Transcript Hints for BRAAN II - West Virginia University

Hints for BRAAN II
Things we learned during the year!
Creating a protocol
1. You must have a Master ID for the PI and Coinvestigators.
Call 304-293-4444 X1 or email at www.
[email protected]
Fill in all boxes
Those items marked in red on side must be
addressed in all protocols and all boxes filled in.
Depending on your protocol, some items in blue
must also be filled in.
Note red type will not go away or turn into blue.
Save
Save work often. Most places have a “Save
Warning”. If you save, you can come back.
Verify
Verify button on top left must be used prior to
submission. It tells you if all required boxes
have been filled in (and if not, which ones need
attention).
Be sure and “verify” after completion of second
item in red “human subject research”.
Always “Save” before “Verify”
Close
After verifying, must click on “close” (located
immediately below “verify”).
Sometimes it is necessary to click on “close” an
additional time in order to get back to IRB
protocol page.
Adding name of PI
Type first two letters of last name of principal
investigator (and members of research team in a
later page) and click on “Search”. The name of
all persons “in the system” should show up.
Choose the correct one and full name, email
address, and other information should appear. If
not, go back and make sure you have a Master
ID.
Add department
First, indicate degree of PI (remember, all boxes
must be filled in).
Next go to colleges and departments. If there is
a + to the left of the college, click on plus.
Departments within the college should be
indicated. Put a mark on the appropriate
department. There can be only one location with
a mark!
Human subject research
There are three questions. All three must be
marked “yes” for your protocol to be considered
human subject research by BRAAN II.
Note there are “help” buttons for information.
Private information (3d question) does not refer
to PHI. There’s a separate place for
protected health information.
Next
At the point that you have the PI, any members
of the research team, and have answered the
questions about human subject research, be
sure to Save, Verify, Close, Close again. This
should cause a whole series of items to appear
along the left side of the form.
Exempt research
Much research (surveys, chart reviews,
questionnaires, interviews), is considered
exempt from IRB review, or “exempt”. This type
of research needs to be submitted in BRAAN.
Even if the “exempt determination is “blue”, it
needs to be filled out for proposals that are
exempt.
Location of Research
If the research is not at one of the sites indicated
at the HSC or at the VA hospital, the best choice
is “WVU”. Even though the actual research
may be done at a particular school or in a
particular county, the PI is at WVU and this
should be the location.
Lay Summary
This should be in “lay” language. Try to make it
8th grade level.
Subjects
Be certain to describe subjects you will be using.
If the subjects are considered “vulnerable” by
federal definitions, additional forms will appear.
Note that WVU students and WVU employees
are vulnerable only if the PI has direct authority
over them.
Sample size
Indicate number of subjects to be used, both at
WVU and worldwide. If this is the only site, the
two numbers should be the same.
The number of subjects must be justified,
particularly if the study is “more than minimal
risk”.
PHI
There is a question asking if protected health
information will be collected and disclosed. If
you indicate “yes”, you will need to fill out
HIPAA forms/HIPAA waivers.
Consent form building
If you will need a consent form, choose whether
the study is no more than or greater than
minimal risk. Also determine if you need assent
forms or parental consent forms.
Choose the appropriate forms and answer the
questions.
Finish
When you have filled out everything and have
attached everything at the appropriate locations
and “think” you are finished, remember to
SAVE, VERIFY, If the indication, says no errors
found, go to CLOSE. You may need to CLOSE
again.
Finish 2
The second CLOSE should have taken you to
“IRB PROTOCOL –Details” page.
Go to select an action (may need to scroll on
right side)
Scroll down to “submit”
REMEMBER: Only PI can submit.
Click “Go”
Continuing Review
Go to activity list
Click on the protocol, then click on details
on the next page, under select an action,
Pick “request for continuing review” , hit go
you will get a split screen; the top half is the
continuing review section, the bottom half is the
protocol
Continuing Review Form
Fill in the top half, hit save, then verify
Extra pages may show up in the right margin,
depending on the information you enter
Complete any additional pages
If you have a no error message you are ready for
the actual protocol
How to enter a protocol in a
continuing review
Continue as with entering a new protocol
When finish, save, verify, close
Go back to the activity page
refresh activity page by clicking on activity list (if
clock appears indicating the system is working)
Activity List
The activity list will split into three sections:
IRB protocol at the bottom
Any amendments in the middle
Continuing review at the top
Click on the continuing review version of the
protocol
Submission
Select submit from the select an action list and
click on go
The continuing review will receive a number Cr-xxx
9999-xxxxx
The status column will allow you to follow
where the continuing review is in the system
Amendments
Click on the protocol from the IRB protocol
section
Select an amendment from the select an action
list
You will see a split screen
The top half is the actual amendment
Fill in the appropriate information
Save and verify
Add protocol
If the protocol has not been entered into the
system, follow the same steps as with a
continuing review
Make any changes to the protocol that are
indicated in the amendment
Save and verify the protocol
Go to the activity list
Submitting amendment
Choose the appropriate protocol from the amendment
section (middle of page)
Click on details
Select “submit” from the select an action section, hit go
Follow protocol process by checking the status column.
You should not submit a second amendment until the
first has been approved.
Finis