Modifications to Approved Research
Any change to an approved protocol must be approved by the IRB before being implemented. This includes changes that reduce risks to subjects as well as administrative changes such as adding or removing investigators. Amendments are to be reported to the Institutional Review Board using the Modification Form. The IRB only recognizes one exception to this rule, specifically where the change is necessary to eliminate apparent immediate hazards to the participants. In such cases, the investigator must submit a report to the IRB explaining the event.
Review of Modifications – Exempt or Expedited
An IRB staff member screens the modification form and, if applicable, the protocol, consent form or material required for submission for completeness and corresponds with the PI by e-mail and/or phone until the submission is complete. The IRB staff conducts a preliminary review of the modification form to determine if the requested amendment is eligible for review under exempt or expedited procedures. To be eligible for review under the exempt or expedited procedures the amendment must be minor. A minor change is one which makes no substantial alteration in:
- The level of risk to participants;
- The research design or methodology;
- The participant population;
- Qualifications of the research team;
- The facilities available to support the safe conduct of the research; or
- Any other factor which would warrant review of the proposed changes by the convened IRB.
If the IRB Chair or an IRB member determines that the research qualifies for exempt or expedited review, the modification is reviewed in the same manner as a new expedited protocol submission whereby IRB staff conducts a preliminary review and forwards the review to the IRB Chair or an IRB member. Modifications of research involving vulnerable populations may be approved via the expedited process. However, for research involving prisoners, the prisoner advocate will also be asked to review the requested change or addendum to determine that it meets the definition of minor change to previously approved research.
Review of Modifications – Full Board
A PI may amend his/her approved protocol by submitting a modification form. The application form used for amendments for exempt, expedited, and full board review is the same. Minor changes can be approved by exempt or expedited review. All other changes will be reviewed by the full board.