Modifications

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When and How to Modify an Approved Protocol
Types of Modifications and Examples
Modification Request Submission Process
Modification Guidance
Responding to Stipulations During a Continuing Review
Federal Regulations

When and How to Modify on an Approved Protocol

Once a protocol has received approval (initial or continuing) by the Institutional Review Board (IRB), any subsequent changes to the study must be reviewed and approved by the IRB prior to implementation.

Note: If a change must be implemented immediately to avoid an immediate, apparent hazard, this needs to be self-reported to the IRB as a deviation.

To request approval of a proposed modification, complete and submit a Modification via the new eIRB system. Instructions on how to do this are listed below. Note: With the new eIRB system you will not be able to submit a Modification with your Continuing Review.

Note: Approved modifications do not extend the approval period of the protocol.

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Types of Modifications and Examples

Modifications are categorized into minor changes and significant changes.

Minor modification/change (Expedited review process)

A proposed change in research-related activities that does not significantly affect the risk/benefit ratio of the study and does not substantially change the specific aims or design of the study.

Examples of minor changes to a protocol include but are not limited to:

  • Addition/deletion of study personnel or change in their role in the study
  • Addition of new research activities that would be considered Exempt or Expedited if considered independently from the main research protocol
  • Modest increase or decrease in proposed enrollment target
  • Alterations in the dosage form (e.g., tablet to capsule or oral liquid) a drug, provided the dose and route of administration remain constant
  • A decrease in the number or volume of biological sample collections, provided that such a change does not affect the collection of information related to safety evaluations
  • A decrease in the length of confinement or number of study visits, provided that such as a decrease does not affect the collection of information related to safety visits
  • Reductions or minor changes in participant payment or liberalization of the payment schedule with proper justification
  • Addition/deletion of study sites with proper authorization from the site(s)
  • Addition of or revisions to recruitment materials or strategies
  • Editorial changes to the approved documents (e.g., correction of typographical errors)

Significant modification/change (Full Board review process)

A proposed change in research-related activities that significantly affects the risk/benefit ratio of the study or substantially changes the specific aims or design of the study.

Examples of significant changes to a protocol may include, but are not limited to:

  • Addition of a new subject population (e.g., control group, additional cohort, etc.)
  • Addition of research procedures that involve greater than minimal risk to subjects (e.g., addition of a new drug to a treatment regimen; addition of invasive procedures; change in route or frequency of drug administration, etc.)
  • Addition of surveys/questionnaires/interview procedures that could have adverse psychological consequences for subjects or damage their financial standing, employability, insurability, or reputation
  • Addition of blood/tissue/cell banking or genetic testing
  • Deletion of follow-up visits that appear necessary for monitoring subject safety and welfare
  • Addition of new significant risks to the Informed Consent Document
  • Changes, which, in the opinion of the IRB Chairperson or his/her designee, do not meet the criteria or intent of a minor modification

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Modification Request Submission Process

  • Initial Submissions, unless requested by the IRB, will not be accepted or processed until after a study has been fully approved.
  • Continuing Studies
  • Submitting your Modification via eIRB
  1. Log into eIRB.
  2. Click on My Home in the upper right corner.
  3. In the My Home workspace, click the Studies Tab.
  4. Click on the Study Name for the study you want for Continuing Review.
  5. Select New Modification in the Study workspace.
  6. Complete the Modification Smart Form. Note: You can no longer do a modification to a study at the time of continuing review. All Modifications to the study must be done prior to your continuing review.

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Modification Guidance

If a proposed modification changes any IRB-approved documents (e.g., the protocol, project summary, consent forms, HIPAA Authorization, HIPAA Waiver, etc.), the IRB requires an updated copy of each document to be submitted for IRB review. Be sure to upload two versions of the revised documents with the electronic modification request:

  • A clean copy of each revised document (changes not highlighted), and
  • A highlighted/redlined copy of each revised document (all deletions redlined and additions highlighted).

Consent Forms

Make sure the footer of your consent form is blank. (clean copy)

Enrollment Increases

Provide rationale for the increase in sample size. Please be specific with a brief reference to statistical methodology being used to recalculate the sample size.

Provide the current number of consented subjects for the study.

Personnel

Study personnel who will obtain consent from subjects are required to be listed on the study Consent Form(s).

Note: If submitting a Modification Request Form to *only* revise study personnel, it is only necessary to upload the clean copy of the revised study documents.

Revisions: Notify the IRB if the role of personnel already on the study will change (i.e., Co-investigator will now be the Principal Investigator or if a Co-Investigator will now be the Research Coordinator)

Deletions: Notify the IRB of study personnel who are no longer working on the study and provide reason for their removal from the current submission.

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Responding to Stipulations during a Continuing Review

This information is available on the Continuing Review page.

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References and Additional Guidance

U.S. Office for Human Research Protections (OHRP) and U.S. Food and Drug Administration (FDA) regulations regarding Modifications to Approved Research