INTERNATIONAL REVIEW BOARD

International Review Board

International Review Board

Introduction

Institutions that participate in human subject research uphold administrative bodies recognized as Institutional Review Boards (1RBs). Institutions charge their IRBs with protecting the rights and welfare of the people who participate in studies conducted under their auspices (Shopes, 2000).

IRBs first appeared following World War II, and became prominent after 1974, when the federal regulations of human subject research identified them as fit mechanisms for protecting research participants. In 1981, following a significant revision of Department of Health and Human Services (DHHS) and Food and Drug Administration (FDA) regulations pertaining to human subject research, IRBs became ubiquitous. This paper aims to discuss whether central and local IRBs are equivalent in their role in the protection of human subjects or not (Gordon, 1997). The Institutional Review Board (Institutional Review Board - IRB) is an autonomous agency designated to approve, monitor, examine, ensure and protect the rights and welfare of those subjects participating in research projects conducted at our institution. The IRB is responsible for ensuring compliance with the Basic Policy of the Department of Health and for the protection of Human Subjects in Research.

Institution has a firm commitment to protecting the rights of persons involved in investigations. Therefore, any research that involves the participation of people can begin until the Institutional Committee for the Protection of Human Subjects in Research has reviewed and approved the research protocol, or has been exempted from future review. All researchers (faculty, staff or student) conducting research with human subjects without adequate review and prior approval of the Institutional Committee for the Protection of Human Beings will default to the institutional rules (Gordon, 1997).

Thesis statement

Central and local IRBs are equivalent in their role in the protection of human subjects.

Discussion

The mission of the IRB is to review research involving human subjects to ensure that the risks to human subjects are minimized, and the rights and welfare of human subjects are protected. All research with human subjects must be approved by the IRB or declared exempt from the Federal Policy before the research may begin (Vagts, 2002).

IRB Local

An IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. According to FDA regulations, an IRB has the authority to approve, require modifications or disapprove a study. This type of IRBs are those that are located within an institution (whether a hospital, university, etc).

IRB Independent

This type of IRBs are used when under certain circumstances, the local IRB is not available, for example, when the researcher is not required to use a local IRB, for any researcher who is not affiliated to any institution, when the trial is conducted in private practice, or when the institution has no IRB itself. Although the FDA regulations are conceptualized for the review of a trial by a local IRB, it is forbidden to use IRBs that are off-site where research is being conducted. Also known as non-institutional IRB or ...