Sponsored Program Services

Principal Investigator Eligibility

Title: Principal Investigator Eligibility
Policy Owner: Office of the Vice President for Research, Sponsored Program Services
Applies to: Applies to all faculty, staff, students and others participating in sponsored program activities
Campus Applicability: All campuses except for UConn Health
Effective Date: June 22, 2015
For More Information, Contact Offices of the Vice President for Research and Sponsored Program Services
Contact Information: (860) 486-3622
Official Website: https://ovpr.uconn.edu/

 

REASON FOR POLICY

This Policy is intended to set forth the eligibility requirements for serving as a Principal Investigator (PI) at UConn.  This Policy also describes the processes for requesting and approving exceptions to the PI eligibility requirements.

DEFINITIONS

Principal Investigator (PI): This title identifies the individual responsible for the conduct of the sponsored program project. This responsibility includes the intellectual conduct of the project, fiscal accountability, administrative aspects, and the project’s adherence to relevant policies and regulations.  A project may have multiple individuals as PIs who share the authority and responsibility for leading and directing the project, intellectually and logistically.  Each PI is responsible and accountable for the proper conduct of the project.

Co-Principal Investigator: This designation refers to individuals who share the responsibility for the project with the Principal Investigator and therefore requires the same qualifications.

Project Director: Although not as commonly used by sponsors, this title is a synonym for Principal Investigator.

POLICY STATEMENT

All externally funded projects conducted at the University of Connecticut are expected to be consistent with the teaching, research, and service missions of the University.  All projects are therefore carried out within departments, centers or institutes, or other administrative units under the direction of a faculty member or comparable professional employee.

By limiting Principal Investigator/Project Director status to a limited set of designated individuals and/or job categories, and by procuring appropriate dean and department head approval, the University is assured that the proposed research is consistent with its missions and that the necessary space, equipment, facilities and qualified personnel are available to conduct the proposed project.  In all cases, the individual designated as Principal Investigator/Project Director is judged to be qualified to conduct an independent research or other educational project.

Faculty members automatically eligible to serve as Principal Investigators/Project Directors include members of the emeritus faculty and those faculty members who hold the following titles:

University Professor
Associate Professor
Assistant Professor
Research Professor
Associate Research Professor
Assistant Research Professor
Professor-in-Residence
Associate Professor-in-Residence
Assistant Professor-in-Residence
Research Scientist
Research Scholar
Extension Educator

Professional staff normally eligible to serve as Principal Investigator:

Professional staff members normally eligible to serve as Principal Investigators/Project Directors include staff who hold titles typically associated with independent activity, whose appointment is subject to a rigorous review of credentials, and who have supervisor approval (i.e., signature on the proposal routing sheet), such as:

Dean
Associate Dean
Assistant Dean
Director
Associate Director
Assistant Director
Extension Professor
Associate Extension Professor
Assistant Extension Professor
Curator
Program Director

Categories of employment normally considered ineligible to serve as Principal Investigator/Project Director:

Instructor
Assistant Instructor
Lecturer
Post-doctoral appointees
Research associates
Assistants and fellows
And visiting and other short-term appointees

Exceptions

In special cases, exceptions may be made. These special cases require the Request for Approval to Serve as Principal Investigator form be completed by the PI Applicant, signed by the PI Applicant, Faculty Sponsor, Department Head and/or Dean and submitted to SPS for review prior to proposal submission.  In the case of a denial by OVPR SPS, appeals may be directed to the Associate Vice President for Research, Sponsored Program Services.

PROCEDURES/FORMS

Please see OVPR SPS form: Request for Approval to Serve as Principal Investigator.

ENFORCEMENT

Violations of this policy may result in appropriate disciplinary measures in accordance with University Laws and By-Laws, General Rules of Conduct for All University Employees, applicable collective bargaining agreements, and the University of Connecticut Student Code.

POLICY HISTORY

Policy created:           6/5/2009

Revised:                    6/22/2015 (approved by the Vice President for Research)                  

 

 

Pre-Award/Advance Account Policy

Title: Pre-Award/Advance Account Policy
Policy Owner: Office of the Vice President for Research, Sponsored Program Services
Applies to: Faculty and staff conducting sponsored program activity at Storrs and the regional campuses
Campus Applicability:  All campuses except UConn Health
Effective Date: July 7, 2015
For More Information, Contact Office of the Vice President for Research, Sponsored Program Services
Contact Information: (860) 486-3622
Official Website: http://ovpr.uconn.edu

 

REASON FOR POLICY

To enable Principal Investigators (PI) who have demonstrated a need to begin project-related activity on sponsored projects prior to receipt of the award notice or executed contract.

APPLIES TO

Faculty and staff conducting sponsored program activity at Storrs and the regional campuses.

