What are the Requirements for Participation in Biological Agents Research at Northwell Health?
Requirements for participation in Biological Agent Research must be satisfied prior to the submission of a registration to use biological agents to the IBC. They include:
Enrollment in Medical Surveillance Program
All research personnel participating in biological agent research must enroll in the Medical Surveillance Program and obtain clearance from Employee Health Services (EHS).
Contact Employee Health Services to enroll at: firstname.lastname@example.org.
In the subject line of the email state: Research Study
In the body of the email provide: Last Name, First Name, Contact Number, Title of Research Study
Regulatory Training (CITI Program)
All individuals involved in research using biological agents must receive the appropriate level based on the type of research involved and should include those involved in the handling and management of biological agents. Northwell Health uses the Collaborative Institutional Training Initiative (CITI) web based training program. If you have not utilized CITI before, create a new account by visiting citiprogram.org. Your affiliation is “Northwell Health.” Under “My Learner Tools for Northwell Health” click on “Add a Course.” Answer all the questions to be automatically enrolled into required courses. For more information on accessing the CITI Program, click here.
As per Northwell Health policy GR101 Use of Biological Agent Research (IBC Approval), all research investigators, staff and laboratory personnel conducting research involving biological agents are required to take the following CITI Program courses:
- NIH Recombinant DNA Guidelines (must be renewed every 3 years)
- Basic Biosafety Training (must be renewed every 3 years)
- Select Agents, Biosecurity and Bioterrorism (must be renewed every 3 years)
- Dual Use Research of Concern (DURC) (must be renewed every 3 years)
- Conflict of Interest (must be renewed every 4 years)
External Interest Disclosure (COI)
Individuals responsible for the design, conduct or reporting of research are required to report annually any potential conflict of interest and update any changes within 30 days of acquiring a new significant interest in order to comply with federal and state laws. 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. Disclosures will be reviewed by the Office of Research Compliance and sent to the Conflict of Interest Committee (COIC) for review if required.
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@example.com.
For more information, click here.