uconn health

InfoEd Portal

The InfoEd eRA portal represents the entire InfoEd enterprise suite that houses all of the various modules.

How To Materials

Listed below are various self-service handouts and instructional sheets with simple instructions on how to perform various functions within the InfoEd eRA portal tool such as login, change your password, or edit preferences within your user profile.

For technical issues with InfoEd, please email era-support@uconn.edu or call 860.486.7944.

Cross-Campus Subawards

  • Issuance, Review and Execution of the Project Agreement: Because UConn Storrs and UCH are separate fiscal entities, a project agreement needs to be executed before funds can be transferred between the two campuses. After the lead organization has received its award, a subaward agreement is prepared by the lead institution: Sponsored Program Services (UConn Storrs) or the Procurement Office (UCH Farmington). This agreement is emailed to the subawardee’s sponsored programs office for review and execution.
    Note:     Subaward agreements must be signed by authorized signatories of both parties. PIs are not authorized to sign.
  • Award/Fund Setup: Separate project accounts are set up at the lead and subawardee’s campuses. Prior to account set-up, all compliance-related approvals should have been obtained, e.g., Institutional Review Board IRB)/Stem Cell Research Oversight (SCRO)/Institutional Animal Care and Use Committee (IACUC)/Institutional Biosafety Committee (IBC).
  • Invoicing: Before invoices can be paid, they must be approved by the lead campus’s principal investigator.
  • Amendments: Competitive project periods often span multiple budget years. If the sponsoring agency awards funds on a budget year basis, issuance and execution of amendments will be necessary to next year’s funding after it has been released to the lead organization by the sponsor.
  • Carryover of Funding and No-Cost Extensions: Carryover of funds and no-cost extensions (NCE) are not authorized without the lead awardee’s written approval. If needed, at least sixty (60) days prior to the end date of the current budget period the PI(s) should seek approval for any carryover or NCE requests.
  • Award Closeout: So that awards may be closed out in accordance with sponsor requirements, final invoices will normally be required no later than 45 days following the termination date of the award project period.

For assistance with cross-campus subawards:

Storrs Graduate Students on UConn Health Projects

There is a mechanism in place that allows Storrs graduate students, both US and international, to be paid directly by UCH as graduate assistants; there is furthermore a mechanism to allow them to have their tuition waived at Storrs. It is not necessary to use the subaward/project agreement mechanism for use of graduate students on grants.

All graduate students (including those at UCH) are enrolled through the Graduate School at Storrs. The only significant issues in the past had been obtaining tuition waivers for graduate assistants at UCH because of the different financial systems at our campuses. UCH’s Human Resources department provides the HR Database of Graduate Assistants to the Bursar’s Office at Storrs a list of all graduate assistants at UCH and they get an automatic tuition waiver similar to graduate assistants at Storrs.

International Students at Storrs are vetted through their International Office while UCH International Students are vetted by Ms. Jaishree Duggal in UCH HR. Both offices work in concert to ensure compliance with applicable immigration laws. International Students are registered through the SEVIS system operated by the Department of Homeland Security, INS, which recognizes the two campuses as separate entities.

Cross Campus Proposal Development

State-of-the-art research is carried out in the twelve schools and colleges and the more than 80 research centers and institutes at the University of Connecticut. The annual expenditures at the University exceed $250 million.

Enhancing interdisciplinary research is a strategic goal for the University. An important component of this is the strengthening of the inter-campus collaborations between Storrs and the Health Center. We can assist faculty in preparing and submitting externally funded inter-campus proposals and awards.

Because UConn (Storrs) and UConn Health (UCH) are two separate fiscal entities, proposals seeking extramural funds are administered similar to sponsored activity involving any other inter-institutional collaborations – where one institution serves as the lead applicant and the other consortium partner acts as the subawardee.

At the proposal stage, the external funding agency will typically require a statement of commitment from each collaborating organization to ensure that there is appropriate programmatic and administrative support and oversight.

In order for Sponsored Program Services (SPS) at Storrs and UCH to approve a Letter of Intent/Consortium Statement, both the lead organization and subawardee proposals need to be routed, reviewed and approved by the respective academic and administrative offices.

