Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

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What type of information might an IRB/IEC request to improve participant safety?

Detailed marketing strategies
Participant performance metrics
Additional backgrounds on the investigational drug
Costs associated with the trial

The correct answer is: Additional backgrounds on the investigational drug

An Institutional Review Board (IRB) or an Independent Ethics Committee (IEC) is responsible for ensuring that research involving human participants is conducted ethically, with a primary focus on participant safety and well-being. One of the critical areas of concern for these review bodies is the investigational drug or intervention being studied. Requesting additional background on the investigational drug is essential for several reasons. This includes understanding its pharmacology, mechanism of action, potential side effects, and any previous data regarding its safety and efficacy from preclinical studies or other trials. Such information helps the IRB/IEC assess the risk-to-benefit ratio of the research. They need to ensure that participants are not exposed to unnecessary risks and that safety measures are in place. By collecting comprehensive and relevant information on the investigational drug, the IRB/IEC can make informed decisions regarding the ethical approval of the study and recommend necessary modifications to protect participants. This context is crucial for evaluating the nature and severity of risks involved, ensuring that adequate monitoring and safety protocols are implemented during the trial.