Children's Hospital Colorado

Research Compliance at Children's Hospital Colorado

The Research Compliance Office, a part of the Compliance and Business Ethics Department, is responsible for ensuring compliance of the clinical research enterprise with all related regulatory policies and guidelines including federal, state, local, as well as the policies and procedures outlined by Children’s Hospital Colorado (CHCO) including:

  • Design, develop, implement and monitor the research compliance program, coordinating institutional-wide initiatives to prevent, detect and respond appropriately to compliance risks.
  • Assess the research compliance needs of the institution and its network and satellite affiliates to recommend tools and approaches necessary to promote and enforce compliance clinical research.
  • Develop a culture of regulatory compliance through training, education, strategic planning, study monitoring and collaborations within CHCO and its affiliates.

Principles and ethics in the conduct of research

Children’s mission statement emphasizes the importance of research as one of our programs we highlight in our effort to improve the health of children. Staff who conduct research in our organization must comply with many ethical principles and regulatory issues which dictate how this research must be performed. Informed consent, conflicts of interest and financial disclosures, advances in use of technology, scientific misconduct, monitoring use of research funds, HIPAA/Privacy, FDA, IRBs, Office of Human Research Protections, National Coverage Decision – these are examples of complex topics or governing bodies in which our research staff are trained and for which they are responsible for ensuring compliance. Compliance and Business Ethics at Children’s Colorado works with our research administrators to audit and monitor areas of potential fraud and risk in clinical research compliance.

  • Ensures that appropriate research compliance policies and procedures are current, and internal controls are in place and widely understood by the campus community;
  • Reviews the ongoing assessment of controls and compliance with established policy and procedures by operational and staff units;
  • Reviews the effectiveness of the education and training programs;
  • Recommends policies and procedures for the improvement of research compliance;
  • Coordinates with other ethics and compliance committees to develop consistent and effective policy and assessment procedures.

Contact us

Should you have any questions, please contact the Research Compliance Officer in the Compliance and Business Ethics Department at 720-777-4512.

Or, choose any of the following methods to contact us to reporting a problem or concern:

  • Compliance Hotline (you stay anonymous): 1-866-568-5420
  • QSRS (available on the Children's Colorado intranet; please select the research category)
  • Email or call our office directly or mail to B450