Researchers should always commit to the highest standards of ethical conduct. The protection of human subjects participating in research is a shared responsibility of all researchers and the Institutional Review Board (IRB).
Environmental or situational factors may impact an already approved IRB protocol. Modifications to a protocol are designed to ensure researchers are responding to their environment and the needs of their participants. While every IRB protocol is different, there are some common reasons why an investigator may want to change an existing protocol. For example:
- Changes in key research staff
- Changes in a funding source or new requirements from grant funded research
- Changes to a recruitment site
- Changes to the study purpose or procedures—For example, adding a new study instrument (e.g., survey or follow-up interview) or data collection falling outside the parameters of the previously approved IRB protocol.
- Changes to the study population—For example, adding a new study population, increasing the recruitment effort, or substantively revising the inclusion or exclusion criteria for the current population.
- Changes to the data storage or changes to the confidentiality of the received or recorded research data—For example, the exempt application states that the investigator will not collect names on their surveys, but later the investigator decides to record identifiable data from an existing dataset.
- Changes to the risks involved in the study—For example, unanticipated risk of being in the field or adding new safeguards to protect participants.
Federal regulations require that all modifications to approved research may not be implemented without prior IRB review and approval (except where necessary to avoid immediate hazards to participants).
IRB procedures, policies, and standards ensure we act responsibly, ethically, and in compliance with federal, state, and local regulations. If researchers have reasons to modify an existing IRB protocol, they should contact their IRB administrator.