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What Is WIRB Protocol?

Western Institutional Review Board (WIRB) is a for-profit independent IRB providing oversight to institutions that conduct clinical studies requiring human subject protection. Studies submitted to WIRB for review must abide by clinical research guidelines defined by the National Institutes of Health.

  1. Requirements

    • WIRB reviews industry-sponsored and industry-initiated research projects that meet the clinical trial provisions of the National Institutes of Health and the Food and Drug Administration. Research projects generally benefit a for-profit entity. Faculty for academic institutions who serve as principal investigators for industry-sponsored research often use WIRB.

    Review Process

    • Private and public institutions send research protocols, sample consent forms and other study-related documents to WIRB for review. A panel at WIRB evaluates the scientific merits behind each study and verifies that it meets local compliance standards, including satisfying HIPAA requirements. WIRB then sends any problems discovered during the review back to the sponsor for resolution.

    Study Changes and Adverse Events

    • Study sponsors must notify WIRB of any modifications to the protocol, consent form or subject materials. Adverse events and problems that arise from the study must also be reported to WIRB.

    History

    • Angela Bowen first created WIRB in 1968 to provide human subject protection for endocrinology research studies and incorporated WIRB as a for-profit institution in 1977. WIRB expanded its services to cover both academic and nonacademic institutions in response to the growing body of federal regulations governing human subjects research in the 1980s. In 2003, WIRB became the first independent IRB to receive accreditation by the Association for the Accreditation of Human Research Protection Programs.

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