Determination Overview
All amendments or modifications to currently approved research must be approved by the IRB prior to implementation, except when necessary to eliminate apparent immediate hazards to the human subjects.
Amendments or changes to the protocol are sometimes referred to as “modifications.” Amendments can also be included with the submission of a Continuing Review. Please reference the Researcher Guide for Amendments & Renewals located on the WVU OHRP website, under IRB guidance, for information on how to create an amendment in protocol submission system.
Full Committee Review
Amendments that do not meet the criteria for expedited review must be reviewed by the Full Committee at a convened meeting. Researchers should allow approximately a month (or more) for a Full Committee review and approval of a major amendment. Please consider IRB dates and agenda deadlines.
Expedited Review
Amendments that meet the criteria for expedited review will be reviewed, at a minimum by one board member as designee or the Chair, according to Expedited Review procedures. Researchers should allow approximately two weeks to one month for an expedited review and approval of a minor amendment reviewed by the expedited process. This is protocol and amendment dependent.
Amendments to protocols that were initially reviewed using the Expedited procedures or by Full Committee may be reviewed by Expedited Review if the amendment fulfills the criteria:
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Initially Approved by Expedited Review Process |
Initially Approved by Full Committee Review |
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Amendments that do not fulfill the above criteria may require Full Board review.
Major and Minor Determination
The following table provides examples of minor changes (reviewed by expedited review procedures) and major changes (reviewed by full board procedures dependent upon the overall level of risk) to previously approved protocols.
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Minor Changes |
Major Changes |
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Minor changes to study documents such as surveys, questionnaires or brochures |
New risk information that could affect the participants willingness to participate in the study. |
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Addition of a new study site (in many but not all cases) |
Major changes to protocol documents given to study subjects. |
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Decrease in the number and volume of sample collections as long as they do not negatively alter the risk/benefit ratio of the study |
New or revised financial conflict of interest management plans (e.g., change in PI or change to study design). |
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Translations of materials already reviewed and approved by an IRB |
Changes in inclusion/exclusion criteria that impact the risk/benefit ratio of the study |
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Editorial changes that clarify but do not alter the existing meaning of a document |
Major changes to the research design and/or research objectives |
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New study documents to be distributed to or seen by subjects that are similar in substance to those previously approved |
Changes to the protocol that affect the risk/benefit ratio adversely or increase risk to study subjects. |
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Changes in payment to subjects or the amount subjects are paid or compensated that are not significant enough to affect the risk/benefit ratio of the study |
Significant changes in study design, as the addition of a new subject population or the elimination of a study arm |
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Minor changes to recruitment procedures, recruitment materials or submission of new recruitment materials to be used in accordance with approved recruitment methods |
New study documents to be distributed to or seen by subjects that include information or questions that are substantively different from materials already approved by the IRB. |
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Minor consent form changes |
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Administrative Changes |
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Additions or changes in study personnel |
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NOTE: The examples above are provided as guidance, the WVU IRB will determine the appropriate level of review.