The WCM IRB relies on a dedicated team of professionals to ensure that all projects undertaken by the WCM research community meet the highest standards of regulatory compliance. The Regulatory Compliance Team is the branch of the Human Research Protections and Compliance Office that oversees use of external IRBs, subject safety and data oversight, and for-cause audit activities.
Our team oversees:
Data and Safety Monitoring Committee (DSMC): An independent committee within the institution that is available to the research community to act as a monitoring entity for clinical trials
ClinicalTrials.gov: A program to provide researchers with assistance in fulfilling the scientific, regulatory, and ethical responsibilities associated with publicly registering and posting trial results on ClinicalTrials.gov
Human Embryonic Stem Cell Research (ESCRO): All WCMC investigators who intend to perform research involving human embryonic stem cells must submit notification to the Tri-Institutional ESCRO Committee. This requirement applies to all HESC research, regardless of the funding sources.
Single IRB (sIRB): The Office of Human Research Protections oversees all arangements between WCM and outside institutions or commercial IRBs to allow reliance on an external IRB, as well as WCM IRB serving as lead IRB for select institutions and studies.
Immediate Reports: Processing of reportable events submitted to the IRB to identify and manage emergent risk and compliance informaiton involving human subjects research. Such information may require corrective action plans (CAPs) protocol or informed consent amendments, or additional compliance management.
|Kelly Balem, RN, CPN|
Sr. Human Research Compliance Specialist
Cancer DSMC Administrator
DSMC Educational Outreach
Human Research Compliance & Reliance Administrator
Single IRB Administrator
|Brigitte Hardrick, BSN, RN, CCRP|
Human Research Compliance Specialist
Human Embryonic Stem Cell Research (ESCRO) Administrator
General DSMC Administrator