Research Regulatory Offices

Research Compliance and Integrity

The purpose of the Office for Research Compliance and Integrity is to provide the Institute with confidence that all research is conducted according to the highest scientific and ethical standards and in compliance with applicable laws, rules, regulations and policies.  

Biomedical research is highly regulated.  Our goal is to ensure NCH researchers and administrators are aware of and compliant with PHS, DHHS, NIH, FDA, OHRP, ORI, or any other government agencies with authority over research activities.

The key to maintaining a high level of compliance in research is to stay knowledgeable about and communicate the rules related to human and animal subject protections, grants management, research misconduct, conflicts of interest, and clinical trial oversight, registration and billing.
The research compliance and integrity mission is accomplished primarily via:

• Written policies
• Communication, education and training for researchers
• Auditing and monitoring of clinical trials
• Maintenance of a hotline to receive complaints
• Investigation of  any allegations of improper/illegal activities
• Remediation of identified problems
• Reporting to executive management  via the NCH Corporate Compliance Officer

Research Conflict of Interest

The Research Institute manages the significant financial interests of Investigators in order to ensure research is free from bias that could result from an investigator’s financial interests.  For more information, refer to our Research Conflict of Interest Policy.  Written requests for public disclosure about a named recipient must be submitted to the following address:

               Vice President and Corporate Compliance Officer
               Nationwide Children’s Hospital, Inc.
               255 East Main Street, Office 231
               Columbus, OH 43215

All written requests will receive a written response within five (5) days of receipt.  

For more information about other compliance topics, please visit the Office of Research Compliance and Integrity website.

To Report a Concern Anonymously, available 24 hours a day, 7 days a week:
Call the Hotline: 1-877-267-1935    
Report Online: https://NationwideChildrens.alertline.com

Jessica Evans, CHRC, RQAP-GLP
Director
Office of Research Compliance and Integrity
700 Children’s Dr.
Columbus, Ohio 43205
(614) 722-2599
Jessica.Evans@NationwideChildrens.org

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 Nationwide Children’s Hospital 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).  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.

For more information, please contact:
Alex Rakowsky, MD
Chair, NCH IRB
(614) 722-2400
Alex.Rakowsky@NationwideChildrens.org