Modifications

Modifications to Approved Research

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 HRPP SOPs, 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 not require a submission, and if it does, it will be reviewed by the HRPP Staff. Minor changes, such as increasing sample size or adding a new survey, may be reviewed by the IRB Chair or Vice-Chair, or designee. Changes that are non-minor, for example, increasing the risk of the study or introducing a new study arm, may require review by the convened IRB. 

Written notifications of review actions will be communicated to the PI through OneAegis. If the request is approved and includes changes to the consent process, 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

PI Responsibilities:

• To conduct the study in accordance with the relevant, current protocol
• To submit a complete description of the proposed changes, when necessary, and receive written approval before implementing changes (unless necessary to address an immediate harm/hazard to participants)
• For administrative changes to exempt research, record those in the study records and report the summary of changes during the annual progress report
• 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. 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.
• 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
• Do exempt studies require Modification approval?

  Studies that are determined IRB Exempt have more flexibility about which changes require prospective approval of the HRPP. Modifications are only required to be submitted if the change is substantive and could alter the exemption status, risk assessment, or ethical considerations, or as specified in SOPs for specific changes. All changes must be documented in the study records and summarized in the administrative check-in.

  Changes that would NOT require a modification include: increasing the number of participants, adding/removing study staff (other than PI), correcting typos, adding survey measures that align with what was already approved, adding a recruitment method that uses the same approved message, etc. Changes like these can be implemented without IRB approval and should be documented in study records for audit/compliance review and reported in summary form during the annual progress report.

  Changes that WOULD require a prospective modification approval include:

  • Adding new identifiable data elements or access to new records
  • Adding new performance sites or collaborating institutions
  • Adding or changing study sponsors and/or funding sources
  • Adding deception and/or incomplete disclosure
  • Changing something that ultimately reduces privacy/confidentiality
  • Bringing in HIPAA/FERPA applicability or other regulatory/legal/local-context concerns
  • Adding any vulnerable, stigmatized, or marginalized populations
  • Adding new methods of data collection (e.g., adding a focus group when the study was only approved for online survey)

  If the PI is unsure whether a modification is or is not required, please reach out to the HRPP office for guidance.