Marie Barron, M. A. HSC COI Operations Manager

HEALTH SCIENCES CENTER

 To promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be free from bias resulting from investigator financial conflicts of interest (42CFR50, subpart F)  To protect the integrity, trust and respect of UNM, its academic community and its research activities (UNM COI Policy E110) HEALTH SCIENCES CENTER

 “Final Rule” published on August 25, 2011  Institutions have 1 year to implement changes ◦ Significant Financial Interest (SFI) definition changed: additional disclosures & threshold changes; related to institutional responsibilities ◦ All investigators are now required to take online COI training. Learning Central (UNM) & Moodle (non-UNM) ◦ Institution provides more information in financial conflicts of interest (FCOI) report to NIH ◦ Identified FCOI held by senior/key personnel are to be made publicly available upon written request  A written response will be provided HEALTH SCIENCES CENTER

 Significant Financial Interests (SFI) ◦ Threshold reduced to $5K for payments and equity interest from a public entity ◦ Salary/payment from a non-public entity that exceeds $5K ◦ Any equity interest in non-public entity ◦ Income from seminars, lectures, teaching engagements unless gov’t/higher ed institution ◦ Reimbursed/sponsored travel unless from a gov’t/higher ed institution ◦ Intellectual property rights and interests unless from UNM or UNM STC HEALTH SCIENCES CENTER

 SFI is not synonymous with an FCOI  SFIs are financial interests the federal regulations and HSC COI Policy requires to be disclosed ◦ FCOI occurs when the COI Committee determines the SFI could directly and significantly affect (bias) the design, conduct, or reporting of the research ◦ If an FCOI is determined, the goal is to manage it such as:  Public disclosure (consent forms, publications, presentations)  Independent monitor  Restrictions in research activities  Reduction/elimination of financial interest ◦ Rarely have instances where it is unmanageable HEALTH SCIENCES CENTER

 Contact COI operations manager/chair for guidance  Declare any outside professional activity/relationship or financial interest for evaluation by the HSC COI Committee HEALTH SCIENCES CENTER

 PreAward Office ◦ All research grants ◦ All research contracts ◦ All cooperative agreements  Human Research Protections Office (HRPO)  Research Allocation Committee (RAC)  Office of Animal Care and Compliance (OACC) ◦ If not previously provided to PreAward Office HEALTH SCIENCES CENTER

 All investigators responsible for the design, conduct, or reporting of research ◦ Faculty ◦ Staff ◦ Students (undergrad, grad, fellows) ◦ Non-UNM collaborators (e.g. subaward recipients, consultants, independent contractors)  Personnel budget sheet of a Preaward proposal  Investigator list of HRPO application  OACC application investigators who did not previously submit form in a PreAward Proposal HEALTH SCIENCES CENTER

 All investigators are required take the online course, including non-UNM collaborators  UNM Investigators ◦ Learning Central: course category, “Grants & Research” or “HSC Research”, HSC Financial Conflicts of Interest Training (HSC )  Non-UNM Investigators ◦ Non-UNM collaborators may provide their own institution’s certification or take UNM HSC course ◦ Moodle: course category, “HSC Conflicts of Interest”, HSC Financial Conflicts of Interest Traininghttps://hsc-moodle.health.unm.edu  Create account username and password in Moodle  Enrollment key = HSCFCOI HEALTH SCIENCES CENTER

 UNM HSC Conflicts of Interest in Research homepage: (link for COI training lookup)  HSC additional COI reporting requirements: _ pdf _ pdf  UNM Conflicts of Interest in Research Policy (E110):  NIH Conflict of Interest homepage:  Code of Federal Regulations DHHS/PHS 42CFR50, Subpart F & 45CFR94: HEALTH SCIENCES CENTER

Marie Barron, M.A. HSC COI Operations Manager Ph: Eric Prossnitz, Ph.D. (through Dec 2012) HSC COI Committee Chair Ph: Mark Parshall, Ph.D. (starting Jan 2013) HSC COI Committee Chair Ph: HEALTH SCIENCES CENTER