If an investigator answered 'YES' to any of the questions on the COI disclosure form, the disclosure is reviewed by the UNM COI Committee before any research can be undertaken. The investigator may also be contacted by the COI support staff for further information. The COI Committee will determine whether the disclosure represents a conflict. The review process is based on compliance with UNM's COI policy and federal regulations.
The COI Committee is a peer-review Committee consisting of ten voting members, including a Chair. Members are senior faculty representing the diverse disciplines and colleges on campus, senior administration staff with responsibility for contracts from Main campus and HSC as well as two outside community members. Currently there are two COI Committees. COI Committee meetings are conducted by the Chair and require a quorum for formal actions. All COI Committee actions require the approval of a majority of a quorum.
The COI Committee considers disclosures associated with all research projects on a case-by-case basis. The COI Committee conducts the review process in a manner that is intended to foster, not hinder research relationships.
If the COI Committee determines that the disclosed interest does not affect the research or that the interest does not compromise the commitments of the individual to UNM, and is not detrimental to UNM, the COI Committee usually determines that no conflict exists. A decision memo is issued via E-mail notifying the disclosing parties, PI, the investigator's Departmental Chair, and Director of the Center, if appropriate. The ORS Contract and Grant Administration, HSC Pre-Award Office, IRB, HRRC are informed as applicable. The COI Committee provides copies of all its decisions to the Provost and to either the VP for Research or the VP for HSC.
If the COI Committee determines that the disclosed interest could influence the research, the COI Committee usually decides a conflict exists. It then usually proposes a resolution strategy to manage the conflict. In some rare instances, the COI Committee determines that the conflict is unmanageable, and that the research cannot proceed unless the investigator either eliminates the conflicting interest or situation, or does not participate in the research. During the process, the investigator may also be invited to meet the COI Committee or a subcommittee to discuss ways to manage the potential conflict.
Examples of managing a conflict:
Where a conflict has been identified by the COI Committee, the investigator must agree to and follow the management plan. The relevant parties are notified as described above. As part of the continuing review process, the COI Committee performs ad hoc checks to ensure compliance with the directives laid out in the management plan. Where a monitor has been assigned to a particular management plan, he or she is required to submit a written report in June and December of each year throughout the duration of the study to the COI Committee for review.
Conflicts must be managed in order for the research, including human and animal research protocols, 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 COI Committee has been successfully managed to allow the investigator to conduct the research. If the study is funded or sponsored by the PHS, the COI Committee is required to notify the agency of the existence of the conflict and assurances that the conflict has been managed. NSF requires notification of unmanaged conflicts.
An investigator may appeal a COI Committee decision to the Provost or designee. No research expenditures will be made pending appeal.