Office for Responsible Outside Interests

Research and Research Project mean any organized program of scientific inquiry that involves a systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge that is performed at or under the auspices of the University. Research includes non-sponsored research, research fellowship and training programs, and research-related activities in undergraduate, graduate, and postdoctoral education.  It also includes some educational activities that are supported by a research sponsor.

Federal funding agencies indicate that Research can be thought of as:

1. "a process to discover new knowledge,"
2. "a scientific study of nature that sometimes includes processes involved in health and disease," and/or
3. "creative and systematic work undertaken in order to increase the stock of knowledge—including knowledge of humankind, culture and society—and to devise new applications of available knowledge."

Federal funding agencies further indicate that one can consider whether the project includes:

• "a systematic, intensive study directed toward greater knowledge or understanding of the subject being studied, or
• a systematic study directed specifically toward applying new knowledge to meet a recognized need, or
• a systematic application of knowledge to produce useful materials, devices, and systems or methods, or
• development [which] may include designing, developing, and improving prototypes and processes to meet specific requirements."

See:  HHS, NCI, NSF

A foreign entity is:

1. A public or private organization located in a country other than the United States and its territories that is subject to the laws of the country in which it is located, irrespective of the citizenship of project staff or place of performance; or
2. A private nongovernmental organization located in a country other than the United States that solicits and receives cash contributions from the general public; or
3. A charitable organization located in a country other than the United States that is nonprofit and tax exempt under the laws of its country of domicile and operation, and is not a university, college, accredited degree granting institution of education, private foundation, hospital, organization engaged exclusively in research or scientific activities, church, synagogue, mosque or other similar entities organized primarily for religious purposes; or
4. An organization located in a country other than the United States not recognized as a Foreign Public Entity.  A Foreign Public Entity is (1) A foreign government or foreign governmental entity; (2) A public international organization, which is an organization entitled to enjoy privileges, exemptions, and immunities as an international organization under the International Organizations Immunities Act (22 U.S.C. 288f); (3) An entity owned (in whole or in part) or controlled by a foreign government; or (4) Any other entity consisting wholly or partially of one or more foreign governments or foreign governmental entities.

Investigators must:

1.    Complete the Required COI Disclosure Training after July 1, 2021.
2.    Complete the Required COI Disclosure Training once every 4 years thereafter.
Note:  OROI may direct an Investigator to complete the training more frequently.
3.    Submit an annual certification.  This can be an Annual Disclosure Certification or Research Certification.
4.    Update their certification within 30 days of a change to an existing Outside Interest.
5.    Update their certification within 30 days of acquiring a new Outside Interest.
6.    Submit a Research Certification for all non-sponsored and sponsored Research.
 

At the time of proposal submission to a federal funding agency, Investigators must have an up-to-date COI certification.  That means each Investigator has:

1.    Submitted either an Annual Disclosure Certification or a Research Certification in the last 364 days, and
2.    Does not have any changes to an existing Outside Interest or new Outside Interest.
 

In the past, University Employees were asked to disclose Outside Commitments in the COC database and Outside Interests in the COI database.

The Conflicts of Interest & Commitment Policy incorporated and replaced the following policies:

1.    Conflict of Commitment Policy
2.    Conflict of Interest (UHAP) Policy
3.    Conflict of Interest in Purchasing Policy
4.    Individual Conflict of Interest in Research Policy
5.    Institutional Conflict of Interest Policy

Now, eDisclosure serves as a single platform to meet all policy disclosure requirements.
 

When you enter into any commitment or obligation, even if it is not in writing, to Conduct Research for or on behalf of an individual or entity outside of UArizona (e.g., delivery of research results or data to the outside individual or entity) it constitutes an Outside Commitment and must be declared as such in advance of the activity, unless there is an existing signed agreement or contract between the outside individual or entity and the University of Arizona, on file with either RII Sponsored Project Services, RII Contracting Services or UAHS Research Administration, and which covers this specific commitment or obligation.

Non-sponsored research must be disclosed for conflict of interest review but is not an Outside Commitment that requires conflict of commitment approval unless you are Conducting the Research for or on behalf of an outside individual or entity.
 

An Investigator is any person who shares the responsibility of Conducting Research.  

This includes, but is not limited to, the Principal Investigator (PI), Co-PI, Co-Investigator, Project Director (PD), Co-PD, Senior/Key Personnel, and any other person, regardless of title or position, who is responsible for Conducting Research performed by or under the auspices of the University.

This does not, however, include individuals whose performance is purely ancillary.  For example, office staff who provide ancillary support or hospital staff who provide intermittent care and do not make contributions to the research data are not Investigators.

Principal Investigators are responsible for identifying the Investigators who are participating in their research and the Office for Responsible Outside Interests will help Principal Investigators identify such individuals.  Principal Investigators should consider the following:

• The significance of the tasks assigned to the individual with regard to Conducting Research (i.e., making a significant contribution to the research results by participating in the design, development, testing, evaluation, conduct, reporting, review or oversight of the research, or in all of these activities);
• The degree of independence the individual may have in performing their assigned tasks;
• Whether the individual will be directly involved in the research intervention or consenting or evaluation of human research subjects; 
• Will the student/trainee be responsible for Conducting Research without direct oversight from an Investigator; and
• Whether the individual will be a collaborator or given authorship credit on a publication related to the Research or present Research findings at a meeting or conference.

For assistance in making this determination, you can review the following resources: Identifying Investigators & COI Disclosers and Who is an Investigator?, or contact OROI.

Conflict of interest (COI) and conflict of commitment (COC) reviews are separate because COI relates to bias in decisions and COC relates to a University employee's time & effort for UArizona, UArizona resources and UArizona Assets.

Sponsors & funders have identified the following concerns: 

1.    conflicts of interest
2.    shadow labs
3.    loss of Intellectual Property
4.    conflicts of commitment, including theft of time, resources and assets
 

Yes, since UArizona receives federal funding, all University Employees are expected to follow federal regulations as embodied in the Conflicts of Interest & Commitment Policy.

As a public University and recipient of federal research funding, UArizona is required to comply with federal regulations, state law and ABOR policies.  Additionally, UArizona has a fiduciary responsibility to ensure inappropriate external influences do not affect the performance of one’s primary duties to UArizona.

The information collected in eDisclosure allows UArizona to ensure development and implementation of management strategies in order to facilitate our faculty’s continued cutting-edge research and that all University Employees meet regulatory requirements.

More information on disclosure requirements can be found on our History of Disclosure Requirements webpage.

UArizona’s policy can be found here: Conflicts of Interest & Commitment Policy