I.  Policy Summary 

Research involving recombinant DNA (rDNA), recombinant or synthetic nucleic acid molecules (r/sNA), a variety of experimentation involving other hazardous biological materials (e.g. infectious agents), potentially hazardous agents (e.g., select agents and toxins of biological origin), and any laboratory- or greenhouse-contained transgenic experiments at NJIT require oversight by an Institutional Biosafety Committee (IBC).  

 II.  Policy Purpose 

NJIT has both legal and ethical obligations to ensure that all NJIT research projects involving recombinant or synthetic nucleic acid molecules, and hazardous biological materials and other potentially hazardous agents are conducted in a manner that protects the researchers, community, and environment from any accidental exposure or unintentional release of infectious agents and toxins. This policy describes the principles that govern the review, approval, reporting, record keeping, and monitoring of research involving hazardous biological materials and other hazardous materials in compliance with all applicable regulations and policies. 

 III.  Policy Scope and Applicability 

As a recipient of funding from the NIH and other Federal sources, NJIT is expected to follow the NIH Guidelines when conducting research with recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules. The NIH Guidelines require that most work involving recombinant or synthetic nucleic acid molecules require registration with, review by, and approval from the IBC of the organization planning to conduct the research. NJIT also requires IBC review and approval for a variety of experimentations that involve hazardous biological materials and other potentially hazardous agents. The IBC is responsible for reviewing research with hazardous and potentially hazardous biological materials and assess the adequacy of the proposed biosafety containment level to protect the researchers, the public, and the environment from the associated risks. This policy is in effect for all units of NJIT regardless of funding and applies to all research involving recombinant or synthetic nucleic acid molecules, hazardous biological materials and other potentially hazardous agents. 

 IV.  Definitions 

• Appropriate Biosafety Levels (BSL) are established in conformance with regulations or guidelines from federal, state, and local agencies including, but not limited to: 
• Centers for Disease Control and Prevention (CDC) 
• National Institutes of Health (NIH) 
• United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) 
• Occupational Health and Health Administration (OSHA) 

Dual Use Research of Concern (DURC) is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security. 

Hazardous Biological Materials are any biological or biologically derived material or, any material which, either by accident or design, contains biological agents that present a risk or potential risk to the health of humans, animals, or the environment. They include, but are not limited to, all of the following: 

• Infectious organisms (e.g., bacteria, chlamydiae, fungi, parasites, prions, rickettsias, and viruses) which can cause disease in humans, animals, or plants or significant environmental or agricultural impact. 
• Materials that may harbor infectious organisms, such as human or primate tissues, fluids, cells, or cell cultures. 
• Recombinant or synthetic Nucleic Acid (r/sNA) are molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids. They are constructed outside of living cells and may also result from replication of previously constructed recombinant molecules. 

Institutional Biosafety Committee (IBC) is a Committee established under the NIH Guidelines to provide local review and oversight of nearly all forms of research utilizing recombinant or synthetic nucleic acid molecules. NJIT has also assigned its IBC the responsibility of reviewing experimentations that involve biological materials and other potentially hazardous agents. The Committee approves procedures for procurement, use, storage, transportation and disposal of biohazardous material. 

Potentially Hazardous Agents (select agents and toxins) have the potential to cause harm to human health or physical harm. Select agents are biological agents and toxins that have been determined to have the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal or plant products. The Federal Select Agent program regulates 68 select agents and toxins. 

Recombinant DNA (rDNA) is an artificially made DNA strand that is formed by the combination of two or more gene sequences.  

Transgenic organisms and products are animals, plants, microbes, or products which have been modified by genetic engineering. 

V.  Policy Statement 

NJIT complies with NIH Guidelines to promote the safe conduct of research involving recombinant or synthetic nucleic acid molecules as well as experiments that involve biological materials and other potentially hazardous agents. NJIT is committed to developing defensive mechanisms against naturally occurring disease and bioterrorism, and at the same time, protecting the health, safety, and security of our communities while conducting research on genetically modified organisms and hazardous biological materials and potentially hazardous agents. All such research at NJIT must be registered, reviewed, and approved by the IBC before work is started. 

VI.  Procedures 

A Registration Document For Biohazards must be submitted by the Principal Investigator to the IBC to initiate the review and approval process prior to the start of any work. For projects that are currently registered, any changes in the facilities, personnel, and experimental protocols associated with them must be updated by submitting an Amendment to Registration Document For Biohazards.  

