Certification for IRB Professionals (CIP) Practice Exam

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What is the purpose of protocol amendments in research?

  1. To change the lead researcher on a study

  2. To update the IRB on changes and ensure ongoing compliance

  3. To terminate a study early

  4. To increase the number of subjects involved

The correct answer is: To update the IRB on changes and ensure ongoing compliance

The purpose of protocol amendments in research is primarily to update the Institutional Review Board (IRB) about any changes to the study protocol, thereby ensuring ongoing compliance with ethical standards and regulations. Protocol amendments may be necessary due to various reasons, such as findings from interim data analysis, changes in the research environment, or improvements in the methodologies being employed. By notifying the IRB, researchers facilitate oversight, ensuring that the safety and rights of participants are maintained throughout the study's duration. This process helps randomize changes in research design or methodology while aligning with ethical standards and regulatory requirements. In contrast, changing the lead researcher, terminating a study early, or increasing the subject count might be specific scenarios that could require a protocol amendment, but they don't encapsulate the broader purpose of maintaining compliance and protecting participant welfare, which is fundamental to the role of the IRB.