Introduction to INSPIR
OCR Seminar Series
January 21, 2004
Mary Banks, RN
Administrator, Office of the IRB
“The Future Is Now”
Yogi Berra
What is INSPIR ?
Integrated
Network
for
Subject
Protection
In
Research
INSPIR Background
• Developed as BRAIN at Baylor
•
•
•
•
•
School of Medicine
Currently used at Baylor and
University of Maryland (BRAAN)
Result of IRB Improvement
Grant (NIH)
Customized to fit Boston
University requirements
Will be used at BUMC and
Charles River Campus
Used by BUMC IRB and IACUC
System Requirements
• January Issue of CR Times
•
•
(www.bu.edu/crtimes)- link
Connecting to INSPIR
Browser
– Macintosh, Netscape version 7
– Safari for Mac
– PC- Internet Explorer 6.0 or higher
• Cookies must be enabled
• Pop-up Blockers must be disabled
www.bumc.bu.edu/Departments/PageMain.asp?Page=8725&DepartmentID=368
Useful Tip
• Attachments (drug brochures,
•
sponsor’s protocol, grant
applications) will have to be
scanned and “attached” to the
IRB application
Extremely helpful if you have a
scanner within the department
to use to scan these
documents
Access to INSPIR
• Website “Getting Access”
• Presence in BU’s electronic
•
•
•
directory
BU Login Name, BUID Number,
and Kerberos password
If you don’t have a presence in
BU’s directory (BMC, VA)
instructions available
Do this now- don’t wait
www.bumc.bu.edu/Departments/PageMain.asp?Page=8636&DepartmentID=368
Difficulties Logging Into INSPIR
• Login issues and technical
•
•
issues will NOT be managed
by the IRB office
Contact the IT INSPIR
Team at BRAAN@bu.edu
Helpful advice on website
under “Help!”
www.bumc.bu.edu/Departments/PageMain.asp?Page=8094&DepartmentID=368
What Does INSPIR Do?
• Allows for IRB protocols to be created,
•
•
•
•
routed, reviewed, signed, and approved
within the system
Provides for transparent processingeveryone who has access can see where
the protocol is at each step in the process
Creates IRB meeting agendas and
minutes
Gives reviewers and investigators access
to the entire study file (including previous
versions that are archived in the system)
Automatically generates continuing review
reminders
Why Be INSPIRed?
• Electronic submission of
protocols
– No longer need to submit multiple
copies to IRB
– Not rely on interdepartmental mail
– No need to hand deliver
documents to the IRB office
– Documents won’t get lost
– Accurate study files- investigator
files will match IRB files
Why Be INSPIRed? (cont.)
• Investigators can track the progress of
•
•
•
•
own protocols
Multiple copies of documents (approval
letters, consent forms, etc.) with
version control can be printed
Applications are automatically routed
for required signatures
Continuing Review process is much
easier because amendments, SAEs,
etc. are cumulatively tracked
Investigators can access INSPIR from
any internet connected computer
2004
Jan
Feb
summer
April
Mar
Mar. 8
IRB office
Stops
Accepting
Paper
Mar. 15
GO LIVE
3/8 - 3/15
IRB office
CLOSED
2/23 - 3/15
Train the Investigators
May
Important Dates for Investigators
and Research Staff at BUMC
• February 23 - March 15
•
•
•
Investigator training
March 8
IRB Office stops
accepting paper
submissions
March 8 - 15
IRB Office closed
March 15
Go Live Date
Investigator Training
• Feb. 23 - Mar.15
• Training will include
–
–
–
–
Online training
Investigator Manual
Large group classes
Small group classes
• Schedule of classes will be
•
posted
Practice site will be available for
investigators to use
IRB Office Stops Accepting Paper
• March 8, 2004
• All paper Progress Reports must
•
•
•
be submitted by this date
Can submit Progress Reports for
March, April and May
Last date to accept new Research
Applications in paper
Last date to accept amendments
in paper
IRB OFFICE CLOSED
• March 8-15
• No paper or electronic
•
•
submissions accepted
during this week
Investigator training will be
ongoing during the week
IRB office staff will be
available for training and to
answer questions
GO LIVE
• March 15, 2004
• First day protocols can be
submitted electronically
– New protocols
– Progress Reports
(Continuing Reviews)
– Amendments
New IRB Applications
• Full Board, Expedited and
•
•
•
Exempt
Submit on paper by
March 8 OR
Must hold and submit on
or after March 15
electronically
Investigators can work on
drafts prior to March 15
Continuing Review
• Progress Reports must be
•
•
•
submitted by March 8 on paper
OR
Must be held until March 15 for
submission electronically
Investigators may submit on paper
for March, April, May only
Studies that expire after May 31,
2004 – Progress Reports must be
submitted electronically
Continuing Review
• After March 8 all Progress
•
Reports (CRs) must be submitted
electronically
To submit a Progress Report the
investigator must first enter the
study into the system using a
new application
Continuing Review
• If PI submits a new protocol
•
•
on March 8 on paper - will
have to re-submit the study
electronically at time of next
Continuing Review
Investigators must ensure that
studies will not lapse
Progress Reports must still be
submitted at least 5 weeks
prior to expiration
Amendments
• After March 8 all
•
amendments must be
submitted electronically
Prior to submitting an
amendment the investigator
must enter the protocol into
the system (by completing a
Research Application for the
study)
Serious Adverse Events
• March 8 deadline does
•
•
not apply to SAEs
SAEs may be submitted on
paper until the study is up
for Continuing Review (or an
amendment is needed)
More information on SAEs
will be coming - the IRB is
modifying the policy on
submitting SAEs to the IRB
Demonstration of INSPIR
• Demonstration site (practice
•
•
•
site) will be available soon for
use by investigators
Final modifications being
made to the system
We will provide investigators
paper copies of screen shots
We will provide an electronic
Investigator’s manual
Go To Demo