Disposal of Recombinant or Synthetic Nucleic Acid Materials, hazardous biological materials, and potentially hazardous agents must be disposed of via the University’s Biological Waste management system. None should be disposed of via the ordinary trash. 

 Any extramural or intramural transfer of recombinant/synthetic nucleic acid materials, hazardous biological materials, and potentially hazardous agents, and transgenic organisms, including transgenic animals and transgenic plants are prohibited without the written approval of the IBC. 

 Any significant research-related incident involving recombinant DNA, recombinant/synthetic nucleic acid materials, hazardous biological materials, and potentially hazardous agents, and transgenic organisms must be reported immediately to the Biosafety Officer. Such incidents include researchrelated spills and accidents in BSL-2 laboratories resulting in an overt exposure as well as inadvertent release or improper disposal of biohazardous or recombinant/synthetic nucleic acid materials. 

 VII. Roles & Responsibilities 

The NJIT IBC, as mandated by the NIH Guidelines, is responsible for assessing the biosafety containment level for research involving recombinant DNA and synthetic nucleic acid molecules. It is also responsible for overseeing experimentations that involve biological materials and other potentially hazardous agents. The NJIT IBC currently oversees research work involving: 

• Recombinant DNA and synthetic nucleic acid molecules (this includes human gene transfer studies) 
• Infectious agents 
• Biological toxins 
• Human-derived tissues, fluids, cells 
• Certain animal-derived tissues, fluids, cells (i.e., from non-human primates, ruminants, swine, chickens or other fowl, or wild vertebrate animals) 
• Federally-regulated toxins of biological origins, Select Agents, experiments with Dual Use Research of Concern potential, and research requiring BSL-2 containment 

In the event that the IBC or the Biosafety Officer becomes aware of any research-related incident, they report them to the NJIT Office of Research. Attempts will be made to rectify the problem by conforming to the requirements of the NIH Guidelines. If an occurrence of non-compliance with the NIH Guidelines is identified, a complete report of the incident will be forwarded to NIH OSP along with any recommended actions within 30 days. 

The Office of Research and the Biosafety Officer will maintain a record of all registration, renewal, and amendment applications as well as the proceedings of the IBC meetings. 

 VIII.  Authority and Responsibility 

The Office of Research holds institutional authority for the issues covered in this policy.  Questions related to this policy are to be directed to the director, research compliance and services.  

Related Policies and Regulations  

https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf (NIH Guidelines) 

https://www.ecfr.gov/current/title-9/chapter-I/subchapter-E/part-121/se… (9 CFR 121.12: Biosafety) 

https://www.ecfr.gov/current/title-42/chapter-I/subchapter-F/part-73 (42 CFR 73: Select Agents and Toxins) 

https://www.ecfr.gov/current/title-9/chapter-I/subchapter-E/part-121 (9 CFR 121: POSSESSION, USE, 

AND TRANSFER OF SELECT AGENTS AND TOXINS) 

https://www.cdc.gov/labs/pdf/SF__19_308133-A_BMBL6_00-BOOK-WEB-final-3… (CDC: Biosafety Manual) 

https://www.ars.usda.gov/northeast-area/docs/she/biological-safety-manu… (USDA: Biological Safety Manual) 

https://www.selectagents.gov/sat/list.htm?CDC_AA_refVal=https%3A%2F%2Fw…% 2FSelectAgentsandToxinsList.html (CDC: Select Agents and Toxins List) 

https://www.phe.gov/s3/dualuse/Documents/durc-policy.pdf (US DURC Policy) 

https://www.osha.gov/bloodbornepathogens/standards#:~:text=What%20is%20…. and  

https://www.osha.gov/sites/default/files/publications/bbfact01.pdf (OSHA’s Bloodborne Pathogens Standard) 

https://www.cdc.gov/labs/BMBL.html (CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition) 

NJIT biological safety resources:

https://www.njit.edu/environmentalsafety/biological-safety

I. Policy Summary

NJIT is committed to complying with the National Institutes of Health (NIH) policy on the use of a single Institutional Review Board (sIRB) of Record for Multi-Site Research. NJIT’s single IRB policy facilitates an arrangement where one IRB provides review services for multiple sites participating in a study. 

