Investigators seeking funding from the National Institutes of Health (NIH) must also satisfy the NIH training requirement before an approved study may be initiated. For more information on the NIH training requirements, go to the following FAQ webpage: http://grants.nih.gov/grants/policy/hs_educ_faq.htm.
To access the training directly and for more information on training requirements, go to NIH Office of Extramural Research.
UConn SPS Subawards Process Overview (PDF)
Subrecipient agreements, either subcontracts or subawards (from here on, both are referred to as “subawards”) are a mechanism for passing funding provided by a prime sponsor through to a subrecipient for the purpose of carrying out a portion of the scope of work of the project. SPS works closely with principal investigators (PIs), fiscal officers (FOs), and department administrators (DAs) in assessing risk, issuing agreements, and monitoring subrecipient progress. When issuing a subaward agreement or amendment, the “subrecipient organization” is the recipient of the pass-through funding; UConn is known as the “pass-through entity (PTE).”
Once a prime award is finalized, and the required documentation from the subrecipient is in place (either at the time of UConn’s prime proposal, or when the need for a subaward has been identified and all appropriate sponsor prior approvals have been obtained), UConn can pass the funding through to the subaward recipient. Subawards are then monitored to ensure compliance with the terms of the subaward and prime agreement. The steps below occur only after a prime award has been received and an account established. For additional information about assembling subaward materials for inclusion in a UConn prime submission, please see SPS’ Proposal Contents page.
STEP 1. SPS Notifies PI and Department of Award Action
SPS’ Award Setup team sends notifications to the principal investigator and department fiscal officer once compliance has been verified and a KFS account has been established. This notification will include a list of subrecipients and their proposed budget amounts and periods of performance (see Step 2 below for information about forward funding subawards).
STEP 2. Fiscal Officer Initiates Purchase Requisition in HuskyBuy
UConn’s HuskyBuy e-procurement system is used to obligate funds from a sponsored programs financial account for the purchase of goods and services. For subaward agreements, HuskyBuy Purchase Requisitions are created by the department fiscal officer (FO) to allocate funding and request SPS drafting, issuance, and execution of a new subaward agreement. Once the subaward agreement has been executed (signed by both the subrecipient and UConn’s authorized signatory), the Purchase Requisition is activated by SPS; the resulting Purchase Order allows the subrecipient to invoice according to the terms of the subaward.
Please Note: If UConn’s prime award has been established for the full dollar value and period of performance (as opposed to incremental funding with anticipated future modification of the prime award or agreement), subawards may be issued for the full dollar value and period of performance. The subrecipient risk assessment (Step 3 below) must categorize the organization/entity as low risk in order for the full amount and period of performance to be issued.
STEP 3. SPS Reviews Documents and Conducts Risk Assessment
SPS staff conduct a thorough review of all subrecipient proposal documents, audit reports, and additional information (including the Subrecipient Profile Questionnaire for entities that are not current members of the Federal Demonstration Partnership). These documents are used to complete a risk assessment, as required by 2 CFR 200.332. Based upon the outcome of the risk assessment, additional language may be incorporated in the draft subrecipient agreement (detailed invoicing requirements, submission of more frequent invoicing, etc.).
STEP 4. SPS Issues Subrecipient Agreement
SPS staff provide the draft agreement to the PI and FO for review and approval. Once approved by the PI, the draft agreement is forwarded to the subrecipient for review and signature. UConn utilizes the agreement templates developed by the Federal Demonstration Partnership to issue federal subawards. While these typically do not require revision, subrecipient requests for negotiation will be considered; this is also true of non-federal subawards, which are issued using the UConn narrative template.
STEP 5. SPS Approves Purchase Requisition
Once the agreement has been signed by an authorized signatory of both UConn and the subrecipient, SPS staff approve the purchase requisition, resulting in a Purchase Order. The Purchase Requisition number serves as the Subaward Agreement Number appearing on the subaward agreement, and is used by the subrecipient when submitting invoices for payment.
