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Conflict of Interest

Conflict of Interest

At proposal submission and award the PI needs to declare conflicts of interest and nepotism.  If nepotism is involved then the PI needs to submit nepotism forms from the Provost office http://www.ou.edu/provost/memos   To determine if you have a conflict of interest refer to http://www.ou.edu/provost/memos Faculty Compliance Issues and Section 5.10 of the Faculty Handbook

Section 5.10 of the Faculty Handbook

For proposal routing the following items are needed, as applicable

  • Conflict of Interest – Disclosure form, Review Form, and COI Management plan (see examples below)
  • Nepotism – nepotism waiver from Provost’s website
  • PHS-FCOI (for all funding coming from Public Health Service and certain other sponsors – see info below) – disclosure form at proposal routing and proof of training at award (additional recurring items may be needed through the life of a project).

Disclosure Form | Review Form (see Section 5.10 of the Faculty Handbook)

COI Management Plan

The COI Management Plan should contain the following:

  1. A list of the players and their relationship
  2. A description of the activity that creates a COI between the players
  3. The plan to manage the COI

For example:

  1. Professor X is the parent of student Y.
  2. Professor X wishes to appoint student Y to his grant.
  3. Dept Chair Professor Y will review the appointment to determine whether student Y is qualified to serve the role on the grant, will establish the stipend for the student, and will conduct normal performance evaluations and approve reappointments, etc. (but Professor Y will direct the student Y work on the research project).

Example 2:

  1. Professor X is a co-founder and co-owner of Company Y, and is also Department Chair.
  2. Company Y wishes to subcontract a grant to Professor X as PI and to rent university space under an FUA.
  3. Associate Dean Z will review and approve the subcontract statement of work and budget and will have signature authority for expenditures on the award for any salary or travel support of Professor X. Associate Dean Z will also review and approve the FUA terms, in collaboration with the Office of Research Services.

Public Health Service (PHS) Conflict of Interest (FCOI) disclosure and training is needed on all proposals/awards being submitted to or funded from a PHS source.  The disclosure form is needed at routing by all PI and CoPI on the proposal. This is a separate requirement from COI (above) and does not negate the probable need to also do the University COI process.

Flow of disclosure, training, and additional information follows.

Submit a PHS-FCOI Disclosure Form

Conflict of Interest Flow

Training Requirement

According to the federal requirements, all PHS-funded “Investigators” at OU must complete the online FCOI training which is available here: https://www.citiprogram.org/. Successful completion of the training is required prior to the expenditure of funds on any newly-funded projects, including noncompeting continuation awards. This applies to all PHS-sponsored research projects as of August 24, 2012. Training must be completed at least every four years. Current PHS awards are not subject to these new requirements until the noncompeting continuation is awarded.

New users to the CITI program must create an account. The same CITI account can be used for both the FCOI requirement and OU's IRB training requirement.

Definitions

Investigator, for the purposes of this policy, means the Principal Investigator and any person listed by the Principal Investigator as responsible for the design, conduct, or reporting of their sponsored program(s). These individuals are listed at the time of proposal submission.

Normally, all senior research personnel should be listed as “Investigators.” All of the following should be considered, to the extent they are responsible for the design, conduct, or reporting of the sponsored program: professorial faculty, research associates, emeritus faculty, research collaborators, visiting scientists, post-docs, GRAs, or students.

PHS means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority of the PHS may be delegated. The components of the PHS include, but are not limited to:

  • Agency for Healthcare Research and Quality (AHRQ)
  • Agency for Toxic Substances and Disease Registry (ATSDR)
  • Centers for Disease Control and Prevention (CDC)
  • Food and Drug Administration (FDA)
  • Health Resources and Services Administration (HRSA)
  • Indian Health Service (IHS)
  • National Institutes of Health (NIH)
  • Office of Global Affairs (OG)
  • Office of the Assistant Secretary for Health (OASH)
  • Office of the Assistant Secretary for Planning and Evaluation
  • Office of the Assistant Secretary for Preparedness and Response (ASPR)
  • Office of Public Health and Science
  • Substance Abuse and Mental Health Services Administration (SAMHSA)

Other agencies may follow PHS regulations, these include (but aren’t limited to) - Alliance for Lupus Research, Alpha-1 Foundation, American Asthma Foundations, American Cancer Society, American Heart Association, American Lung Association, Arthritis Foundation, CurePSP, JDRF - Juvenile Diabetes Research Foundation, Lupus Foundation of America, Patient-Centered Outcomes Research Institute (PCORI), and Susan G. Komen Foundation

Questions

Inquiries about the NIH FCOI regulation for grants and cooperative agreements may be directed to: VPRFCOI@ou.edu

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