  • Lead Organization: One campus is the lead organization; the other campus participating in the project is the subawardee. The decision regarding which campus serves as the lead applicant typically is dictated by the scope of the project – the lead organization performs a substantive role in conducting the project and maintains appropriate oversight of all scientific, programmatic, financial, and administrative matters related to the grant.
  • Budgets: The subawardee’s proposed costs (direct and F&A) get rolled-up into the lead organization’s budget. Each site (Storrs or UCH) applies and receives its respective F&A costs. The lead organization waives F&As associated with the first $25K of inter-campus subaward.  Subawardee personnel cannot be included as personnel in the lead organization’s budget.
  • Internal Review/Approval by the Subawardee Organization: At least 10 business days before the funding agency’s deadline, the subawardee principal investigator needs to submit internal forms (Storrs or UCH routing and significant financial interest, scope of work, budget and budget justification plus any additional documents requested to the subawardee’s sponsored programs office [Storrs SPS or UCH ORSP]). After review and approval by that office, the subawardee investigator will submit the approved consortium statement, scope of work, budget and budget justification plus any additional requested documents to the lead organization’s principal investigator.
  • Internal Review/Approval at the Lead Organization: The principal investigator for the lead organization should route the complete application to his/her respective sponsored programs office, using the normal review, compliance, and approval processes and by that office’s stated deadline.

Staff Contacts

Roles and Responsibilities

Subawardee Pre-Award

  • Prepares budget that includes all subawardee costs (direct and F&A), budget justification, scope of work, internal forms, and consortium statement.
  • Routes sub’s proposal for internal review/approval (dept., dean) and submits to SPS/ORSP for review and approval.
  • Submits sub’s proposal (consortium statement, scope of work, budget/ budget justification, etc.) to lead ’s PI for inclusion in lead’s proposal to be submitted to sponsor.

Lead Applicant Pre-Award

  • Prepares the entire application budget — all lead organization costs, including the sub’s budget and lists subawardee as consortium partner.
  • Routes proposal (including sub’s budget and consortium statement) through SPS/ORSP for review and approval.
  • Submits proposal to sponsor.
  • Notifies subawardee of sponsoring agency’s funding decision.

 

OVPR Training Resources

The Office of the Vice President for Research is responsible for assessing and addressing the education and information needs of UConn staff and faculty involved in sponsored research and compliance activities across UConn’s schools and colleges on all University campuses.

This section of the website provides educational information and support including tutorials, manuals, job aides, videos, and other reference guides to help and support faculty, staff, and students.

Subscribe to the UCRESADM-L Listserv for more information on educational opportunities and other OVPR notices.

Learn something new everyday!

Office of University Compliance

EthicsThe mission of the Office of University Compliance is to assist the University and UConn Health in achieving their financial, operational and strategic goals while maintaining compliance with all associated laws and/or regulations.

The Office of University Compliance accomplishes this goal by identifying institutional risks; performing audits, reviews and investigations; augmenting institutional compliance through effective education and training programs; and fostering the values of knowledge, honesty, integrity, respect and professionalism as outlined in the University’s Code of Conduct.

How to Register

ClinicalTrials.gov Protocol Registration and Results System1. Request an account by emailing Ellen Ciesielski, UConn/UConn Health’s ClinicalTrials.gov PRS Administrator. You will be sent an automated email from the PRS system with your username and password.

2. On the PRS log-in page, in the Organization field, enter “UConnHealth” (no spaces) if your account was created under UConn Health or “UConn” if your account was created under UConn.

3. Click on the blue “Create New Record” button on the far right of the page. The system will walk you through the creation of the record. Data entered on previous pages will be retained so that you can return to complete the record at a later date.

The person who creates the record is the “Record Owner.” The Record Owner may be the Principal Investigator (PI) or someone designated by the PI to create/update the record on his/her behalf. The PI must perform the final review and approval of the record and each subsequent update in the PRS. The PI is responsible for ensuring that accurate information about the trial is entered and that updates to the record are completed in a timely manner (see table below for specific deadlines).

Complete the below fields as follows:

      • Organization’s Unique Protocol ID: Enter the IRB number.
      • Secondary IDs: Enter the grant number.
      • Record Verification Date: Enter the month and year in which you are completing the record. This field will need to be updated each time you update the record after it is registered.
      • Primary Completion Date: Enter the anticipated final data collection date, specifically regarding the Primary Outcome Measure.
      • Responsible Party: Select the Principal Investigator from the drop-down menu.
      • Collaborators: Add any other organizations providing support, including funding, design, implementation, data analysis and reporting.