II. Policy Purpose

The purpose of this policy is to establish the administrative foundation of NJIT to facilitate compliance with NIH’s single IRB requirement, provide instructions to investigators considering ceding oversight to another IRB or requesting the NJIT IRB to serve as the IRB of record for multi-site collaborative projects, and enhance and streamline the IRB review process for multi-site research studies.

III. Policy Scope and Applicability

As of January 20th, 2020, all non-exempt cooperative research that is funded by a Common Rule agency are required to rely on a single IRB [45 CFR 46.114(b)]. The Single IRB mandate requires a single IRB to be designated for NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research. Under this policy, a single IRB is designated to review and approve the research protocol for all participating sites, rather than requiring each site to obtain separate IRB approvals. The sIRB policy was established to streamline the IRB review process and reduce administrative burden for researchers, institutions, and IRBs. It applies to domestic awardees and participating domestic sites, and does not apply to exempt human subjects research or research that is not funded by the NIH.

IV. Definitions
Authorization Agreement (Reliance Agreement)

The agreement that documents respective authorities, roles, responsibilities, and communication between an institution/organization providing the ethical review and a participating site relying on the designated IRB.

Cooperative Research

Cooperative research projects are those projects that involve more than one institution.

Multi-site Study
A study that uses the same protocol to conduct non-exempt human subjects research at more than one site.

Participating Site
A domestic entity in a multi-site study that will rely on the sIRB to carry out the site’s IRB review of human subjects research for the multi-site study. 

Same Protocol

Protocols that address the same research questions, involve the same methodologies, and evaluate the same outcomes are considered to be the “same protocol.”

Single IRB (sIRB)
The selected IRB of record that conducts the ethical review for participating sites of the multi-site study.

SMART IRB

An online system designed to harmonize and streamline the IRB review process for multisite studies, while ensuring a high level of protection for research participants. SMART IRB is an integrated, comprehensive platform that facilitates the creation of reliance agreements for single protocols involving multisite studies and is freely available for institutions and investigators. SMART IRB is not an IRB, but a system that efficiently completes the reliance process for a study being conducted with another SMART IRB participating institution. SMART IRB is funded by the National Center for Advancing Translational Sciences and intended to serve as a roadmap for institutions to implement the NIH Policy on the Use of a Single IRB for Multisite Research. It has about 1200 participating institutions. 

V. Policy Statement

NJIT complies with the NIH policy on the use of a single Institutional Review Board of Record for Multi-Site Research and expects all faculty, staff, and students involved in NIH funded multi-site research to comply fully with all applicable conditions set forth in the reliance agreements. 

VI. Reliance Process

NJIT has joined SMART IRB and uses its online system to create and enter into reliance agreements with other institutions participating in multisite studies. Investigators are encouraged to reach out to the NJIT IRB if they intend to rely on an external IRB, or have NJIT IRB serve as the IRB of record. The single IRB process involves designating a single IRB to review and approve the research protocol for all participating sites in a multi-site research study. The process typically involves the following steps:

1. Determining if the study is subject to the single IRB policy: The single IRB policy applies to certain types of federally-funded research studies that involve multiple sites conducting the same protocol. The study team is responsible for determining if the single IRB policy applies to their proposed study.

2. Identifying the Lead Study Team: The research team is responsible for identifying the Lead Study Team. The Lead Study Team is responsible for initiating the single IRB review process and assuming additional responsibilities. Specifically, it is responsible for providing the IRB of Record with details about the study (studywide protocol, template consent document/s, instruments, recruitment), and information on all sites that will be engaged in human subjects research. The Lead Study Team is also responsible for communicating any required information about the sIRB to any funding agencies as part of the grant or contract application. 

3. Selecting the single IRB and obtaining approval: The study team should identify a single IRB to review and approve the research protocol for all participating sites. The selection of the IRB should be based on factors such as expertise, capacity, and cost. The Lead Study Team should submit the research protocol to the designated single IRB for review (usually the IRB of their institution) and approval. The IRB will evaluate the protocol to ensure that it meets the ethical and regulatory requirements for the protection of human research participants.