STEP 6. SPS Distributes Fully Executed Agreement
SPS staff provide the Purchase Requisition and KFS numbers, along with the fully executed agreement, to the subrecipient, and update the InfoEd Agreement record to reflect its completion.
STEP 7. PI and Department Monitor Subrecipient Performance
Principal investigators and department grant administrators should review invoices from subrecipients to ensure that expenditures are consistent with the proposed budget, costs are incurred within the period of performance and are allowable, expenses are aligned with technical progress, and cost sharing, if required, is appropriately reflected. If the subaward is issued from a federal prime award, the following invoice certification must be included:
“I certify to the best of my knowledge and belief that the information provided herein is true, complete, and accurate. I am aware that the provision of false, fictitious, or fraudulent information, or the omission of any material fact, may subject me to criminal, civil, or administrative consequences including, but not limited to violations of U.S. Code Title 18, Sections 2, 1001, 1343 and Title 31, Sections 3729-3730 and 3801-3812.”
STEP 1. SPS notifies PI and Department of Award Action
SPS’ Award Setup team sends notifications to the principal investigator and department fiscal officer once compliance has been verified and a KFS account has been established. This notification includes a list of subrecipients and their proposed budget amounts and periods of performance. Actions resulting in a need for amendment of a subrecipient agreement include the addition of incremental funding, no-cost extensions, etc.
STEP 2. Fiscal Officer Revises Existing HuskyBuy Purchase Order
Purchase Order Amendments (POAs, also known as Purchase Order Revisions) are used to revise existing HuskyBuy Purchase Orders for purposes such as addition of funds, extension of periods of performance, etc. Once submitted, the POA routes to SPS Post-Award for review and approval.
STEP 3. SPS Reviews Documents and Conducts Risk Assessment
SPS staff conduct a thorough review of all subrecipient proposal documents, audit reports, and additional information (including the supplemental Subrecipient Profile Questionnaire for entities that are not current members of the Federal Demonstration Partnership). These documents are used to complete a risk assessment, as required by 2 CFR 200.332. Risk assessments are revisited with each subsequent amendment to ensure that no further action or risk mitigation is necessary.
STEP 4. SPS Issues Bilateral Amendment
SPS staff draft an amendment and provide to the PI and FO for review and approval. Once approved by the PI, the draft amendment is forwarded to the subrecipient for review and signature.
STEP 5. SPS Approves Purchase Order Action
Once the agreement has been signed by an authorized signatory of both UConn and the subrecipient, SPS staff approve the Purchase Order Amendment, resulting in an update to the existing Purchase Order. The original Purchase Requisition number/Subaward Agreement Number should continue to be used by the subrecipient when submitting invoices for payment.
STEP 6. SPS Distributes Fully Executed Amendment
Distribution of fully executed amendments takes place as for new agreements once both UConn and the subrecipient have signed the amendment. SPS staff provide the Purchase Requisition and KFS numbers, along with the fully executed amendment, to the subrecipient, and update the InfoEd Agreement record to reflect its completion.
STEP 7. PI and Department Continue to Monitor Subrecipient Performance
Principal investigators and department grant administrators should continue to review invoices from subrecipients to ensure that expenditures are consistent with the proposed budget, costs are incurred within the period of performance and are allowable, expenses are aligned with technical progress, and cost sharing, if required, is appropriately reflected. If the subaward is issued from a federal prime award, the following invoice certification must be included:
“I certify to the best of my knowledge and belief that the information provided herein is true, complete, and accurate. I am aware that the provision of false, fictitious, or fraudulent information, or the omission of any material fact, may subject me to criminal, civil, or administrative consequences including, but not limited to violations of U.S. Code Title 18, Sections 2, 1001, 1343 and Title 31, Sections 3729-3730 and 3801-3812.”
