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

Additions and removals to study staff should be completed using the Staff Amendment Form. Study staff amendments are required for all non-exempt research.

Investigators wishing to revise/amend research that has been approved by expedited procedures or by the full board may submit non-study staff 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 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, faculty advisor, or when adding external staff, 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.

Changes to the Principal Investigator on an Active Study

To initiate a change in the Principal Investigator (PI), follow these steps:

1. Complete and submit a Staff Amendment Form: This form should include information about the current PI and must be signed by the outgoing PI, the incoming PI, and the department chair for the new PI.
2. Revise the currently-approved IRB Application: Update the IRB application to include the new PI’s information in the appropriate sections. The revised application should be signed by both the new PI and the department chair for the new PI.
3. Update study documents: Revise relevant study documents (e.g. consent forms, recruitment materials, etc.) to reflect the new PI’s name and contact information. Please submit marked copies of the revised documents in Word format. If the study is in data analysis only and changes are not relevant to all study documents, only submit those documents that require revisions.
4. Submit updated Conflict of Interest (COI) information: Be sure to have the incoming PI submit required disclosure updates to the FCOI Office.

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

A full list of IRB meeting dates is available on the IRB Submissions Timeline page.