Conflict of Interest for Research Administrators

August 2007

Susan MacNallyCompliance Coordinator, Research IntegrityResearch and Graduate Studies

“Please create a conflict of interest…

Yes, I really mean this. Please conduct research,

write papers, give talks, consult, publish books,

serve on boards and panels, invent, start

companies, testify, collect honoraria... do the

things that create a healthy, vibrant campus

where research and scholarship thrive. As a

result, you will often create conflicts of interest.

Good for you.”

James A. Roberts,

Vice Provost for Research and Graduate Studies

Research@KU, May, 2006

A Conflict of Interest is…

…the possibility, from the perspective of an

independent observer, that an individual’s

private financial interests or his or her families’

interests,

may influence their professional actions,

decisions

or judgments.

Conflict of Interest in the Headlines

New York Times, August 1, 2006New York Times, August 1, 2006

Tough-Talking Journal Editor Faces Accusations of Leniency By DONALD G. McNEIL Jr.

“…In one case, the authors of a study on the use of antidepressants during pregnancy, published in JAMA in February, neglected to disclose fees and research money from drug makers. The study found that pregnant women who stopped taking antidepressants risked renewed depression.

In another case at JAMA, the authors of a study saying that women with migraines were more likely to get heart disease did not mention they had received money from companies that make painkillers. The authors of a study linking some arthritis drugs to cancer omitted mention of speaking fees. …”

Appearance, Reality and COI

The existence of a COI does not mean that unethical behavior has occurred

The existence of a COI can cast doubt on integrity

An undisclosed COI has great potential for damage

The existence of a COI does not mean that unethical behavior has occurred

The existence of a COI can cast doubt on integrity

An undisclosed COI has great potential for damage

Individualand

InstitutionalIntegrity

What is at Stake?Perceptions that

Public funds have been used for private

gain

An investigator’s research may be biased

An investigator has behaved unethically

KU is a poor steward of public funds

KU research may not be credible

KU is not fulfilling its mission

The University recognizes that

Conflicts may be inherent in trying to balance various roles

Failure to disclose is a breach of policy

Employees may be able to act in dual roles if an approved management plan is in place

Conflicts may be so profound that they require severance of relationship

In other words, the University recognizes that

Conflicts happen

Some conflicts can be managed

Some conflicts must be eliminated

Disclosure is an individual responsibility

How does COI affect research administrators?

Policies – who, what, how often

Processes – reporting and COIC

Compliance – reviews, consequences

Policies – Federal

PHS, NSF•1995-federal standards•Institutions•Investigators

Policies – Kansas Board of Regents

KBOR

PHS, NSF• 1995-

Compatible with federal

• Broader than federal

• Sets reporting requirements

Policies – All

KBOR

PHS, NSF

KU•F/US Handbook•Supplemental policies

WHO has to file?

Faculty and Unclassified Staff (KBOR)ALL Full-timeSome Part-time – researchers, those with conflict

Faculty and Unclassified Staff (KBOR)ALL Full-timeSome Part-time – researchers, those with conflict

Investigators (PHS/NSF) Anyone responsible for the design, conduct or reporting of researchCan include Adjuncts, USS, Students

Investigators (PHS/NSF) Anyone responsible for the design, conduct or reporting of researchCan include Adjuncts, USS, Students

HOW Often are COI reports required?

Upon employment

Annually, on academic year cycle

Ad hoc, wheneverone’s circumstances change

All of the above

KBOR COI Forms

CONFIDENTIAL

FORM A DECLARATION FOR CONFLICT OF INTEREST AND CONFLICT OF TIME COMMITMENT

EMPLOYEE IDENTIFICATION

Name:

Last Name First Name Middle Initial

Department/Division Position Title Phone/e-mail

Full Time Employee First Time Filing This Form

Part Time Employee Annual Update

Adjunct Appointment Ad Hoc Report

SECTION A - CONFLICT OF INTEREST

1. Ownership: Ownership interest in any corporation, partnership, trust, joint venture, and every other business interest, including land used for income which you or other members of your household own or have owned within the preceding 12 months, which represents a legal or equitable interest exceeding $10,000 or five percent whichever is less. Ownership of intellectual property, e.g., patents, royalties, and copyrights is also included. Ownership of funds and holdings acquired through the Regents retirement programs are not included.

Are there any ownership interests you have or a member of your family has which meet this criteria and could an independent observer conclude that they appear to influence or potentially conflict with any of your research/educational activities?