Please consult with your assigned Post-Award/Award Management contact to determine whether sponsor prior approvals are required to add a subaward/subcontract after award. In most cases, a full subrecipient proposal will be required, to include a Subrecipient Information & Compliance Form, scope of work, budget, budget justification, and key personnel documents. An internal budget revision may also be required. Once all documents have been assembled and prior approvals received, subaward review and drafting follow the same steps outlined above.
The use of material transfer agreements (MTAs) is widespread in today’s research and development environment. Biological materials, such as reagents, cell lines, plasmids, and vectors are the most frequently transferred materials, but MTAs may also be used for other types of materials, such as chemical compounds.
Sponsored Program Services – Contracts Team reviews and approves all MTAs for incoming materials. For these MTAs, complete the Cell-Line Biological Materials Registration or the Human Embryonic Stem Cell Registration form, as applicable. Submit the completed form with the MTA and any pertinent approvals to spscontracts@uconn.edu.
Technology Commercialization Services creates and processes all MTAs that cover transfers of research materials outside of UConn, to both non-profit and for-profit institutions. Please submit requests and questions to Ana Fidantsef, PhD at ana.fidantsef@uconn.edu.
Many grant-funded research collaborations involve issuing a subrecipient agreement (subaward or subcontract, depending upon UConn’s prime funding agreement) to collaborating institutions to provide a portion of the UConn grant award (which serves as “pass-through entity,” or PTE) to the collaborator/subrecipient. Contractor Purchase Orders, by contrast, are used to contract for consulting services. All grant-funded Subaward agreements are drafted by Sponsored Program Services (SPS) and provided to the Principal Investigator (PI) for review before they are sent to the subrecipient entity for signature. All grant-funded Contractor agreements for consulting services must be reviewed by Procurement Services and the PI before they are sent to the Contractor for execution.
The pass-through entity (PTE) is responsible for making case-by-case determinations to determine whether the entity receiving Federal funds is a subrecipient or a contractor. In determining whether an agreement between the issuing entity and another non-Federal entity is classified as a subrecipient or a contractor, the substance of the relationship is more important than the form of the agreement. All of the characteristics listed below may not be present in all cases, and UConn must use judgment in classifying each agreement appropriately.
Subrecipients – Per §200.1 a subrecipient is an entity that receives a subaward from a pass-through entity to carry out part of a Federal award; but does not include an individual that is a beneficiary of such program. A subrecipient may also be a recipient of other Federal awards directly from a Federal awarding agency. In general, a subrecipient relationship with UConn will include the following characteristics (per §200.331):
Contractor – Per §200.1, a contract means a legal instrument by which a non-Federal entity conducts procurement transactions under a Federal award. In general, a contractor relationship with UConn will include the following entity characteristics (per §200.331):
Subaward agreement requests must be submitted to subawards@uconn.edu.
Contractor Agreement requests must be submitted to Procurement Services via the Hiring of a Consultant form
Or go to each section in the guide:
Animal Care Services (NetID restricted link) provides animal husbandry and veterinary care for vertebrate animals housed at the Storrs Campus, excluding the farm animals under the supervision of the Department of Animal Science. ACS veterinarians have University-wide responsibilities for assisting faculty and the IACUC in protocol review, facility inspections, and training. The Animal Care and Use Program is accredited by AAALAC International.
For further information, please contact acsinfo@uconn.edu.
The InfoEd eRA portal is secured with the UConn NetID single sign-on. All users are required to have a valid UConn NetID. UConn faculty and staff including UConn Health faculty and staff are automatically set up with an account. Graduate students and external users (e.g. UConn affiliates) should request access after obtaining an UConn NetID through University Information Technology Services (UITS).
If you still cannot access the InfoEd eRA portal after verifying your correct credentials and attempting to login, contact the eRA Help Desk at 860.486.7944 to verify that you have an account on the particular system. If you do not have an account or you need additional permissions, you can request access by completing the eRA Access Request Form.
