Memorial Sloan Kettering Cancer Center’s (MSK’s) office of Research Outreach and Compliance (ROC) is charged with implementing a comprehensive compliance program to ensure adherence with federal/state regulations and internal policies, including educational trainings and outreach efforts to the MSK research community and beyond. While ROC’s responsibilities are broad, the goals are focused on maintaining the highest level of research integrity and compliance in order to protect our research participants (both human and animal), investigators, and our institution.
Why we ROC
Led by our fierce, indomitable leaders, Eric Cottington, PhD, Senior VP, Research and Technology Management and Debra Schaller-Demers, MSOM, Director, ROC, our office has grown over the past year, both in staff numbers and increased responsibilities. ROC team members include:
- Sandy Iyer-Horan, MPH, Research & Regulatory Compliance Manager
- Dominic Nunziato, Research Outreach and Compliance Coordinator
- Asmita Kumar, PhD, IBC Manager
- Nancy Middleton, CPIA, IACUC Manager
- Tracy Kral-Stack, IACUC Coordinator
Explore ROC’s Services
ROC provides compliance oversight, administration and support of the following:
- Tri-Institutional Responsible Conduct of Research (RCR) course- biannually
- Institutional Animal Care and Use Committee (IACUC)
- The Institutional Biosafety Committee (IBC)
- Embryonic Stem Cell Research Oversight (ESCRO) Committee
- Export Control program
- Grant Management Compliance
- Outreach/Education/Weekly Newsletters/Events
- Authorship- NIH Public Access/PMC
A Day in the Work-Life…
Although the bulk of my career was in IRB administration, the transition to research compliance as the Research and Regulatory Compliance Manager has been a seamless next step in broadening my understanding of the breadth and various touch points in research administration. Below is a snapshot of my daily responsibilities at MSK.
- One of my main responsibilities is grant management compliance, including grant/protocol congruence, post-award. On a daily basis, I review Notice of Awards alongside grant application content and decipher whether any required human subjects, animal, stem cell or biosafety committee review approvals are in place. This involves a fair amount of collaboration with other departments and sometimes the PI as well, if the information is not readily available. Monthly compliance validation reports and quarterly out of compliance reports are generated to analyze trends, identify systems issues, and establish corrective actions. The goal is to maintain the most effective and highest quality compliance program at MSK. I serve as an alternate member of the Institutional Animal Care and Use Committee (IACUC) and actively review protocols as well as conduct animal facility inspections.
- I review Material Transfer Agreements for export control issues when the material is being sent outside of the U.S. This involves performing a restricted parties screening (we use Visual Compliance) and answering a variety of export control questions from PIs and research staff: e.g., “A PhD from Iran wants me to send him a plasmid from my lab. What should I do?” MSK frequently works with international researchers and collaborators and it is important to identify any activity that may require export control authorizations.
- The Tri-Institutional Stem Cell Initiative (Tri-SCI) ESCRO Committee is a joint endeavor by MSK, Weill Cornell Medicine, and The Rockefeller University to ensure that research involving human embryonic stem cell (hESC) and covered human pluripotent stem cell (hPSC) research is conducted in a manner consistent with and in compliance with established regulatory and institutional requirements at the three institutions. The procedures for review and conduct of hESC research and covered hPSC research at the three institutions are based on the National Academy of Sciences Guidelines for Human Embryonic Stem Cell Research. I work with our investigators to ensure submissions are agenda-ready and to verify that required trainings have been completed.
- I participate in facilitating our tri-institutional Responsible Conduct of Research course. ROC administers this course twice per year (Fall and Spring), with the number of trainees exceeding 350 per semester; no small feat from a planning, logistics, and educational content point of view. The training meets NIH training grant career award and NSF award requirements. The course delves into the ethical considerations surrounding the responsible conduct of research, including 9 topic modules: mentoring, collaboration, research misconduct, authorship, conflict of interest, and related topics.
Our team is customer focused and always available to meet with individuals or present to departments on any of the compliance subject areas under our purview. As part of our outreach efforts, ROC distributes two weekly electronic newsletters, MSK Research Weekly and Funding Opportunities Weekly, to keep the MSK research community abreast of changes in policy and legislation and upcoming institutional or externally sponsored educational events and funding opportunities.
What is the key to ROC’s success? COFFEE. In all seriousness, we also have a motivated, hard working and cohesive team with full support from leadership. This enables continued enhancements to our outreach and compliance endeavors. Oversight coupled with education are the main components in preventing non-compliance, promoting research integrity and advancing MSK’s mission of dedication to excellence in the prevention, treatment, and cure of cancer through patient care, research, and education.
Memorial Sloan Kettering Cancer Center
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