be
sure that the paper
clip you are selecting
is the file not the
document (file is the
pink bar).
This window will pop-up and from
here you can select the file
containing the approval memo to
be printed. The header should
say:
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Anonymity VS. Confidentiality: No study can be both!
However, to be technical, a study may include two different modes of data collection.
Anonymity
Confidentiality
• A “strictly anonymous” study design is one in
which it is impossible to trace data or information
back to the research subject from whom it was
obtained.
• “Confidential” research participation means that
the data from the research subject(s) can
potentially be identified or linked to a particular
individual.
• In other words, the data cannot be identified to
any particular research participant, not even by
the researcher. There is total separation.
• Any data collected face-to-face (consumer survey,
focus groups, standing in front of a classroom, etc.)
is automatically considered in the category of
being “confidential” as opposed to “anonymous.”
• No study design that involves the creation of a
code linking the subject’s identity to a pseudonym
or a number can be termed an anonymous study,
as the identity of the subject can be traced to the
data
• This is true even when the researcher assigns a
coding number to the subject—and this number
cannot be traced back to the subject—because the
researcher him/herself knows who provided the
data.
Thank you!
• Thank you for your patience and hard work!
• Please share suggestions for improving this training guide.
• The eIRB looks formidable at first, but it will make sense. Some of its best features are:
-Automatic notices when your protocol is approaching expiration.
- Accessibility on mobile devices.
- Real-time updates about the protocol state.
Once again, Thank you!
Version 10/7/14.
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