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Deborah Motton, Assistant Vice Chancellor for Research dmotton@ucmerced 209-383-8655

Deborah Motton, Assistant Vice Chancellor for Research dmotton@ucmerced.edu 209-383-8655. THE NEW 2011 PHS CONFLICT OF INTEREST REGULATIONS: “Final Rule” Major Changes to the PHS Regulations. Why?. Increased interest by public and government in institutional practices/research

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Deborah Motton, Assistant Vice Chancellor for Research dmotton@ucmerced 209-383-8655

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  1. Deborah Motton, Assistant Vice Chancellor for Research dmotton@ucmerced.edu 209-383-8655 THE NEW 2011 PHS CONFLICT OF INTEREST REGULATIONS:“Final Rule”Major Changes to the PHS Regulations

  2. Why? • Increased interest by public and government in institutional practices/research • Increased interactions between universities/academic endeavors and industry

  3. Timeline • ANPRM issued in May 2009 –request for comments • NPRM issued May 2010 – incorporating comments • Final Rule issued in August 2011 • Implementation August 24th, 2012

  4. Application • Will apply to all PHS (NIH) funded researchers and all grants, continuations, and contracts, including subcontracts

  5. What must be disclosed? • Previous: Only those Significant Financial Interests the investigatordeemed related to the PHS-funded research • New Rule: All Significant Financial Interests related to the investigator’s institutional responsibilities • Institution determines relatedness.

  6. New thresholds: • Previous: Threshold of $10,000 for disclosure of income or equity interests • New Rule Threshold of $5,000 and includes any equity interest in non-publicly traded entities • Dovetails w/ CA state regulations on disclosure

  7. Travel: • Previous: No disclosure of travel • New Rule: Must disclosepurpose of trip, sponsor/organizer, destination, and duration of reimbursed travel or travel related to “Institutional Responsibilities”

  8. Public Accessibility • Previous: No requirement • New Rule: Institution must make information available concerning FCOIs held by senior/key personnel via a publicly accessible website or by a written response to any requestor within five business days

  9. Training • Previous: No requirement • New Rule Each Investigator must complete training prior to engaging in researchrelated to any PHS-funded project and at least every four years

  10. Implementation Plan • Use electronic system, Kuali-Coeus, to integrate reporting/disclosure • Will only roll out to PHS funded researchers • Kuali-Coeus not online until summer 2012 • Work w/ Sponsored Projects on paper based implementation until Kuali-Coeus available.

  11. Communication • UC Merced Faculty have received 3 emails informing them of the changes to the regulations: June 8th, Aug 6th, Aug 7th (UCOP training email) • Directed communication to NIH funded or potentially funded PIs went out Aug 27th, 2012. • Must complete training by Sept 30th, 2012

  12. Information Sources • Office of Research Compliance and Integrity site: http://rci.ucmerced.edu/2.asp?uc=1&lvl2=45&lvl3=45&lvl4=77&contentid=54 • UC COI policy: http://www.ucop.edu/research/policies/documents/12-0133-phs-researcher-financial-disclosure.pdf • NIH info page: http://grants.nih.gov/grants/policy/coi/

  13. Questions?

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