Research Financial Conflict of Interest

www.akronchildrens.org/giving
What Do You Need To Know?
•
•
•
•
•
•

Financial Conflict of Interest Regulations
Key Definitions
Institution Responsibili...
What do you mean by FCOI?
• You might have a potential conflict of interest if:
– Your personal or private interests might...
Why is this of interest to the Institution?
• Protecting the integrity and credibility of the
Hospital, employees and staf...
What is a Significant Financial Interest?
• A financial interest that reasonably appears to be
related to the Investigator...
Significant Financial Interest
• If the interest is with a non-publicly traded entity,
and:
– the aggregate value of any s...
Significant Financial Interest
• Is income exceeding $5000 related to intellectual
property rights and interest not reimbu...
In other words………
• A Significant Financial Interest is one that the
Institution reasonably determines could directly
and ...
Financial Interest does NOT include…
• Salary, royalties, or other remuneration from the
Institution.
• Income from the au...
Financial Interest does NOT include…
• Equity interests or income from investment
vehicles, such as mutual funds and retir...
Institution Responsibilities
• Maintain an up-to-date, written, enforced Conflict of
Interest policy that is publicly acce...
Who is on the COI Committee?
•
•
•
•

Director, Rebecca D. Considine Research Institute
Hospital Compliance Officer
Hospit...
Role of COI committee
• Meet or communicate at least semi-annually to
review disclosures of significant financial interest...
How can a conflict be managed?
•
•
•
•
•

Public disclosure of Significant Financial Interests;
Monitoring of research by ...
Who has final authority over the plan?
• If the COI committee and the individual with the
conflict do not agree with the m...
Investigator Responsibilities
• Complete training prior to conducting research
and at least every 4 years
• Complete the a...
Research Financial Conflict of Interest Form

www.akronchildrens.org/giving
Components of the COI form (1of 7)
Akron Children's Hospital
FINANCIAL DISCLOSURE FORM
Time-point:
• Initiation
• One Year...
Components of the COI form (2 of 7)
Please complete all of the information below and
retain a copy of this form for your r...
Components of the COI form (3 of 7)
5. Contact and Mailing Information for Investigator or SubInvestigator for whom the Qu...
Components of the COI form (4 of 7)
Financial arrangements (if with a publicly traded entity)
whereby the aggregate value ...
Components of the COI form (5 of 7)
Financial arrangements (if with a non publicly traded entity)
whereby, the aggregate v...
Components of the COI form (6 of 7)
Is income exceeding $5,000 related to intellectual property
rights and interest not re...
Components of the COI form (7 of 7)
I declare that the information provided on this form is, to the
best of my knowledge a...
Regulations, Guidelines and Resources
42 CFR Part 50, Subpart F: Grants and Cooperative
Agreements
21 CFR 54: Financial Di...
Reference Websites
www.fda.gov/
www.archives.gov › Federal Register
grants.nih.gov/grants/policy/coi/fcoi_webinar_for_nih_...
Questions?
Contact the Rebecca D. Considine Research Institute
at 330-543-3193.

www.akronchildrens.org/giving
About Akron Children’s
• Ranked a Best Children’s Hospital by U.S.
News & World Report
• 8th largest children’s hospital i...
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Research Financial Conflict of Interest

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Akron Children's Hospital provides training to investigative researchers to ensure the research supported by us is conducted without bias and with the highest scientific and ethical standards. The training covers financial conflict of interest regulations, institution and investigator responsibilities, forms and references.