VII. Roles & Responsibilities

Principal Investigators are ultimately responsible for determining the need for a single IRB review for their research projects involving human subjects. The Office of Research serves as the campus signatory for single IRB reliance agreements, is responsible for reviewing requests for single IRB review, and facilitating the process if NJIT IRB is either selected as the IRB of Record or will be ceding review to an IRB of another institution. The reliance agreement documents the arrangement and establishes expectations about communication, reporting, and procedures. If an NJIT PI will lead the study team and NJIT IRB is selected to be the IRB of record, s/he must follow the processes listed at 

https://smartirb.org/wp-content/uploads/Implementation-Checklist-and-Documentation-Tool-F.pdf

If an NJIT investigator elects to rely on another IRB to review, approve, and oversee a research study, the reviewing IRB takes on all IRB oversight responsibilities. The NJIT investigator is responsible for providing key local context information about state law, study team member training and qualifications, and any applicable conflict of interest situations to the reviewing IRB. NJIT and its investigators are responsible for the protection of human subjects, compliance with applicable laws, regulations, ethical standards, and the terms as set forth in our Federal Wide Assurance.

VIII. Authority and Responsibility

The Office of Research holds institutional authority for the issues covered in this policy. Any questions regarding this policy should be directed to the director of research compliance and services in the Office of Research.

Related Policies and Regulations

Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html

Guidance on Implementation of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-004.html

Single IRB Policy for Multi-site Research Frequently Asked Questions (FAQs) 

https://grants.nih.gov/faqs#/hs-single-IRB-policy-for-multi-site-research.htm

Related Resources

https://smartirb.org/

For IRBs and Institutions

https://smartirb.org/irbs-and-institutions/#:~:text=As%20part%20of%20SMART%20IRB,that%20study%20throughout%20its%20duration.

For Investigators

https://smartirb.org/investigators/

The director for research compliance is charged with maintaining accurate records of conflicts of interest. The assistant director will review the FCOI disclosures in consultation with the director of pre-award services prior to the expenditure of funds to determine if a financial conflict of interest exists that could directly and significantly affect the design, conduct, or reporting of the research award.

If a financial conflict of interest exists, the assistant director of research compliance will report this finding to the executive director, sponsored research programs administration. The executive director will call for a meeting with the senior vice provost for research, the dean of the relevant college or school, and other appropriate university officers to determine if the conflict is manageable and, if so, will assist in developing and implementing a management plan. The assistant director of compliance will periodically review compliance with the management plan.

If new senior key personnel are identified, they will complete a FCOI disclosure and have it reviewed by the assistant director of research compliance prior to participation with an existing award.

VIII.  Authority and Responsibility

The Office of Research holds institutional authority for the issues covered in this policy. Any questions regarding this policy should be directed either to the executive director, sponsored research programs administration or the director of research compliance and services in the Office of Research.

Related Policies and Regulations

42 CFR 50, Subpart F

VI. Procedures

All current administrative procedures relating to human subjects research can be found on the NJIT Research Compliance website.

All IRB protocols are submitted via the NJIT online grant management system, Streamlyne. Eligible individuals have login access to the system to input their protocol details. Problems with access or questions on system functionality should be addressed to the IRB administrator.

Once the Institutional Review Board (IRB) has reviewed a protocol and approved for the procedures and subjects described in the protocol:

All research must be conducted in accordance with the procedures outlined in the approved protocol.

The protocol is approved until the expiration date listed in the approval letter and must be reviewed for renewal on an annual basis for as long as the research remains active. The PI must submit a request for Continuing Review at least 30 days prior to the expiration date. If the study’s approval expires, investigators must stop all research activities immediately (including data analysis) and contact the IRB Office for guidance.

The principal investigator is responsible for the following:

• Conducting the research in a manner consistent with the requirements of the IRB and federal regulations 45 CFR 46.
• Obtaining informed consent and research privacy authorizations using the currently approved forms and retain all original, signed forms, if applicable.
• Requesting approval from the IRB prior to implementing any modifications.
• Promptly reporting to the IRB any unanticipated problems involving risks to subjects, as well as serious and unexpected adverse events.
• Maintaining accurate and complete study records.
• Reporting all non-compliance issues or complaints regarding the project promptly to the IRB.
• All research records must be kept for a minimum of three (3) years after the project is finished. Once the project is complete, the PI must submit a Request to Close to the IRB.

VII. Roles & Responsibilities

The IRB is an autonomous university committee with the authority to approve or disapprove protocols involving human subject research as defined by HHS Revised Common Rule 45 CFR 46.

The IRB administrator is responsible for assisting PIs and co-investigators with the process of protocol submission and assists the committee chair(s) in organizing all IRB-related workflow and processes.

