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New PHS FCOI Regulations

New PHS FCOI Regulations. In effect August 24, 2012. Investigators must Disclose All Significant Financial Interests. Related to their institutional responsibilities, regardless of the SFI’s relationship to their PHS-sponsored research

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New PHS FCOI Regulations

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  1. New PHS FCOI Regulations In effect August 24, 2012

  2. Investigators must Disclose All Significant Financial Interests • Related to their institutional responsibilities, regardless of the SFI’s relationship to their PHS-sponsored research • Remuneration from, or equity in, a publicly traded or non-publicly traded entity • IP-related income, except that which is received through the University • Reimbursed or sponsored travel

  3. University Determines Financial Conflict of Interest (FCOI) • Is the SFI related to PHS-sponsored research? • SFI affected by the research? • Entity’s financial interest affected by the research? • Does the SFI constitute an FCOI? • Could it directly and significantly affect the design, conduct or reporting of the research?

  4. FCOI Must be Managed • Provide reasonable expectation that the research will be free from bias due to FCOI

  5. University Reports (Managed) FCOIto PHS • Prior to expenditure of research funds • Within 60 days of identifying new FCOI • Annual Updates

  6. University Trains Investigators • When? • Prior to Investigators engaging in research • Every 4 years thereafter • What? • Institution’s CoIpolicy • Investigator responsibilities regarding disclosure of SFIs • PHS COI regulations

  7. PHS FCOI Administration Flow chart

  8. To All PHS Investigators • New regulations pertaining to financial conflicts of interest in research sponsored by the U S Public Health Service (PHS)will go into effect on August 24, 2012. These regulations, Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought, found at www.gpo.gov/fdsys/pkg/FR-2011-08-25/html/2011-21633.htm, differ significantly from the regulations they are replacing in the following ways: • Current regulations require investigators to disclose to UMB only those financial conflicts of interest relating to their research. The new regulations require investigators to disclose all significant financial interests1 relating to their UMB responsibilities and UMB is then responsible for determining whether or not the financial interest is related to PHS-funded research and poses a potential conflict of interest. • Current regulations specify a threshold ($10,000) at or under which disclosure of a financial interest is not required. While the new regulations lower the threshold to $5,000, they require institutions to apply stricter specifications, if stricter specifications are in effect at the institution. Due to State of Maryland requirements, therefore, there will be no lower threshold at UMB. All significant financial interests will need to be disclosed. • Failure by UMB to report financial conflicts of interest to the PHS awarding component in a timely manner will necessitate a retrospective review of research to determine whether or not the design, conduct or reporting of the research was biased. • The new regulations require all Investigators to receive training in the PHS regulations and the UMB conflict of interest policy and procedures. • Information about each financial conflict of interest will be posted to a publicly accessible UMB web page. • A UMB policy is being drafted to cover these new regulations and will be disseminated as soon as it has been approved. The new policy does not replace the existing USM Conflict of Interest policy and UMB procedures implementing that policy. Rather, the new policy covers conflicts of interest in PHS-funded research at UMB. • Training sessions and online modules are also being developed. It is anticipated that several training sessions will be offered in advance of the August 24 implementation date. • Updated information on the regulations, the new UMB policy implementing the regulations, and training opportunities will be posted on the Research Integrity Office web page (www.umaryland.edu/research_integrity/COI/CoI%20Index). As always, please do not hesitate to contact Alison Watkins (athom001@umaryland.edu) or Joe Giffels (jgiff001@umaryland.edu) in the Research Integrity Office with questions, concerns and suggestions. 1Significant Financial Interests include remuneration during the past twelve (12) months from a publicly traded entity or a non-publicly traded entity; income from intellectual property rights, except such income paid through the University; and reimbursed or sponsored travel, except by Federal, state or local governments, higher education institutions, academic medical centers or teaching hospitals, or research institutes affiliated with higher education institutions

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