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Research Financial Conflict of Interest

  1. 1. Research Financial Conflict of Interest www.akronchildrens.org/giving
  2. 2. What Do You Need To Know? • • • • • • Financial Conflict of Interest Regulations Key Definitions Institution Responsibilities Investigator Responsibilities FCOI Forms References www.akronchildrens.org/giving
  3. 3. What do you mean by FCOI? • You might have a potential conflict of interest if: – Your personal or private interests might lead an independent observer to question whether your professional actions or decisions are determined by considerations of significant personal interest, financial or otherwise. www.akronchildrens.org/giving
  4. 4. Why is this of interest to the Institution? • Protecting the integrity and credibility of the Hospital, employees and staff is essential when conducting research activities. It is critical that investigators comply with all applicable federal and state laws, in addition to the rules of funding agencies. www.akronchildrens.org/giving
  5. 5. What is a Significant Financial Interest? • A financial interest that reasonably appears to be related to the Investigator’s institutional responsibilities, and: – If with a publicly traded entity, the aggregate value of any salary or other payments for services received during the 12 month period preceding the disclosure, and the value of any equity interest during the 12 month period preceding or as of the date of disclosure, exceeds $5000 www.akronchildrens.org/giving
  6. 6. Significant Financial Interest • If the interest is with a non-publicly traded entity, and: – the aggregate value of any salary or other payments for services received during the 12 month period preceding the disclosure exceeds $5000; or – is an equity interest of any value during the 12 month period preceding or as of the date of disclosure www.akronchildrens.org/giving
  7. 7. Significant Financial Interest • Is income exceeding $5000 related to intellectual property rights and interest not reimbursed through the Institution, or • Is reimbursed or sponsored travel related to your institutional responsibilities. www.akronchildrens.org/giving
  8. 8. In other words……… • A Significant Financial Interest is one that the Institution reasonably determines could directly and significantly affect the design, conduct or reporting of your research. www.akronchildrens.org/giving
  9. 9. Financial Interest does NOT include… • Salary, royalties, or other remuneration from the Institution. • Income from the authorship of academic or scholarly works; • Income from the authorship of seminars, lectures, or teaching engagements sponsored by or from advisory committees or review panels for U.S. Federal, state or local governmental agencies, US committees or review panels for U.S. Federal, state or local governmental agencies; U.S. institutions of higher education; research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers; or www.akronchildrens.org/giving
  10. 10. Financial Interest does NOT include… • Equity interests or income from investment vehicles, such as mutual funds and retirement accounts, so long as the Investigator does not directly control the investment decisions made in these vehicles. www.akronchildrens.org/giving
  11. 11. Institution Responsibilities • Maintain an up-to-date, written, enforced Conflict of Interest policy that is publicly accessible at https://www.akronchildrens.org/cms/research/index.html • Inform investigators of policy • Provide forms for completion • Provide training for investigators via CareLearning • Review completed Conflict of Interest forms for any conflicts and if identified, submit information to COI committee www.akronchildrens.org/giving
  12. 12. Who is on the COI Committee? • • • • Director, Rebecca D. Considine Research Institute Hospital Compliance Officer Hospital Privacy Officer Chief Medical Officer www.akronchildrens.org/giving
  13. 13. Role of COI committee • Meet or communicate at least semi-annually to review disclosures of significant financial interests; • Determine if a plan is warranted to eliminate, reduce or manage any conflict; • Review managed conflicts semi-annually or as new information arises www.akronchildrens.org/giving
  14. 14. How can a conflict be managed? • • • • • Public disclosure of Significant Financial Interests; Monitoring of research by independent reviewers; Modification of the research plan; Divestiture of Significant Financial Interests; Severance of relationships that create actual or potential conflicts; or • Oversight by the Conflict Manager of any financial transactions in which the conflict may be relevant www.akronchildrens.org/giving
  15. 15. Who has final authority over the plan? • If the COI committee and the individual with the conflict do not agree with the management plan, the matter will be referred to the Vice President and General Council, who will have final authority. www.akronchildrens.org/giving
