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Research at URI

Conflicts of Interest in Research

A conflict of interest is a situation in which an investigator's outside financial interest(s) or obligation(s) (real or perceived) have the potential to bias a research project or cause harm to human subjects participating in a research project.

Investigators at University of Rhode Island (URI) are subject to URI policies, as well as specific Rhode Island State law and federal regulations.

Policies, Procedures and Guidance

Federal Regulations

The URI Conflict of Interest in Research Policy and Procedure to compliant with the 2012 Public Health Service (PHS) financial conflict of interest (FCOI) reporting and training requirements. The new federal requirements are intended to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of sponsored research will be free from bias resulting from Investigator financial conflicts of interest.

For more information see: http://grants.nih.gov/grants/policy/coi/

State Regulations

The Rhode Island Public/Private Partnership Act was developed to allow employees of the University of Rhode Island, Rhode Island College, and the Community College of Rhode Island to enter into public/private partnerships in education that involve faculty and staff members from those institutions and encourage the marketing of inventions developed by faculty and staff for the benefit of both the inventor and the public, while continuing to ensure that Rhode Island's public employees adhere to the highest standards of ethical conduct, as embodied in the R.I. Code of Ethics.

The Public/Private Partnership Act authorizes the Rhode Island Board of Education to approve relationships between institutional employees and private entities in which there is an actual or perceived conflict of interest or conflict of commitment between the employee's interests and the interests of the institution by whom he or she is employed. The Act therefore also obligates the Board of Education to impose such restrictions as are necessary to manage, reduce, or eliminate any actual or potential conflict.

For more information see:

Disclosure Process

For Investigators with PHS awards or awards that must follow federal PHS regulations, investigators must complete a disclosure of significant financial interests (SFI):

  1. Proposal-Related Disclosures: Prior to submitting proposals for internal or external funding and at time of fund award.
  2. Ad Hoc Disclosures: Within 30 days of joining a research project already in progress or within 30 days of acquiring a new SFI.
  3. Travel Disclosures: Within 30 days of any reimbursed or sponsored travel undertaken by the Investigator related to his or her Institutional Responsibilities.
  4. Annual Disclosures: On an annual basis as part of the Noncompeting Continuation or other Process

Non-PHS funded investigators must complete a disclosure of significant financial interests (SFI):

  1. Proposal-Related Disclosures: Prior to submitting proposals for internal or external funding.
  2. Ad Hoc Disclosures: Within 30 days of joining a research project already in progress or within 30 days of acquiring a new SFI.

For all disclosures: URI Disclosure of Significant Financial Interest Form

For more information on the disclosure process, see:

If a Significant Financial Interest is Disclosed

The URI Conflict of Management Committee (CIMC) is responsible for the review and assessment of all financial disclosures related to research projects at URI and for determining any actions required to ensure that real or perceived financial conflicts of interest are managed or eliminated. The URI Office of Research Integrity provides the operational support required to implement and administer CIMC decisions.

If a financial interest is disclosed, the CIMC or a subcommittee of CIMC will determine whether a financial interest with an external entity (or travel sponsored by an external entity if travel disclosure is required) is related to a particular research project or protocol on a case-by-case basis.

If the CIMC (or subcommittee) determines that a financial interest (or travel sponsored by an external entity when travel disclosure is required) is reasonably related to an investigator's institutional responsibilities, CIMC (or subcommittee) will determine whether the Investigator will be required to eliminate or manage the Financial Conflict of Interest, as appropriate. 

A Financial Conflict of Interest may be eliminated by divestiture of Equity Interests; termination of the relationship that gives rise to the Significant Financial Interest (such as consulting); abandoning the proposal; terminating the sponsored project; and similar measures.

If the Investigator does not want to eliminate a Financial Conflict of Interest or the appearance of a Financial Conflict of Interest and CIMC determines that it can be managed, the Investigator must develop a written management plan. The Designated Official will assist the Investigator in developing the plan.  Per the Rhode Island Public/Private Partnership Act, the management plan along with the RI Disclosure Form (also known as Appendix A), must be submitted to the RI Board of Education for review.

For additional information, refer to the URI Conflict of Interest in Research Policy

Conflict of Interest Forms

Training

URI is required to provide training regarding URI's Policy and the regulations to Investigators. Training is required for PHS funded investigators (and investigators with awards from agencies that follow PHS regulations) prior to URI submission of the grant proposal and at least every four years thereafter. Investigators must also complete training within a period of time determined by the Institutional Official if (i) the URI Policy is substantively amended in a manner that affects the requirements of PHS funded Investigators or (ii) URI determines that the Investigator has not complied with this Policy or with a management plan related to his or her research.

Financial Conflict of Interest training is available on: http://www.citiprogram.org

Training consists of three required modules and two optional modules. We highly recommend that investigators review the two optional modules as they contain key information on URI specific policies and procedures and Conflict of Commitment.

If you already have a CITI account, complete the following steps to locate the training:

  1. Log in to CITI.org;
  2. Click 'Add a Course or Update Your Learner Groups';
  3. Scroll down to Question 4 'Conflicts of Interest' and check "Yes";
  4. Click 'continue';

If you do not already have a CITI account, you first need to create an account and select University of Rhode Island as your participating institution.

Reporting Allegations
Allegations involving possible conflicts of interest in research should be brought to the attention of the Vice President for Research and Economic Development 401-874-4576 or Ted Myatt, Director of Research Integrity, 401-874-2636, tedmyatt@mail.uri.edu as promptly as possible.

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