PIs and their co-investigators are responsible for submitting and completing protocols via Streamlyne for consideration by the IRB.

VIII. Authority and Responsibility

The Office of Research holds institutional authority for the issues covered in this policy. Any questions regarding this policy should be directed to the senior vice provost for research at irb@njit.edu.

Related Policies and Regulations

Office for Human Research Protections (OHRP) 45 CFR 46.

I. Policy Summary

The purpose of this policy is to establish procedures for the awarding, management, and monitoring of subawards and contractual agreements in accordance with 2 CFR 200, Uniform Guidance (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards), and State of New Jersey requirements for pass-through funding.

II. Policy Purpose

This policy ensures NJIT provides the oversight required by federal and state regulations to verify that Subrecipients and Contractors comply with programmatic, financial, and compliance terms. It specifically addresses:

• Distinction between Subrecipients and Contractors.
• Risk-based monitoring protocols.
• Management of State-funded MOAs (Memorandums of Agreement) where NJIT acts as a pass-through entity.

III. Policy Scope and Applicability

This policy applies to all Sponsored Research Programs conducted under the auspices of NJIT. It covers all funds (Federal, State, and Private) managed by the Office of Research (OR). Consistency in administration is required regardless of the funding source to ensure institutional compliance.

IV. Definitions

• Subrecipient: An entity that receives a subaward to carry out part of a Federal or State program; creates a federal assistance relationship. (See 2 CFR 200.1).
• Contractor: An entity that receives a contract for the purpose of providing goods and services for the pass-through entity’s own use; creates a procurement relationship.
• MOA (Memorandum of Agreement): Often used for funding transfers between NJIT and State Agencies. When NJIT passes these funds to a third party, the third party is typically treated as a subrecipient under Uniform Guidance.
• Pass-Through Entity (PTE): NJIT, where it provides a subaward to a subrecipient to carry out part of a sponsored program.
• Uniform Guidance (UG): 2 CFR 200, the foundation for all federal grant management.

V. Contractor vs. Subrecipient Determination (2 CFR 200.331)

NJIT must make a case-by-case determination for every outgoing agreement.

VI. Policy Statement & PI Responsibilities

The Office of Research is the sole authority for negotiating and executing agreements. PIs cannot sign agreements or authorize work to begin without a fully executed document and a Purchase Order (PO).

The PI is responsible for:

1. Technical Oversight: Ensuring deliverables are met on time.
2. Invoice Review: Verifying that costs align with technical progress.
3. Conflict of Interest: Ensuring all subrecipient key personnel have filed required COI disclosures.
4. State MOA Compliance: Ensuring specific state reporting metrics (if applicable) are gathered from the subrecipient.

VII. Contract Negotiation and Execution

The Director of Pre-Award Services (or designee) is responsible for:

1. Risk Assessment: Performing a pre-award risk assessment of the subrecipient (audit history, SAM.gov status).
2. Flow-down Provisions: Ensuring all "Prime" award terms (Federal or State) are legally incorporated into the subagreement.
3. SAM.gov Verification: Confirming the entity is not debarred or suspended.

VIII. State of New Jersey Specific Requirements

For agreements funded via State Agency MOAs, the following additional documentation is required during the setup phase:

• NJ Business Registration Certificate (BRC): Required for all NJ-based contractors/subrecipients.
• Chapter 51/Executive Order 117: Pay-to-Play compliance forms for certain threshold amounts.
• AA302 (Affirmative Action): Evidence of a valid employee information report.

IX. Risk-Based Monitoring (2 CFR 200.332)

NJIT evaluates subrecipients to determine the appropriate level of monitoring.

High-Risk Indicators:

• First-time subrecipient with NJIT.
• Prior audit "Material Weaknesses" or "Significant Deficiencies."
• Foreign entities or complex SOWs.
• Large dollar amounts (>$500k/year).

Monitoring Actions:

• Standard: Review of financial/technical reports.
• Enhanced: Requirement for backup documentation (receipts, payroll logs) with every invoice.
• Audit: On-site or virtual desk audits of the subrecipient’s financial systems.

X. Management of Equipment (2 CFR 200.313)

Subrecipients must manage equipment acquired with federal/state funds in accordance with the specific terms of the subaward. The PI must ensure the subrecipient maintains an inventory of "Government-Funded Property" and provides a final inventory report at closeout.

