Research Compliance

RICOResearch Integrity and Clinical Operations Core (RICO)

The UMCCTS unites Regulatory Knowledge and Support with other investigator support services through the Research Integrity and Clinical Operations (RICO) Core.

The RICO Core transforms the support environment for researchers and their staff by building an accessible and responsive investigator-focused program.  It assists investigators with new educational initiatives, professional staff services and electronic tools.  This transformation also benefits the institution by measuring and tracking the institution’s regulatory compliance with investigator-held Investigational New Drug (INDs) and related reporting obligations.

To maximize efficiency, other UMCCTS domains that have synergy with regulatory affairs are housed with the RICO Core, such as Participant and Clinical Interaction Resources and Clinical Research Ethics.

RICO Leadership

Co-Directors:  Walter H. Ettinger, MD, MBA
                     President of UMass Memorial Medical Center
                     Associate Vice-Provost of Clinical and Population Research, UMMS
                     Sheila B. Noone, PhD
                     Assistant Vice Provost for Clinical Research, UMMS 

Regulatory Knowledge and Support

The University of Massachusetts Medical School (UMMS) and its clinical affiliate, UMass Memorial Medical Center (UMMHC), are committed to ensuring regulatory compliance and Good Clinical Practice (GCP) in human subjects research. This is increasingly important for clinical studies utilizing new and emerging technologies and novel approaches to diagnosis and treatment of critical health problems.

UMMS and the UMMHC have established the following regulatory priorities:

  • Continuing education for the entire research community and all institutional oversight committees.
  • Evaluation and redefinition of core competencies for research personnel.
  • Ease of access to dedicated services and proactive support for investigator-initiated research.
  • Harmonization of multi-layered processes for study approval.
  • Expansion of current quality improvement initiatives to ensure continuous feedback to GCP education, oversight committees and institutional leadership on the status of regulatory knowledge and evolving needs for institutional support.
  • Establish a new academic program for research and scholarship in the ethical, legal and social implications (ELSI) of clinical research through the recruitment of a new academic leader in the field (See section 8).

Currently UMMS and UMMHC are home to over 850 open human studies, approximately 310 of which are clinical trials, such as drug or device interventions. These studies are conducted at the Medical School, in one or more member hospitals of the clinical system or in the community at affiliated specialty centers. The UMMS holds the federal-wide assurance (FWA) for both institutions, with the Institutional Review Board meeting twice per month.

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