I. PURPOSE
The purpose of this policy is to (a) provide guidelines for ensuring New York Medical College (NYMC) and Touro University (TU) are compliant with the National Institutes of Health’s Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (“NIH Guidelines”), the Center for Disease’s Control’s Biosafety in Microbiological and Biomedical Laboratories (“BMBL”), as well as with all other applicable federal, state, and local regulations and (b) safeguarding the health and safety of individuals who conduct research with recombinant and synthetic nucleic acid molecules and/or biohazardous agents.
II. POLICY
It is the policy of NYMC and TU that all research involving recombinant or synthetic nucleic acid molecules must be registered with and approved by the IBC. The IBC must also review all research with potential pathogenic organisms or microbial hazards that require biosafety level 2 or higher containment levels and work practices in compliance with NIH Guidelines, the current edition of the CDC, BMBL, and applicable NYMC and TU policies and procedures. The institution must report failures of compliance with the NIH Guidelines to the NIH Office of Science Policy (“NIH OSP”).
III. SCOPE
This policy applies to all individuals, including, but not limited to faculty, staff, students, contractors, and volunteers, that conduct research and experiments involving recombinant or synthetic nucleic acid molecules and/or biohazardous agents at NYMC and campuses in the TU system whose research activities are governed by the NYMC IBC (regardless of the funding source).
IV. DEFINITIONS
A. CDC: Center for Disease Control and Prevention
B. BMBL: Biosafety in Microbiological and Biomedical Laboratories
C. IBC: Institutional Biosafety Committee
D. PI: Principal Investigator
E. BSO: Biological Safety Officer, designated to be the Director of the Office of EH&S
F. EH&S: Environmental Health & Safety Department
G. Biohazardous Agents: Potentially infectious materials or recombinant agents that are classified amongst Risk Groups 2 or 3 as defined by the CDC, NIH Guidelines and the World Health Organization.
H. Biosafety Level (BSL): Levels of protection in ascending order (numerically designated from “1” to “4”) by the degree of protection provided to personnel, the environment, and the community. Standard microbiological practices are common to all levels; specialized practices and means of physical containment enhance worker safety, environmental protection and address the risk of handling agents requiring increasing levels of containment. BSL 4 level work is not conducted at NYMC.
I. Animal Biosafety Level (ABSL): Levels of protection in ascending order (numerically designated from “1” to “4”) by the degree of protection provided to personnel, the environment, and the community specific to the use of agents in live animals. Standard microbiological practices are common to all levels; specialized practices and means of physical containment enhance worker safety, environmental protection and address the risk of handling agents requiring increasing levels of containment. ABSL3 and ABSL 4 level work is not conducted at NYMC.
J. Human Gene Transfer: Under NIH Guidelines Human Gene Transfer is the deliberate transfer into human research participants of either:
1. Recombinant nucleic acid molecules, or DNA or RNA derived from recombinant nucleic acid molecules; or
2. Synthetic nucleic acid molecules, or DNA or RNA derived from synthetic nucleic acid molecules, that meet any one of the following criteria:
a. Contain more than 100 nucleotides;
b. Possess biological properties that enable introduction of stable genetic modifications into the genome (e.g., cis elements involved in integration, gene editing);
c. Have the potential to replicate in a cell; or
d. Can be translated or transcribed.
K. NIH Guidelines: The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (available at https://aspr.hhs.gov/S3/Documents/NIH_Guidelines.pdf ) specify the biosafety practices and containment principles for constructing and handling:
1. Recombinant nucleic acid molecules;
2. Synthetic nucleic acid molecules, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules; and
3. Cells, organisms, and viruses containing such molecules.
L. NIH OSP: The Office of Science Policy works across the biomedical research enterprise to ensure NIH policy evolves in tandem with rapidly advancing science and technology.
