521. Submitting Amendments for Full Committee or Expedited Review

Updated August 23, 2021

Prior IRB approval must be obtained for all amendments or modifications to research previously approved by the full committee or via expedited procedures unless immediate changes are necessary to protect participants or others. The latter requires reporting to the IRB.

Requests to amend or modify approved, non-exempt research project must be submitted as subsequent Amendment packages for the existing project in IRBNet. Amendments may be submitted for Full Committee, Expedited, or Administrative Review as outlined below or as described in IRB policy (see Review Types).

Amendment packages requiring Full Committee Review must be submitted and determined to be complete by the meeting deadline. Amendment packages submitted for Expedited Review may be submitted at any time; meeting dates and deadlines do not apply to expedited reviews.

Requirements for Amending Approved Documents in IRBNet

For amendments that involve changes to approved documents, after logging-in to IRBNet and creating a new Amendment package for the approved project, investigators must complete the following steps:

Amended Applications, Researcher Forms, and Study Documents

When possible, study documents should be added to IRBNet in MSWord or another editable format.

Instructions for Amending/Modifying Existing Documents in IRBNet

From the list of study documents, download the application/document you are changing and save it to your computer where it can easily be found.
Using track changes, modify the saved app/doc; include “track changes” in the filename
Accept all changes in the revised document; change “track changes: to “clean” in the filename
Return to project in IRBNet and select Designer.
From Designer, select “Add New document” and add the document with track changes
Again, from Designer use the pencil icon and replace the existing app/doc with the newly revised clean version.

Instructions with graphics for modifying a document are available in the IRBNet library.

Amendments for Full Committee or Expedited Review

Generally, the type of review for amendments mirrors that of the initial review: Full Committee or Expedited Review. For information about exceptions, see IRB policy for project amendments for non-exempt research or Review Types; and the section below for Administrative Review for personnel changes and additions/deletions of study sites.

Mandatory Submission Requirements for Full Committee or Expedited Review

Amendment packages for modifications to approved non-exempt projects in IRBNet must include the following:

Amendment Request Form
Electronic signature of the Principal Investigator (PI)

Additional Requirements for Specific Amendments for Full Committee or Expedited Review

Change in Project Title

Updated IRBNet record to reflect new title in the top table of the Project Overview screen to reflect change in Part I, Cover Sheet
Requires changes to Part I, Cover Sheet
Likely requires changes in recruitment and consent materials

Change in PI

Changing the PI requires request by the current PI and endorsement and acceptance by the new PI. The PI change package is shared with the new PI if he/she/they is not already on the research team and is signed by the existing PI (or Responsible Official (RO) if the existing PI is not available) and the new PI. The package consists of the following:

Updated IRBNet record to reflect new PI in the top table of the Project Overview screen so change is reflected in Part I, Cover Sheet
Amended Part I, Cover Sheet to change PI
Amendment Request Form if other changes are requested along with the change in PI
Amended recruitment and consent materials (as applicable)
For clinical investigations, new Investigator Form 1572
Linked Training and Credentials for the replacement PI to the project

Addition, Removal, or Change in Funding or Sponsor

Requires changes to Part I, Cover Sheet
Likely requires changes to recruitment and consent materials
May require new or modified Department of Defense Research form for research conducted or supported by the Department of Defense (DOD)

Addition of Prisoners as Participants

Requires changes to Part I, Cover Sheet
Requires changes to the Protocol
Requires Research with Prisoners form
Likely requires changes to recruitment and consent materials

Changes to Study Purpose or Procedures

Require changes to the Protocol
Likely require changes to recruitment and consent materials
May require Research with Specimens form if changes involve blood or biological specimens
May require documentation of regulatory committee approval
May require addition or removal of study materials (e.g., surveys, questionnaires, instruments, data logs)
May require new or amended HIPAA Authorization or Waiver if changes involve Protected Health Information

Changes Involving Drugs or Devices

Require changes to Part I, Cover Sheet
Require changes to the Protocol
Require new or amended Research with Drugs or Research with Devices form
Likely require new or updated clinical protocol, investigator brochure, package insert or labeling, or device manual
Likely require changes to recruitment and consent materials
If risk increases to greater than minimal, may require changes in consent process to obtain signed consent
If risk increases to greater than minimal, may require changes in Review Type

Changes that Increase Participant Risk or Reduce Research Benefits

Require changes to Part I, Cover Sheet
Require changes to the Protocol
Likely require changes to consent materials
If risk increases to greater than minimal, may require changes in consent process to obtain signed consent
If risk increases to greater than minimal, may require changes in Review Type

Changes Involving Participant Privacy, or Data Handling and Storage

Require changes to the Protocol
Likely require changes to recruitment and consent materials
If risk increases to greater than minimal, may require changes in consent process to obtain signed consent
May require new or amended HIPAA Authorization or Waiver if changes involve Protected Health Information
May require new or amended Data Use Agreement
If risk increases to greater than minimal, may require changes in Review Type