Research Financial Conflict of Interest

Research Financial Conflict of Interest

www.akronchildrens.org/giving

What Do You Need To Know?
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Financial Conflict of Interest Regulations
Key Definitions
Institution Responsibilities
Investigator Responsibilities
FCOI Forms
References


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.


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.


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


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


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.


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.


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

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.


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


Who is on the COI Committee?
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Director, Rebecca D. Considine Research Institute
Hospital Compliance Officer
Hospital Privacy Officer
Chief Medical Officer


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


How can a conflict be managed?
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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


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.


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

Research Financial Conflict of Interest Form


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):


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)


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


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:


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 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 :

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?


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:


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

Reference Websites
www.fda.gov/
www.archives.gov › Federal Register
grants.nih.gov/grants/policy/coi/fcoi_webinar_for_nih_grantees .pd
f


Questions?
Contact the Rebecca D. Considine Research Institute
at 330-543-3193.


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


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