research financial conflict of interest

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Research Financial Conflict of Interest


What Do You Need To Know?

• 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?

• 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?

• 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 HospitalFINANCIAL 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. Protocol Number and Title:

2. Study Sponsor: Other Sponsor(s): 3. Principal Investigator Name: 4. 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 Sub-Investigator 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 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?




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/2011-

21633.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.pdf


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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