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Modifications

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.

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 Changes

  • 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 Michael Kelly (eirbsystem@northwestern.edu or (312) 503-0126) who 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.

Personnel Changes

Changes to the Primary Contact, Study Team Members, individuals listed on the Study Access List or the PI Proxy may be requested at any time.

Changing The Primary Contact

  1. Open the study by clicking the study’s name.
  2. Click Assign Primary Contact from the My Current Actions list on the left side of the screen
  3. A new window opens.
  4. Click Clear to remove the current Primary Contact.
  5. Begin typing the name of the new contact.
  6. Select the correct name from a list of matching names that appear, and
  7. Click OK.

Tips:

  • To change the primary contact, you must be a member of the study team or an individual listed on the Study Access List with “edit” privileges.
  • Modifications or continuing review submissions have the same primary contact as the initial study.

Changing Study Team Members

The addition or removal of study team members must be made in the section of the eIRB+ study titled “Study Team Members”.

Tips:

  • If the Principal Investigator is being changed, the PI name must be updated in the “Basic Information” section.
  • The Regulatory Coordinators for the study will only be added to the Study Team Members section if they are a study team member.
  • Personnel changes may also require a change to other study documents housed in eIRB, including the protocol, consent document, and recruitment materials.  In such cases, these documents should be revised as well during the revision process.

Note:  Adding personnel to the Study Member list will not give that individual access to make changes to the eIRB+ study or receive eIRB+ notifications regarding the project. A person must be added to the Study Access List with “Edit” Privileges to be able to make changes to the study application.

Updating Study Access List (Regulatory Coordinators Or Submitters)

Study Access members assist the Primary Contact in keeping the study application updated for the study team.  They may or may not be a study team member.

  1. To update the Study Access List, you must be a member of the study team or listed on the Study Access List with “Edit” privileges.
  2. Click “Assign Study Access List” from the My Current Actions list on the main page of the study application.
  3. A new window opens.
  4. Click Clear to remove individuals from the current list select their names and select ”delete”.
  5. Begin typing the name of the new Study Access member.  Select the correct name from a list of matching names that appear, grant them “edit” access, and
  6. Click OK.

 Updating The PI Proxy List

  1. To update the PI Proxy list, you must be the PI or the Primary Contact.
  2. Click “Manage Submission Rights” from the My Current Actions list on main page of the study application.
  3. A new window opens.
  4. Begin typing the name of the new PI Proxy.  Select the correct name from a list of matching names that appear, grant them “submission” access, and
  5. Click OK.

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.

EIRB+ Instructions

  1. Access to eIRB+ is available on the eIRB+ page.
  2. After logging in, choose “My Studies” and filter by PI or Study Number to find the applicable study.
  3. Choose the applicable study from the resulting list.
  4. 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.
  5. After clicking the “New Modification” button, the form will open. Complete all questions on the main page of the Modification submission.
  6. You will then be asked to update the study application to reflect the changes described in the Modification form that you just completed.
  7. When you have reached the Final Page of the application, click “Finish”.
  8. Important:  The PI or PI Proxy must click the “Submit” button under “My current Actions” on the main page of the new study.

Post-Submission Process for Modifications

Protocol Changes

  • 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.

Recruitment Changes

  • 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.

Post Submission Process for Modifications

workflow graphicPI submits the Modification in eIRB+

The IRB Review Process Begins:

Pre-Review:
The Modification submission is pre-reviewed by an IRB coordinator. The coordinator ensures that the submission is complete and meets the IRB’s requirements.  The investigator may be asked to make changes to the submission and/or study documents.

Once the pre-review is complete, the submission is routed to either a single reviewer for submissions that qualify for Expedited Review or to a convened panel for submissions requiring Full Board Review.

IRB Review:

The Modification will receive the one of the following determinations by the IRB:

  • Approved: The Modification is fully approved by the IRB.  No further action is required.
  • Modifications Required to Secure Approval: The Modification is approved on the condition that the PI meet specific conditions.  These conditions are specified in the determination letter issued by the IRB.

The PI’s response is reviewed by the IRB to ensure that the conditions for approval have been met.  When the conditions are met, an approval letter is issued with the effective date of the approval.  None of the modifications requested by the PI in the submission may begin until full approval is secured.

  • Deferred:  The Modification submission lacks sufficient information for approval.  For example, the IRB may require additional information regarding the risks and benefits, privacy and confidentiality protections, and/or the informed consent process.

The determination letter will specify the basis for the deferral and the information required.  The PI’s response is assigned to the same IRB panel that issued the Deferral. When the panel determines the conditions are met, an approval letter is issued.  None of the modifications requested by the PI in the submission may begin until full approval is secured.

  • Disapprove:  The Modification submission does not meet the federally mandated criteria for approval.

The determination letter will specify the basis for disapproval.  The PI may respond to the IRB and the response will be reviewed at a convened IRB meeting.  After the subsequent deliberation, a new determination is made by the IRB.  None of the modifications requested by the PI in the submission may begin unless full approval is secured.