How to Submit IBC Registrations and Renewals?
Requirements for participation in Biological Agent Research must be satisfied prior to the submission of a registration to use biological agents to the IBC. Forms can be obtained on the Feinstein website or by contacting the IBC office at firstname.lastname@example.org.
Upon completion and concurrence of the BSO, submit the following to email@example.com:
- IBC Registration Form
- Risk Assessment Form
- Investigators Brochure
- SOPs developed in consultation with BSO
- Informed Consent(s), and any other supporting documents
IBC meeting dates and submission deadlines are posted on the IBC page of the Feinstein website.
How Long is IBC Approval Valid for?
Registrations are approved for a maximum 5-year period, subject to annual review. Approval is valid for a 5 year period. Principal Investigators are required to conduct an annual self-assessment of their biological agent registrations and submit an update if there are any changes to approved registrations. IBC approval must be obtained prior to initiating any changes. The PI is responsible to ensure each member of the research team has access to the approved registration and that are aware of their responsibility to ensure that biological agent use is conducted in accordance with the registration, Northwell and Institutional policy, and federal and state regulations.
How to Add New Personnel or Amend Responsibilities of Personnel?
To add new personnel to an approved registration, submit an Administrative Change Request Form. This form may also be used to amend or add responsibilities of previously approved personnel. Submit the completed form with original signature as PDF to firstname.lastname@example.org. Requirements for participation in biological agent research must be satisfied prior to request.
What are the Requirements for Participation in Biological Agents Research at Northwell Health?
Required 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)
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: email@example.com.
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
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 firstname.lastname@example.org.
For more information, click here.