No Yes (If Yes, disclose on Form B, section C)

2. Compensation: Receipt of salary, anything of value, or economic benefit in return for services rendered conferred within the past 12 months or to be conferred in excess of $10,000, including consulting fees in excess of $10,000 from any one entity.

Have you or your family received or do you expect to receive compensation as defined above and could an independent observer conclude that said compensation influences or potentially conflicts with any of your research/educational activities?

No Yes (If Yes, disclose on Form B, section D)

Declaration Form A

Question B.1.

Have you read the Regents COI Policy?

Yes

Form A has 6 yes/no questions. Only one has a correct answer.

KBOR COI Forms

CONFIDENTIAL

Form B DISCLOSURE OF CONFLICT OF INTEREST AND/OR TIME COMMITMENT INTERESTS

(ONLY TO BE COMPLETED IF REQUIRED BY ANSWERS TO FORM A DISCLOSURE)

SECTION I - CONFLICT OF INTEREST

In compliance with federal, Regents, and University of Kansas policies, disclosure of relevant significant financial interest is required of all full time faculty and unclassified staff and all other members of the University community who are responsible for the design, conduct, or reporting of research or educational activities. The disclosure of interests includes those of the University employee, his or her spouse, dependent children, and other members of the personal household.

Significant Financial Interest means anything of monetary value including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria), equity interests (e.g., stocks, stock options, or other ownership interests), and intellectual property rights (e.g., patents, copyrights, and royalties from such rights). The term does not include any of the following:

i. Salary, royalties, or other remuneration from the University including funds and holdings acquired through the Regents retirement programs;

ii. Income (e.g., salary, fees, or other continuing payments) in an amount of $10,000 or less per annum from any one business enterprise or entity when aggregated for the employee and members of his/her family.

iii. Financial interest in any one business enterprise or entity if the value of those interests does not exceed a five percent ownership interest when aggregated for the employee and members of his/her family and the value of that five percent ownership interest does not exceed $10,000.

A. EMPLOYEE IDENTIFICATION

Name:

Last Name First Name Middle Initial

Department/Division Position Title Phone/e-mail

Disclosure Form B

Each section in Form B

corresponds to a

question on Form A

If you declare that you

have a significant

interest on form A, then

you must disclose details

on Form B

KBOR COI Forms

CONFIDENTIAL

Form B DISCLOSURE OF CONFLICT OF INTEREST AND/OR TIME COMMITMENT INTERESTS

(ONLY TO BE COMPLETED IF REQUIRED BY ANSWERS TO FORM A DISCLOSURE)

SECTION I - CONFLICT OF INTEREST

In compliance with federal, Regents, and University of Kansas policies, disclosure of relevant significant financial interest is required of all full time faculty and unclassified staff and all other members of the University community who are responsible for the design, conduct, or reporting of research or educational activities. The disclosure of interests includes those of the University employee, his or her spouse, dependent children, and other members of the personal household.

Significant Financial Interest means anything of monetary value including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria), equity interests (e.g., stocks, stock options, or other ownership interests), and intellectual property rights (e.g., patents, copyrights, and royalties from such rights). The term does not include any of the following:

i. Salary, royalties, or other remuneration from the University including funds and holdings acquired through the Regents retirement programs;

ii. Income (e.g., salary, fees, or other continuing payments) in an amount of $10,000 or less per annum from any one business enterprise or entity when aggregated for the employee and members of his/her family.

iii. Financial interest in any one business enterprise or entity if the value of those interests does not exceed a five percent ownership interest when aggregated for the employee and members of his/her family and the value of that five percent ownership interest does not exceed $10,000.

A. EMPLOYEE IDENTIFICATION

Name:

Last Name First Name Middle Initial

Department/Division Position Title Phone/e-mail

Disclosure Form B

CONFIDENTIAL

FORM A DECLARATION FOR CONFLICT OF INTEREST AND CONFLICT OF TIME COMMITMENT

EMPLOYEE IDENTIFICATION

Name:

Last Name First Name Middle Initial

Department/Division Position Title Phone/e-mail

Full Time Employee First Time Filing This Form

Part Time Employee Annual Update

Adjunct Appointment Ad Hoc Report

SECTION A - CONFLICT OF INTEREST

1. Ownership: Ownership interest in any corporation, partnership, trust, joint venture, and every other business interest, including land used for income which you or other members of your household own or have owned within the preceding 12 months, which represents a legal or equitable interest exceeding $10,000 or five percent whichever is less. Ownership of intellectual property, e.g., patents, royalties, and copyrights is also included. Ownership of funds and holdings acquired through the Regents retirement programs are not included.

