Do you need to make a modificati0n in eIRB? The Research Integrity Office has updated two questions to help the IRB identify, at a glance, what has changed in your submission and why. This includes a change to questions 4 and 5 in the Modification Request Questionnaire (MRQ), along with the addition of questions 4.1 and 5.1. Complete and accurate responses to these new questions will help ensure that your modification is reviewed and approved as quickly as possible.
Questions 4 and 4.1
Questions 4 and 4.1 ask about changes that affect subject participation or risks to subjects. Select “yes” for Q. 4 if the modification will alter the procedures subjects will undergo (like adding a study visit) or will increase or decrease the risks they may face (often the case if you have a new investigator’s brochure).
If you answer “yes” to Q. 4, you must also answer Q. 4.1. Here, provide a brief, “in a nutshell” description of how the modification alters participation or risks. You may also include a reference to a separate memo or other document, such as a summary of changes. However, even if you have such a document, it is most helpful to provide a few sentences in Q. 4.1 that give the IRB an overview of the changes so that we know right away where to direct our attention.
Questions 5 and 5.1
Question 5 has been broken down into two separate questions. Q. 5 now asks what has changed, and Q. 5.1 asks why. For example, if you are submitting a modification to revise the risks section of your consent form, your responses might look like this:
Q. 5: High blood pressure, dizziness, and allergic reaction have been added to the risks section of the consent form. A new investigator’s brochure for the study drug has also been submitted.
Q. 5.1: The new investigator’s brochure includes data from additional studies that revealed these new risks. See the summary of changes on page 73 of the IB for further details.
Make sure that your response to Q. 5.1 provides a specific scientific or logistical reason for the changes listed in Q. 5. If you are submitting changes requested by the study sponsor, find out the rationale from the sponsor. We will return the modification to you if you respond to Q. 5.1 with: “The sponsor requested these changes.”
If you have questions about the revised MRQ, please feel free to call our helpdesk at 503-494-7887, option 1.