DEFINITIONS

Pre-Award Account:  A pre-award account will be used for federal grants where costs are allowed up to 90 days prior to the official start date of the award under expanded authorities granted to the University.

Advance Account:  Advance accounts will be established for those federal and non-federal awards not eligible for pre-award coding.  Costs can only be incurred on advance accounts as of the sponsor approved start date.

POLICY STATEMENT

The Office of the Vice President for Research, Sponsored Program Services (OVPR SPS) will establish Pre-Award or Advance Accounts under the following conditions:

There is a demonstrated need by the PI to incur expenditures prior to the proposed start date (pre-award accounts) or prior to receipt of the executed contract (advance accounts).  Acceptable reasons for requesting an account include, but are not limited to the following:

  • Making employment offers and completing payroll authorizations
  • Equipping a lab or purchasing supplies
  • Purchasing equipment early to take advantage of a discounted price

Accounts also require that:

  • A full copy of the proposal for the project is on file in OVPR SPS
  • OVPR SPS personnel are able to determine that pre-award expenditures are allowed, or in the case of advance accounts, it is likely that an award is forthcoming or contract will be executed
  • When applicable, required compliance approvals have been obtained

This policy does not apply to Federal earmark funding.

ROLES AND RESPONSIBILITIES

Principal Investigators are responsible for submission of pre-award or advance account requests that are consistent with this policy and in accordance with our published procedures.

OVPR SPS is responsible for responding to inquiries about this policy or procedures and approving account request.

ENFORCEMENT

Violations of this policy may result in appropriate disciplinary measures in accordance with University Laws and By-Laws, General Rules of Conduct for All University Employees, applicable collective bargaining agreements, and the University of Connecticut Student Code.

PROCEDURES/FORMS

See OVPR SPS website for Pre-Award or Advance Request Form.

POLICY HISTORY

Policy created:    2/19/2008

Revised:             7/7/2015 (Approved by the Vice President for Research)

Administrative Review and Approval of Proposals for External Support

Title: Administrative Review and Approval of Proposals for External Support
Policy Owner: Office of the Vice President for Research, Sponsored Program Services
Applies to: Principal Investigators and all others involved in the submission of a sponsored program proposal
Campus Applicability:  All campuses except for UConn Health
Effective Date: June 24, 2015
For More Information, Contact Sponsored Program Services
Contact Information: (860) 486-3622
Official Website: http://research.uconn.edu

REASON FOR POLICY

The timely submission of proposals for internal UConn review and approval allows for thoughtful consideration and review of sponsored project proposals for compliance with University, Federal, State and sponsor policies.  Additionally, Sponsored Program Services professionals review proposals against the administrative requirements of the sponsor’s announcement, including budgets and budget justifications to identify potential administrative or financial challenges to the success of the proposal.

POLICY

All proposal submissions seeking external support for research and other sponsored projects must be submitted to the Office of the Vice President for Research (OVPR) Sponsored Program Services (SPS) for review and approval prior to submission to an external sponsor, even when institutional sign-off is not required by the sponsor.

All letters-of-intent and pre-proposal submissions seeking external support for research and other sponsored projects must be submitted to Sponsored Program Services for review and approval prior to submission to an external sponsor if the signature of an authorized official, a detailed budget, or cost share commitment is required.

Proposals submitted without SPS approval may be administratively withdrawn or the offer of funding (award) may not be accepted if the submission is found to be non-compliant with University, Federal, State or sponsor policies.

SPS requests a minimum of five (5) business days prior to the agency or submission deadline for review and approval of the full proposal, internal forms and budget.

The University of Connecticut reserves the right to withdraw any proposal or refuse acceptance of any award that does not comply with this policy.

ROLES AND RESPONSIBILITIES

The Executive Director of Sponsored Programs and Faculty Services has overall responsibility for this policy.

The Principal Investigator accepts the responsibility for the timely submission of all proposals and pre-proposals that require SPS approval to SPS.

The Department Head, Center Director and/or Dean attests to the academic purposes of the proposed project and its appropriateness in terms of budget, committed effort, space and equipment.

The Executive Director of Sponsored Programs and Faculty Services is the authorized signatory for all proposals for sponsored programs. In the absence of the designated official, arrangements are made to ensure timely signing by alternate University signatories.

Principal Investigators, Department Heads, Deans and other individuals as required are responsible for authorizing and signing internal processing documents, but are not authorized to sign a sponsored projects proposal as the institutional official on behalf of the University.

PROCEDURE/FORMS

See OVPR SPS website: Proposal Preparation Guidelines

ENFORCEMENT

Violations of this policy may result in appropriate disciplinary measures in accordance with University Laws and By-Laws, General Rules of Conduct for All University Employees, applicable collective bargaining agreements, and the University of Connecticut Student Code.