Are there any ownership interests you have or a member of your family has which meet this criteria and could an independent observer conclude that they appear to influence or potentially conflict with any of your research/educational activities?

No Yes (If Yes, disclose on Form B, section C)

2. Compensation: Receipt of salary, anything of value, or economic benefit in return for services rendered conferred within the past 12 months or to be conferred in excess of $10,000, including consulting fees in excess of $10,000 from any one entity.

Have you or your family received or do you expect to receive compensation as defined above and could an independent observer conclude that said compensation influences or potentially conflicts with any of your research/educational activities?

No Yes (If Yes, disclose on Form B, section D)

Declaration Form A

~92%

+

~8%

WHAT information is disclosed?

Significant financial interests

of employee or other household member

which exceed defined thresholds AND

which an independent observer could conclude

influences or potentially conflicts with

employee’s research or educational activities.

Significant financial interests

of employee or other household member

which exceed defined thresholds AND

which an independent observer could conclude

influences or potentially conflicts with

employee’s research or educational activities.

Ownership Compensation Fees/Commissions OfficeOffice

KU/KBOR COI Reporting Process

Declare Form A

Management Plan

COI Committee Review/Respon

se

Disclose Form B

If Yes

Must be resolved before award expenditures

In compliance for proposal submission

If No

RI

Checking COI compliance for proposal submission

Review WHO has to file

PI makes the call as to who is an Investigator

Check compliance in CTS system

All F/US

Others PI Decides

Check COI in CTS/COI Lite

Note PI decision in file

Yes

No

COI Forms

Checking COI compliance for proposal submission

Up to date, no disclosures

Not up to date

Good to go!

Must verify they have begun to file by proposal submission date

Not in database

No fully-signed report on file RI will follow up

Contact RI immediately

Stop! Message

Checking proposal for COI disclosures

If disclosed interest is involved as a sponsor, subcontractor, provider of services, contact RI

RI will check to see whether a management plan is in place and, if not, will work with PI and COIC to create one

The funding agency may have to be notified.

KU COI information on the web

www.rgs.ku.edu/rcrwww.rgs.ku.edu/rcr

Web-facilitated reporting

Download forms

Policies

FAQs

Web-facilitated COI Reporting

New employees fill out paper forms

All others via websiteView prior reports

Confirm no changes

Fill out new reportsPrint reports

https://webapp.research.ku.edu/COI/home.html

Web-facilitated COI Reporting

https://webapp.research.ku.edu/COI/home.html

Web-facilitated COI Reporting – secure KU login

https://webapp.research.ku.edu/COI/home.html

Web-facilitated COI ReportingUser’s reports

Prior reports

Scroll down to begin new report

or confirm most recent report

Web-facilitated COI Reporting

Confirm no changes

Fill out new reports

https://webapp.research.ku.edu/COI/home.html

Web-facilitated COI Reporting-User’s reports

Confirm or Begin New Report?Confirm most recent report

Done completely online – no printouts, no signatures required.

Fully-executed hard copy of prior report must be on file at RI.

Confirm or Begin New Report???

Begin new report onlineIf you have a new significant interest to disclose.

Print both Form A and Form B. All signatures required.

In Compliance = Fully Executed3 Required Signatures*•Individual•Chair, Director or Unit Head•Dean or Vice Provost

*some administrators require only one signature

Frequently Confused with COI

Consulting PolicyOverseen by Office of the ProvostForms on Provost’s websiteSend forms to Office of the Provost

Frequently Confused with COI

State of KansasStatement of Substantial Interests

Very similar to COI questionsRequired of certain State employeesNotification from Provost every AprilSent directly to Topeka

Why Comply with COI?

Preserve credibility, reputation

Sanctions for non-complianceIndividual can be barred from submitting proposalsMay be noted on employee record

“…This follows them for the rest of their life.”Dr. Catherine D. DeAngelis, Editor in Chief, JAMA

“Disclose and Manage – it works

… So, go out there and create productive and ethical

conflicts of interest. Just make sure you fully disclose

and have a management plan that will protect

KU's integrity and yours.”

James A. Roberts

Vice Provost for Research

and Graduate Studies

Questions about COISusan MacNally

Compliance Coordinator

Research Integrity, RGS

864-4148

sumac@ku.edu

William Sharp

Director

Research Integrity, RGS

864-7430

Conflicts of Financial Interest can arise with significant levels of

Ownership

Compensation

Office or Directorship

Fees and Commissions

Examples of disclosures You have 10% ownership in a company. The company is worth less than $10K. The company business is not related to your research.

