ANNOUNCEMENT:

Dear IUB Colleagues:

Welcome to the updated Indiana University Bloomington IRB website.  As a part of the development of the new Indiana University Office of Research Administration (ORA), and to address questions raised by the DHHS Office of Human Research Protections involving study review processes the IUB IRB is working with very closely with the Indianapolis IRB office at the Indianapolis campus to update and streamline its policies, procedures, and operations.  For the short term, approvals for IUB IRB protocols may be delayed.  We are aware of the need for timely approval of human subjects protocols and everyone is working diligently to have protocols reviewed and approved appropriately. 

As part of this transition, new policies and procedures for obtaining human subjects research approval have been developed for the Bloomington campus and are provided on this website.  We understand that these new forms will require training and assistance.  We are in the process of scheduling formalized training sessions.  In the interim, any questions regarding these forms can be addressed to:

IRB HELP@indiana.edu or (812) 855-3067

As a result of this transition, new application forms were created.  Effective immediately, the forms included on this website must be used for IUB IRB submissions.  Please refer to the information below for guidance on what forms need to be submitted.  After you have completed the forms applicable to your submission (e.g., continuing review, amendments, new study etc.) you may submit them electronically to:

IUB_HSC@indiana.edu

We appreciate your patience and understanding during this transition and will be in touch with you as more details are finalized regarding what procedures will change in the review and approval process. 

Please feel free to contact us with your concerns and questions.

Best Regards,

Dr. Peter Finn, IRB Chair
Dr. John Kennedy, IRB Vice Chair

Frequently Asked Questions

The forms seem to apply to Indianapolis, are long and may not be applicable to my given situation.  Is all this detail necessary?
New forms have been developed for the Bloomington campus and there is a difference in length and detail for the information being requested.  The need for this level of detail is to help ensure that the University, together with the research community, address the minimum regulatory requirements of the 45 CFR 46 (the Common Rule), the FDA regulations, and other applicable regulations. 

If the Indianapolis Office is currently processing the studies for both campuses, how will they determine what studies need to be addressed first?

To accommodate the number of research study protocols from all campuses processed in Indianapolis, including Bloomington, the following criteria have been developed that will be used to determine the level of priority for review:

• Studies involving the provision of necessary health care services
• Expired studies
• Studies due for a continuing review (especially those with an imminent expiration date)
• Studies where funding is being held for IRB approval
• Studies involving vulnerable populations (e.g., children, prisoners, etc.)
• Studies involving federal funding

The priority level of the studies will be based on the number of criteria involved.   The above criteria are not listed in the order of importance and existing studies will take priority over new studies. 

What has the University done to help alleviate the backlog and address delays?
The ORA has provided additional resources to help reduce the backlog.  Additional steps that have been taken to help improve the turnaround times for review include extending staff hours (including weekends), contracting for temporary additional IRB staff from a consulting firm, and scheduling of additional IRB committee meetings.  These efforts will permit several improvements to be made to the review and approval process.  A new computer system will be put into place to support the IUB IRB administration.  Eventually, this system will permit researchers to complete protocols online and have them electronically submitted directly to the IRB for review and processing. 
 
Steve Martin, Associate Vice-President for Research Administration
Dr. Peter Finn, IUB-IRB Chair
Dr. John Kennedy, IUB-IRB Vice Chair

Other helpful links:

IUB Human Subjects Protection Tutorial and Test:  http://www.indiana.edu/~rcr/index.php

IUPUI IRB Standard Operating Procedures (SOPs) for research: http://www.iupui.edu/%7Eresgrad/human-sop/Standard_Operating_Procedures%20_03%2008.pdf

For all other questions, please contact the: IUB_HSC@indiana.edu or (812) 855-3067