POLICY HISTORY

Policy created:  6/12/2008

Revised:           6/24/2015 (approved by the Vice President for Research)

 

Subrecipient Monitoring Policy

Title: Subrecipient Monitoring Policy
Policy Owner: Sponsored Program Services
Applies to: Faculty and Staff conducting sponsored program activity
Campus Applicability:  All Campuses except for UConn Health
Effective Date: June 18, 2015
For More Information, Contact Office of the Vice President for Research, Sponsored Program Services
Contact Information: (860) 486-3622
Official Website: http://ovpr.uconn.edu

REASON FOR POLICY

To provide guidance to the University community in complying with the Office of Management and Budget (OMB) Uniform Guidance 2 CFR Part 200, subpart F and Circular A-133 (hereinafter, referred to as “Single Audit”), specifically with respect to its regulations regarding the oversight of subrecipients on federally sponsored programs.

APPLIES TO

This policy applies to faculty and staff at the Storrs and regional campuses who are working with subrecipients.  For federal awards/subawards issued with a start date before December 26, 2014, 2 CFR Part 215 and 220 (OMB Circulars A-21, A-110), and A-133 apply.  New funds (i.e., new awards, continuation funding, and supplements, etc.) received with a start date on or after December 26, 2014 are subject to the OMB Uniform Grant Guidance (2 CFR Part 200) unless specified otherwise in the terms and conditions of the award document.

Definitions

OMB Uniform Grant Guidance (2 CFR Part 200—Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards): Consolidates and supersedes eight previous OMB Circulars (A-21, A-50, A-87, A-89, A-102, A-110, A-122 and A-133), which specifies grant management and audit responsibilities. Single audit regulations also describe the prime recipient/awardee’s responsibility for monitoring subrecipients.

OMB Circular A-133: The circular that specifies federal and recipient audit responsibilities; it also describes recipient’s responsibilities for monitoring subrecipients.

Prime Agency/Sponsor: The agency providing funds directly to the University.

Prime Recipient/Awardee: The institution or non-Federal awardee that receives an award directly from the sponsor.

Subrecipient: The legal entity to which a subaward is made and is accountable to the prime recipient for the use of the funds provided.  Subrecipients must adhere to the terms and conditions of the prime award passed down to the subrecipient organization in the subaward agreement (subrecipient may also be referred to as subawardee, subgrantee, or subcontractor).

Prime Award: Funds obligated by a Sponsor/funding agency to the University for a specific project.

Subaward: An agreement entered into by the University with another entity (i.e., the subrecipient).  The University agrees provide funds to the entity to conduct a portion of the work specified in the statement of work (SOW) submitted as part of the proposal.

Kuali Financial System (KFS): The University of Connecticut at Storrs and regional campuses financial system of record.

Catalog of Federal Domestic Assistance (CFDA) Number: A unique five digit number assigned to each federally funded assistance program.  The first two digits identify the agency and the last three digits identify the program.

Principal Investigator (PI): Individual responsible for the development, writing, and conduct of a sponsored award, including primary responsibility for the technical and fiscal management of the award.

POLICY STATEMENT

It is the responsibility of the University to ensure our subcontractors meet the terms, conditions, as well as the regulations by sponsors from which funds are received.  As a condition of accepting funding from a sponsor, the University is obligated in its role as primary recipient to undertake stewardship activities as well as comply with federal and state laws, sponsor requirements and University policy.  When the University assigns responsibility for conducting a portion of the work to a subrecipient, the University remains responsible to the sponsor for the management of funds and meeting project performance goals.  Thus, the monitoring of technical and financial activities associated with a subrecipient is an integral part of the University’s stewardship of sponsored funds

The University will assess the subrecipient organization’s financial and internal controls and may include additional terms and conditions in the subrecipient agreement consistent with the level of risk identified.

Note: A significant financial interest held by the PI in the subrecipient entity must be disclosed to the Conflict of Interest Office.