You have equity in excess of $10,000 in a company.Your hold only 1% ownership in the company.The company is related to your area of research.

Your spouse is employed by a company that does R&D in your field of research.S/he receives over $100K in salary.S/he does not have an officer position with the company.

You have 10% ownership in a company. The company is worth less than $10K. The company business is not related to your research.

You have equity in excess of $10,000 in a company.Your hold only 1% ownership in the company.The company is related to your area of research.

Your spouse is employed by a company that does R&D in your field of research.S/he receives over $100K in salary.S/he does not have an officer position with the company.

What is disclosable?Your live-in lover is an officer or director of a company.S/he is paid $2K per year.The company’s work is relevant to your area of research.

Your spouse is an independent consultant in your area of research.S/he receives $20K per annum for consulting.

You have many speaking engagements due to your exciting discovery.Over the course of the year, your speaking fees add up to $15K.

Conflicts of interest can pose risks to:

Direction and Control of Research

Publication and Dissemination of Research

Education and Direction of Student’ Research and Career Development

Appointments and Promotions

University Commitment

Use of University Facilities and Resources

Service on University Committees

University values that guide management of conflicts

Ensuring unbiased research

Maintaining a free marketplace of ideas

Directing education of students

Ensuring best use of public funds

Preserving our identity as a university

Some Management Plan Strategies

Public disclosure of relevant financial interestsIn publications and oral presentations, to laboratory students and staff, to collaborating colleagues

Disqualification from participation in some portion of research / development program

PI status on University research funded by company

Monitoring of research by independent reviewers

Modification of research plan

Divestiture of significant financial interest

Severance of relationships that create conflicts

Allowable? Manageable?PI Walter Wiggle invents a widget. PI Walter Wiggle invents a widget.

KU patents widget and licenses it to WidgetWorks. KU patents widget and licenses it to WidgetWorks.

Dr. Wiggle has no ownership in WidgetWorks.Dr. Wiggle has no ownership in WidgetWorks.

Dr. Wiggle receives royalties through KU. Dr. Wiggle receives royalties through KU.

Dr. Wiggle participates on Scientific Advisory Board.Dr. Wiggle participates on Scientific Advisory Board.

Dr. Wiggle’s wife Wanda is the CFO of WidgetWorks.Dr. Wiggle’s wife Wanda is the CFO of WidgetWorks.

Dr. Wiggle is offered a BoD position.Dr. Wiggle is offered a BoD position.

WidgetWorks wants to employ Dr. W’s GRAs.WidgetWorks wants to employ Dr. W’s GRAs.

Allowable? Manageable?PI Samuel Script creates artificial intelligence software. PI Samuel Script creates artificial intelligence software.

KU copyrights software. Dr. Script creates start-up, KU copyrights software. Dr. Script creates start-up, Scriptel, to develop and market the software. Scriptel, to develop and market the software.

KU licenses software to Scriptel.Dr. Script and KU are KU licenses software to Scriptel.Dr. Script and KU are owners of Scriptel. Dr. Script and KU receive royalties from owners of Scriptel. Dr. Script and KU receive royalties from Scriptel.Scriptel.

Dr. Script pursues further research on the software.Dr. Script pursues further research on the software.

What roles can Dr. Script assume at Scriptel?What roles can Dr. Script assume at Scriptel? Scientific Advisor? Board of Directors? COO?Scientific Advisor? Board of Directors? COO?

Scriptel funds research project to develop software. Scriptel funds research project to develop software. Can Dr. Script act as PI?Can Dr. Script act as PI?

WidgetWorks wants to employ Dr. W’s GRAs.WidgetWorks wants to employ Dr. W’s GRAs.

What roles can Dr. Script assume at Scriptel?What roles can Dr. Script assume at Scriptel? Scientific Advisor? Board of Directors? COO?Scientific Advisor? Board of Directors? COO?

Scriptel funds research project to develop software. Scriptel funds research project to develop software. Can Dr. Script act as PI?Can Dr. Script act as PI?

WidgetWorks wants to employ Dr. W’s GRAs.WidgetWorks wants to employ Dr. W’s GRAs.

Management Plan ElementsBackground

Details of outside interest and relation/involvement with employee’s work at KU

Management strategies to implement (as appropriate)Separation of timeUse of University facilities and resourcesPublic disclosure Recusal / disqualification from participationEmployment of students in outside interestMonitoring of research, transactions with outside interest

Oversight person or committee

Timetable (if appropriate)

Dated signatures of employee, unit head, dean / vice provost