Office of University Counsel

 

Conflicts of Interest in Research Policy Summary

Adopted by Regents and effective July 11, 2000; revised May 12, 2003.

(Click here to view the full Conflicts of Interest in Research Policy.)

Disclosure requirements apply for all of the following types of research:

  • Sponsored Research, Human Subject Research, Animal Subject Research
  • Research funded by a formal award from UNM sources based on submission of a proposal (such as RAC awards)

Applicable to: All investigators, faculty, staff and students. It is the PI's responsibility to identify all people responsible for tasks that could have a "significant effect" on the design, conduct, or reporting of the research, and provide this information to ORS or HSC Pre-Award.

Each named investigator must then disclose relevant financial interests before the proposal goes out by turning in a disclosure form to ORS or HSC Pre-Award. Subaward institutions must submit assurances of compliance, or else their investigators may use UNM's process.

The conflicts of interest process occurs while the proposal is pending. If your situation changes after the proposal is submitted, or after the award is received, a new disclosure is required. Conflicts of Interest are inevitable in modern research universities and do not imply any impropriety on the part of the investigator. A conflict of interest may exist despite the highest standards of conduct and candor. The Conflicts of Interest Committee works with the investigator to attempt to resolve or manage the conflict. Most conflicts can be managed without impeding the research.What must be disclosed:Generally, the following financial interest must be disclosed:

  • More than $10,000 in consulting income, salaries, or equity
  • More than 5% equity in a company
  • Intellectual Property rights and royalties other than through than UNM/STC
  • Other financial interests of value

Significant financial interests include those of the investigator, his or her spouse or domestic partner and dependent children.

Other significant interests include serving as an entity's:

  • Director
  • Officer
  • Partner
  • Trustee
  • Manager
  • Employee

When in doubt, it is safer to disclose. Definition of Conflict Of Interest:"A situation associated with an investigator's participation in UNM research where it reasonably appears, on an actual or potential basis, that

  • the investigator's significant financial interest could directly and significantly affect the design, conduct or reporting of UNM research activities; or the investigator's situation could directly and significantly compromise his or her professional commitments or allegiance to UNM."

In other words, a conflict arises if an outside financial interest could put pressure on an investigator's objectivity. Also, full-time faculty members and researchers must devote their primary professional efforts and allegiance to UNM. Other activities should not interfere or significantly conflict with this responsibility. Examples of situations requiring disclosure:

  • You are on the Board of a company that sells a service, and the proposed research might make that service obsolete. Your daughter owns 10% of the sponsoring company.You receive consulting fees from the sponsoring company, or from one of its competitors. Your husband's consulting company submitted a proposal to the same federal agency for similar work. After the project is completed, you expect to consult for the sponsor on how best to use the results. You have a private treatment facility that can help patients for whom the experimental protocol fails.

What happens after disclosure. If you disclose a significant financial interest, the Committee will review it and evaluate to see whether there might be a conflict. If the Committee believes there might be a conflict, it will consult with you. If the Committee decides there is a conflict, the Committee will work with you to attempt to manage the conflict. Possible elements of the management plan might include some of the following:

  • Public disclosure, Monitoring Modification of the research plan Reassignment of workersBlind trustEscrow account Exclusion from negotiations Exclusion from some portion of the research.The conflict must be managed for the research to proceed or for a new or continuation award to be accepted. There is no guarantee that every conflict can be managed, but, to date, almost every conflict identified by the Committee has been successfully managed to allow the investigator to conduct the research.

Disclosure form: http://www.unm.edu/~ors/pdf_files/unm_forms/COI_disclosure_form.pdf