All investigators should continually assess research protocols to ensure that human subjects are adequately protected from research risks.
If, in the process of conducting research, an investigator discovers that the experience for human subjects differs significantly from that described in the protocol, the investigator should take appropriate action. Modest variation might lead to revision of the consent procedure. Serious reactions might necessitate suspension of research until procedures can be modified to better protect the human subjects.
The investigator is responsible for ensuring that any changes to a protocol are submitted to the IRB for review before the changes are incorporated into research. Only those procedures specifically approved by the IRB may be initiated, unless the change is needed immediately to eliminate hazards to subjects.