The mission of the Office of Research Compliance (ORC) is to provide comprehensive regulatory guidance to the research community and oversight of research throughout the Northwell Health to ensure the responsible conduct of research. This includes the development of training and education, auditing and monitoring, and distribution of policies, procedures and standards of conduct that promote adherence to applicable laws, regulations and institutional policy.
Functions of the ORC
- Conduct regular auditing and monitoring of research conducted at or on behalf of Northwell Health;
- Respond to research compliance concerns or allegations related to research misconduct, HIPAA violations, audit findings or improper/illegal activities from faculty, staff, research participants, and federal or state agencies with the adoption of procedures to protect the anonymity of complainants and to protect whistleblowers from retaliation;
- Provide regulatory support for investigator-initiated studies;
- Provides support, guidance and education on export controls regulations in research;
- Oversee the compliance components of the Northwell Health Human Research Protections Program (HRPP) and Animal Research Program, and serve as the research compliance liaison to the Hofstra-Northwell Health School of Medicine and any non-Northwell Health regulatory committee (e.g. IRB, IACUC, IBC);
- Manage the processes for review of potential conflicts of interest in research and the administration of the Individual and Institutional Conflict of Interest Committees (COIC & ICIC);
- Develop and distribute written standards of conduct, as well as written policies and procedures compliant with federal regulations and local requirements;
- Develop and implement regular, effective compliance education and training for all Northwell Health personnel engaged in research; and
- Serve as the research liaison to Northwell Health privacy and security, risk, audit and compliance committees.