For studies reviewed by UConn Health:

      • Board Name: UConn Health IRB
      • Board Affiliation: UConn Health
      • Board Contact phone and e-mail: 860.679.8729; irb@uchc.edu
      • Board Contact Address:  UConn Health IRB, 263 Farmington Avenue, Farmington, CT 06030-1511

For studies reviewed by UConn Storrs and Regional Campuses:

      • Board Name: UConn IRB
      • Board Affiliation: UConn
      • Board Contact phone and e-mail: 860.486.0986; irb@uconn.edu
      • Board Contact Address: UConn IRB, 438 Whitney Road Extension, Unit 1246, Storrs, CT 06269

    The Final Rule dictates that ClinicalTrials.gov record fields are updated on the below schedule:

    Data Field Deadline for Updating
    (i.e., not later than the specified date)
    Study Start Date 30 calendar days after the first subject is enrolled (if the first human subject was not enrolled at the time of registration).
    Intervention Name(s) 30 calendar days after a nonproprietary name is established.
    Availability of Expanded Access 30 calendar days after expanded access becomes available (if available after registration); and 30 calendar days after an NCT number is assigned to a newly created expanded access record.
    Expanded Access Status 30 calendar days after a change in the availability of expanded access.
    Expanded Access Type 30 calendar days after a change in the type(s) of available expanded access.
    Overall Recruitment Status 30 calendar days after a change in overall recruitment status. If Overall Recruitment Status is changed to “suspended,” “terminated,” or “withdrawn,” the Why Study Stopped data element must be submitted at the time the update is made.
    Individual Site Status 30 calendar days after a change in status of any individual site.
    Human Subjects Protection Review Board Status 30 calendar days after a change in status.
    Primary Completion Date 30 calendar days after the clinical trial reaches its actual primary completion date.
    Enrollment At the time the primary completion date is changed to “actual,” the actual number of participants enrolled must be submitted.
    Study Completion Date 30 calendar days after the clinical trial reaches its actual study completion date.
    Responsible Party, by Official Title 30 calendar days after a change in the responsible party or the official title of the responsible party.
    Responsible Party Contact Information 30 calendar days after a change in the responsible party or the contact information for the responsible party.
    Device Product Not Approved or Cleared by U.S. FDA 15 calendar days after a change in approval or clearance status has occurred.
    Device Product Not Approved or Cleared by U.S. FDA 15 calendar days after a change in approval or clearance status has occurred.
    Record Verification Date Any time the responsible party reviews the complete set of submitted clinical trial information for accuracy and not less than every 12 months, even if no other updated information is submitted at that time.

    Whom do I contact if I have questions?

    Contact Ellen Ciesielski, eciesielski@uchc.edu, UConn/UConn Health’s ClinicalTrials.gov Administrator.

    Is more information available?

    For the latest on the modernization efforts to the PRS, visit https://register.clinicaltrials.gov/prs/beta/public/release-notes-prod.

    To receive regular updates about ClinicalTrials.gov and the PRS, sign up for the Hot Off the PRS! bulletin published by the National Library of Medicine.

    For more information about the NIH policy requirement, see: https://directorsblog.nih.gov/2016/09/16/clinical-trials-sharing-of-data-and-living-up-to-our-end-of-the-bargain/

    For more information about the ICMJE registration requirement, see: http://www.icmje.org/news-and-editorials/

    For more information about Final Rule issued by the U.S. Department of Health and Human Services, see: https://www.nih.gov/news-events/news-releases/hhs-takes-steps-provide-more-information-about-clinical-trials-public

    To receive notification of future draft FDAAA 801 documents, join the NIH FDAAA Update LISTSERV at: https://list.nih.gov/cgi-bin/wa.exe?SUBED1=fdaaa-update-l&A=1

    Request System Access Changes

    Basic InfoEd Access

    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).

