October 9, 2012
To Whom It May Concern,
The Northwestern University (NU) IRB Office requires that for all industry sponsored studies which are greater than minimal risk, the following research related injury section be included in the consent form:
“If you have an injury or illness from taking the study (drug or device) or 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 or device) or study 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.”
The language is written broadly enough to avoid conflicting with the vast majority of Clinical Trial Agreements (CTA). 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 the following conditions:
1. The PI provides the IRB Office with written confirmation from NU’s 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 and title, PI, and Sponsor; and
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; and
3. All documentation is uploaded to the applicable study by clicking “Add Supporting Documents” at the time of initial submission. If OSR is unable to provide documentation by the time of initial submission, it must be provided during the pre-review process.
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.
Projects will not be assigned to an IRB meeting until these requirements are met.
Thank you for your cooperation regarding this matter.
Sincerely,
Heather J. Gipson, JD, MA
Northwestern University
Director, Institutional Review Boards
Replaces letter dated 5-10-12. Revised to clarify that edits (additions and/or deletions) to the RRI section are not allowed.