M. Recombinant or Synthetic Nucleic Acid Molecules: In the context of the NIH Guidelines, recombinant and synthetic nucleic acids are defined as:
1. Molecules that:
a. are constructed by joining nucleic acid molecules; and
b. that can replicate in a living cell, i.e., recombinant nucleic acids
2. Nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids; or
3. Molecules that result from the replication of those described in (i) or (ii) above.
N. Risk Group (RG): Risk Group Classification criteria as defined by the World Health Organization (WHO) and utilized by the CDC and NIH.
1. Risk Group 1 (RG1): no or low individual and community risk. A microorganism that is unlikely to cause human disease or animal disease.
2. Risk Group 2(RG2): Moderate individual risk, low community risk. Laboratory exposures may cause serious infection, but effective treatment and preventative measures are available and the risk of spread of infection is limited.
3. Risk Group 3(RG3): High individual risk, low community risk. Laboratory exposures have a high risk of causing serious infection. Effective treatment and preventive measures are available.
4. Risk Group 4(RG4): High individual and community risk. Effective treatment measures are typically not available. BSL4 level work is not conducted at NYMC.
V. PROCEDURES
A. Requirement for IBC Approval.
1. Before engaging in research, academic activity, and/or experiments involving biohazardous agents or recombinant or synthetic nucleic acid molecules, the work must be registered with the IBC, reviewed by the BSO, and be submitted for review to and approval (when required) by the IBC.
2. All work with recombinant and/or synthetic nucleic acid molecules and biohazardous agents of BSL2 or higher at NYMC and campuses in the TU system whose research activities are governed by the NYMC IBC must be registered with the IBC (regardless of exemption status under the NIH Guidelines).
3. The process of approval for work with materials designated as exempt under the NIH Guidelines is detailed below in section G.
4. PIs working with recombinant and/or synthetic nucleic acids must review section III of the guidelines to determine which category their research falls under.
5. Any work covered by the NIH guidelines Sections III-A, III-B, III-C, or III-D must be approved by the IBC, and in some cases NIH officials, prior to initiating work.
6. Work designated as Section III-E or work designated as exempt (Section III-F) may be initiated simultaneously with submission of a protocol to the IBC.
7. The NIH Guidelines can be found on the NIH website and on the IBC website in Mentor.
8. If a PI’s work is not explicitly covered by the NIH Guidelines, the IBC may not authorize initiation of experiments until NIH establishes the containment requirement (NIH Guidelines Section IV-B-2-b-(8)).
B. Responsibilities of the Investigator.
1. It is the responsibility of the PI to ensure that work is properly categorized, reported to the IBC, laboratory personnel are properly trained, and all incidents of noncompliance are reported to EH&S.
2. The PI is responsible for full compliance with the NIH Guidelines in the conduct of recombinant or synthetic nucleic acid molecule research.
3. The specific responsibilities of the PI can be found under Section IV-B-7 of the NIH Guidelines.
4. Any violation of the NIH guidelines, regardless of how small, must be reported as detailed in Section V-O below.
5. PIs unsure what category their work falls into should contact EH&S, the IBC, or NIH/CDC for advisement.
C. BSL1 Agents.
1. Work with BSL1 agents as well as tissue culture work with human cell lines or primary human samples covered under 29 CFR 1910.1030 (OSHA’s “Bloodborne Pathogens” standard) does not require IBC registration and approval, unless those cells are modified or have been previously modified by introduction of recombinant or synthetic nucleic acids as defined above.
2. If such work with BSL1 agents does involve modified cells or cells previously modified by introduction of recombinant or synthetic nucleic acids, the PI shall submit an IBC protocol for review.
D. PCR (primers and products).
1. PCR (primers and products) do not need to be registered with the IBC unless the PCR product will be cloned (incorporated into some sort of plasmid, vector, or genomic DNA that can self-replicate or replicate within a cell, bacterium, virus, fungi, or other organism).
2. If the PCR will be cloned, the PI shall submit an IBC protocol for review.
E. Protocol Review Requirements/Process (Registration).
1. To initiate the protocol review process, the PI must electronically complete the appropriate registration form(s) in Mentor under the IBC tab.
