Conflict of Interest at LSUHSC-Shreveport

Conflict of Interest at LSUHSC-Shreveport

Instructional Guide to Completing

the Conflict of Interest in Research Annual Disclosure Form

Welcome!

The purpose of this presentation is to take you step-by-step through the completion of the COI in Research Annual Disclosure form.

The form may be printed and completed by hand or submitted electronically.

If you choose to submit electronically, you must send a hard copy of the signature page with an original signature to the Grants Office in room 1-214.

Financial Conflict of Interest (FCOI) Regulations

42 CFR Part 50 Subpart F Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought (grants and cooperative agreements) http://grants.nih.gov/grants/compliance/42_CFR_50_Subpart_F.htm

45 CFR Part 94 Responsible Prospective Contractors (contracts) http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/ecfrbrowse/Title45/45cfr94_main_02.tpl

These regulations went into effect on October 1, 1995

What is the Purpose of Disclosing Financial Information?

In an era of tremendous public investment in academic research, legislators and policymakers and others justifiably expect heightened public accountability from research institutions.

A conflict of interest simply means there is the potential for a conflict to arise, the conflict may never manifest.

By providing complete transparency, you protect yourself and the Institution.

Importance of Disclosing Financial Information

It is very important you are completely forthcoming in regards to any financial situations that could cause an actual or perceived conflict of interest.

Disclosing this information does not count against you in anyway or prohibit you from conducting your research. This is to protect you and the Institution!

If you have a significant financial interest, you may be asked to submit a management plan to the COI Committee explaining how you will manage, reduce or eliminate the conflict of interest (e.g., assign independent department personnel to monitor the project, abstain from board discussion involving the project, modification of research plans, consider divesting or withdrawing from the conflicted activity).

What is a Significant Financial Interest?

Significant Financial Interest: anything of monetary value that when aggregated within the 12 month fiscal year accumulates to $10,000 or more. This can include, but is not limited to: Compensation Equity interests when aggregated for the immediate

family Royalty income

What is a Significant Financial Interest?

Significant Financial Interest does not include: Salary, compensation, royalties, or other remuneration from

LSUHSC-Shreveport; Income from seminars, lectures or teaching engagements

sponsored by public agencies or non-profit entities; Income from service on advisory committees or review

panels for public agencies or non-profit entities; Interest in mutual funds where the covered individual has

no control over the selection of holdings.

The COI Annual Disclosure Form

The remaining slides will take you through completing the Conflict of Interest in Research Annual Disclosure form.

If after this presentation you still have questions, please feel free to contact Jennifer Toups at extension 5-5416 or [email protected].

COI Annual Disclosure Form

At the top of the first page please enter your first and last name and your title at LSUHSC-Shreveport (e.g., Assistant Professor, Chair, Coordinator, Administrative Assistant, etc)

Enter your Department or Departments if you have a joint position and are engaged in research with more than one Department.

For Campus/Business Unit, enter Shreveport, E.A. Conway, or where you are located.

Please enter your office extension, or extension at which you can be reached, and pager number if you use a pager.

Annual Fiscal Years begin in July and end the last day of June (July 1 to June 30) therefore please enter the year in which the Fiscal Year starts, or list using both (e.g., 2009-2010)

COI Annual Disclosure Form

Annual Submission – select this option if this is your yearly disclosure form that will be due at the beginning of each new fiscal year (July 1)

New Employee Submission – mark this option if you are newly hired and are submitting your form after the start of a new fiscal year.

Updated Submission – this is to be used when a change has occurred in your financial status which would need to be disclosed to the COI Committee in order to maintain transparency

Section 1: Potential Conflict of Interest in Research Generally Allowable Following Disclosure

COI Annual Disclosure FormSection 1

Question #1: Will you or a member of your immediate

family/household receive compensation or gratutities from any individual(s) or entity(s) doing business with the Institution?

To answer this question you must first understand the terms and definitions.


Terms and Definitions: Family - A person's spouse, domestic partner, children, parents, siblings,

equivalents by marriage, or other individuals residing in the person's household.

