ARCHIVE

January 31, 2007

OPRS Announcement # 15 - 01/31/07 - Assent form templates

December 22, 2006

OPRS Announcement # 14 - 12/22/06 - A holiday message from the OPRS Executive Director

December 11, 2006

OPRS has updated its Mission Statement and is introducing a new Vision Statement as we prepare for the
New Year and beyond.

November 6 , 2006

OPRS Announcement # 12 - 11/6/06  – Jesse Brown VA Consent form approval process and VA-HIPAA authorization template

November 2 , 2006

OPRS Announcement # 13 - 11/2/06 – New Continuing Review for Research Form, Revised New Project Submission Forms

October 19, 2006

OPRS Announcement # 11 - 10/19/06 - New Consent form and authorization for research template

October 4, 2006

Electronic Documentation

eIRB has revolutionized the IRB submission process at Northwetern University. When submitting documents (protocols, etc) to the IRB, they should be in electronic format. To help request these documents from a sponsor, OPRS has provided an updated version of the electronic documentation letter: Electronic Documentation Letter

 

September 19, 2006

OPRS Announcement # 10 New definition of Authorized Project Personnel and new option for satisfying the requirement for initial training in human subject protections.

 

August 18 , 2006

Authorized Research Personnel

The Northwestern University IRB has revised it's definition of Authorized Research Personnel. IRB forms have been updated to reflect the new definition, see the Forms Page for the current submission forms. Here is the new definition:

Authorized project personnel includes all persons who will have a significant role in the conduct of the research, including all Principal Investigators and Co-Investigators, any individuals who are individually named on a grant or contract application, who are listed on a FDA form 1572 (for the conduct of the research at NU or an affiliate), who are named as contact persons in the informed consent documents or recruitment materials for research, who are obtaining informed consent to participate in research, or who are obtaining individually identifiable health information under an NU Business Associate Agreement.

 

June 28, 2006

IRB Brown Bag Seminars 2006

Visit the "Education and Training" page for more information on these training opportunities. These one-hour seminars are open to all investigators and research staff who conduct research with human subjects at Northwestern University and its affiliated institutions. Registration is required.

 

May 24, 2006

OPRS Announcement # 8 - Continuing Review: revised OPRS policy for determining the IRB approval period

 

May 23, 2006

Official Announcement regarding eIRB (the new online submission application) has been issued to all research Principal Investigators at Northwestern University. This announcement can be downloaded using the link below:

Download the Announcement

May 22, 2006

The format of the IRB web site has been revised, with new menu options. If you have any suggestions on how the site could be improved, please send them to irb@northwestern.edu

January 18, 2006


The New Project Submission Forms (NPSF) have been revised and new versions are posted on-line. To find the current version of these forms please visit the "Forms" page at: www.research.northwestern.edu/research/OPRS/irb/forms/ The IRB requires that the current version of any form be used.

December 13, 2005


Revisions to NU HIPAA Research Policy

August 1, 2005


The Biomedical Consent Form Template and Instructions, Additional Elements and Suggested Language Consent Forms have been updated. For the current version, please visit: http://www.research.northwestern.edu/research/oprs/irb/templates/

July 14, 2005


OPRS has created a new email service to distribute important messages related to the Northwestern University Institutional Review Board. For information and instructions to sign up, visit www.research.northwestern.edu/research/oprs/irb/email/

May 6, 2005


The Security Rule Announcement is now available on the OPRS web site at: www.research.northwestern.edu/oprs/irb/hipaa/docs/hipaaSecurityAnnouncement.doc.

There is also a HIPAA security rule Acknowledgment Form that can be found here: www.research.northwestern.edu/oprs/irb/hipaa/docs/hipaaAcknowledgeForm.doc

March 2, 2005


OPRS office in Evanston

A new temporary satellite office for the Protection of Human Subjects (OPRS) is now located in 204 Annenberg Hall, Evanston campus. Erik Kjeldgaard, IRB Coordinator for Social and Behavioral Sciences, is available full time to assist with completing IRB applications and forms, answering questions, and providing IRB related information. Forms and other IRB materials may be dropped off with Erik in room 204 Annenberg or, if more convenient, in our drop box located in room 131-132 Annenberg Hall (mailroom). Erik can reached by phone at (847) 467-1723, fax at (847) 467-3112, or e-mail at e-kjeldgaard@northwestern.edu.

Dr. Penelope Peterson, Dean of SESP has been gracious enough to provide this temporary space until June 2005. You will be notified once our permanent office space has been established.

Thank you, and we look forward to providing you with direct access to OPRS on the Evanston campus.

January 24, 2005


A new template for the referral slip has been posted. Please down load the current version from here: Informed Consent by opening the Simple Recruitment Form.

January 18, 2005


A new REVISIONS OF SUBJECT RECRUITMENT/ RETENTIONS MATERIAL FORM (INCLUDES MEDIA RELATIONS) has been posted, for information and access to the form please visit the IRB Forms Page

January 11, 2005


Updated

• Biomedical Consent Form Template
• Social/Behavioral Consent Form Template
• Instructions, Additional Elements and Suggested Language Consent Forms

These documents have been modified to reflect recent changes in the standard Research Related Injury clause. For more information and guidance, please visit the Informed Consent page.

December 1, 2004


A new form for adverse event reporting to the IRB has been posted to the OPRS web site. For information regarding the use of this form please read the guidelines. To download the current version of the IRB forms, please visit the OPRS Forms Page

Revised version of the consent form templates for both biomedical and social science consent forms have been posted and are available here.

Welcome to the new OPRS web-site!!!


The September 1, 2004 launch of the revised OPRS web-site includes a number of new policies, procedures and forms. General information about our new forms is below. For additional guidance and instructions, please refer to the web link on each form.

It is important to note that all OPRS forms have been updated. When developing new submissions, please refer to the OPRS web-site for the most recent form. Each form is identified by a version date.

Re-submission Form

• If a project has lapsed in periodic review there will be a re-submission process for PI's to complete if they choose to continue their research.
• This form must be completed no later than 60 days after project expiration.
• Because the project status is expired, no research may be conducted until the IRB has reviewed and approved the re-submission.
• Please contact OPRS for additional information on this new process.

Form for Umbrella/Training Grants:

• A new form has been developed to be used to submit training and umbrella grants for IRB review and approval. This form should be completed for both new project and periodic review submissions.

AE Summary Table:

• This does not replace individual submissions for all projects under the grant.
• At the time of submitting a periodic review, a PI is to complete an AE summary table which will list all of the adverse events that have occurred since the initial review or the last periodic review.

Request to Waive Consent - Verbal & Written:

• This form is to be completed when a PI wishes to request a waiver of written or verbal consent for all or part of a study.

HIPAA:

• HIPAA is now incorporated within the various new project submission forms. Unless HIPAA is being revised, the PI no longer needs to complete a separate HIPAA Response Form. However, if applicable, the necessary HIPAA Exception and Waiver of Authorization Forms must be submitted.

Authorized Personnel List:

• This new form is now available as a separate document for submissions with the Revision Form when changes are being requested.

Termination Form:

• At the time of closure, a PI must complete a Termination/Closure Form. This new form has been developed to initiate the closure process and must be completed before OPRS or the IRB can close the project.