2. Incomplete submissions will not be reviewed by the IBC.
3. All individuals that will be working on the project must be listed on the protocol, and must demonstrate completion of all training requirements, including all basic annual and biosafety training as required by EH&S, any hazard-specific training, and completion of CITI training on the NIH Guidelines.
4. The IBC may make changes to the requirements for the use of a recombinant or synthetic nucleic acid molecules and/or biohazardous agents at any time, as required by changes to the NIH Guidelines or applicable federal, state, or local laws and guidelines.
5. PI are required to update registration information whenever there are any changes in the protocol.
6. The status of a registered project must be provided to EH&S every year of experimental duration via the appropriate annual renewal form.
7. Protocols must be resubmitted for a full committee review every three years.
F. Commencement of Work Involving Recombinant or Synthetic Nucleic Acid Molecules or Biohazardous Agents.
1. Research defined by the NIH Guidelines as categories III-A, III-B, III-C, or III-D cannot proceed until full written approval is obtained from the IBC and appropriate NIH officials where applicable (for category III-A and III-B).
2. Research defined by the NIH guidelines as category III-E and category III-F may begin concurrently with submission of the protocol for review by the IBC.
3. Unapproved work with materials under III-A, III-B, III-C, or III-D, or work conducted under III-E prior to submission of a protocol to the IBC, is a violation of the NIH Guidelines and must be reported as detailed in Section V-O below.
4. All individuals working on the research project must comply with all requirements of the approved IBC protocol; protocol compliance is periodically reviewed by EH&S during laboratory inspections, and compliance reports will be made to the PI and the appropriate departmental chairperson.
5. In instances of non-compliance, reports will also be made to the IBC and to the Office of the Dean of the school in which the PI holds a faculty appointment.
G. Procedure for Work Designated Exempt by the NIH Guidelines Category III-F.
1. Work with materials designated as exempt will undergo a limited review procedure by the Chair of the IBC and another IBC member chosen at random to confirm that the work does indeed fall under the exemptions of the NIH Guidelines.
2. PI’s must check the exemptions list in the NIH Guidelines to verify and justify why their research may be exempt.
3. For a designation of exempt status, the PI must submit a short form that lists the materials used in the project and a short explanation of the work to be done.
4. This short form will be reviewed by the IBC chair and another committee member chosen at random in an expedited fashion.
5. If the work is found exempt under the NIH Guidelines it will receive expedited approval from the IBC chair.
6. If found not to be exempt, as most protocols are not, then a full IBC protocol form must be completed and reviewed by the full IBC panel at a meeting. Potentially exempt work may always be submitted as a full protocol for full committee review if the PI so chooses. 7. It is NYMC policy that work that falls partially under category III-A, III-B, III-C, III-D, or III-E is not considered exempt.
H. Ordering Recombinant or Synthetic Nucleic Acid Molecules and Biohazardous Agents.
1. All Purchase Order requisitions for any recombinant and/or synthetic nucleic acid molecules that are defined as non-exempt by the NIH Guidelines and for all RG2 or RG3 agents must be approved by EH&S as a part of the purchasing approval sequence.
2. In order for EH&S to expedite approval of a Purchase Order, a valid IBC protocol number relating to the materials requested for purchase should be included with the requisition.
3. If the materials relate to an approved protocol that has exceeded the three-year renewal date, the protocol must first be submitted for a renewal review before EH&S approves the purchase(s).
4. Work to be completed under new protocols (NIH Guidelines Sections III-A, III-B, III-C, and III-D) must be approved before orders can be placed. Orders associated with work under III-E can be placed at the time of submission of the protocol.
I. Use of Risk Group 3 and/or Select Agents.
1. If a research protocol involves work with RG3 and/or select agents, and/or other regulated pathogenic organisms, additional review and approval is required by the IBC and EH&S.
2. Additional approval by governmental agencies may be required, depending upon the agent involved.
3. No RG3 agents may be transferred to NYMC or TU campuses without prior written approval from EH&S.
J. Disposal of Recombinant or Synthetic Nucleic Acid Molecules or Biohazardous Agents.
1. Recombinant or synthetic nucleic acid materials and/or biohazardous agents must be inactivated before disposal to prevent accidental release to the environment.
