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Overview

The Office of Research Compliance (ORC) provides comprehensive regulatory guidance to the research community and oversight throughout 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.

ORC Regulatory Affairs Division

The ORC Regulatory Affairs Division provides a variety of support services for Northwell Health investigators, external investigators or external institutions in navigating regulatory pathways for research and related activities with FDA-regulated products—including drugs, biological products and devices. Our regulatory guidance areas include:

Navigating regulatory pathways

  • Regulatory needs for research with FDA-regulated products

IND/IDE services and resources

  • Consultation and supports for IND and IDE including expanded access uses
  • Fee-based monitoring services

Investigational product management

  • Guidance and tools for managing investigational products
  • Regulatory requirements for using controlled substances in research

If you need our services, please complete our Regulatory Affairs Intake Form.

Disclosing external interests & COI management

Research requirements

Basic science, animal and clinical researchers, and individuals responsible for the design, conduct or reporting of research—or those serving on institutional research review committees—are required to do the following:

  • Disclosure: Complete an External Interest Disclosure (COI) electronically through COI Smart at least once a year, or within 30 days of any new significant financial interest. The reporting period for this annual disclosure is for any external interests you have held in the past 12 months. Disclosures will be reviewed by the Office of Research Compliance and sent to the Conflict of Interest Committee (COIC) for review if required.
  • CITI Training: Complete CITI training in conflicts of interest through the Collaborative Institutional Training Initiative (CITI) to meet educational requirements. Please note that conflict of interest training must be renewed every four years. For more information about CITI training, visit the Northwell intranet. 

Non-employees conducting research at or on behalf of Northwell Health are required to comply with institutional policies pertaining to conflicts of interest. Researchers that are not employed by Northwell Health (e.g., students, volunteers, collaborators) for whom a disclosure is required must submit a request for access to COI Smart. Please submit your request to [email protected] and specify your non-employed status in your email.

Requests for access to COI Smart: In order to access the system, you need to have an active profile in COI Smart. If you received an automated email message including your username and an embedded link to COI Smart, you are active. For all other users, please contact [email protected] and access will be granted.

Research COI policy & contact for public inquiries

Other COI related policies are available through the Northwell Health intranet, including the GR065 Review and Management of External Interests (COIs) in Research (Individual).

Public requests for information regarding significant financial interests for key senior research investigators on NIH-funded projects determined to be financial conflict of interests (fCOI) can be directed to [email protected] or (516) 266-5024.

Important contact information

Research compliance general number: (516) 266-5024
Email: [email protected]

Corporate Compliance helpline: (800) 894-3226
Report concerns online through northwell.ethicspoint.com
Corporate Compliance website

COI Compliance: [email protected]
Export Controls: [email protected]
Regulatory Affairs: [email protected]