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. Additionally, Principal Investigators must provide project specific training to study personnel prior to the initiation of any experiments.
Enrollment in Medical Screening and Surveillance
The requirement for medical screening is based on the risk assessment and is dictated by the biologic agent(s). Personal health status may impact an individual’s susceptibility to infection, ability to receive immunizations or prophylactic interventions. Therefore, all personnel are provided the opportunity to consult with Employee Health Services (EHS). As determined by the IBC, study personnel may be required to enroll in medical screening. Records/copies of all EHS administered questionnaires, provider encounters, and/or declinations, will be confidential and maintained by EHS.
Enrollment consists of a risk based screening with EHS and may be required as determined by the IBC. Screening includes completion of a medical questionnaire, consultation with EHS. As determined by EHS and study personnel, screening can result in medical surveillance.
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, Study Registration # and Title
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)
Project Specific Training
Principal Investigators are responsible for training laboratory and research staff in the proper handling of all biological agents, including the proper use of all safety and bio-containment equipment. Documentation of training must be maintained by the PI and be available upon request. Template for Biological Agent Training Disclosure may be used by PIs to provide agent/project specific training. Assistance with training in biological agent use is available upon request. Training must be completed PRIOR to the initiation of any experiments. In addition or alternatively, the Biological Agent Training Disclosure Template may be used by PIs to document training of study personnel on project specific biological agent use, in accordance with the IBC approved registration/risk assessment.
Other institutional requirements that must be completed prior to participating in research