Office for Responsible Outside Interests

Why do I have to disclose my Outside Employment and Outside Commitments to the Office for Responsible Outside Interests?

The University requires that all Investigators (regardless of their U of A FTE) and all University Employees with a 0.50 FTE or greater submit an Outside Commitment, Outside Employment or Other Support form in eDisclosure for review because the University has a fiduciary responsibility to ensure that inappropriate external influences outside the course and scope of one’s University employment or research activities do not affect the performance of one’s primary duties to the University. Outside Activities raise important questions related to time and energy allocation, University resource allocation, intellectual property protection and potential for conflicts of interest.

What happens if someone who is participating in a Research Project funded by the PHS/NIH does not comply with the Conflicts of Interest & Commitment Policy?

In accord with PHS/NIH policy (42 CFR § 50.605(3)), a retrospective review will be conducted if the Office for Responsible Outside Interests determines that an Investigator participating in any University project funded by the PHS/NIH (excluding Phase I SBIR/STTR grants) has not (a) complied with this Policy; or (b) complied with a required FCOI management plan; or (c) disclosed a SFI or SPI in a timely manner to allow appropriate review and management. Consistent with PHS/NIH grants policy 42 CFR § 50.606(c), “in any case in which a determination is made that a PHS/NIH-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with an FCOI that was not managed or reported by the Institution as required, the Investigator will be required to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations.”

Does the public have access to conflict of interest information?

For Research Projects funded by PHS/NIH agencies, excluding Phase I SBIR/STTR grants, the University is required to respond within five (5) business days of receipt of a written request from a member of the public for information regarding determination of an FCOI of senior/key personnel for the funded project. Such public requests must comply with the requirements of 42 CFR § 50.605(a)(5) and 45 CFR § 94.5(a)(5) of the NIH grants policy.

Pursuant to A.R.S. § 38-509, all disclosures of Substantial Interests, as defined by A.R.S. § 38-502, are available for public inspection.

What must University Administrators disclose in eDisclosure?

University Administrators must disclose:

A University Administrator is any University Employee in a position of administrative leadership of a college, academic department, business, or other administrative unit, where a regular job requirement is to make institutional decisions on behalf of the University of Arizona. The role of a University Administrator includes, but is not limited to, the following positions (whether such positions are staffed on an interim, full-time, or part-time basis):

  • University Senior/Associate/Assistant Vice Presidents
  • University Provost
  • University Senior/Associate/Assistant Vice Provosts
  • University Deans
  • University Vice/Deputy/Associate/Assistant Deans
  • University Directors
  • University Department Heads/Chairs
  • University Business Officers/Managers
  • University Division Chiefs, Center Heads/Directors
  • University Employees with the authority to sign agreements on behalf of the University of Arizona or Arizona Board of Regents
  • University Employees whose duties and responsibilities include contracting or services related to Research administration, Research contracting, Research compliance, responsible conduct of Research, sponsored projects services, or technology transfer and who are in a position to influence decisions or commit University resources in the performance of the University Employee’s duties and responsibilities.
  • Individuals who serve as Chairs on the University’s Institutional Review Board committees, regardless of whether such individuals are University Employees.

I will be serving on a board for a university in Europe, providing strategic planning advice for the university. I will be reimbursed for travel expenses, but will also receive honoraria for visits. How do I disclose this?

This should be disclosed as a Foreign Interest by selecting “Remuneration or Reimbursement (excluding sponsored travel)” and “Sponsored or reimbursed travel.” For Foreign Interests, there is no dollar threshold.

 

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

I am planning a personal trip to a foreign country this summer (outside my time paid by UA). There will be no money from UA spent, or received. Is there a form to fill if I give a seminar (unpaid, published materials)?

Below, please find a list of the potential points of disclosure. 

COC Form – Outside Activity

If your seminars meet the definition of Outside Commitment, you should submit a COC form in eDisclosure to get prior approval to engage in the Outside Activity.

Outside Commitments: (1) are professional and other activities that are related to a University Employee’s professional expertise, outside of their University duties and responsibilities; (2) are for the benefit of an external entity or individual and are not covered by a fully executed written agreement between the University and the external entity; and (3) require a time commitment. Outside Commitments include Outside Employment, independent contracts for consulting services, private consulting groups comprised of University Employees, volunteer/pro bono work, appointments at postsecondary educational institutions, and foreign components, as that term may be updated by the University’s Office for Responsible Outside Interests.

