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).<\/p>\n
Additions and removals to study staff should be completed using the Staff Amendment Form<\/a>. Study staff amendments are required for all non-exempt research.<\/p>\n 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<\/a>. 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.<\/p>\n Changes to exempt research are submitted to the IRB using the Clari\ufb01cation Form<\/a> and are only needed when limited IRB review was used to approve the research, when the change a\ufb00ects the provisions to protect the privacy of the subjects and to maintain con\ufb01dentiality 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.<\/p>\n To initiate a change in the Principal Investigator (PI), follow these steps:<\/p>\n Minor changes in previously approved research may ordinarily be reviewed using expedited procedures, unless those changes:<\/p>\n Examples of minor changes include:<\/p>\n 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<\/a>. Changes that are typically considered “more than minor” are those that:<\/p>\n Examples of changes that may require review at a convened meeting include:<\/p>\nChanges to Exempt Research<\/h2>\n
Changes to the Principal Investigator on an Active Study<\/h2>\n
\n
Amendment Review<\/h2>\n
Amendments Reviewed by Expedited Procedures<\/h3>\n
\n
\n
Amendments Reviewed by the Convened IRB<\/h3>\n
\n
\n