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Protocols and IRBs

A clinical trial requires a well-designed protocol, collaboration among various medical specialties, and timely and accurate reporting of the findings. It is conducted under the direction of a principal investigator (PI) and approved by an Institutional Review Board.

What Is a Protocol?

A protocol is the study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment. Every doctor/researcher and research facility involved in the clinical trial must follow the protocol.

Role of the Institutional Review Board

An institutional review board (IRB) is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim of protecting the rights and welfare of the research subjects. The purpose of an IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect those individuals participating as subjects in a research study. To accomplish this purpose, IRBs review research protocols and related materials (e.g., informed consent documents and investigator brochures) on an ongoing basis throughout the duration of the clinical trial.

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