You can also use this decision tree to determine if the activity is an Outside Commitment: Outside Commitment Decision Tree.

  

COI Disclosure – Foreign Interests

If you do end up receiving a payment of any amount, an in-kind contribution or Other Support, it must be disclosed as a Foreign Interest.

 

COI Disclosure – Foreign Travel

PHS and Dept of Energy Investigators only: Must disclose any reimbursed or sponsored travel related to your institutional responsibilities, regardless of the amount, unless received from a Federal, state, or local government agency of the United States; a domestic Institution of Higher Education; or a domestic research institute that is affiliated with a domestic Institution of Higher Education.

  

COI Disclosure – Foreign Affiliations

As part of your eDisclosure submissions, you must disclose whether you have a foreign affiliation.

I am planning a personal trip to a foreign country. There will be no money from UA spent, or received. Is there a form to fill if I give a seminar (unpaid, published materials)?

Below, please find a list of the potential points of disclosure. 

COC Form – Outside Activity

If any of your activities during your travel meet the definition of Outside Commitment, you should submit a COC form in eDisclosure to get prior approval to engage in the Outside Activity.

Outside Commitments: (1) are professional and other activities that are related to a University Employee’s professional expertise, outside of their University duties and responsibilities; (2) are for the benefit of an external entity or individual and are not covered by a fully executed written agreement between the University and the external entity; and (3) require a time commitment. Outside Commitments include Outside Employment, independent contracts for consulting services, private consulting groups comprised of University Employees, volunteer/pro bono work, appointments at postsecondary educational institutions, and foreign components, as that term may be updated by the University’s Office for Responsible Outside Interests.

You can also use this decision tree to determine if the activity is an Outside Commitment: Outside Commitment Decision Tree.

  

COI Disclosure – Foreign Interests

If you do end up receiving a payment of any amount, an in-kind contribution or Other Support, it must be disclosed as a Foreign Interest.

 

COI Disclosure – Foreign Travel

PHS and Dept of Energy Investigators only: Must disclose any reimbursed or sponsored travel related to your institutional responsibilities, regardless of the amount, unless received from a Federal, state, or local government agency of the United States; a domestic Institution of Higher Education; or a domestic research institute that is affiliated with a domestic Institution of Higher Education.

  

COI Disclosure – Foreign Affiliations

As part of your eDisclosure submissions, you must disclose whether you have a foreign affiliation.

I am planning a personal trip to Japan (outside my time paid by UA). There will be no money from UA spent, or received. I would like to plan for some visits to colleagues at local universities while traveling. Is there a COI form I need to fill in?

Below, please find a list of the potential points of disclosure.

COC Form – Outside Activity

If your visits or seminars to Japanese universities meet the definition of Outside Commitment, you should submit a COC form in eDisclosure to get prior approval to engage in the Outside Activity.

Outside Commitments: (1) are professional and other activities that are related to a University Employee’s professional expertise, outside of their University duties and responsibilities; (2) are for the benefit of an external entity or individual and are not covered by a fully executed written agreement between the University and the external entity; and (3) require a time commitment. Outside Commitments include Outside Employment, independent contracts for consulting services, private consulting groups comprised of University Employees, volunteer/pro bono work, appointments at postsecondary educational institutions, and foreign components, as that term may be updated by the University’s Office for Responsible Outside Interests.

You can also use this decision tree to determine if the activity is an Outside Commitment: Outside Commitment Decision Tree.

  

COI Disclosure – Foreign Interests

If you do end up receiving a payment of any amount, an in-kind contribution or Other Support, it must be disclosed as a Foreign Interest.

 

COI Disclosure – Foreign Travel

PHS and Dept of Energy Investigators only: Must disclose any reimbursed or sponsored travel related to your institutional responsibilities, regardless of the amount, unless received from a Federal, state, or local government agency of the United States; a domestic Institution of Higher Education; or a domestic research institute that is affiliated with a domestic Institution of Higher Education.

  

COI Disclosure – Foreign Affiliations

As part of your eDisclosure submissions, you must disclose whether you have a foreign affiliation.