XI. Invoice and Payment Certification

Per 2 CFR 200.415, all invoices must include the following certification statement signed by the subrecipient's authorized official:

"By signing this report, I certify to the best of my knowledge and belief that the report is true, complete, and accurate, and the expenditures, disbursements, and cash receipts are for the purposes and objectives set forth in the terms and conditions of the Federal (or State) award..."

XII. Roles and Responsibilities Matrix

I. Policy Summary

This policy governs the establishment of Advance Accounts (Pre-award spending) for Principal Investigators (PI) at NJIT. It allows for the commencement of project-related activities prior to the formal execution of an award when there is high certainty of funding. This ensures project continuity while maintaining compliance with federal "Allowable Cost" standards.

II. Policy Purpose

The purpose of this policy is to facilitate timely project starts and minimize retroactive cost transfers. Under 2 CFR §200.458, certain costs incurred prior to the effective date of the federal award are allowable only with written approval from the Federal awarding agency or as authorized by the institution under expanded authorities.

This policy:

• Standardizes the workflow for advanced account requests.
• Mitigates institutional risk if an award is not finalized or the terms change.
• Ensures all pre-award expenditures meet the three pillars of federal cost principles: Reasonableness, Allocability, and Consistency.

III. Policy Scope and Applicability

This policy applies to all sponsored projects, including federal, state, and private grants/contracts, administered through the NJIT Office of Research.

IV. Definitions

• Advance Account: An institutional fund (index) created prior to the official award start date to capture allowable expenditures.
• Allowable Costs: As defined by 2 CFR §200 Subpart E, costs must be:

1. Reasonable: Necessary for the performance of the project and what a "prudent person" would spend.
2. Allocable: Specifically identifiable to the project in proportion to the benefit received.
3. Consistently Applied: Treated the same way (Direct vs. F&A) under like circumstances.

• Uniform Guidance (UG): 2 CFR Part 200, the federal framework for managing grants.

V. Policy Statement

A. Risk Assessment and Negotiation

Establishment of an advanced account involves institutional risk. The Office of Research will assess the "imminence" of the award. Areas of concern that may delay or prevent account setup include:

• Restrictive publication or intellectual property clauses.
• Uncertainty regarding the final period of performance (start/end dates).
• Potential for significant changes in the Scope of Work (SOW).

Note: The PI and their respective Department/School assume full financial responsibility. If the award is not realized or costs are deemed unallowable by the sponsor, the Department must provide a non-sponsored collateral index to cover the expenses.

B. Consultant and Subrecipient Restrictions

Advance account authority is non-transferable. NJIT does not authorize pre-award spending for subrecipients or consultants until the prime award is fully executed, and a formal sub-award is issued.

C. Equipment Procurement

Under Uniform Guidance, equipment purchases are generally discouraged during the pre-award period. Any such purchase requires specific justification and written approval from the Senior Vice Provost for Research to ensure compliance with 2 CFR §200.313.

VI. Procedures

A. Request Requirements

A PI may request an advance account for up to 90 days prior to the anticipated start date if:

1. The proposal has received official institutional endorsement.
2. The PI provides written evidence (e.g., an email from a Program Officer) that an award is forthcoming.

B. Account Scenarios

 C. Monitoring and Closeout

• 90-Day Review: If no award is received within 90 days of account setup, the Office of Research may issue a "Stop Work" order or require a formal extension request.
• Conversion: Upon award acceptance, the post-award unit will remove the "Advance" status and reconcile all charges.
• Ineligibility: Human and Animal subject research (IRB/IACUC) cannot commence until all ethical approvals are active, regardless of account status.

VII. Roles & Responsibilities

• Principal Investigator (PI): Initiates request, provides "imminent" documentation, and monitors spending to ensure it remains within the proposed budget.
• Department Chair/Dean: Reviews and acknowledges financial liability for the "at-risk" funds.
• Office of Research: Validates sponsor terms, assesses risk, and provides final institutional authorization.
• Post-Award Management: Converts the account to "Active" status upon receipt of the final Notice of Award (NoA).

VIII. Authority and References

• Institutional Authority: NJIT Office of Research.
• Federal Authority: 2 CFR §200 (Uniform Guidance).
• Sponsor Specifics: NIH Grants Policy Statement (Part 7.5); NSF Proposal & Award Policies & Procedures Guide (PAPPG).