Conflict of Interest Disclosure FAQs
The University policy that covers the COI disclosure process is UNM Faculty Handbook Policy E110: Conflict of Interest in Research.
The conflict of interest disclosure requirements apply to all investigators (e.g., principal investigator, co-principal investigator, faculty, staff, students and non-UNM consultants) who will be involved in the design, conduct or reporting of:
- Sponsored UNM research.
- Non-sponsored UNM research that is: (a) Human subject research; (b) Animal subject research; or (c) Research funded by a formal award from internal UNM sources based on submission of a proposal.
Yes. Non-UNM investigators submit their COI disclosure using the UNM annual disclosure.
Investigators are urged to submit their COI disclosure during the official submission period. For each academic year, the official submission period is from mid-August through mid-September. The call for submissions occurs every August, however, investigators are able to submit a disclosure at any time during the academic year.
COI disclosures are submitted electronically via Opinio through the portals found on our "Submit A Disclosure" webpage.
COI disclosures are considered current for the academic year unless there are changes to your disclosure that would require re-submission, such as a change in significant financial interests or a change in outside interests or activities.
Yes. The system generates an email notification when your disclosure has been submitted.
The COI disclosure is reviewed by the COI Compliance Specialist and the COI Committee may have access to your information.
The U.S. Department of Health and Human Services (DHHS) has issued a final rule in the Federal Register that amends the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42.C.F.R. Part 50 [go to Subpart F]) and Responsible Prospective Contractors (45 C.F.R. Part 94). An institution applying for or receiving PHS/NIH funding from a grant or cooperative agreement must comply with all of the revised regulatory requirements. Major changes to the previous regulations from 1995 include:
- Lower financial disclosure thresholds ($5000 minimum threshold);
- New conflict of interest training (every 4 years for investigators receiving PHS funds);
- New public accessibility requirements;
- Increased transparency for travel reimbursement
Public Health Service (PHS/NIH) project-specific disclosure submissions, by federal regulation, are required for each PHS/NIH proposal submitted. Submission is needed prior to the time of every new proposal submission to a PHS/NIH agency.
Each disclosure will receive an initial review by the COI Compliance Specialist. If there are disclosable interests related to institutional responsibilities in a disclosure, it will be sent to the COI Committee for full committee review. The committee will determine if measures are necessary to manage, reduce, or eliminate any potential or actual conflict of interest found in the disclosure and what form that will take. Notification of decisions are sent to investigators via e-mail.
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 two outside community members.
Notifications regarding decisions on disclosure content are sent by e-mail to the investigator. The names of investigators having disclosures that DO NOT have disclosable interests related to institutional responsibilities are included on the list of compliant investigators and require no further action unless the investigator has a change in their disclosable interests which require the submission of a Material Change disclosure. Disclosures having disclosable interests related to institutional responsibilities will be sent to the COI Committee for full committee review. The Committee will decide if further action is needed in the form of a decision memo with stipulation or a management plan. Notification of committee decisions are sent to investigator via e-mail.
A management plan is a formal document that lays out a plan to manage, reduce, and/or eliminate any potential or actual conflict of interest based on the details included in the disclosure. The plan will be issued by the COI Committee and must be signed by both the investigator and the assigned monitor.
An investigator may appeal a COI Committee decision to the Provost or their designee. No research expenditures will be made while the appeal is pending.
The committee can implement any of the following:
- Modification of the research protocol to mitigate or eliminate the conflict
- Involve an independent investigator to collect, analyze, and interpret the data
- Appoint a monitor to oversee the research
- Disclosure of the financial interest in publications and presentations
- Severance of the investigator's relationships that create the conflict
- Exclusion of the investigator from participation in some part of the research
- Blind trust escrow account
A material change is a change from the investigator's original Annual COI Disclosure that warrants re-disclosure. This disclosure must be submitted within 30 days of the change. Material change disclosures are submitted through the material change portal found on our "Submit A Disclosure" webpage.
- An acquisition of a Significant Financial Interest that has subject matter overlap with the investigator's research on behalf of the institution.
- Appointment on a board that has subject matter overlap with the investigator's research on behalf of the institution.
- Change in a funding agency that would make the investigator subject to the 2011 Public Health Services (PHS) regulations: 1. Promoting Objectivity in Research (42.C.F.R. Part 50 [go to Subpart F]) or 2. Responsible Prospective Contractors (45 CFR Part 94)
Investigators submitting a proposal to the Office of Sponsored Projects (OSP) will certify in CayuseSP that all members of the research team have submitted their COI disclosure for the current academic year. The proposal reviewer will cross-check the members of your research team with a list of investigators who have current COI disclosures on file. If a member of your research team is not included on the list, an email will be sent to you with the names of the investigators who need to submit a disclosure along with a link to the COI disclosure website.
The IRB will cross-check the members of your research team with a list of investigators who have current COI disclosures on file. If a member of your research team is not included on the list, an email will be sent to you with the names of the investigators who need to submit a disclosure along with a link to the COI disclosure website.