Compensation - Income or monetary value given in return for services. All compensation (i.e., dollar value equal to or greater than $1.00) must be reported if the aggregate amount is $10,000 or more.

Business Entity - Any corporation, partnership, sole proprietorship, firm, franchise, association, organization, holding company, joint stock company, receivership, business or real estate trust or other legal entity organized for profit and nonprofit entities that may provide support to Investigators as salary, consulting, or board compensation. The term does not include LSUHSC-S or any other entity controlled by LSUHSC-S. For Investigators, a Business Entity does not include a client to whom they provide professional services as an individual and outside of their LSUHSC-S duties.


If the answer is “No”, please mark appropriately and proceed to question #2.

If you or a member of your family do receive compensation from an individual or business entity conducting business with LSUHSC-Shreveport that when aggregated over 12 months amounts to a significant financial interest, then please mark “Yes” and describe the nature and the amount (in U.S. dollars) of the compensation per fiscal year (July 1 to June 30)


Question #2: Will you serve on the board of directors or scientific

advisory board of a business that provides financial support for Institution research conducted by you or a member of your immediate family or household?

If you do not serve on a board for any business entity that sponsors or supports research at LSUHSC-Shreveport, please check “No” and proceed to question #3.


Question #2 continued: If you do serve on a board of a business entity that

is engaged in research here at LSUHSC-Shreveport, please check “Yes”.

Briefly describe your role (Chair, committee member, consultant, etc) and what responsibilities you have as a board member.

Explain what kind of research is involved (e.g., a novel anti-inflammatory medication for rheumatoid arthritis patients)


Question #3: Will you serve in an executive position in a for-profit

or not-for-profit business which conducts research or other activities in an area related to your Institutional duties?

If you do not serve in an executive role for a business in an area related to your field, please mark “No” and proceed to question #4


Question #3 continued If you do serve in an executive capacity, please

mark “Yes” and answer the following: Please list the name of the business Briefly describe your position (e.g., President & CEO) Give a brief summary of the kind of activities conducted

by the business and how it is similar to your Institutional work


Question #4: Will you have a financial interest in a for-profit

business which conducts research or other activities in an area related to your Insitutional duties?

If you will not have a financial interest please mark “No” and proceed to question #5.


Question #4 continued: If you do have a significant financial interest in a

business which is involved in activities related to your Institutional position, please mark “Yes” and:

Give the name of the business entity Provide a brief summary of the nature of the business

activities conducted Describe your role with the business entity and the dollar

amount of financial interest you have invested in the company (e.g., Co-founder with $20,000 in equity shares)


Question #5: Will you have a financial interest in a business that

competes with services provided by the Institution?

If you do not have a financial interest in a business entity that competes with the academic and/or medical services of LSUHSC-Shreveport, please mark “No” and proceed to Section 2.


Question #5 continued: If you do have a significant financial interest in a

business that competes with the services offered by LSUHSC-Shreveport, mark “Yes” and give the answers to the following:

Please list the name of the business Briefly describe the type of activities conducted by the

business and explain how they compete with LSUHSC-Shreveport

Section 2: Potential Conflict of Interest in Research Generally Proscribed

Generally does not mean always!!!

There are always exceptions!

Although the section is inquiring about potential circumstances where the conflict of interest is too great for the Institution to permit, there are cases where these conflicts, if properly managed, are permissible.

Transparency protects you and the Institution!

Example of a Permissible Potential COI

An Institutional official presents at different conferences across the country where he receives an honorarium. The invitation to speak at the conferences was precipitated by the official’s position at LSUHSC-Shreveport and the reputation of our clinical research. The event will also benefit LSUHSC-Shreveport by informing potential sponsors of the different areas of research in which our clinical trials are conducted.

Example of a Permissible Potential COI

Technically this is a situation where the speaker would profit from the reputation of LSUHSC-Shreveport. However, in this situation there is potential benefit for the Institution as well and the speaker may be allowed to continue attending such conferences.

