Annual FCOI Disclosure FAQs

Q. What University policy covers FCOI disclosures?

A. The University policy that covers the FCOI disclosures process is Faculty Policy E110: Conflicts of Interest in Research

Q. Am I required to submit an FCOI disclosure?

A. The conflict of interest disclosure requirements apply to all investigators (principal investigator, co- principal investigator, faculty, staff, students and non-UNM consultants) who will be involved the design conduct or reporting of:

1. Sponsored UNM research.

2. Nonsponsored 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.

 

Q: Are non-UNM investigators required to submit an FCOI disclosure?

 

A: Yes. Non-UNM investigators submit their FCOI disclosure via the NON-UNM investigator disclosure site which can be found at the following link. (ADD LINK)

 

Q. When do I submit my FCOI disclosure?

A. Investigators are urged to submit their FCOI disclosure during the official submission period. For the each academic year, the official submission period is from mid August  thorugh mid September.  The were will be a call for submissions every August. However, investigators are able to submit a disclosure at any time during the academic year.

Q. How do I submit my FCOI disclosure?

A. FCOI disclosures are submitted electronically via Opinio. The link to the disclosure site can be found at the following link: 

Q. Will I be notified automatically that my disclosure has been successfully submitted?

A. No. The system does not allow for automatic notification that your disclosure was successfully submitted.

Q. How long will my disclosure be considered current?

A. FCOI disclosures are considered current for the academic year if there are no changes to your disclosure that require resubmission Example: a material change

Q. Who will have access to my disclosure information?

A. The FCOI disclosure is a confidential disclosure. Only the FCOI Program Specialist and FCOI Committee will have access to your information.

Q. What is the FCOI Committee?

A: The FCOI 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 a as well as two outside community members.

Q. What is the FCOI review process?

A. Each disclosure will receive an initial review where it will be reviewed for completeness and will be assigned a corresponding risk color.

  • RED- High Risk
  • YELLOW- Medium Risk
  • GREEN- Low Risk
  • BLUE- Family Member Collaboration
  • PINK- Incomplete Disclosure
  • GRAY- No disclosure related to IR

The initial review done by the FCOI Program Specialist will be additionally reviewed by the Chair and Vice Chair for approval prior to going to full committee review.

The Full FCOI Committee will review each case that has been assigned a RED and/or YELLOW risk factor. NOTE: **All GREEN cases will be block voted as they pose the lowest risk and do not present an actual or potential conflict of interest. **

If after a Committee review a management plan is deemed necessary; one will be created by the FCOI Program Specialist. In order to manage, reduce or eliminate the potential or actual conflict of interest. If you disclosed interest related to your institutional responsibilities you will be notified of the Committee's decision via e-mail.

Q. What is an FCOI management plan?

A. A management plan is a formal document that will lay 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 FCOI Committee and must be signed by both the investigator and the monitor.

Q: What are examples of ways to manage a conflict of interest?

A: 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

Q: How will I be notified of the Committee’s decision?

A:  If in the submission of your disclosure you DID NOT have disclosable interest related to your institutional responsibilities you WILL NOT be notified by the Committee. You will be included on the list of compliant investigators and no further action is needed on your part unless there is a change that requires re-submission of your disclosure.

If you in the submission of your disclosure you had disclosable interest related to your institutional responsibilities- you will be notified via email and you will be issued a decision memo or management plan for your records.

Q: What if I do not agree with the management plan or the Committee’s decision?

A: An investigator may appeal a FCOI Committee decision to the Provost or designee. No research expenditures will be made pending appeal.

Q: How will Pre-Award know that I have submitted my FCOI disclosure?

A: Investigators submitting a proposal to the Office of Sponsored Projects will certify in CayuseSP that all members of the research team have submitted their FCOI disclosure for the 2014-2015 academic year. The proposal reviewer will crosscheck the members of your research team with a list of investigators who have current FCOI 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 their and a link to the disclosure site.

Q: What is Material Change?

A: A material change is a change from the investigators original Annual FCOI Disclosure that warrants re-disclosure.

Examples

  1. An acquisition of a Significant Financial Interest that has subject matter overlap with the investigators research on behalf of the institution.
  2. Appointment on a board that has subject matter overlap with the investigators research on behalf of the institution.
  3. Change in funding agency that would make the investigator subject to the 2011 Public Health Service (PHS) Regulations:
    • Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F)
    • Responsible Prospective Contractors (45 C.F.R. Part 94)

Q: When am I required to submit a material change?

A: You must submit a new disclosure within 30 days of that change.

Q: How do I submit a material change?

A: Material changes are submitted via the Material Change portal located on the FCOI disclosure submission webpage: http://researchcompliance.unm.edu/submit-fcoi-disclosure

Q: How will the IRB know that I have submitted my FCOI disclosure?

A: The IRB will be will crosscheck the members of your research team with a list of investigators who have current FCOI 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 their and a link to the disclosure site.

Contact COI Staff

Address
1805 Sigma Chi NE
MSC05:
1 University of New Mexico
Albuquerque, NM 87131

Contact

Sue Marker
email: coiresearch@unm.edu
phone: 505/277-1045