The FDA requires that all research to be conducted in humans be approved or declared exempt by an institutional review board (IRB). Many institutions have established their own IRBs to review the research being conducted within their own facility. The FDA holds the individual institution responsible for meeting all federal regulations applicable to the functioning of the IRB. Institutions often find it difficult to maintain compliance with federal regulations due to many reasons including lack of personnel trained in the federal regulations protecting human subjects; limited available time and resources; inability to obtain required membership to conduct review meetings; and poor record keeping.
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As a result, a growing number of academic and hospital institutions are contracting with independent IRBs for the review of all clinical research to be conducted within the institution. An independent IRB is a review board that is not owned or operated by the research organization for which it provides review services. The independent IRB is subject to the same federal and state regulatory requirements applicable to all IRBs.
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In response to the growing need for compliance with the federal regulations, independent IRBs specializing in the protection of human subject rights have developed across the United States.
P R I N C I P A L I R B is an independent IRB that maintains the ability to review all types of research and is FDA compliant.
REVIEW BY PRINCIPAL IRB FOR
INSTITUTIONS’ RESEARCH INCLUDES:
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Research review initiated by drug or device sponsors will be provided at no cost to the institution, but will rather be financed through individual fees to be paid by the drug or device sponsors of the research.
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Research conducted within the institution by personnel (e.g. residents, nurses) or through grants will be reviewed at a reduced rate.
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The institution will receive comprehensive reports for the research currently being conducted within the facility.
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For existing and ongoing studies at an institution, the FDA does not permit studies to be “transferred” to another IRB, but require each study is reviewed by the new IRB. Although this process may seem cumbersome, it protects the institution and quickly establishes compliance for any study which may have inadvertently been approved without following the regulatory guidelines. The transition is generally completed quickly, and does not interfere with any ongoing research.
Following this transition, the institution will request investigators involved in the research to submit their new studies to P R I N C I P A L I R B.
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Have more questions about P R I N C I P A L I R B's review of Institutional Research?
Please do not hesitate to CONTACT US or call 919-910-7743.