Research Regulatory Offices

The Office for Research Compliance and Integrity

The Office for Research Compliance and Integrity provides the institution with confidence that all research is conducted according to the highest scientific and ethical standards.  This mission is accomplished primarily via educational programming and auditing.  The Office serves as a central collection point for reviewing, analyzing and reporting research compliance and integrity data.

For more information, please contact:

Jessica Evans, RQAP-GLP
Director, Research Compliance
(614) 722-2599
Jessica.Evans@NationwideChildrens.org

Report a Concern Anonymously
Corporate Integrity Hotline: 1-877-267-1935
Available 24 hours a day, 7 days a week

Report a Concern Online: https://nationwidechildrens.alertline.com
 

Institutional Review Board (IRB)

The purpose of Nationwide Children's Institutional Review Board (IRB) is to review and provide oversight of all research involving human subjects at Children's Hospital, Inc and its affiliated institutions. This function is federally-mandated and regulated by the Department of Health and Human Services (45 CFR 46, including Subpart D which applies specifically to research in children) and the Food and Drug Administration (21 CFR 50 and 56). Children's Hospital, Inc and the IRB exempt no research from review and approval. In addition the IRB is guided by the tenets of the Belmont Report, the International Committee on Harmonization's statement on Good Clinical Practices and the Declaration of Helsinki. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy. Research that has been reviewed and approved by the IRB may be subject to review and disapproval by officials of the institution. However, those officials may not approve research if it has been disapproved by the IRB.

The Institutional Review Board (IRB) conducts a scientific, ethical, and regulatory review of all research involving children and adults at Nationwide Children's Hospital and its affiliated organizations. Meetings of the full board are held twice a month to review protocols. In 2002, the IRB offices underwent a routine inspection by Food and Drug Administration officials. Finding no deficiencies during this intensive five-day review, the inspectors reported that the IRB adheres to applicable statutory requirements and government regulations. Additional submission forms and relevant information were added to the IRB intranet site to improve access, education, and service. At year-end, 435 active clinical research projects were on file in the IRB office, which is a testimony to the breadth and depth of clinical research operations on the campus.

The Children's Hospital IRB membership includes an ethicist, psychologists, pharmacologists, physicians, Ph.D.s, nurses, lay persons, and individuals unaffiliated with Children's. The composition of the committee is strictly regulated by the federal government The IRB members take their responsibilities seriously and are among the hardest-working committee members at Children's Hospital.

For more information, please contact:

Alex Rakowsky, MD
Director, Regulatory Compliance
(614) 722-2400
RakowskA@ccri.net