This form is also used if you are requesting additional security permissions for InfoEd (e.g. a Department Administrator requesting view access to proposals/protocols/accounts in his/her department or school) or another system. It is also for revoking access. You may type directly on the form and print it. The form must be signed by the applicant/requester and the applicant’s/requester’s supervisor and scanned or emailed to era-support@uconn.edu.
IRB approval must be obtained prior to initiating any research activity that meets either the DHHS definition of research involving human participants or the FDA definition of clinical investigation involving human participants and prior to implementing amendments to previously approved research (except when necessary to eliminate apparent immediate hazards to participants). The IRB will publish submission deadlines for studies requiring review by the convened board at the start of each semester. New submissions requesting expedited review or exempt status can be submitted at any time and are reviewed on an on-going basis.
All forms required for an IRB submission are available on the IRB website. The PI is responsible for submitting complete forms and required supporting documentation. The PI must sign all submissions. Students are required to sign the submission when the research is student initiated (research is related to the doctoral dissertation or master’s degree). The signature of the Department Head or Dean is required for all submissions unless the research is funded by an external grant or contract. The signature of the medical monitor is required for interventional studies that are monitored by a physician. The IRB staff and reviewer reserve the right to return any submission that is incomplete or on out-dated forms.
Investigators make an initial determination for which type of review is appropriate for their study (full board, expedited, or exempt) and submit the required number of copies of the protocol and supporting documentation. Upon receipt, the IRB staff, in consultation with the Chair or an IRB member, screens the protocol to verify the PI’s initial determination. The protocol is then placed into the appropriate queue for review. The Chair, or his/her designee, makes the final determination of the type of review required and the appropriate expedited or exempt category.
A protocol application must be submitted to the IRB for any study for which research is the intent and the researcher proposes to use or involve any of the following:
The IRB reviews projects when the research:
Per 45 CFR 46.102, Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
In some cases, the UConn IRB must review pilot research and protocol development, including but not limited to the following activities:
*Please note that the Office for Human Research Protections (OHRP) considers the Principal Investigator as well as all research personnel to be human subjects if testing procedures are to be conducted on them. Therefore, even when pilot tests are conducted on study personnel, the protocol must be reviewed and approved by the IRB prior to initiation. Please refer to the policy on the Involvement of UConn Students and Employees in Research.
Pilot studies should be identified as such in applications to the IRB. The informed consent process must explain to subjects that the research is a pilot study.
Procedures that are not considered to be pilot research and do not need to be reviewed by the IRB include, but may not be limited to, the following:
The meeting schedule and submission deadlines are posted on the web. Adjustments to the meeting schedule may be made due to holidays or other issues. Adjustments will either be noted in the published meeting schedule (when known in advance) or announced via e-mail. The submission deadline for full board reviews is 10 working days prior to the meeting date.
Material requiring full-board review must be submitted by the published submission deadlines to provide sufficient time for screening and review prior to the meeting date. The IRB staff will send the agenda and material to IRB members via hand delivery or express mail within 2 – 3 working days after the submission deadline to allow members to have at least 7 working days for review of the material prior to the meeting date.
Under unusual circumstances, the Chair may call an emergency meeting of the board. However, such a meeting will not be called due to the negligence of the investigator to submit material on time. An emergency meeting may be called, for example, when a quorum for the originally scheduled meeting was not met and review is required to prevent lapse of a study, or if an investigator is faced with a situation beyond his/her control. If not already distributed, material must be distributed to members as soon as possible to allow for sufficient review. The investigator may be asked to attend the meeting to address questions, or provide additional information or clarification.
Under unusual circumstances, the IRB staff, in consultation with the Chair, may also add an item to the agenda after the submission deadline. Such circumstances generally involve situations in which an investigator is faced with a situation beyond his/her control and an amendment must be made to the protocol. The material must be distributed (via hand delivery, e-mail or express mail) to members as soon as possible to allow for sufficient review.
