OPRS Announcement Web based IRB System Announcement The Office

							OPRS Announcement # 8 - 05/24/2006
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1.  Web-based IRB System Announcement:

The Office for the Protection of Research Subjects has today posted an announcement
regarding the implementation of a web-based IRB submission process for Northwestern
University faculty. If you conduct human subjects research at Northwestern, or her
affiliated institutions, please download the announcement and share it with any staff
members who are involved in supporting your research activities. You can find the
complete announcement at:
http://www.research.northwestern.edu/research/oprs/irb/whatsnew/documents/eIRBMem
oMay232006.pdf

2.   Revised OPRS Policy for Determining the IRB Approval Period:

OPRS is implementing a new process for calculating the IRB approval period in those
cases when the IRB approval for the continuing review application is approved up to 30
days prior to the expiration of the current approval period. This is consistent guidance
from the Office of Human Research Protections (OHRP), which can be accessed at the
following URL:
http://www.hhs.gov/ohrp/humansubjects/guidance/contrev2002.htm#HOW%20IS%20T
HE%20CONTINUING%20REVIEW%20DATE%20DETERMINED .

This change in our procedures will allow us to retain the anniversary date of the last IRB
approval and avoid what many investigators have experienced as a cycle of persistent
shortening of the approval periods to less than 365 days, when the research has been
previously approved for a year.

If continuing review applications are approved by the IRB more than 30 days prior to the
expiration date, then a new approval period will be assigned (because the 30-day rule
does not apply). The OPRS will try and assign continuing review applications to panel
meetings which will preserve the anniversary date whenever possible, but will not hold
review of an application for more than 15 calendar days. Therefore, please target the
submission of your Continuing Review for 45 days prior to the IRB project expiration
date.

The revisions to the OPRS procedures impact the notification of IRB approval in the
following ways:

>> IRB approval letter template:
o     The Continuing Review IRB approval letter template has been updated to reflect the
approval period dates [formatted as,mm/dd/yyyy-mm/dd/yyyy] in the header section.
o     While this change does not affect the manner in which the IRB approval period is
determined for a New Project (NP), the template of the NP letter has been revised to
display the approval period in a manner consistent with the template of the Continuing
Review letter
o     The IRB approval letter template for all other submissions (Revisions, Adverse
Events and, Protocol Violations) will not be affected.
Effective immediately, the header section of the approval letter will appears as follows:

IRB project #: [Insert Project number]
Meeting Date (or Review Date): [Insert Meeting Date (or Review Date)]
Approval period: [Insert approval period, mm/dd/yyyy-mm/dd/yyyy]
Study Sites: [Insert Study Sites]
Project Title: [Insert Project Title]

>> The IRB approval stamp on the consent form has also been revised. The new version
now reads:
Northwestern University Institutional Review Board
 IRB #: [Insert Project number]
 Approved to consent subjects through: [Insert expiration date]

Please note that the consent form stamp (above) will no longer indicate the IRB approval
date.

3.   OPRS/IRB NEW website

The format of the IRB web site has been revised, effective 05/22/2006, with new menu
options. The webmaster is transitioning from our previous format and we apologize in
advance for any inconvenience that you may encounter while consulting the new website.
If you are having trouble accessing any of the menu options or have any suggestions on
how the site could be further improved, please send questions and/or comments to
irb@northwestern.edu

Please direct your questions to the IRB in the following manner:
1. For questions regarding the web-based system, please contact Jacques Logan at (312)
503-7943
2. For, questions regarding the changes in OPRS policy regarding continuing review,
please contact Debbie Gibson at (312) 503-4661
3. For questions regarding the new OPRS/IRB website, please contact Andrew Ellis at
(847) 467-1723.

For general queries, you may contact OPRS at 312-503-9338 or irb@northwestern.edu

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