    1. If you have an UConn NetID, first try to see if you can login to the InfoEd eRA system at https://www.infoed.uconn.edu.  If you are trying to access the UConn Health instance of InfoEd please login at https://uchealth.infoed.uconn.edu.
    2. If you cannot login, make sure you are using your correct NetID and password combination or your correct username and password. Consult the https://netid.uconn.edu website tools to verify your NetID and password credentials or contact the eRA Help Desk at 860.486.7944.
    3. Faculty may also add undergraduate students to InfoEd using a new automated process

    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.

    Account 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.

    Other Export Control Resources

    Websites

    PowerPoint Presentations and Audio Presentations

    Export Control Training

    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.

    Policy and Guidelines

    Export Control Compliance Requirements for Project Personnel

    • Export control compliance package (technical review, project personnel information, technology control plan)
    • Annual Training
    • Compliance letter to be signed/certified

    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.

    Policy

    UConn’s Export Control Policy can be found here.

    Guidelines

    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.

    Marking Documents

    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 Control Definitions

    Commodity Jurisdiction Ruling
    Where an article is arguably covered by both the EAR and ITAR, a request can be made to the State Department to determine which agency will have jurisdiction over the export of the article.
    Deemed Export
    The transfer, release, or disclosure of technical data or technology to a foreign national within the United States (including university campuses). A transfer is the same as exporting it to the home country of the foreign national.
    Export
    Export as used in export control regulations, has an expansive meaning. Generally, an export includes any: (1) actual shipment of any covered goods or items; (2) the electronic or digital transmission of any covered goods, items or related goods or items; (3) any release or disclosure, including verbal disclosures or visual inspections, of any technology, software or technical data to any foreign national; or (4) actual use or application of covered technology on behalf of or for the benefit of any foreign entity or person anywhere. The official definition of export under the EAR and ITAR should be consulted when determining whether a specific act constitutes an export. As is evident, export is defined so as to preclude the participation of foreign graduate students in research that involves covered technology without first obtaining a license from the appropriate government agency.
    The Export Administration Regulations (EAR)
    The Export Administration Regulations (EAR), Title 15, sections 730-774 of the Code of Federal Regulations (CFR) are promulgated and implemented by the Department of Commerce. The EAR regulate the export of goods and technology identified on the Commerce Control List (CCL), Title 15 CFR 774, Supp. 1. Technology means specific information necessary for the development, production, or use of a product. The information takes the form of technical data or technical assistance. Technical data may take forms such as blueprints, plans, diagrams, models, formulae, tables, engineering designs and specifications, manuals and instructions written or recorded on other media or devices such as disk, tape, read-only memories. Each good or technology listed on the CCL is associated with a unique Export Control Classification Number, which consists of a set of digits and a letter. (Refer to § 738.2(c) of the EAR for a complete description of each ECCN’s composition.) The Country Chart in Supplement No. 1 to part 738 of the EAR contains licensing requirements based on destination and reason for control. The reasons for control are: Anti-Terrorism (AT); Chemical and Biological Weapons (CB); Crime Control (CC); High Performance Computer (XP); Missile Technology (MT); National Security (NS); Nuclear Nonproliferation (NP); Regional Stability (RS); Short Supply (SS); and United Nations Sanctions (UN). Items controlled within a particular ECCN may be controlled for more than one reason. The complete text of the EAR and CCL are available online.
    Foreign Persons
    Foreign person means any natural person who is not a lawful permanent resident as defined by 8 U.S.C. 1101(a)(20, http://www.law.cornell.edu/uscode/text/8/1101 or who is not a protected individual as defined by 8 U.S.C. 1324(a)(3), http://www4.law.cornell.edu/uscode/8/1324.html. 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, as well as international organizations, foreign governments and any agency or subdivision of foreign governments (e.g. diplomatic missions).
    Fundamental Research
    Fundamental Research , as used in the export control regulations, includes basic or applied research in science and/or engineering at an accredited institution of higher learning in the United States where the resulting information is ordinarily published and shared broadly in the scientific community. Fundamental research is distinguished from research which results in information which is restricted for proprietary reasons or pursuant to specific U.S. Government access and dissemination controls. University research will not be deemed to qualify as Fundamental Research if: (1) the University or researcher accepts any restrictions on the publication of the information resulting from the research, other than limited prepublication reviews by research sponsors to prevent inadvertent divulging of proprietary information provided to the researcher by sponsor or to insure that publication will not compromise patent rights of the sponsor; or (2) the research is federally funded and specific access and dissemination controls regarding the resulting information have been accepted by University or the researcher. The EAR definition of Fundamental Research can be found at 15 CFR 734.8, the ITAR definition at 22 CFR 120.11.
