FINANCIAL CONFLICT OF INTEREST POLICY CHANGE
Public Health Service (PHS) regulations governing Financial Conflict of Interest have new requirements effective August 24, 2012. PHS governed agencies include: 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 (HIS), National Institutes of Health (NIH), and Substance Abuse and Mental Health Services Administration (SAMHSA). The major changes include:
- Reporting interests related to all institutional responsibilities rather than only sponsored projects
- Monetary threshold for reporting reduced from $10,000 to $5,000
- Required training prior to engaging in research related to any PHS-funded grant and at least every four years, and immediately under circumstances of non-compliance
- Additional institutional official review of initial disclosures
- Reporting travel related to institutional responsibilities but not paid by ASU or sponsored funds
- Reporting income from non-profit entities
- Public access to financial conflict of interest (FCOI) information
- For all identified FCOIs, Institutions must develop and implement a management plan that may include management, reduction or elimination of the significant financial interest
- PHS authority applies before, during, or after an award with regard to any Investigator disclosure of financial interests, regardless of whether or not the disclosure resulted in the Institution’s determination of an FCOI
We have developed a list of Frequently Asked Questions as an aid to understanding the regulations.
OKED has made every effort to implement these revised regulations with minimal impact on Investigators, however, some changes to our business practices are required.
Questions can be directed to ORIA at email@example.com or by calling 480-965-6788.
Arizona State University is dedicated to upholding the principles of free and unbiased inquiry, the transfer of ideas and technologies for the benefit of the public, and stewardship of the resources entrusted to it as an integral part of its institutional mission. The University recognizes that faculty and employees are increasingly engaged with private industry and are building complex relationships with private companies. It is essential that financial and other relationships with outside entities do not create situations that are, or appear to be, in conflict with the values of free and unbiased inquiry.
Disclosures of financial interest are to be made prior to the submission of a proposal for funding; the University has developed mechanisms to ensure that conflicts of interest will be satisfactorily managed, reduced, or eliminated prior to the expenditure of any funds on an award. The disclosure should be updated annually or whenever there is a change in the information disclosed.
Federal regulations and University policies require researchers to disclose significant financial (RSP 206) or business interests (ACD 204-08) which, due to their relationship to research or other scholarly activities, could give rise to a real or perceived conflict of interest. The University has separate policies and procedures to address research or individual conflicts of interest, but a single reporting option is available.
Single reporting option
Reporting of a real or perceived financial conflict of interest is done by completing the online COI Certification at http://era.oked.asu.edu. Based upon your responses, you may need to provide additional information to the Office of Research Integrity and Assurance. Please contact the Office of Research Integrity and Assurance (firstname.lastname@example.org), for additional information. This fulfills the reporting requirements for financial conflicts of interest for ASU employees.
Research Requirements –
Each investigator who plans to participate in a sponsored project needs to file a COI Certification to identify any significant financial interests, including those of his or her family (spouse and dependent children); s/he should recertify that statement with each proposal for research and sponsored project support via the ORSPA Proposal Routing process.
Procurement/State Reporting Requirements
An ASU employee who has, or whose relative (spouse, child, child’s child, parent, grandparent, brother or sister of the whole or half blood and their spouses and the parent, brother, sister or child of a spouse) has a substantial interest in any contract with, sale to, purchase from, service for, or decision by ASU, must also disclose the substantial interest to ASU and the employee must refrain from participating in any manner in the contract, sale, purchase, or decision.
Employees doing business with ASU to supply equipment, material, supplies or services to ASU on a sponsored project may only do so after public competitive bidding. Contact the ASU Purchasing and Business Services Department for a description of the competitive bidding requirements. See http://cfo.asu.edu for additional information.
Reporting using the single reporting option described above fulfills both the research and State reporting requirements.
Questions can be sent to email@example.com or call (480) 965-6788.
Starting a spin-off company
The Arizona Board of Regents oversees the commercialization of university developed technology which does not have an immediate obvious market or use whether such entities are composed of employees, non-employees or both. For information about starting a spin-off company see the Arizona Technology Enterprises (AzTE) website or contact Charlie Lewis at firstname.lastname@example.org or 480-884-1993.
• HHS Conflict of Interest Information
• NSF Grantee Standards
• NIH Frequently Asked Questions regarding Conflict of Interest
• NIH COI Tutorial
• FAR Clause Part 3 - Improper Business Practices and Personal Conflicts of Interest