Chemotherapy Biotherapy Certification ONS Practice Testq

What must hospitals have to participate in clinical trials?

1. Informed consent committee

2. Institutional review board

3. Patient safety liaison

4. Clinical trial funding

The correct answer is: Institutional review board

To participate in clinical trials, hospitals must have an institutional review board (IRB). The IRB is an independent committee that plays a crucial role in the ethical oversight of clinical research. Its primary function is to ensure the protection of the rights, welfare, and well-being of research participants. The board reviews the trial protocols, informed consent documents, and the overall methodology to ensure that the research complies with ethical standards and regulatory requirements. The presence of an IRB is essential because it helps to minimize potential risks to participants and ensures that they are fully informed about the nature of the study and any risks involved before giving their consent. This oversight is a fundamental requirement outlined by regulatory agencies such as the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS). Informed consent committees, while important, are typically part of the broader responsibilities of the IRB and not a required separate entity. Patient safety liaisons and clinical trial funding serve specific roles that may support clinical trials but are not mandatory for participation.