Understanding the difference between “minor” and “major” changes
IRB Committee Member Help: Understanding the difference between “minor” and “major” changes. When reviewing a study at a convened meeting of the full committee, the IRB can approve research, with “minor” changes to be verified by the Chair. When the IRB requires the researcher make changes and asks the IRB Chair to verify the changes, this review by the Chair of minor changes represents expedited review. Review of modifications by the chair has to follow regulations governing expedited review. If the Chair is asked to evaluate, or make a judgment about, or assess, or otherwise make a substantive determination on behalf of the full board, then the change cannot be approved by the Chair, because the Chair is doing more than verifiying.
The table below summarizes the differences between “minor” changes that may be verified by the Chair, and “major changes” that require deferral of approval and review by the convened IRB.
| Minor changes | Major changes |
| “Minor” changes mean changes that are approvable under expedited criteria | “Major” changes involve information directly relevant to the IRB’s required regulatory determinations (for example, that risks to subjects are minimized). |
| Minor changes may be verified by the IRB Chair after a convened meeting under expedited criteria | Major changes require the convened IRB assess and determine whether regulatory criteria are met; not verifiable by the IRB Chair alone because the convened IRB must evaluate |
| A “minor” change must be specified by the IRB at a convened meeting (that is, listed in reviewer comments and included in minutes). | Broad instructions to researchers require the convened IRB review the researcher’s response (for example, “Revise the injury language section so it does not include exculpatory language” requires review by the convened IRB to determine whether the researcher’s proposed revisions are acceptable. The convened IRB may not approve without a complete description of proposed changes). |
AAHRPP provides the following note about minor changes: “The IRB should exercise caution before using the expedited procedure to review clarifications, explanations or additional information, or when a subcommittee seems to be needed to review requested modifications. In addition, the IRB should exercise caution before delegating to an IRB member the authority to negotiate changes without review of those changes by a convened IRB.”
| Example “minor” changes | Example “major” changes |
| Participants must be 18 years or older. | Explain why participants younger than 18 years of age will be allowed to participate |
| Drop the placebo-controlled arm of this study. | Provide additional justification for the use of placebo |
| The consent process (see patient information sheet and consent document, page 2) indicates that participants will be offered counseling services. Include a phone number or contact information for the counseling service in the consent document. | Clarify whether participants will be offered counseling services at the end of the study. |
| Insert the DOH IRB toll-free phone number (866-433-2775) as part of required contact information on page 4 of the consent document. | Revise the consent document so it is readable by the participant population |