Good Clinical Practice (GCP) Practice Exam

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What is one of the essential components of an IRB according to the ICH GCP?

A minimum of three members
Members must be from the same institution
At least one member must have a nonscientific area of interest
Members must be involved in the protocol's administration

The correct answer is: At least one member must have a nonscientific area of interest

One of the essential components of an Institutional Review Board (IRB), according to the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, is that at least one member must have a nonscientific area of interest. This requirement is critical because it ensures that the IRB has a diverse perspective when reviewing research proposals. A member with a nonscientific background can bring insights related to ethical, social, or community issues that may not be apparent from a purely scientific viewpoint. This diversity contributes to a more comprehensive review of the ethical considerations involved in clinical research. Having nonscientific members helps to protect the rights and welfare of participants by ensuring that their perspectives are considered in the decision-making process. It promotes a more holistic approach to research ethics, recognizing that the implications of clinical trials extend beyond scientific merit or feasibility. This aspect of IRB composition highlights the commitment to ethical standards and participant welfare in the research process, a cornerstone of GCP principles. A balanced perspective on ethical issues is essential in conducting responsible research, making this element an integral part of the IRB’s function.