The University will perform the following stewardship activities with regard to subrecipients:

  • Advise subrecipients of requirements, including but not limited to financial and non-financial reporting, imposed on them by federal laws, regulations of the flow-down provisions of the prime award and any supplemental requirements imposed by the University dependent on level of risk as determined by the University;
  • The University shall provide the best information available to describe a federal award to each subrecipient including the CFDA number, prime award number, award year, and the name of the sponsor as required by OMB Uniform Grant Guidance or Circular A-133;
  • Require each subrecipient to permit the sponsor and/or the University and its auditors to have access to the pertinent records and financial statements, as necessary;
  • Monitor expenditures and activities of the subaward to confirm that funding provided to the subrecipient is used for purposes authorized in the agreement and that performance goals articulated in the statement of work are achieved.  As part of this activity, PIs are required to sign invoices authorizing payments to subrecipients.  This requirement cannot be delegated;
  • Confirm subrecipients expending $500,000 (before 12/26/2014) or $750,000 (on or after 12/26/2014) or more in federal awards during the subrecipient’s fiscal year are compliant with OMB Circular A-133 or Uniform Grant Guidance audit requirements by requesting audit confirmation from all subrecipients. The subrecipient is to certify whether findings were or were not reported as part of their audit;
    • Upon receipt of a subrecipient audit report that include findings:
      • the University will review and determine whether funds are required to be returned to UConn or any financial adjustments necessary as a result of the audit’s disclosed findings;
      • the University will confirm that the subrecipient has taken appropriate and timely corrective action;
      • the University will issue a management decision letter to the subrecipient as required by regulation.

If a material weakness or other reportable condition exists, management actions, including termination of the agreement, may be taken as appropriate.

ROLES AND RESPONSIBILITIES

Principal Investigator

  1. Obtains proposal-relevant documentation from subrecipient, including Subrecipient Checklist and Consortium Statement, and submits with proposal for review and approval to the Office of the Vice President, Sponsored Program Services (OVPR SPS).
  2. Monitors the technical progress of a subrecipient’s performance as defined in the subaward.
  3. Ensures that subrecipient has met all deliverables.
  4. Ensures that subrecipient has complied with all applicable public policy requirements and objectives.
  5. Reviews invoices for cost allowability, compliance with federal regulations, prime award and subaward terms and conditions.  In addition, ensures that the amount billed is consistent with technical/progress reports and production of deliverables.
  6. Approves invoices for payment via KFS. This task may not be delegated.
  7. Submits invoices for payment in a timely manner and retain copies for departmental records.
  8. Notifies OVPR SPS when problems arise regarding invoicing or performance.

Department Grant Administrator

  1. Assists PIs in meeting their monitoring responsibilities, as specified above.

OVPR SPS

  1. Initiates Pre-qualification subrecipient reviews; consults with the appropriate University departments as necessary to perform subrecipient risk assessment for first-time subrecipients.
  2. Negotiates and executes subaward agreements between the University and subrecipient organizations, including appropriate language requiring adherence to federal regulations and other sponsor requirements as applicable.
  3. Provides special terms and conditions in the subaward to manage risk.
  4. Issues and collects annual single audit certification letters and Subrecipient Profile Questionnaire for non-A-133 subrecipients.  Issues management decision on subrecipient audit findings.
  5. Documents annual compliance certifications.
  6. Performs a final review of costs charged and facilitates close-out of all commitments.
  7. Assists to resolve financial questions related to invoices.
  8. Ensures that the University’s subrecipient monitoring procedures are compliant with Federal, non-Federal, and other applicable regulations.
  9. Provides training and guidance in interpreting regulations, subaward terms and conditions and executing these guidelines and requirements.

ENFORCEMENT

Violations of this policy may result in appropriate disciplinary measures in accordance with University Laws and By-Laws, General Rules of Conduct for All University Employees, applicable collective bargaining agreements, and the University of Connecticut Student Code.

PROCEDURE/ FORMS

Related procedures and guidance are available on the OVPR SPS website under the heading of Subawards.

POLICY HISTORY

Policy created3/22/2013

Revised:            6/18/2015 (Approved by the Vice President for Research)

Restrictions of Publication Rights and Foreign Nationals in Sponsored Research Contracts

Title: Restrictions of Publication Rights and Foreign Nationals in Sponsored Research Contracts
Policy Owner: Vice President for Research and Graduate Faculty Council Executive Committee
Applies to: Faculty, Staff, Students, Others
Campus Applicability:
Effective Date:  April 6, 2004
For More Information, Contact Sponsored Program Services
Contact Information:  (860) 486-3619
Official Website: https://ovpr.uconn.edu/services/sps/proposals/

 

 

INTRODUCTION

This policy outlines the conditions under which UConn can accept restrictions on publication rights and foreign nationals in sponsored research contracts.  This policy is necessary because federal export control regulations (including International Traffic in Arms Regulations – ITAR) severely restricts all publication by PIs and carries severe sanctions.  Under these regulations federal agencies can withhold the right to publish, including a thesis.  Accordingly, the policy’s goal is to safeguard graduate students’ progress towards graduation while allowing them to gain valuable experience working on such sponsored research projects.

KEY ELEMENTS OF THE POLICY

A grant with restrictions on foreign nationals and publication rights can be accepted only if the following conditions are met:

1)      The Principal Investigator (P.I.) must show that graduate students will not be employed on the project for more than 6 months.  This determination will be made on a case-by-case basis and is not automatic.  Six months is the maximum appointment to be considered.  Furthermore, in the future similar work should be done by a technician or post-doc.

