Final answer:
Amendments to IRB-approved protocols typically require prior IRB approval unless they aim to eliminate immediate hazards to participants. IRBs review changes to ensure ethical conduct and participant safety in research studies.
Step-by-step explanation:
IRB Protocol Amendments
Amendments involving changes to IRB-approved protocols generally require prior IRB approval. An IRB, or Institutional Review Board, is integral to the ethical conduct of research as it assesses the potential risk to human participants. Sometimes, minor changes like changing funding sources may not require approval, but substantial changes certainly do. This includes alterations that could influence participant risk, involve changes in study procedures, or change in the informed consent process. IRBs exist to protect the rights and welfare of human research subjects and to ensure that the research is conducted in accordance with all applicable regulations.
Exceptions to requiring prior IRB approval for protocol amendments may include cases where there is an immediate hazard to the subject's safety, or if the change is necessary to eliminate apparent immediate hazards to research participants. All other changes usually require the IRB's review and approval before implementation. It is imperative that researchers follow IRB guidelines strictly and report any modifications for review to uphold the integrity of the research and protect participants.