521. Submitting Amendments for Full Committee or Expedited Review

Updated Oct. 4, 2019

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 other 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 researcher form
  • Electronic signature of the 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 is not already on the research team and is signed by the existing PI (or 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 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
  • Requires changes to Part II Application
  • Likely requires changes to recruitment and consent materials
  • May require new or modified agency-specific researcher forms if change involves addition of support from DOD, DOE, DOJ, or EPA; or requires compliance with FERPA or PPRA (per DoEd regulations)

Addition of Vulnerable Population*

*Vulnerable populations include pregnant women or fetuses, prisoners, children, adults with impaired decision-making capacity, and persons living in foreign countries (i.e., for International Research)

  • Requires changes to Part I, Cover Sheet
  • Requires changes to Part II Application
  • May require new or updated population-specific researcher form (or Research: International form)
  • Likely requires changes to recruitment and consent materials

Changes to Study Purpose or Procedures

  • Require changes to Part II application
  • Likely require changes to recruitment and consent materials
  • May require Education Records/Classroom Survey researcher form if changes affect or invoke FERPA or PPRA (per DoEd regulations)
  • May require Research: Blood or Biological Specimens researcher 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 Part II application
  • Require new or amended Research: Investigational Drug or Research: Investigational Device researcher 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 Part II application
  • 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 Part II Application
  • 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 Education Records/Classroom Survey researcher form if changes affect or invoke FERPA
  • May require new or amended Data Use Agreement
  • If risk increases to greater than minimal, may require changes in Review Type.