2)      The student must understand that the work cannot be part of his/her thesis because of the restrictions.  In addition, it is important that the student or post-doc understands that he/she cannot discuss the research with others in the lab and cannot allow anyone (besides the P.I.) access to the research data.   This information will be conveyed to each student and post-doc in a letter provided by the P.I.

3)      The P.I. must outline procedures to guarantee in writing that no other employee in the lab will have access to the data.  The PI must also guarantee that the work and resulting data will not be discussed in group meetings.

4)      The P.I., as well as each graduate student and post-doc, must sign the statements described in Sections 2 and 3 of this Policy.  OSP must get a signed copy of each statement before funds are released.

5)      The P.I. must be informed by OSP that the consequences of federal oversight on contracts with these restrictions can be severe, both for the individual and the institution.  The procedures outlined in this Policy are designed to protect him/her.

6)      The Associate Vice Provost may meet with the affected graduate student to ensure that he/she understands the Policy.

Financial Conflicts of Interest in Research

Title: Financial Conflicts of Interest in Research
Policy Owner: Vice President for Research
Applies to: Faculty, Staff, Students
Campus Applicability: Storrs and Regional Campuses
Effective Date: January 23, 2015
For More Information, Contact Director, Sponsored Program Services
Contact Information: (860) 486-3622
Official Website: https://ovpr.uconn.edu/services/rics/fcoi/

 

  1.  BACKGROUND

Investigators at the University of Connecticut (University) promote the research mission of the University relating to the discovery and dissemination of knowledge that emerges from that research. Participation in activities of professional associations, industry collaborations, and other public and private entities can assist in meeting these expectations, while also serving the academic interests of the University. In addition, such participation brings enhanced national and international status to the University and the State. Over the past decade, the opportunity for University faculty and staff to engage in external professional and entrepreneurial activities has increased markedly, and is encouraged by the state and federal governments because of the resulting economic development benefits. The State of Connecticut has determined that the commercialization of University research and technology transfer is critical to Connecticut’s long-term economic growth.

However, it is vital that Investigators adhere to state and federal regulations dealing with avoiding and managing potential and existing conflicts of interest.  In order for the University to maintain public trust and support in carrying out its mission, including all sponsored activities, the University must demonstrate that it subjects itself to the highest standards of ethical behavior.

2.  PURPOSE

This Policy on Financial Conflicts of Interest in Research (Policy) provides guidelines to promote objectivity in research.  The Policy establishes standards to ensure that the design, conduct, and reporting of research funded by extramural sponsors will not be biased by any conflicting financial interest of an Investigator.  The University encourages Investigators to engage in appropriate outside relationships,  but significant financial interests related to these relationships need to be disclosed, reviewed, and managed in accordance with this Policy.

3.  APPLICABLE FEDERAL REGULATIONS

The following federal regulations inform this policy:

Public Health Service (PHS)

http://grants.nih.gov/grants/policy/coi/fcoi_final_rule.pdf

National Science Foundation (NSF)

http://www.nsf.gov/pubs/policydocs/pappguide/nsf10_1/aag_4.jsp

Food and Drug Administration (FDA)  https://www.fda.gov/RegulatoryInformation/

In summary, the federal policies and regulations stipulate:

a.       Disclosures of significant financial interests by ALL Investigators;

b.       Institutional certification that all proposed and ongoing sponsored research is either free of financial conflicts of interest, or that such conflicts are  managed, reduced or eliminated, and reported as required by applicable regulations;

c.       The implementation of an institutional mechanism for managing financial conflicts of interest in research;

d.      Notification of sponsors, as required, of management plans and if the University is unable to manage financial conflicts of interest satisfactorily;

e.       Monitoring of compliance, procedures for retroactive review in cases of non-compliance, enforcement mechanisms, and sanctions where appropriate;

f.       Maintenance of records relating to this policy for at least three years following the termination of a given project; and,

g.       Providing information and training to Investigators, as required by applicable regulations.

4.  DEFINITIONS

Business means any corporation, partnership, sole proprietorship, firm, franchise, association, organization, holding company, joint stock company, receivership, business or real estate trust, or any other legal entity organized for profit or charitable purposes.

Clinical Investigation (PHS) means any experiment in which a drug is administered or dispensed to, or used, involving one or more human subjects. An experiment here is any use of a drug, except for the use of a marketed drug in the course of medical practice.

Clinical Investigation (FDA) means any experiment that involves a test article and one or more human subjects, and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The term does not include experiments that are subject to the provisions of part 58 of the chapter, regarding non-clinical laboratory studies.

