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COI: Disclosing Financial Interests

Find information and links on disclosing financial interests.

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Gifts

A Gift is the giving of research support to UCSD on the part of an entity donor with charitable intent and without consideration, in the form of cash, equipment, software, or other similar support. Gifts are used to support a UCSD investigator's independent or collaborative research in general. Read more on financial interest reporting requirements for Gifts.

Clinical Trials

A Clinical Trial is the controlled, clinical testing or comparison in human subjects of investigational new drugs, approved drugs, devices, treatments, or diagnostics.

A Clinical Trial is conducted to assess the safety, efficacy, benefits, costs, adverse reactions, and/or outcomes of these tests or comparisons. It may be conducted under an industry-initiated protocol or an investigator-initiated protocol. In addition, a clinical trial is most often used in conjunction with obtaining new drug or device approval from the U.S. Food and Drug Administration. Although they can be designed with the sole purpose of collecting and analyzing data about an approved drug or device in order to contribute to medical knowledge about the treatment of a disease or medical conditions. 

Read more on how to disclose on clinical trials.

PHS Sponsored Research (effective August 24, 2012)

The Public Health Service (PHS) regulations on Objectivity in Research (revised in August 2011) are designed to promote objectivity by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of PHS Research Activities will be free from bias resulting from an Investigators’ Financial Conflicts of Interest (FCOIs).   New rules for FCOI in all research sponsored by PHS, including the National Institutes of Health (NIH), require disclosure of significant financial interests by Investigators who participate in PHS-funded research either directly or through a subaward.  The new rules also apply to a handful of non-federal sponsors who have adopted the PHS requirements. 

The new regulations apply only to grants and cooperative agreements awarded on or after August 24, 2012, including noncompeting continuing awards.  Read more on finanical interest reporting requirements for PHS Sponsored Research.

Federal (Non-PHS) Sponsored Research

Beginning in 1995, federal regulations, as well as the University of California policy's on disclosure of financial interests and the management of conflicts of interests related to sponsored projects, began requiring researchers at UCSD, who receive funding from a particular federal sponsor, to disclose certain significant financial interests. Significant refers to specific financial thresholds, as well as the researcher's financial interests or the financial interests of the entity, that could reasonably appear to be affected by the federal sponsored research. Read more on financial interest reporting requirements for federal (non-PHS) sponsored research.

Non-Federal Sponsored Research

The State of California mandated in 1982, that principal investigators are required to disclose their financial interests when their research project is being funded or supported in whole or in part by a non-federal sponsor, such as a non-profit foundation or for-profit company.

In addition, State of California law also requires financial disclosure when a gift is received from a non-federal sponsor and has been designated for a specific principal investigator or a specific research project. Read more on financial interest reporting requirements for non-federal sponsored research.

Service Agreements

A service agreement is a legally binding agreement between the University and an external entity, such as a private corporation or federal agency. A service agreement sets forth the terms and conditions pertaining to specific goods or services to be provided by the University. 

The primary purpose of most service agreements and incoming purchase orders is for a one-time or non-continuous business or commercial activity, for which it is shown conclusively that satisfactory facilities, goods, and/or services do not exist elsewhere.

For purposes of this type of agreement, services are defined as small, specifically-designed projects and are confined to those projects that provide services involving classification, diagnostics, or testing of a sponsors data, samples, mechanisms, procedures, or products. These services are performed using University resources, including personnel, equipment, or facilities.

Read more on financial interest reporting requirements for service agreements.

Material Transfer Agreements

A Material Transfer is the transfer of tangible research materials between UCSD and other entities to conduct scientific research. They are used to support an investigator's independent or collaborative research through the use of novel, tangible, research tool, or material.

Some of the most frequently transferred materials include reagents, cell lines, plasmids, and vectors. However, material transfers may also include; chemical compounds, software, databases, gene chips, and small devices. Examples can include:

  • A UCSD investigator wishes to receive a plasmid from an organization to test the effects of mutations isolated in a yeast expression system.
  • A UCSD investigator wishes to send Poly(tetraphenyl)silole to an organization to evaluate in a chemical sensor array to determine its value in the detection of various chemicals.
Read more on financial interest reporting requirements for material transfer agreements.

Vendor Relationships

Publication of Research Results

Many scientific journals and funding agencies have implemented requirements for authors to disclose related financial interests to improve the integrity of science and manage conflicts of interest. Full disclosure removes the suspicion that something of relevance to objectivity is being hidden and allows readers to form their own opinions on whether a conflict of interest exists and what relevance that has to the study.  Read more on financial interest reporting requirements for publication of research results.

Sponsors Exempt from Disclosure

Certain sponsors of research are exempt from University non-governmental entity financial disclosure requirements. See a list of sponsors exempt from conflict of interest disclosure.

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