Modifications to Approved Research
When and How to Modify an Approved Protocol
Once a protocol has received approval (initial or continuing) by the 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 devation.
To request approval of a proposed modification, complete and submit a Modification Request Form.
Note: Approved modifications do not extend the approval period of the protocol.
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Types of Modifications
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.
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:
Examples of minor changes to a protocol include but are not limited to, the following:
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Addition/deletion of study personnel or change in their role in the study
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Addition of new research activities that would be considered
Exempt or
Expedited if considered independently from the main research protocol
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Modest increase or decrease in proposed enrollment target
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Alterations in the dosage form (e.g., tablet to capsule or oral liquid) a drug, provided the dose and route of administration remain constant
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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
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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
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Reductions or minor changes in participant payment or liberalization of the payment schedule with proper justification
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Addition/deletion of study sites with proper authorization from the site(s)
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Addition of or revisions to recruitment materials or strategies
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Editorial changes to the approved documents (e.g., correction of typographical errors)
Examples of significant changes to a protocol may include, but are not limited to, the following:
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Addition of a new subject population (e.g., control group, additional cohort, etc.)
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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.)
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Addition of surveys/questionnaires/interview procedures that could have adverse psychological consequences for subjects or damage their financial standing, employability, insurability, or reputation
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Addition of blood/tissue/cell banking or genetic testing
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Deletion of follow-up visits that appear necessary for monitoring subject safety and welfare
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Addition of new significant risks to the Informed Consent Document
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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
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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 provide two (2) versions of the revised documents with the electronic modification request:
1. A clean copy of each revised document (changes not highlighted), and
2. A highlighted/redlined copy of each revised document (all deletions redlined and additions highlighted).
Consent Forms
Leave both the approval and expiration dates blank (clean copy)
List the IRB File # in the footer (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-1: If submitting a Modification Request Form to *only* revise study personnel, it
is only necessary to submit the clean copy of the revised study documents.
Additions - Include the training dates & NR1 - Signature Page for Additional Personnel after Study Approval with original signatures of staff to be added. Specify their role in the study (i.e. Principal Investigator, Co-Investigator, Research Coordinator, etc.)
Revisions - Notify the IRB if the role of personnel already on the study will change and provide an NR1 - Signature Page for Additional Personnel after Study Approval with original signature of the personnel affected (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 NR-1 listing.
Responding to IRB stipulation requests
All submissions to the IRB must be signed by the study Principal Investigator. This includes all revisions to study documents, continuing reviews, initial review documents, and any responses to stipulations or audits.
If we receive an email directly from the PI with a response to stipulations, then the signature is not needed.
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