Financial Conflict of Interest (FCOI) means a situation in which significant financial interests in a business, or other personal considerations provided by a business, may compromise, or have the appearance of compromising, an Investigator’s professional judgment in conducting or reporting research, the results of which could affect the aforementioned business, either directly or indirectly.  An FCOI exists when the University, through its designated official(s), reasonably determines that an Investigator’s Significant Financial Interest is related to a research project and could directly and significantly affect the design, conduct or reporting of the research.

Human Subject (PHS regulations “Protection of Human Subjects” 45 CFR Part 46, as administered by OHRP) means a living individual about whom an Investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information.

Human Subject (FDA regulations 21 CFR 50) means an individual who is, or becomes, a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.

Immediate Family means the Investigator’s spouse/domestic partner and dependent children.

Institutional Responsibilities are an Investigator’s professional responsibilities on behalf of the University, which include research, teaching, and service as, e.g., outlined in the Policy on Faculty Professional Responsibilities (http://policy.uconn.edu/?p=659).

Intellectual Property means a product of the intellect that has commercial value, including copyrighted works, patents, business methods, and industrial processes.

Investigator means the principal investigator and any other person (regardless of title or position) who is responsible for the design, conduct or reporting of research or educational activities. This may include faculty and research staff (research associates and assistants, postdoctoral fellows, graduate students, visiting scientists engaged in research conducted at the University) as well as consultants.

Research (PHS regulation 45 CFR 46.102(d)) 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.

Significant Financial Interest (SFI)

1.      Significant Financial Interest means:

For PHS and all sponsors that follow the 2011 PHS FCOI Regulations[1] For NSF and all other sponsors:
With regard to any publicly traded entity, an SFI exists if the value of any remuneration[2] received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000; orWith regard to any non-publicly traded entity, an SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s Immediate Family) holds any equity interest (e.g., stock, stock option, or other ownership interest); or

 

Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.

An equity interest that when aggregated for the Investigator and the Investigator’s Immediate Family exceeded $5,000 over the last 12 months, and/or is expected to exceed $5,000 in value over the next 12 months as determined through reference to public prices or other reasonable measures of fair market value; or when the Investigator (or the Investigator’s Immediate Family) holds a 5% or greater equity interest (e.g., partnership, ownership, stock, stock option, or other ownership interest) in a single publicly traded entity or holds any equity interest in a non-publicly traded entity; orSalary, royalties or other payments not from the University for services (e.g., consulting fees or honoraria) that when aggregated for the Investigator and the Immediate Family over the last 12 months exceeded $5,000 or are expected to exceed $5,000 over the next 12 months;
Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their Institutional Responsibilities.

2.      In addition, the following needs to be disclosed for Clinical Investigations covered by FDA regulations:

a.       Compensation made to the Investigator in which the value of compensation could be affected by the outcome of the study/research project.

b.      A proprietary interest in the tested product, including, but not limited to, a patent, trademark, copyright or licensing agreement.

c.       Significant payments of other sorts, which are payments that have a cumulative monetary value of $25,000 or more made by the sponsor of a covered study to the investigator or the investigators’ institution to support activities of the investigator exclusive of the costs of conducting the clinical study or other clinical studies, (e.g., a grant to fund ongoing research, compensation in the form of equipment or retainers for ongoing consultation or honoraria) during the time the clinical investigator is carrying out the study and for one year following completion of the study.

 

3.      The term Significant Financial Interest does not include the following types of financial interests:

a.       Salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the University, including intellectual property rights assigned to the University and agreements to share in royalties related to such rights;

b.      Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;

c.       Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or

d.      Income from service on advisory committees or review panels for a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.

e.       Travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

Sponsor means an individual company, or any entity which takes responsibility for the initiation, management, and/or financing of a research project, but which does not actually conduct the investigation.

5. PROCEDURES

I. Notification

A copy of this policy will be sent to all current Investigators and will be provided to all new Investigators upon hire.  The policy is also available on the UConn website under “University Policies.”

II. Training

All PHS-funded Investigators must complete training prior to engaging in PHS-funded research and at least every four years thereafter as well as under the following circumstances (in the timeframes noted in parentheses):

a.       The University’s Financial Conflict of Interest policy changes such that Investigator requirements are affected (within 60 days).

b.      An Investigator is new to the University (prior to engaging in PHS-funded research).

c.       The University finds that an Investigator is not in compliance with the Policy or a management plan, as applicable.

