Conflict of Interest in Research Do I have to?

(as defined by UNM Policy E110) Questions we ask Are you engaged in UNM Research? (as defined by UNM Policy E110)

UNM research means a systematic investigation designed to develop or contribute to generalizable knowledge, including basic and applied investigations and product development, that is: 1. Funded by or through UNM (including outside sponsored funding);  2. Conducted at UNM, regardless of funding; or   3. Non-sponsored and conducted off campus by UNM employees.

Are you an Investigator? (as defined by UNM Policy E110)

Investigator means the principal investigator, the co-principal investigator and any other person (including faculty, staff and students) who is responsible for the design, conduct or reporting of UNM research. Any individual responsible for a task that could have a significant effect on the research design, conduct or reporting is considered to be an investigator, even if the individual does not have sole or primary responsibility for the task or the research.

Non-UNM Investigator means any person who is: 1 Non-UNM Investigator means any person who is: 1. Responsible for the design, conduct or reporting of UNM research; and  2. Employed by an entity other than UNM, working pursuant to a sub-award with another entity, working as an independent contractor or collaborator, or otherwise not employed by UNM.

Conflict of Interest in Research What’s the Purpose?

To protect The integrity, trust, & respect of UNM The investigator The objectivity & integrity of research

To Comply. With Federal regulations/guidelines To Comply With Federal regulations/guidelines With Sponsor rules or guidelines

Conflicts & Disclosure Conflicts of Interest in Research may occur when research investigator's professional or financial relationships and interests outside UNM may compete with his or her professional obligations to UNM and/or may impact objectivity of his/her UNM research. Conflicts need not be eliminated in every situation, as long as they can be managed. Conflicts of interest (COI) are an inevitable part of conducting research and do not necessarily suggest any impropriety on the part of the investigator. Disclosure is required under Faculty Handbook Policy E:110 & federal regulations.

When Do I Do It? Annual Call for Disclosure – in August Anytime during the year All COI disclosures are at http://researchcompliance.unm.edu/submit-fcoi-disclosure When there is a change to the investigator’s situation

Types of COI Disclosures Annual Disclosures (due at the beginning of Academic Year) UNM Investigator Non UNM Investigator PHS/NIH Disclosures (project specific; to be filled out at the time of applying for funds or to report a material change – within 30 days of the material change) Non-PHS/NIH Material Change Disclosure (to be filled out within 30 days of the material change) [web site link: http://researchcompliance.unm.edu/submit-fcoi- disclosure ]

What is the Process? Complete the online Opinio survey Disclosures are Confidential Initial review by Office Of Research & Compliance Determination notifications sent via email No disclosable interest found Disclosable interests reported and subject to Committee review

Decisions COI Committee Review Disclosable interests do not necessarily constitute a conflict of interest Conflict can be managed by a Decision Memo with Stipulation Conflict best managed with a Management Plan with an appointed Monitor Decision notifications and the associated documents are emailed to the Investigator

What about PHS and NIH funded research?

COI Process for PHS Projects At the time proposal is submitted to PHS agency, all investigators must have completed & submitted their COI disclosures to the COI office. Principal Investigators are responsible to identify key members of the research team (listed on the proposal) and to instruct them to disclose but UNM is also responsible to the funding agency if this is not done.

PHS Projects - Newly Added Investigators All newly-added investigators to the grant application or an existing project/award must submit a completed conflict of interest disclosure form within 30 days after beginning work on the research. The PI and co-PI are responsible for informing newly- added investigators of this requirement and ensuring that they submit disclosure forms within 30 days after beginning work on the research.

COI Process for PHS Projects Complete a UNM PHS project- specific COI disclosure Disclosure and reporting rules are mandates of PHS agencies. Bolstered enforcement by PHS.

Public Health Service (PHS) Projects major Public Health Service (PHS) agencies are: National Institute of Health and its affiliated agencies (NIH) Center for Disease Center (CDC) Food & Drug Administration (FDA) Substance Abuse & Mental Health Services Administration (SAMHSA) Indian Health Services and many others

What are the Numbers?

2016-2017 Academic Year (as of March 11, 2017) Risk Level Count High 27 Moderate 66 Low 92 Family collaboration only 80 No Outside Interests 2089 Sponsored Travel only 1 2015-2016 Academic Year Risk Level Count High 19 Moderate 31 Low 45 Fam. Collaboration only 50 No Outside Interests 1420 Sponsored travel only 5 by Ana AT 5/18/17

COI in Research Program: Contact us at… Office of Research & Compliance 505.277.5358 & 505.277.1045 http://researchcompliance.unm. edu/coi Office Hours: 8:00 am – noon & 1pm - 5:00pm Monday through Friday COI in Research handled by: Sue Marker, Compliance Assistant 505.277.1045 Receptionist: Arlene Brummett Director: Ana Andzic Tomlinson