COI: Disclosing Financial Interests

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. 

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 financial interest reporting requirements for PHS 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.

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.

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.