IRB Amendment Type

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NOTICE

From: Research Compliance Administration
Subject: Guidelines for Determining an Amendment Type

Modifications to Previously Approved Research. The IRB requires that any proposed changes in approved research, during the period for which IRB approval has already been given, be reviewed and approved prior to implementing these changes to determine whether the modified research continues to fulfill the criteria for approval, except where necessary to eliminate apparent immediate hazards to the human participants. Investigators may request approval of proposed changes by the completion and submission of an Amendment form. This guidance document provides additional information for determining whether an Amendment may be reviewed and approved using expedited review procedures or if the Amendment must be reviewed at a convened IRB meeting. Please note that it is ultimately the RCA staff and IRB who makes the review level determination.

Minor Changes in Approved Research. Minor amendments are reviewed using the expedited review procedure. Proposed change(s) are considered minor when the research meets all of the following criteria:

the proposed change(s) do not significantly alter the risk to benefit assessment;
the proposed change(s) do not significantly affect the safety of the subjects;
the proposed change(s) do not involve the addition of invasive procedures (procedures not otherwise eligible for expedited review, e.g. collection blood samples in limited amounts;
the proposed change(s) do not involve the addition of procedures, interactions or interventions that add significant medical, social, or psychological risks;
the proposed change(s) do not involve addition of a vulnerable population in research not otherwise eligible for expedited review; and
the proposed change(s) do not significantly alter the scientific question or the scientific quality of the study

Examples of minor amendments:

Decrease in the amount of blood drawn
Title change
Principal investigator change
Addition of co-investigators
Clarifiaction of issues
Additional risks due to advers event (e.g. IRB requested addition)
Dose reduction
Requested changes by Radiation Safety Office
Extended accrual period
Addition of urine pregnancy test
Addition of audio taping
Advertisements or changes in recruitment when changes are easily compared to the informed consent document
Final taped message prepared from IRB-approved text
Addition of subjects

Major Changes in Approved Research. Major Amendments are reviewed at a convened IRB meeting. Proposed changes potentially involve increased risks or discomforts or decrease potential benefit.

Examples of major amendments:

Increase in the amount of blood drawn
Safety issues
Extension of the study duration
Multiple changes in the study design
New software in devices
Additional arm added to the study
Additional population
Increase in the medication dose
Increase in infusion rate
Additional radiation exposure
Addition of videotaping of subjects