Research Related Injury Language

The Northwestern University (NU) IRB Office requires that all industry sponsored studies which are greater than minimal risk include the following research-related injury language in the What else do I need to know?  section of the  consent document:

"If you have an injury or illness from the study device, taking the study drug, or the procedures required for this study, the reasonable medical expenses required to treat such injury or illness may be paid for by the study sponsor.

The coverage for such injury or illness is only available if the Northwestern University principal investigator and study sponsor, if applicable, have decided that the injury/illness is directly related to the study drug, device, or procedures and is not the result of a pre-existing condition or the normal progression of your disease, or because you have not followed the directions of the study doctor. If your insurance is billed, you may be required to pay deductibles and co-payments that apply.  You should check with your insurance company about any such payments."

[Describe any compensation available for research-related injury dictated by the Clinical Trial Agreement or contract.]

The language is written broadly enough to avoid conflicting with the vast majority of Clinical Trial Agreements (CTAs).  As such, edits are not allowed.  This includes the deletion and/or addition of language to the research-related injury section.  In rare instances when there may be a  conflict, the IRB is willing to consider the use of non-template language under all of the following conditions:

  1. The Pl provides the IRB Office with written confirmation from the Northwestern Office for Sponsored Research (OSR) that the IRB's template language is not in keeping with the clinical trial agreement (CTA) and the proposed changes are necessary to avoid violating the terms of the CTA. When contacting OSR for written confirmation, please provide them with the IRB project number, study title, Pl's name,  and the name of the Sponsor.
  2. The research-related injury language is written in lay language.  The IRB reserves the right to modify the language to meet this requirement.  Investigators are advised to avoid cutting and pasting CTA language into the consent form as it is usually written at a reading level not acceptable to the IRB.  
  3. All documentation is uploaded into the Supporting Documents section of the applicable study at the time of initial submission.  If OSR is unable to provide documentation at the time of initial submission, it must be provided during the pre-review process.
Please note:  If  the IRB has previously approved the same non-template language under a different study, please let us know. The IRB will take this into consideration when reviewing the study. However, be aware that prior approval of non-template language does not preclude the IRB from disapproving or modifying the language if it is later found to be unacceptable. Studies will not be assigned to an IRB meeting until these requirements are met.