III. Disclosure of Significant Financial Interests

Each Investigator must disclose his/her known SFIs (including those of the Investigator’s Immediate Family) that reasonably appear to be related to the Investigator’s Institutional Responsibilities,  or that would reasonably appear to be affected by the research for which funding is sought or are in entities whose financial interests would reasonably be affected by the research. In determining whether a financial interest has to be disclosed, the Investigator shall consult the definition of SFI within this policy and, if in doubt, resolve in favor of disclosure.

1.      Disclosure for each Proposal Submission:  At the time of submission of a new proposal, an Investigator must have completed their online financial disclosure in the InfoEd External Interests Module. The University will not submit a proposal until such disclosure has been submitted.

2.      Changes in SFI: An updated disclosure shall be completed and filed within thirty (30) days at any time when an Investigator acquires or discovers a new reportable SFI not disclosed in the last disclosure.  For existing Investigators on a project, new or newly identified SFIs will be reviewed promptly to determine if an FCOI exists, create a management plan if necessary and report the newly identified FCOI to the sponsor within 60 days if required.

3.      Human Subject Research:  When research involves human subjects, the Investigator must disclose SFIs to the Institutional Review Board (IRB) with every submission of protocols.  If an Investigator has an FCOI, but a management plan is not on file, the IRB will contact the VPR or their designee and hold approval of the protocol until the FCOIR makes a determination.

4.      New Investigators:  If research is ongoing and an Investigator newly participating in the project discloses an SFI related to that research, those SFIs will be reviewed promptly to determine if an FCOI exists, create a management plan if necessary and report the newly identified FCOI to the sponsor within 60 days if required.

IV. Determination, Resolution, and Management of a Conflict of Interest

1.      The VPR will review SFI Disclosure Forms and, if an SFI is disclosed, the Investigator will be required to complete a Supplemental Information Request to Significant Financial Interest Disclosure.  The VPR or his/her delegate performs an initial administrative review and refers all disclosed SFIs to the Financial Conflict of Interest in Research Committee.

2.      The Financial Conflict of Interest in Research Committee (FCOIR) is appointed by the VPR and serves as the resource with respect to the determination of relatedness of SFIs and the identification and management of COIs.  The FCOIRC shall include an appointed chair and (5) additional appointed members with broad representation across the University, and one community member who is not a University employee.  Members shall serve three-year staggered terms.

3.      The FCOIRC, with the help of the Investigator and/or his/her department head and based on guidelines consistent with all applicable regulations, will determine if the SFI is related to a sponsored research project and, if so related, whether the SFI constitutes a financial conflict of interest (FCOI).

4.      If the FCOIRC identifies an FCOI, it will resolve the conflict by elimination, mitigation, or the creation of a management plan.  The Investigator has to agree in writing to the conditions listed in such management plan.  The following are examples of conditions that may be imposed:

Public disclosure of SFIs, including disclosure on manuscripts submitted for publication, on abstracts and posters submitted for presentation, and on informed consent documents;

a.       Monitoring of the research by independent reviewers;

b.      Modification of the research;

c.       Disqualification from participation in all or a portion of the activities that could be affected by the FCOI;

d.      Divestiture or reduction of the SFI;

e.       Severance of relationships that create actual or potential conflicts.

5.      An FCOI must be eliminated or a management plan agreed to before a related award will be set up. Neither the institution nor an Investigator may expend funds unless it has been determined that no FCOI exists or that the FCOI is manageable in accordance with the terms of a management plan.

V. Notification/Reporting

If an FCOI is identified, the FCOIRC is responsible for:

1.      Notification of the Investigator of the management plan designed by the Committee for his/her FCOI;

2.      Notification of the Office for Sponsored Programs (OSP) to assure that no spending of funds from related grants occurs without prior approval of the FCOIRC.

3.      Notification of the Office of Research Compliance of FCOI management plan when the research involves human subjects.

4.      Notification of research sponsors, as required, of any FCOIs, including any measures taken to reduce, manage, or eliminate such conflicts.  The elements of such a report shall include, at least, the items enumerated under the FCOI Regulations.

The VPR or his/her delegate will notify the above individuals, offices, and sponsors on behalf of the FCOIRC.  Reasonable efforts will be made to maintain the privacy of information gathered in the FCOIRC’s deliberations, within the limits imposed by applicable laws and regulations.

VI. Maintenance of Records

All records related to the implementation of this policy (e.g., Individual Financial Disclosure Forms, Supplemental Information Forms, minutes of the meetings of the COI in Research Management Committee, notifications to funding agencies, actions taken to resolve or mitigate FCOIs, etc.) will be maintained securely by the VPR for a period of at least three (3) years beyond the termination or completion of the sponsored award to which they relate, or until the resolution of any action involving those records, whichever is longer.  FCOI records shall be subject to periodic review for compliance with this policy by the VPR or by any agency per applicable regulations.

