Module 5 Journal Quiz Question

Journal Quiz 5 Question: Discuss your understanding of the scope, purpose, and function of the Institutional Review Boards (IRB).

Module 5 Journal Quiz Answer

My Understanding of the Scope, Purpose, and Function of the Institutional Review Boards (IRB)

            IRB is an appropriately constituted group under the FDA regulation formally designed to review and monitor all biomedical research projects involving human subjects as participants. My understanding of the IRB’s purpose is that the agency protects human beings when they are subjects in research. IRB ensures that the researchers have taken the appropriate steps to protect the rights of human subjects and their welfare. Human subjects’ rights include the right to confidentiality, privacy, and the right to enter and exit the study at will. To complete its purpose, the IRB utilizes a group process to review the relevant protocols and materials to ascertain that human participants are protected from harm. FDA regulations regulate the scope of the IRB. Under the FDA regulations, IRB has the authority to approve, request modification, or disapprove a research project (Federal Drug Administration, 2019). The basis of approval or disapproval is the relevant federal, state, or university regulations.

            I believe that IRB acts as a watchdog, ensuring that researchers adhere to relevant ethical standards and regulations protecting the subjects. The primary function of an IRB is protecting the rights and welfare of human subjects. IRB also ensures that the involved researchers, affiliate institutions, and respective investigators comply with the relevant ethical standards, principles, and human subject research regulations. Although the investigator in the research has the primary responsibility to ensure that research protocols are in accordance with the applicable regulations and standards, the IRB office offers assistance to the investigator to ensure compliance. IRB assesses potential risks in research, considers the probability of the risk occurring, and determines the degree of harm that may be caused.


Federal Drug Administration (2019). Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical Trials.

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