The Office for Research Compliance and Integrity (ORCI) provides The Research Institute and Nationwide Children's Hospital with confidence that all research is conducted according to the highest scientific and ethical standards.
ORCI is committed to furthering the mission and strategic plan of The Research Institute at Nationwide Children's by providing the institute with confidence that all research is conducted in compliance with applicable laws, rules, regulations and promotion of the highest scientific and ethical standards.
Director, Research Compliance and Integrity
ORCI requires the efforts and interactions of the following groups and committees:
IRB (the Institutional Review Board) for research involving humans
IACUC (the Institutional Animal Care and Use Committee) for research involving animals
IBCSC (the Institutional Biological and Chemical Safety Committee) for research involving hazardous materials, select agents or recombinant DNA
Patents, Copyrights and Conflicts of Interest Committee
The Office of Clinical Research Administration and the Clinical Studies Center at Nationwide Children's Hospital
ORCI facilitates training and educational opportunities for managing compliance of federal regulations for research purposes. Classroom instruction and personalized presentations are available.
Clinical Research: Putting the Pieces Together
Module I: Ethics and Regulations
Module II: Study Management
Contact Debbie Fine, Director of Research Services, at (614) 355-3416 or at Debbie.Fine@NationwideChildrens.org.
eIRB Training: Navigating the eIRB System
Contact Linda Wilson, IRB regulatory specialist, at (614) 722-2708 or at Linda.Wilson@NationwideChildrens.org.
The Research Compliance program relies on the collaboration and combined efforts of researchers, support staff, and many others. The goal is to provide the information, support, and systems of administration needed to meet the laws, rules, and policies governing research in the most efficient and effective way. The compliance program is designed to be proactive, transparent, and integrated to prevent problems before they happen without impairing research.
In November 2005, the Department of Health and Human Services Office of Inspector General (OIG) released draft compliance program guidance for recipients of research awards from agencies of the U.S. Public Health Service. The document lists eight elements “widely recognized as fundamental to an effective compliance program.”
The Children’s Hospital Research Compliance Program’s foundation is based on these elements, which apply to all Children’s Hospital research staff, administrators, students, and other persons involved in the design, administration, financial management, conduct, and reporting of research of sponsored program activities at or through Children’s Hospital, regardless of the source of funding or the location where the activity is conducted.
ORCI utilizes educational programming, research process auditing and open communication to ensure compliance with applicable laws, rules regulations and promotion of the highest scientific and ethical standards.
Education- Education is a key component of compliance. ORCI works closely with Education staff to develop training material and opportunities, and establish education requirements and documentation systems.
Auditing- A critical component of the ORCI effort is conducting internal audits. The audits are usually of a routine nature, but may be classified as “directed” or "for cause."
Audits may be “directed” as requested by the IRB or as preparation of investigators for external inspection from a sponsor or regulatory authority (by conducting an internal “pre-audit” and facilitating remedial action as necessary). “For cause” audits may be conducted when a problem is suspected:Studies for routine audit are chosen by random selection, based on risk level:
*Unmonitored/minimal external monitoring
*High profile*High enrolling
Communication- Open communication is vital for developing institutional compliance. Staff is welcome to contact us to ask questions, express an opinion, report research concerns or to get acquainted with our processes. We look forward to meeting and assisting you. We look forward to meeting and assisting you.
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