Any proposed change to research previously approved by the fully convened IRB requires review and approval by the IRB prior to implementation. Minor changes must be reviewed by at least one member of the IRB and may not require consideration by the fully convened IRB. Substantive changes will require review by the fully convened IRB.

Minor Changes to Full Board Research

Minor changes to studies previously determined to require Full Board review are likely to qualify for an expedited review procedure. 

• Minor changes typically include:

  • Administrative changes such as editorial changes, wordsmithing, addition of clarifying questions, addition or deletion of similar questions to those previously approved

  • Revisions to recruitment & consent materials/methods that are similar to previously approved such as a new advertisement using similar language previously approved or adding a clarifying statement in the consent form

  • Revisions to study instruments or other materials that do not fall outside the scope of the original approved instruments and do not alter risks to participants

  • Adding or changing study personnel

  • Adding a new study site (in most cases)

Submission Requirements for Minor Changes

Prepare an Amendment Application and include all applicable materials. At least one member of the IRB will conduct the review and determine if the proposed changes are minor and if IRB approval criteria are still satisfied.

• If changes are determined to be minor and qualify for Expedited Review, at least one member of the IRB will conduct the review and RCS will communicate any additional requirements to secure approval.
• If changes are determined not to be minor, the amendment will be reviewed by the fully convened IRB. RCS will communicate next steps to the investigator.

Substantive Changes to Full Board Research

Substantive changes to studies previously determined to require Full Board review will require review by the fully convened IRB.

• Substantive changes include but are not limited to:

  • Changes that adversely affect the risk/benefit ratio of the study or specifically increase the risk to subjects

  • Changes that significantly alter the risk to benefit assessment or affect the safety of subjects

  • Changes that involve the addition of procedures, interactions, or interventions that add significant physical, social, or psychological risks

  • Changes that significantly alter the hypothesis or research design

  • Changes in inclusion/exclusion criteria

  • Changes to a study population

  • Significant changes in study design

  • New or revised financial conflict of interest disclosures and/or management plans

Submission Requirements for Substantive Changes

Prepare an Amendment Application and include all applicable materials. The proposed changes will be reviewed by the fully convened IRB to determine if the study continues to satisfy the IRB approval criteria. RCS will communicate next steps to the investigator.