  16. 16. Investigator Responsibilities • Complete training prior to conducting research and at least every 4 years • Complete the annual Financial Disclosure Form by the Hospital deadline • Certify prior to submission of a research application that the COI form has been completed or updated • Disclose new reportable interests within 30 days • Comply with any management plan, if applicable www.akronchildrens.org/giving
  17. 17. Research Financial Conflict of Interest Form www.akronchildrens.org/giving
  18. 18. Components of the COI form (1of 7) Akron Children's Hospital FINANCIAL DISCLOSURE FORM Time-point: • Initiation • One Year Post Study Completion (if new information) • Study Completion • Other (describe):       www.akronchildrens.org/giving
  19. 19. Components of the COI form (2 of 7) Please complete all of the information below and retain a copy of this form for your records. 1. 2. 3. 4. Protocol Number and Title:       Study Sponsor:       Other Sponsor(s):       Principal Investigator Name:       This Financial Disclosure form Principal Investigator (as listed in # 3) OR is submitted for: Sub-Investigator OR Other Name: (Please Print)       www.akronchildrens.org/giving
  20. 20. Components of the COI form (3 of 7) 5. Contact and Mailing Information for Investigator or SubInvestigator for whom the Questionnaire is submitted (as listed in #4): Street Address:  City:      State:      Zip Code: Telephone:      Fax:      E-mail Address:   6. Indicate by marking YES or NO if any of the financial interests or arrangements of concern to FDA (and described below) apply to you, your spouse, or dependent children. Additional information may be attached if more space is needed. YES NO      www.akronchildrens.org/giving
  21. 21. Components of the COI form (4 of 7) Financial arrangements (if with a publicly traded entity) whereby the aggregate value of any salary or other payments for services received during the 12 month period preceding the disclosure, and the value of any equity interest during the 12 month period preceding or as of the date of disclosure, exceeds $5,000? If yes, please describe: www.akronchildrens.org/giving
  22. 22. Components of the COI form (5 of 7) Financial arrangements (if with a non publicly traded entity) whereby, the aggregate value of any salary or other payments for services received during the 12 month period preceding the disclosure exceeds $5,000? If yes, please describe:        If with a non-publicly-traded company, is an equity interest of any value during the 12 month period preceding or as of the date of disclosure? If yes, please describe :       www.akronchildrens.org/giving
  23. 23. Components of the COI form (6 of 7) Is income exceeding $5,000 related to intellectual property rights and interest not reimbursed through the Institution?. If yes, please describe :         Is reimbursed or sponsored travel related to your institutional responsibilities? If yes, please describe:        www.akronchildrens.org/giving
  24. 24. Components of the COI form (7 of 7) I declare that the information provided on this form is, to the best of my knowledge and belief, true, correct, and complete. Furthermore, if my financial interests and arrangements, or those of my spouse and dependent children, change from the information provided above during the course of the study or within one year after the last patient has completed the study as specified in the protocol, I will notify Akron Children's Hospital promptly. 7. Signature (of person listed in #5):       8. Date:       www.akronchildrens.org/giving
  25. 25. Regulations, Guidelines and Resources 42 CFR Part 50, Subpart F: Grants and Cooperative Agreements 21 CFR 54: Financial Disclosure by Clinical Investigators   45 CFR Part 94: Responsible Prospective Contracts • Revised Final Rule published on 8-25-11 • http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/201121633.pdf 21 CFR Part 312.53(c)(4): Financial Disclosure Information www.akronchildrens.org/giving
  26. 26. Reference Websites www.fda.gov/ www.archives.gov › Federal Register grants.nih.gov/grants/policy/coi/fcoi_webinar_for_nih_grantees .pd f  www.akronchildrens.org/giving
  27. 27. Questions? Contact the Rebecca D. Considine Research Institute at 330-543-3193. www.akronchildrens.org/giving
  28. 28. About Akron Children’s • Ranked a Best Children’s Hospital by U.S. News & World Report • 8th largest children’s hospital in country* • Magnet® Recognition for Nursing Excellence   • Largest pediatric provider in NE Ohio • 2 hospital campuses • 20+ primary care locations • 60+ specialty location • Nearly 4,500 employees • 750+ medical staff *Source: 2012 Becker's Hospital Review www.akronchildrens.org/giving

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