2. Autoclave treatment or an approved method of chemical inactivation may be used; approved methods are material dependent.
3. Autoclaved materials cannot be disposed of as normal solid waste and must be treated as regulated medical waste.
K. Transfer of Recombinant or Synthetic Nucleic Acid Molecules and Biohazardous Agents.
1. Intra-facility transfers of recombinant or synthetic nucleic acid molecules or biohazardous agents that require IBC approval must not be conducted without first notifying EH&S.
2. Inter-facility transfers of recombinant and synthetic nucleic acid molecules and/or biohazardous agents must comply with all applicable national and international regulations (e.g. International Air Transportation Association (IATA) regulations).
L. PI Responsibilities.
1. Register and get approval for research with biohazardous agents and recombinant or synthetic nucleic acid molecules by the IBC and/or the BSO.
2. Comply with this policy and all guidelines published by the NIH, Center for Disease Control and Prevention (“CDC”), and NYMC.
3. Report incidents with recombinant or synthetic nucleic acid molecules or biohazardous agents to the IBC and/or the BSO.
4. Full responsibilities are under NIH Guidelines Section IV.B.7.
M. IBC Responsibilities.
1. Review and approve research activities involving recombinant or synthetic nucleic acid molecules and biohazardous agents for compliance with NIH Guidelines (as described in section IV.B.2.b) and CDC guidelines.
2. Review incidents/accidents with biohazardous agents and/or recombinant or synthetic nucleic acids and non-compliance with the most recent edition of the NIH Guidelines and the CDC BMBL.
3. Adopt emergency plans covering accidental spills and personnel contamination resulting from recombinant or synthetic nucleic acid molecule research.
4. Report incidents and items of non-compliance to the BSO or EHS and to the NIH OSP and other appropriate agencies when required (see Section V-O below).
N. EH&S Responsibilities.
1. Receive and pre-screen all IBC protocols before the protocols are presented to the IBC.
2. Administratively approve amendments to IBC approved registrations that do not involve changes to work procedures, containment, or the recombinant or synthetic nucleic acid molecules or biohazardous agents utilized.
i. Examples of changes that can be approved administratively include the specification of project funding, personnel changes, and project title changes.
ii. Changes not able to be approved administratively are addressed through a review by the IBC of the proposed amendments.
3. Ensure training of researchers and IBC officials is up to date and accurate.
4. Ensure that research involving recombinant, synthetic nucleic acid molecules, or biohazardous agents complies with all relevant regulations, policies, and procedures.
5. Ensure that periodic inspections are conducted in laboratories where work with recombinant or synthetic nucleic acid molecules or biohazardous agents takes place.
6. Report incidents and items of non-compliance to the IBC and to the NIH OSP and other appropriate agencies when required (see Section V-O below).
7. Develop action plans for incidents and non-compliance which may include rescinding approvals for work with recombinant or synthetic nucleic acid molecules and/or biohazardous agents. Plans will be reviewed and adopted by the IBC.
O. Violation of the NIH Guidelines.
1. The institution must report any and all violations or failures of compliance with the NIH Guidelines to the NIH OSP and other appropriate agencies when required.
2. Any compliance concerns and/or failures/violations of NIH Guidelines are to be reported to the BSO/EHS or the IBC.
i. If reported to the IBC first, IBC will then report to the BSO of EHS.
ii. If reported to the BSO/EHS first, BSO/EHS will inform IBC of the violation.
iii. Once BSO/EHS and IBC are made aware of a violation, failure, or non-compliance concern, the BSO/EHS and IBS will coordinate an institutional report for submission to the NIH OSP.
3. Any violation, no matter how small, must be reported and may result in sanctions on the institution and/or the PI.
VI. EFFECTIVE DATE
This policy is effective immediately.
VII. POLICY MANAGEMENT
Executive Stakeholder: Vice President for Research
Oversight Office: Environmental Health & Safety
