Amendments to Approved Research

The IRB must review changes to previously approved research before implementation. The only exception to this requirement is if it is necessary for the investigator to make a change to the research in order to eliminate apparent hazards to the subject(s).

Changes to Expedited and Full Board Studies

Investigators wishing to revise/amend research that has been approved by expedited procedures or by the full board may submit those changes using the Amendment Form. In addition to the Amendment Form, all applicable documents that need to be revised or added as a result of the amendment must be submitted for review (e.g., changes to the IRB application, recruitment and screening materials, informed consent materials or process, questionnaires, surveys, etc.). Revisions to materials should include a version indicating all the changes (e.g., track changes, highlighting, all capital letters, strikethroughs, etc.) and a clean version for approval.

Changes to study staff should be completed using the Staff Amendment Form.

Changes to Exempt Research

Changes to exempt research are submitted to the IRB using the Clarification Form and are only needed when limited IRB review was used to approve the research, when the change affects the provisions to protect the privacy of the subjects and to maintain confidentiality of the data, when there is a change to the PI, and when the change may alter the criteria so that the research no longer qualifies for an exemption. If you have questions about whether the change you wish to make to exempt research requires review, please contact the IRB office. If changes are necessary to the Exemption Application and supporting documentation, the materials should include a version indicating all the changes (e.g., track changes, highlighting, all capital letters, strikethroughs, etc.) and a clean version for approval.

Amendment Review

Amendments Reviewed by Expedited Procedures

Minor changes in previously approved research may ordinarily be reviewed using expedited procedures, unless those changes:

• Alter the risk to benefit assessment, so as to provide more risk to subjects
• Affect the safety of the subjects
• Significantly alter the study design or scientific aims
• Affect a subject’s willingness to continue participation in the study

Examples of minor changes include:

• Minor wording or formatting changes to consent forms, recruitment materials, or interviews
• Minor changes to enrollment numbers
• Adding/removing/changing a study visit or procedure that does not alter the risks
• Change to the eligibility criteria if it does not affect the risk/benefit assessment

Amendments Reviewed by the Convened IRB

Amendments to research that is reviewed and approved by the convened IRB and that involve more than minor changes will be reviewed at a convened meeting. Changes that are typically considered “more than minor” are those that:

• Add risk to the subjects health, safety or welfare
• Significantly alter the design or scientific aims of the study
• Affect a subject’s willingness to continue participation in the study

Examples of changes that may require review at a convened meeting include:

• Addition of a vulnerable population
• New Information about risks to subjects
• Removal of safety evaluations
• Any change determined by the IRB to not meet the criteria or intent of a minor change