Investigators are responsible for ongoing requirements in the conduct of approved research. This includes obtaining prior approval from the IRB for any modifications of the previously approved research before implementing the proposed modification.
If the investigators change the research in order to eliminate apparent immediate hazards to subjects without prior IRB approval, they should report those changes promptly to the IRB via the Safety/Other form located on the main study screen of the applicable study in eIRB+.
Change in the Number of Participants
- If the protocol describes the number of participants to be studied, submit a new protocol that has been revised to reflect the change in the number of participants.
- If the consent document describes the number of participants to be studied, submit a new consent document that has been revised to reflect the change in the number of participants.
Changes to Research the IRB Determined to be Exempt
If the IRB determined that your research meets one or more of the Exemption categories, you may edit your project procedures and documents without re-submitting to the IRB so long as the research remains minimal risk and stays within the boundaries of the exemption categories that the IRB found applied to the research
It is a best practice recommendation to create a note-to-file in your research record to document the changes you make and your determination that these updates did not change the scope of the study or risk to participants. You can download a template note-to-file template on the IRB Office’s Study Support Resources and Templates webpage.
If your proposed changes constitute any of the following, submit a track change version of the protocol you submitted to the IRB in a new IRB application using the “copy submission” function in eIRB+:
- add procedures that could affect risks to participants; or
- add procedures that do not fit within the exemption categories; or
- add new types of participants to your study that include vulnerable populations (e.g., adding children, individuals with cognitive impairments, prisoners, etc.); or
- Change of Principal Investigator.
Examples of changes that would likely require IRB review:
- Removal of the consent process, or use of deception or incomplete disclosure.
- Significant changes to the recruitment procedures.
- Adding sensitive questions to a survey or interview process (e.g., questions regarding illegal activities; questions causing psychological or
- emotional discomfort for participants; traumatic events such as childhood, sexual, or domestic abuse; suicide; or other probing questions that could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation).
- Collection of new or additional identifiable information.
- Changes to the data storage plan that may affect confidentiality.
- Adding any new physiological measures that were not already determined to be exempt.
Consent Document Changes
- Click “IRB” in the top left navigation area and select the Active tab.
- Click the name of the approved study.
- Open a new Modification submission. Answer all questions. Upload on the Modification page the reason for revising the consent form. Include and upload any relevant sponsor correspondence.
- Click the Documents tab.
- Click the consent form in the Final column and save it to your computer.
- Open the document and revise it using the Track Changes functionality in Word to create a document with tracked changes. Do not use highlighting to indicate changes.
- Update the version date.
- When finished, replace the original document with the tracked-changes version in the modification.
- When the IRB approves the document, all tracked changes will be accepted and comments removed in the final version.
- Funding information is described in the “Sources of Funding and Other Support” section in the eIRB+ study. Remember to revise the funding section to reflect any changes to the current funding status.
- If you are unable to find the name of your funding source from the drop down menu, please contact email@example.com and they will assist in adding the funding source to the menu.
- If the funding change involves the addition of a new grant, upload a copy of the entire grant into the funding section of the eIRB study next to the funding agency.
- Research funded by the Departments of Defense, Education, Energy, Justice, National Institutes of Justice, or the Environmental Protection Agency must comply with additional regulations. Several Federal Agencies have additional requirements for Investigators conducting human subjects research. Reference Appendix A1-A8 of the NU Investigator Manual for guidance in compliance with these regulations.
- The protocol and consent form often mentions the funding source. With a change in funding, you may also need to submit a revised protocol and consent form to reflect the change in funding.
Preparing a Modification in eIRB+
Making modifications to your current study may require additional changes to study procedures or study documents housed in eIRB+, including the protocol, consent form, and recruitment materials.
- Only one Modification may be under review at any time (except changes in study personnel).
- Multiple changes may be bundled into one Modification submission. Minor modifications to approved research may undergo expedited review. More substantial modifications, especially those that change the risk-to-benefit ratio, may require review by a fully convened Board which typically takes longer to process. Plan carefully if you bundle changes so as to not delay the review of a change that could be done under expedited review.
- Access to eIRB+ is available on the eIRB+ page.
- After logging in, choose “My Studies” and filter by PI or Study Number to find the applicable study.
- Choose the applicable study from the resulting list.
- The main page for the study will appear. Select the New Modification button located in the left column of the page. If you do not see this option, there is currently a modification under review. You must wait until the current modification is complete.
- After clicking the “New Modification” button, the form will open. Complete all questions on the main page of the Modification submission.
- You will then be asked to update the study application to reflect the changes described in the Modification form that you just completed.
- When you have reached the Final Page of the application, click “Finish”.
- Important: The PI or PI Proxy must click the “Submit” button under “My current Actions” on the main page of the new study.
- The protocol is located in the Basic Information section of the study application. In the Modification submission, remove the outdated protocol and replace with a tracked changes version of the revised protocol.
- Remember to update the version date when revising the protocol.
- If applicable, also upload the Summary of Changes and any other relevant sponsor correspondence.
- Editing the protocol may affect other parts of the study record. Go through and update the study application to reflect all changes in the protocol.
- Changes to the recruitment process must be made in the section of the eIRB study titled “Consent Forms and Recruitment Materials”. All new or revised recruitment materials must be uploaded into this section.
- Outdated materials should be removed.
- In the Modification submission, also upload a tracked version of the revised recruitment material or a clean copy of any new materials.
- Changes to the recruitment process may also affect other study documents, including the protocol. In such cases, these documents should be revised as well during the revision process.
Study Site Changes
- Changes to the study sites must be made in the section of the eIRB+ study titled “Sites”.
- If the new sites have their own IRB approval, the approval letters should be uploaded into the supporting documents section of the study application.
- In cases where NU IRB will serve as the IRB for the new site, a signed IRB authorization agreement should be uploaded into the “Supporting Documents” section of the study application.
- Changes to the study sites may also affect other study documents, including the protocol and consent forms. In such cases, these documents should be revised as well during the revision process.
Study Title Changes
- Update the title in the “Basic Information” section in the eIRB+ study.
- The protocol and consent form usually contain the study title. With a change in study title, you will also need to submit a revised protocol and consent form to reflect the change in title.
Note: The project title must match the procedures being conducted in the research study. It should not be changed to match the new title of a new grant.