Pre-Award Services is housed within Sponsored Program Services (SPS) and reports to the Vice President for Research. Pre-Award Services consists of a team of expert research administrators who serve as dedicated central resources in all matters related to University and sponsor policies for proposal development and submission. Pre-Award Services is responsible for the review, approval and, in many cases, submission of research proposals on behalf of the University. All proposals are reviewed for compliance with sponsor guidelines as well as federal, state, local and University regulations and policies prior to approval and submission to the sponsor.
For more information, please visit the Pre-Award Contact page.
Websites
The University of Connecticut has implemented mandatory export control training for UConn researchers involved in any research that is export controlled.
As a result, any UConn investigator listed as project personnel for a grant, contract, or cooperative agreement where export control regulations apply must complete export control training certification prior to starting any work on that project. Such certification is valid for one (1) year from the date the training is completed. Certification must be completed annually if the investigator is still personnel on a project where export control regulations apply.
The training is available online and offered through the CITI Program. The Export Control Course offers eleven modules. They are:
Introduction to Export Compliance (ID: 16800)
Export Compliance for Researchers: Part I (ID: 16801)
Export Compliance for Researchers: Part II (ID: 16802)
Export Compliance for Research Administrators (ID: 16803)
Export Compliance and Biosafety (ID: 16805)
Export Compliance for Operational Departments (ID: 16806)
Export Compliance for International Shipping (ID: 16807)
Export Compliance and Purchasing (ID: 16808)
Export Compliance and International and Foreign Waters (ID: 16809)
Export Compliance and Collaborations (ID: 16810)
Export Compliance and United States Sanctions Programs (ID: 16812)
You will need to complete three modules to meet the training requirement.
Under Required, complete Introduction to Export Compliance (ID: 16800).
And under Supplemental, complete:
Export Compliance for Researchers: Part I (ID: 16801).
Export Compliance for Researchers: Part II (ID: 16802)
You may be required to complete other modules based on the nature of the regulations that apply to your research project. Research Integrity and Compliance Services will let you know if additional modules are required.
Once the required training certification has been completed, you will have met your export control training requirements for the year. Please make a note of the date of the certification as you will be required to complete the training again prior to the annual expiration date.
Export Control Compliance Requirements for Project Personnel
Project account will not be set up and no funding will be released until the compliance requirements are complete. Adding new personnel: New personnel cannot begin work on an active export controlled project unless the personnel has been approved by OVPR and the sponsor. Contact exportcontrol@uconn.edu if you wish to add someone new to an active export controlled project. |
UConn’s Export Control Policy can be found here.
These guidelines and sample documents are designed to determine if the EAR or the ITAR affect a particular research project, and to take appropriate action to ensure compliance with the Federal Export Control regulations.
In order to ensure that items are appropriately identified as EAR or ITAR controlled, the following processes will be implemented for all hardcopy or electronic documents that contain EAR or ITAR controlled Technical Data:
The following statement shall be included on the cover page, sleeve, or cover of any design file, software disc, or document (hardcopy or electronic) containing EAR or ITAR controlled Technical Data:
This document contains technical data whose export is restricted by the Arms Export Control Act (Title 22, U.S.C., Sec 2751, et q.) or the Export Administration Act of 1979, as amended, Title 50, U.S.C., App. 2401 et seq. Violations of these export laws are subject to severe criminal penalties.
Include the appropriate following statement in the footer on each page of design files or documents (hardcopy or electronic) which contains EAR or ITAR controlled Technical Data:
This page contains EAR Restricted Data.
This page contains ITAR Restricted Data.
Export: Any oral, written, electronic (such as email, internet, etc.) or visual disclosure, shipment, transfer or transmission outside the U.S. to anyone, including a U.S. citizen, of any commodity, technology (information, technical data, or assistance), software, source codes, or equipment.
Deemed Export: A deemed export refers to the sharing or release of controlled technology, technical data or source code to a foreign person within the United States. Deemed exports may occur through such means as an in-person demonstration of lab processes, an oral briefing, or a lab visit, as well as electronic transmission of non-public data to a foreign person. This exchange is “deemed” to be an export to the country of the foreign national.