The main concern is disclosure!


Question #1: Will you participate in Institutional research involving a

technology owned by or contractually obligated (by license or option to license) to a business in which you or a member of your immediate family or household has a financial interest or holds an executive position?

If the answer is “No” then please mark the form appropriately and proceed to question #2


If you or someone in your immediate family falls into any of the description provided in Question #2, then please mark “Yes” and include the following information: Name of the business entity Position in the company in which you or a member of your immediate

family hold (ex: my spouse is on the Board of Directors for Company XYZ)

Explain what services you or your family member provide for the business/technology (e.g., raise money for funding, serve on committee)

Please explain the nature (e.g. stocks, license, interest shares) of the financial interest and the dollar amount.

Describe what kind of research is being conducted that involves the business/technology described in Question 1

Give a brief explanation of the product or technology being used.


Question #2: Will you assign students, postdoctoral fellows, or other

trainees to Institutional research projects sponsored by a business in which you or a member of your immediate family or household has a financial interest? (this may occur in the future)

If the answer to Question #2 is “No”, please mark the form appropriately and proceed to Question #3


If it is possible you will be assigning students, post docs, or other trainees to work on research that is sponsored by a business in which you or someone from your immediately family have a significant financial interest, please mark “Yes” and then answer: The name of the business entity The nature (form of financial interest) and amount of interest in

the business Briefly explain what kind of projects the assign students, post

docs, or trainees will be given to complete.


Question #3: Will you participate in Institutional research, clinical

trials, or service agreements which are funded by grant or contract from a business in which you or a member of your immediate family or household has a financial interest?

If you are not involved with any of the above circumstances, then please mark “No” and proceed to Question #4.


If you participate in research that is funded by an entity in which you or someone in your immediate family has a significant financial interest please mark “Yes” and provide: The name of the business entity The nature (form of financial interest) and the

amount (in dollars) Briefly describe the research being conducted here

at LSUHSC-Shreveport for this sponsor or grant.


Question #4: Will you accept support for Institutional research under

conditions that require research results to be held confidential, unpublished or inordinately delayed in publication without prior written approval from the OSPTT?

This is typically covered in the contract language negotiated by the Institution. If you need to verify that this language is present you can contact the OSPTT. If the correct language is present, or this question is not applicable to your circumstances, please mark “No” and proceed to Question #5.


If you have agreed to hold results confidential, unpublished or delayed in publication without obtaining previously written approval, then please mark “Yes” and answer: The name of the person or business to which this

agreement was made Provide a summary of the conditions to which were

agreed to regarding the information.


Question #5: Will you make referrals of Institution business to an

external business in which you or a member of your immediate family or household has financial interest?

If you will not make any referrals, please mark “No” and proceed to Question #6.


If you will be referring services the Institution provides to another business entity in which you or a member of your immediate family hold a significant financial interest, please mark “Yes” and answer the following: Provide the name of the external business Describe the nature (form of financial interest) and

the amount (in U.S. dollars)


Question #6: Will you associate your name with the Institution in

such a way as to profit financially by trading on the reputation or goodwill of the Institution or gain by reason of your official position for personal gain or benefit of any other person or business entity?

If you will not be using the Institution’s name for personal benefit, please mark “No”.


If you are involved in circumstances where you use the Institution’s name for personal benefit, please mark “Yes” and provide a detailed explanation of the circumstances and how you would be using the Institution’s name.

Congratulations!

You’ve successfully completed the COI-R form!

COI Annual Disclosure FormSignature Page

If submitting electronically please print out the signature page, sign, and send to the Office of Sponsored Programs and Technology Transfer in room 1-214.

For all other submission, you may send via campus mail in an appropriately marked envelope or deliver to room 1-214 in the medical school building.

Thank you for your time!

We know your time is valuable and we appreciate your efforts to complete and submit the COI-R form.

If you still have questions, please contact the Conflict of Interest office at extension 5-5416.

Conflict of Interest at LSUHSC-Shreveport

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