Research Investigators

 All Investigators on each subaward will be required to complete the training and disclosure requirements. An Investigator means any person who shares the responsibility of Conducting Research. Conducting Research includes the design, development, testing, evaluation, conduct, reporting, review, and oversight of a program of scientific inquiry.  Each Investigator will need to submit an individual disclosure.

In case helpful, below is a brief overview specific to subrecipients but more Information for Non-UA Subcontractors, Consultants, and Collaborators can  be found on our website.

Subrecipients will be presented with two options. They will need to either (1) have an implemented and enforced federally-compliant conflict of interest policy and process and agree to be responsible for compliance under their policy and pursuant to the subcontract or consulting agreement including reporting requirements (our office reviews each subrecipient’s policy to determine it is compliant) or (2) comply with UArizona’s Conflicts of Interest & Commitment Policy (more details on the fees that apply can be accessed from link above).  Our office will be in direct contact with the subrecipients to share a complete overview of all the related requirements. Our office will also provide any assistance and guidance the subrecipient may need.

Financial Conflict of Interest (FCOI) means an Outside Interest is Related to, or can be perceived to be Related to, an individual’s institutional responsibilities.

FCOI determinations answer the question: Could it reasonably appear to someone outside of UA (e.g., front page of the newspaper) that a decision made in the conduct of research was influenced by your Outside Interest?  That influence could affect the design of the project, a decision to exclude data, a decision to delay publication of research results, a decision to overemphasize or underemphasize research results, etc. for the benefit of your Outside Interest.

Related to is a defined term that refers to the condition in which it may reasonably appear that decisions made by the Investigator in the performance of his/her institutional responsibilities could directly and significantly affect the value of his/her Significant Financial Interests or be in conflict with Significant Personal Interests or Foreign Interests.

Relatedness includes situations in which an Investigator’s Outside Interests would reasonably appear to affect, or to be affected by, the individual’s Research or other institutional responsibilities.

Relatedness is not a judgment on whether an Investigator would deliberately make choices in the Conduct of Research or the performance of their Institutional Responsibilities based on considerations related to their Outside Interest. Rather, “Relatedness” refers to the condition in which it may reasonably appear that choices made in the Conduct of Research or other performance of the individual’s institutional responsibilities could be directly and significantly influenced by the existence of an Outside Interest. 

An up-to-date COI disclosure (either an Annual Disclosure or Research Certification submitted within the last 364 days) is required at the time of proposal to a federal funding agency.

Additionally, Federal regulations prohibit expenditures on Awards until after the COI review process is complete. Our office desires to see all funded research go forward without delay.

Therefore, to avoid Award Holds, you are asked to submit Research Certifications early. Generally, Research Certifications are available in eDisclosure 60 days prior to the project start date listed in the Institutional Proposal. (For certain clinical trials, it may be fewer than 60 days) eDisclosure will send a notification to the Investigator as part of the UAccess Research/Sponsored Projects integration. If at any time you have been informed that any given project was not funded  you would then advise sponsor@arizona.edu as soon as possible that the specific project will not be funded and no action is required for the Research Certification.
 

The Human Subjects Protection Program requires protocol personnel submit a Research Certification via eDisclosure for each project they are listed on in eIRB.  For sponsored research, the Human Subjects Protection program has mapped IRB protocol roles to the sponsored project personnel categories. This mapping tool can be used to ensure protocol personnel complete Research Certifications: Investigator Mapping.

If this activity meets the definition of an Outside Commitment, it should be disclosed for conflict of commitment review.  The Outside Commitment Decision Tree on our Disclosure Requirements webpage may be of assistance in making this determination.

If you are an Investigator, receipt of remuneration (includes stipends and honorariums) in the amount of $5,000 or more will make this a Significant Financial Interest that needs to be disclosed.

Disclosures must be submitted in eDisclosure.  If you experience any issues in eDisclosure, please contact OROI at coi@arizona.edu.

There is not enough information to determine whether this should be disclosed for conflict of interest review.  (e.g., Is it a UArizona grant?  Are you funded by a PHS agency or the Dept of Energy?)  Please contact OROI at coi@arizona.edu or visit our office hours (1st & 3rd Thursday, 2 pm – 3 pm; Connect via Zoom) for assistance.

If this activity meets the definition of an Outside Commitment, it should be disclosed for conflict of commitment review.  The Outside Commitment Decision Tree on our Disclosure Requirements webpage may be of assistance in making this determination.

If you are an Investigator, this is a Foreign Interest that must be disclosed for conflict of interest review.  Foreign Interests are:

• Participation in a foreign talent or similar-type program
• All resources and other support, both domestic and foreign, for ongoing research projects, including those conducted at a different institution
• In-kind contributions from domestic and foreign institutions or governments that support your research activities
• Any payment, reimbursement, travel support or other compensation, of any amount, that you personally receive, or will personally receive, from a foreign entity

(If this was a U.S. institution, it would need to be disclosed if you are funded by a PHS agency or the Dept of Energy, even if the value is less than $5,000.)

If your UArizona FTE is 0.50 or greater and this activity meets the definition of an Outside Commitment, it should be disclosed for conflict of commitment review.  The Outside Commitment Decision Tree on our Disclosure Requirementswebpage may be of assistance in making this determination. Individuals can also contact OROI at coi@arizona.edu.

Also, please see: Guidance for Consulting or Employment at Other Postsecondary Institutions.

“It is permissible for members of the faculty on sabbatical leave to supplement their compensation from the university to cover such special expenses resulting from the approved sabbatical leave program, through fellowships, scholarships, employment, or grants-in-aid. Such special expenses referred to might include such items as travel, secretarial assistants, tuition, research, and publication. Additional compensation expected is to be fully explained on the application form and approved before the leave is granted. Should opportunities for supplemental compensation develop after the sabbatical leave has begun or after the application form has been submitted and approved, such opportunities must be cleared with the university at the earliest opportunity.”  See ABOR 6-207(F).

Investigators, as defined in the Conflicts of Interest & Commitment policy, are required to submit a Research Certification for each Research Project, both non-sponsored and sponsored.  OROI relies on the PI to make this determination.  “Who is an Investigator?” can be used to help determine if you are an Investigator.

For IRB protocols, the Human Subjects Protection Program has guidelines for who needs to submit a Research Certification - Investigator Roles & COI Disclosures in eIRB.  OROI happy to assist you in contacting them or you can reach out to them via email - vpr-irb@email.arizona.edu.

University Employees are asked to disclose their Outside Interests (Significant Financial Interests, Significant Personal Interests, Foreign Interests), Outside Commitments and Substantial Interests so that determinations of what is and is not a conflict can made through OROI. The review processes are available on our COC & COI Review Processes webpage. 

The Disclosure Tables and Outside Commitment Decision Tree on our Disclosure Requirements webpage are available to assist individuals in determining what needs to be disclosed. Individuals can also contact OROI at coi@arizona.edu.

Financial Conflict of Interest means an Outside Interest is Related to, or can be perceived to be Related to, an individual’s institutional responsibilities.  Relatedness is a defined term that means it may reasonably appear that decisions made by the Investigator in the performance of his/her institutional responsibilities could directly and significantly affect the value of his/her Significant Financial Interests or be in conflict with Significant Personal Interests or Foreign Interests.  More information can be found here: Relatedness.

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