Commerce Control List: The US Department of Commerce’s Export Administration Regulation (EAR) Commerce Control List (CCL) categorizes items by type and function.
(0) Nuclear Materials, Facilities and Equipment, Firearms, Ammunition, and Miscellaneous Items
(1) Special Materials and Related Equipment, Chemicals, “Microorganisms,” and “Toxins”
(2) Materials Processing
(3) Electronics
(4) Computers
(5) Telecommunications and Information Security
(6) Sensors and Lasers
(7) Navigation and Avionics
(8) Marine
(9) Aerospace, Propulsion Systems, Space Vehicles, and Related Equipment
If an item is subject to the EAR but not specifically listed on the CCL, then it may considered “EAR99” with some restrictions.
US Munitions List: The US Department of State’s International Traffic in Arms Regulations (ITAR) U.S. Munitions List (USML) regulates defense articles, services, and related technical data through 21 categories of articles.
US Person: A citizen of United States, a lawful permanent resident of the US (a “Green Card” holder), a refugee, or someone here as a protected political asylee or under amnesty. US Persons also include organizations and entities in the US, including US universities. The general rule is that only US Persons are eligible to receive controlled items, software or information without first obtaining an export license from the appropriate agency unless a license exception or exclusion is available.
Foreign Person: Any person who is not a US Person. It also means any foreign corporation, business association, partnership, trust, society or any other entity or group that is not incorporated or organized to do business in the United States. Examples of foreign persons include those in F-1, J-1, or H-1B status at UConn, such as international students, post-doctoral scholars, research staff, and UConn/UCHC foreign national employees.
Fundamental Research: Research in science, engineering, or mathematics, the results of which ordinarily are published and shared broadly within the research community, and for which the researchers have not accepted restrictions for proprietary or national security reasons.
Technical Data: Information that is required for the design, development, production, manufacture, assembly, operation, repair, testing, maintenance, or modification of defense articles. This includes information in the form of blueprints, drawings, photographs, plans, instructions and documentation. It also includes software directly related to defense articles. This definition does not include information concerning general scientific, mathematical, or engineering principles commonly taught in schools, colleges, and universities. This definition also does not include basic marketing information on function or purpose or general system descriptions of defense articles.
Technology: Technology refers to specific information necessary for the development, production, or use of a product. Under U.S. export control regulations, this includes technical data, blueprints, plans, diagrams, models, formulas, and instructions, whether in tangible or intangible form. Technology is controlled when it is listed on the Commerce Control List (CCL) or U.S. Munitions List (USML) and may require authorization before being shared with foreign persons or entities.
Dual Use: Dual use refers to items, information, and software that are primarily commercial or civil in nature but also have potential military applications. Dual use items that are identified on the Export Administration Regulation‘s Commerce Control List (CCL) have an Export Control Commodity Number (ECCN) and are of elevated strategic concern. Dual use items that are subject to regulation but are not identified on the CCL are termed “EAR99.” Dual use items may require an export license depending on the item, the recipient, the recipient’s citizenship or country of destination, and the item’s application.
Defense Service: The following situations are considered Defense Service:
Controlled Unclassified Information (CUI): Information that the U.S. Government creates or possesses—or that an entity creates or possesses for or on behalf of the government—that requires safeguarding or dissemination controls in accordance with applicable laws, regulations, and government-wide policies.
Country of Concern: A foreign country of concern (FCOC) is a nation identified by the U.S. government as posing heightened risks to national security, research integrity, or economic competitiveness. Entities outside these countries but owned or controlled by them are also subject to restrictions.
License: A formal authorization issued by a U.S. government agency—such as the Department of Commerce (BIS) or Department of State (DDTC)—that permits the export, reexport, transfer, or disclosure of controlled items, technology, or services to a foreign person or destination. A license is typically required when an export cannot be made under a license exception or general authorization due to the item’s classification, end use, end user, or destination.
