What is the IBC Comprised of?
The IBC is a committee collectively qualified through the experience and expertise of its members to oversee the use of biological agents in research, recombinant or synthetic nucleic acid molecule technology research, capable of identifying any potential risk to public health or the environment in accordance with the applicable regulations. Our IBC committees are comprised of individuals with diverse preclinical, clinical and professional expertise from throughout the organization and surrounding community.
What are the Requirements for Participation in Biological Agents Research at Northwell Health?
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 the citiprogram.org website to register. Your participating institution is “Northwell Health“.
Go to “My Learner Tools” for Northwell Health and select “Add a Course or Update Learner Groups”. Select the appropriate type of research you will be conducting and the required courses will pre-populate in your course profile. For more information on accessing the CITI Program, click here.
CITI curriculum for biological agent research is as follows
Pre-Clinical: NIH Recombinant DNA Guidelines; Basic Biosafety Training; Select Agents, Biosecurity and Bioterrorism and Dual Use Research of Concern (DURC)
Clinical: NIH Recombinant DNA Guidelines; Basic Biosafety Training
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
Conflict Of Interest (COI) Disclosure
Individuals responsible for the design, conduct or reporting of research are required to complete an External Interest Disclosure (COI Disclosure) electronically through COI Smart at least annually and should be updated within 30 days of any new significant financial interest. Click here for direct access to COI Smart.
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:
- 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.
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.