    Office of Foreign Assets Control Regulations (OFAC Regulations)
    The Office of Foreign Assets Control Regulations ( OFAC Regulations), 31 C.F.R. Parts 500-597, are administered by the U.S. Department of the Treasury, through the Office of Foreign Assets Control . They regulate economic trade with foreign countries and administer the statutory economic trade sanctions imposed against several foreign countries. The sanctions range from partial to full trade embargoes and are imposed in addition to other U. S. export control law penalties. Information regarding sanctions in effect can be found at the OFAC web site (http://www.treasury.gov/about/organizational-structure/offices/Pages/Office-of-Foreign-Assets-Control.aspx). OFAC regulations apply to all persons subject to U.S. jurisdiction. This includes American citizens and permanent resident aliens wherever they are located; any individual or entity located in the U.S.; corporations organized under U.S. laws, including foreign branches; and—solely in the case of Cuba—entities owned or controlled by any of the above (including foreign-organized subsidiaries of U.S. corporations). The regulations define prohibited transactions with foreign countries and set forth sanctions for engaging in such conduct. Such prohibited transactions include transactions involving designated foreign countries or their nationals; transactions with respect to securities registered or inscribed in the name of a designated national; importation of and dealings in certain merchandise; and holding certain types of blocked property in interest-bearing accounts. Persons subject to U.S. jurisdiction are also prohibited from dealing with specific entities or individuals known as “specially designated nationals,” found in the Specially Designated Nationals List ( SDNL), appended to the OFAC regulations and available at http://www.treas.gov/offices/enforcement/ofac/sdn/index.html. No one subject to U.S. jurisdiction may participate in any activity with anyone on the SDNL.
    The International Traffic in Arms Regulations (ITAR)
    The International Traffic in Arms Regulations (ITAR), 22 CFR 120-130, are promulgated and implemented by the Department of State to regulate defense articles, services, and related technical data that are identified on the Munitions Control List (MCL), 22 CFR 121.1. Defense Article refers to any item or technical data designated in the MCL. This term includes technical data recorded or stored in any physical form, models, mock‑ups or other items that reveal technical data directly relating to items designated in the MCL. It does not include basic marketing information on function or purpose or general system descriptions. Defense Service is defined as the furnishing of assistance (including training) to foreign persons, whether in the United States or abroad in the design, development, engineering, manufacture, production, assembly, testing, repair, maintenance, modification, operation, demilitarization, destruction, processing or use of defense articles; t he furnishing to foreign persons of any technical data controlled under the ITAR, whether in the United States or abroad; and the military training of foreign units and forces, regular and irregular, including formal or informal instruction of foreign persons in the United States or abroad by correspondence courses, technical, educational, or information publications and media of all kinds, training aid, orientation training exercise, and military advice. Technical Data refers to information (other than software as defined in 22 C.F.R. § 120.10(4)) 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 as well as software as defined in 22 C.F.R. § 121.8(f) 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 or information in the public domain as defined in § 120.11. It also does not include basic marketing information on function or purpose or general system descriptions of defense articles. Complete, on-line versions of the ITAR and MCL are available at: http://www.gpoaccess.gov/cfr/ (Government Printing Office site) and at http://fas.org/spp/starwars/offdocs/itar (Web site for the Federation of American Scientists).
    Public Domain
    Public Domain (22 CFR 120.11) means information that is published and that is generally accessible or available to the public: (1) through sales at newsstands and bookstores; (2) through subscriptions which are available without restriction to any individual who desires to obtain or purchase the published information; (3) through second class mailing privileges granted by the U.S. Government; (4) at libraries open to the public or from which the public can obtain documents; (5) through patents available at any patent office; (6) through unlimited distribution at a conference, meeting, seminar, trade show or exhibition, generally accessible to the public, in the United States; (7) through public release (i.e., unlimited distribution) in any form (e.g., not necessarily in published form) after approval by the cognizant U.S. government department or agency; and (8) through fundamental research.