Modifications

 Changes to IRB-approved studies

A modification is any proposed change to an IRB-approved protocol, regardless of the level of initial review. When a study is approved by the IRB, it must be carried out as stated in the approved documents.  Any changes must be prospectively approved by the IRB as noted in IRB Policy 10: Modifications, unless the change is necessary to eliminate an apparent immediate hazard to the research participants (See Reportable Events tab for reporting requirements for this exception).

Review of Changes


Administrative changes, such as the correction of typographical errors or adding study staff, may be reviewed by the IRB Staff. Minor changes, such as increasing sample size or adding a new survey, may be reviewed by the IRB Chair or Vice-Chair. Changes that are non-minor, for example, increasing the risk of the study, may require review by the convened IRB. 

Written notifications of review actions will be communicated to the PI through OneAegis (formerly IRBManager). If the request is approved, the final approved consent form(s), if changed, will be stamped and uploaded to OneAegis. Generally, approval of a Modification will not alter the expiration or administrative check-in date already assigned. 

How to submit a modification in OneAegis (formerly IRBManager)

PI Responsibilities:

  • To conduct the study in accordance with the relevant, current protocol
  • To not make any changes to the research without written IRB approval, except where necessary to eliminate apparent immediate hazard to the research participants 
  • To submit a complete description of the modification
  • To include applicable sponsor correspondence if the modification is requested by the sponsor
  • To follow the IRB's determination with regard to the necessity of re-consenting currently enrolled participant or notifying participants who have completed the research interventions 

FAQs

  • Why must changes be reviewed?
    Federal regulations require that changes to IRB-approved research receive prior IRB approval, unless the change is to eliminate apparent immediate hazards to subjects. IRB approval letter notices sent to PIs for each IRB submission state the requirement to receive IRB approval for changes prior to initiation of those changes.
  • What is required to receive IRB approval of changes?
    To initiate IRB review of a change to research, the PI or study staff must submit a Modification Request xform in OneAegis (formerly IRBManager). The form will ask for justification/rationale for the requested changes and will ask if participants need to be notified of the change(s). The xform asks additional questions or requires attachments depending on the type(s) of changes being requested. If changes are being made to the consent or other study documents, both a tracked changes and clean version need to be attached. All new documents must also be attached to the xform for IRB review.
  • How will changes to full board studies be reviewed?
    If your study is greater than minimal risk, or required initial full board review, non-minor changes will require full board review at a monthly convened committee meeting. Please review the meeting schedule and plan appropriately to ensure timely review. Minor changes to approved research do not require convened IRB review.
  • What are minor modifications?

    A minor modification is a proposed change in research related activities that does not impact the risks or benefits associated with the study or change the purpose or design of the study, does not add procedures involving more than minimal risk to participants, and does not add procedures that do not fall into categories (1)-(7) of research that can be reviewed using the expedited procedure. Examples:

    • Changes in the PI
    • Changes to recruitment and advertising
    • Removing a questionnaire or adding survey questions
    • Consent form changes to add/remove information that is consistent with the already approved version
    • Increasing study enrollment numbers
    • Adding a study site that conducts the same protocol already approved by the IRB
    • Changing data storage and backup procedures consistent with university policy
  • What are major changes?

    Major, or substantive, changes are those that increase risk, reduce safety, affect the risk to benefit ratio, alter the study design, or present significant scientific or ethical concerns.  Examples:

    • Major change to study design or research aims
    • Numerous changes to study protocol, consent, and other materials
    • Adding sensitive questions (i.e., suicidality, illicit drug use, sexuality) to the data collection tool 
    • Changes to safety monitoring or safety reports that indicate concerns
    • Expanding eligibility criteria such that the risk assessment is impacted
    • Increases to physical and/or psychological risk/discomfort
    • Adding vulnerable populations to greater than minimal risk research