VII. Subrecipients

If a subrecipient carries out a portion of the work, University shall take reasonable steps to ensure that any subrecipient and subrecipient Investigator complies with the applicable FCOI regulation.

University will establish, via a written agreement, the governing FCOI policy.

1.      Sub-recipient will certify that its FCOI policy complies with the respective regulations and, further, sub-recipient will report identified FCOIs for its investigators in a time frame that allows University to report identified FCOIs to the awarding agency.

2.      Alternatively, if a sub-recipient lacks a compliant FCOI policy, the subrecipient will be governed by the University’s FCOI policy; University will solicit and review sub-recipient Investigator disclosures and identify, manage and report FCOIs to the sponsor.

In the event that a sub-recipient notifies University of an FCOI for sub-recipient Investigators for which University is the prime awardee, University will promptly notify the sponsor.

VIII. Public Accessibility

Prior to expending any funds under a PHS-funded grant, cooperative agreement or contract, the VPR shall ensure public accessibility of information about the FCOI, via a written response to any requestor within five (5) business days of a request, of information concerning an SFI which was disclosed and is still held by the senior/key personnel on the project, which is determined to be related to the PHS-funded research, and which is determined to be a FCOI. The information shall consist of the information required to be provided under the FCOI Regulations.

IX. Monitoring Compliance /Mitigation

1.      The VPR will monitor for compliance with the policy.

2.      If the VPR learns of an SFI that was not timely disclosed or was not timely reviewed, the VPR, or his/her delegate, shall, in consultation with the FCOIRC and no later than the sixtieth (60th) day after learning of the SFI:

a.       determine whether the SFI is an FCOI; and

b.      if an FCOI exists, implement an interim management plan or implement other interim measures to ensure the objectivity of the research going forward.

3.      If an FCOI was not timely identified or managed or if an Investigator fails to comply with a management plan, the VPR shall no later than the 120th day after determining noncompliance:

a.       complete and document a retrospective review and determination as to whether research conducted during the period of noncompliance was biased in the design, conduct, or reporting of the research; and

b.      implement any measures necessary with regard to Investigator’s participation in the research between the date that the noncompliance is identified and the date the retrospective review is completed.

4.      For PHS-covered research projects, the retrospective review shall cover key elements as specified by federal regulations and may result in updating the Financial Conflict of Interest Report, notifying the PHS awarding component, and submitting a mitigation report as required by federal regulation.

5.      University will notify the PHS of instances in which the failure of an Investigator to comply with this policy or a management plan appears to have biased the design, conduct, or reporting of funded research.  The University will make information available to HHS or the PHS awarding component as required by federal regulation.

X. Appeals

1.      In situations where an Investigator disputes the decision of the FCOIRC, the Investigator may request to present the case to the FCOIRC in person. An Investigator who disagrees with the FCOIRC’s determination may appeal in writing to the VPR. An appeal may be made in regard to whether the professional judgment of the Investigator is likely to affect his or her conduct of research, but Investigators may not contest the terms and conditions of this.

2.      The VPR may agree with the FCOIRC’s findings and/or recommendations, or may amend such findings and/or recommendations. The VPR shall promptly notify the Investigator and the FCOIRC in writing of the conclusions of his/her review, including the actions that must be taken by the Investigator to comply with this policy.

3.      Upon receipt of the VPR’s written report, the Investigator must promptly comply with the actions specified in that report.

XI. IMPLEMENTATION AND ENFORCEMENT

The Provost is the senior administrator responsible for overseeing the implementation of this Policy. The Provost has delegated the disclosure/review/management process to the Vice President for Research or his/her designee (VPR). The VPR, in consultation with the Dean of the appropriate School and the Investigator(s) Department Head, will review all breaches of the policy, including:

a.       failure to comply with the process (by refusal to respond, by responding with incomplete or knowingly inaccurate information, or otherwise);

b.      failure to remedy conflicts; and

c.       failure to comply with a prescribed management plan

Sanctions and penalties for those who knowingly and willfully disregard this policy, or refuse to comply with its terms, will be determined by the VPR, in consultation with the Dean of the appropriate School, with advice from the Investigator(s) Department Head and the Department  of Faculty and Staff Labor Relations . Sanctions include, but are not restricted to:

  • Letter of reprimand
  • Notification to professional and/or scientific societies, funding agencies and/or professional journals
  • Reassignment of duties
  • Termination of grant support
  • Adjustment of research space allocation
  • Adjustment of salary
  • Suspension
  • Dismissal

XII. Audit Procedures

In order to ensure that all declarations are being made and financial conflicts managed, the University will implement a relevant audit program through the University’s Office of Audit and Management Advisory Services.

January 23, 2015

[1] E.g. American Heart Association and American Cancer Society
[2] For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value