REGULATORY COMPLIANCE

• SBU policy requires the review of all recombinant synthetic nucleic acid molecules (rsNAM) work performed on campus or funded through the University. This is based on the federal requirements for entities receiving federal funding to subject all rsNAM work to the IBC review.  The IBC's primary function is to ensure that work complies with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), is performed with appropriate biocontainment (Biosafety Level), and persons involved in the work are experienced in the proposed work or a suitable trainer is provided. The NIH Guidelines promote the safe conduct of research involving rsNAM by specifying appropriate biosafety practices and procedures for research involving the construction and handling of either rsNAM or organisms and viruses that contain rsNAM.  NIH oversight of research involving rsNAM biosafety issues is predicated on the ethical and scientific responsibilities with goals to promote the exchange of important scientific information, enable high-quality research, and help advance all field s of science employing rsNAM. 
  
  The IBC will review submitted applications, determine if they fall under the NIH Guidelines, and take the appropriate actions to ensure that works takes place in compliance with federal, state and local guidelines and regulations. The IBC is administered by the ORC under the authority of the Vice President for Research. Current information on the IBC, applying to the committee for protocol review and other questions related to the IBC purview gobe directed to the Office of Research Compliance website.

Research and teaching involving the use of vertebrate animals conducted under the auspices of SBU is reviewed by the Institutional Animal Care and Use Committee (IACUC) in compliance with federal regulations. The IACUC at Stony Brook is accredited through AAALAC International. The IACUC works closely with faculty, students and staff to ensure that meaningful scientific research is conducted that:

• Avoids or minimizes discomfort, distress, and pain in experimental animals consistent with sound scientific practices.
• Uses the minimum number of animals necessary to obtain valid results.
• Considers non-animal models whenever possible.

Projects involving animal research require a project description and protocol details be submitted to the IACUC for approval prior to initiating work. Current information on the IACUC, applying to the committee for protocol review and other questions related to the IACUC purview can be directed to the Office of Research Compliance website. 

The Human Research Protection Program provides leadership and oversight on matters related to the protection of human subjects participating in research and ensures that such research is carried out with the highest ethical standards and in an environment where all who are involved in the conduct of human subject research understands their responsibility for protecting the rights, safety, and welfare of subjects. SBU's research protection program (HRPP) is accredited by the Association for Accreditation of Human Research Protection Programs, Inc. (AAHRPP). Current information on the IRB, applying to the committee for protocol review and other questions related to human subjects can be found on the Office of Research Compliance website. 

The Stem Cell Research Oversight (SCRO) Committee provides oversight of all issues related to the ethical, legal, scientific, and policy issues related to the derivation and research use of embryos and stem cells including human embryonic stem cells (hESC), human induced pluripotent stem cells (hiPSCs), human extended pluripotent stem cell (hePSC) lines and any derivatives of these cell lines at Stony Brook University. More information related to human stem cells can be found on the Office of Research Compliance website. 

The U.S. Department of Health and Human Services designated the U.S. National Authority for Containment (NAC) in January 2018. It is located at the Centers for Disease Control and Prevention (CDC).

NAC was designated to implement the World Health Organization (WHO) Global Action Plan to Minimize Poliovirus Facility–Associated Risk after Type-Specific Eradication of Wild Polioviruses and Sequential Cessation of Oral Poliovirus Vaccine Use (GAPIII) in the U.S.

In July 2022, WHO replaced GAPIII with the WHO Global Action Plan for Poliovirus Containment (GAP IV). WHO expects to complete the transition to GAPIV by July 2025.

Purpose: identify infectious Poliovirus and PIM
In addition to identifying laboratories that work with poliovirus, the NAC also seeks to identify facilities with poliovirus potentially infectious materials (PIM). PIM should be identified based on where and when the specimens were collected, not based on any test results. PIM includes human fecal samples and upper respiratory secretions collected for polio or non-polio related work in a time and place where one of the following apply:

1. Wild poliovirus (WPV) was circulating
2. Vaccine-derived poliovirus (VDPV) was circulating
3. Oral polio vaccine (OPV) was in use

Historical domestic and international specimens are more likely to fall into the categories above. Also, PIM cultured in some common cell lines to isolate other viruses of interest may unintentionally amplify poliovirus. Respiratory or enteric viral isolates obtained from PIM specimens using poliovirus-permissive cell lines are also considered PIM. 

Extracted nucleic acid and specimens that may contain only OPV (i.e., OPV PIM) are not subject to GAP containment at this time; however, these materials are still considered part of the U.S. poliovirus inventory and should be reported in the U.S. Poliovirus Containment Survey.

Please review the WHO Country and Territory-Specific Poliovirus Case Data and the Country Information on Last Use of Trivalent Oral Poliovirus to determine if a biological specimen or environmental sample in your inventory may contain poliovirus. If you need assistance with using the tables, contact the NAC.

Poliovirus-essential facilities
All facilities that continue to handle and store wild and vaccine-derived poliovirus types 2 and 3 and oral polio vaccine type 2 infectious materials must be certified as a poliovirus-essential facility (PEF) to retain these materials. PEFs serve critical national and international functions. Those functions include vaccine production, vaccine testing, public health and virologic research, and diagnostics.

The NAC strongly encourages any U.S. facility to destroy unneeded or nonessential materials containing poliovirus. All facilities retaining poliovirus will require certification as a PEF when WHO declares poliovirus eradicated.

GAPIV specifies all poliovirus containment requirements including:

• facility risk management
• biosecurity
• engineering controls
• community population immunity
• local sanitation standards

GAPIV focuses on risk elimination as a primary goal, wherever possible. GAPIV has shifted to a risk- and evidence-based approach for risk control. This approach does not change the tolerance for minimal risk.

Please visit the U.S. Poliovirus Containment Program to find out more information.

If your laboratory works with, possess or has questions related to Wild poliovirus (WPV) or polio potentially infectious materials (PIM) you must contact: 
Christopher Kuhlow, Biological Safety Officer
Tel: (631) 632-3717
christopher.kuhlow@stonybrook.edu