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Major and Minor Amendments

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:

Initially Approved by Expedited Review Process

Initially Approved by Full Committee Review

  1. The amendment continues to pose no more than minimal risk to subjects.
  2. The amendments do not involve any procedures that do not meet Expedited categories 1 through 7.

  1. Amendments do not pose an increased risk to subjects; AND
  2. Amendments constitute a minor change to previously approved research (see examples below).
  3. Any added procedures must fall within Categories (1)-(7) of research that may be reviewed using the expedited procedure.

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.

Minor Changes

Major Changes

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.

Addition of a new study site (in many but  not all cases)

Major changes to protocol documents given to study subjects. 

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).

Translations of materials already reviewed  and approved by an IRB

Changes in inclusion/exclusion criteria that  impact the risk/benefit ratio of the study

Editorial changes that clarify but do not  alter the existing meaning of a document

Major changes to the research design and/or research objectives

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. 

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

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.

Minor consent form changes


Administrative Changes


Additions or changes in study personnel


NOTE: The examples above are provided as guidance, the WVU IRB will determine the appropriate level of review.