KUMC Conflict of Interest Committee: Frequently Asked Questions

Frequently Asked Questions

1. What is the requirement for reporting conflict of interest?

2. What is conflict of interest?

3. How do federal regulators and professional organizations view this issue?

4. What are some situations that might create conflict of interest?

5. How does KUMC oversee conflict of interest issues?

6. What financial interests and activities should be reported?

7. What is the process of disclosure?

8. How are potential conflicts of time commitment reviewed?

9. How are potential research conflicts reviewed?

10. What is the requirement for ad hoc reporting?

11. Are there other conflict of interest disclosures?

12. What if I notice a mistake after I've submitted my form to the database and printed a copy?

13. Where do I submit my form?

14. Where can I obtain more information?

1. What is the requirement for reporting conflict of interest?

Kansas Board of Regents and the University of Kansas Medical Center (KUMC) policies require annual reporting of conflict of interest by all full-time and part-time faculty and unclassified staff. The policies reflect federal requirements for ensuring objectivity in research. All KUPI and KUHA employees and KUMC students and residents who participate in research are required to complete the Conflict of Interest Disclosure Form.

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2. What is conflict of interest?

Conflict of interest refers to situations in which financial interests or time commitments may compromise, or have the appearance of compromising, scientific judgment, integrity of research data, fulfillment of professional duties, or the safety and welfare of research volunteers.

Conflicts can be individual or institutional in nature. Individual conflict of interest may be associated with financial incentives in research, business ownership, consulting, intellectual property development, outside employment, and commitment to external organizations. Institutional conflict of interest arises from financial interests of the university or senior officials that might color the review, approval, or monitoring of research.

It is important to note that potential conflicts frequently arise in university settings, often as part of desirable and legitimate professional development. Activities such as consulting and commercialization of technologies represent the fulfillment of our mission to translate scientific discoveries into beneficial products and services. It is KUMC policy to encourage interactions that promote public benefit while ensuring the integrity with which those activities are accomplished.

Since 1995 federal agencies have required notification about conflicts in federally funded research. More recently, federal, professional and public scrutiny has dramatically increased, following highly publicized cases in which financial interests may have affected the integrity of research and the safety of human subjects. During 2001, guidelines on managing individual and institutional conflict of interest were released by the federal Office of Human Research Protections (OHRP), the Association of American Universities (AAU), the Association of American Medical Colleges (AAMC), and the American Medical Association (AMA). The General Accounting Office (GAO) encouraged Congress to strengthen federal oversight.

The 2004 guidance issued by the Department of Health and Human Services and a survey by the American Association of Medical Colleges stress the importance of conflict of interest identification and management in protecting human subject safety. Professional publications are requiring more detailed conflict of interest disclosures for acceptance of research manuscripts.

The consensus of these agencies and organizations is that financial interests related to research must always be disclosed; that appropriate management may suffice in some cases; and that certain financial relationships should be prohibited if they threaten the welfare of human subjects or the public trust in science.

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4. What are some situations that might create conflict of interest?

Situations that create potential individual conflict of interest:

Basic or clinical research in which the researcher or members of the researcher's family (defined as spouse, children, siblings, parent, equivalents by marriage (in-laws), or other household members) has a financial, managerial, or ownership interest in the sponsoring company
Research on a product developed by a company for which the individual is a consultant
Research on a technology in which the individual holds equity or receives a share of royalties
Service on the board of directors of a business which supports the individual's research
Recruitment bonuses or other enrollment incentives in clinical research
Research in which the sponsor dictates the content or timing of publication
Use of students to perform services for a company in which a faculty member has an ownership interest
Purchase of equipment or research supplies from a firm in which the individual has a financial or other interest

Situations that create potential institutional conflict of interest:

University equity holdings or royalty interests that might prejudice decisions about promotion and tenure, assignment of laboratory space, use of institutional resources, or approval of research
Financial interests or board membership by institutional officials which could unduly influence decisions made for the university
University research on products from a company in which the university holds equity or receives royalties
Industry contributions for facilities or endowed chairs

The annual Conflict of Interest disclosures for all faculty and unclassified staff are submitted to the individual's Department Chair, Director, or Unit Head for initial review. Potential conflicts of time commitment are reviewed by the Chair/Director, in conjunction with the Dean. If a research-related conflict of interest is identified, the Conflict of Interest Committee reviews the disclosure. The Committee is comprised of university and external members.

Conflict of Interest Committee Membership

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6. What financial interests and activities should be reported?

Faculty and unclassified staff are required to report any significant financial interests that could appear to influence or conflict with research or other university duties. Disclosure must be made of all relevant personal interests, including those of the researcher’s family (defined as spouse, children, siblings, parent, equivalents by marriage [in-laws], or other household members), which exceed the Regents' policy thresholds (a legal or equitable interest exceeding $10,000 or 5% whichever is less.).,. These may include, but are not limited to, consulting fees, stock holdings, equity interests, outside professional positions, outside professional salary, and loans.

Pooled resources such as mutual funds and Regents' retirement accounts are generally diversified and sufficiently removed from individual influence that they do not conflict with objectivity in research. These interests do not have to be reported.

External time commitments should be reported if they relate to university responsibilities. These include consulting, outside employment, public service, pro bono work or service as an officer in an external entity.

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7. What is the process of disclosure?

The Office of Compliance distributes forms and instructions through broadcast e-mail each fiscal year. All faculty and unclassified staff must return Form A to their chair, center director, or unit head. If any potential conflicts are identified on Form A, then Form B must be completed to report details.

Disclosure of conflicts by Chairs/Directors/Unit Heads will follow a similar process, but review will start with the appropriate Dean.

**All disclosures and reviews are held in strict confidence**

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8. How are potential conflicts of time commitment reviewed?

Chairs/Directors/Unit Heads and Deans review consulting and other time commitments to ensure that they (a) enhance the individual's professional development; (b) do not interfere with teaching, research and service to the institution; and (c) are consistent with the objectives of the institution.

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9. How are potential research conflicts reviewed?

Potential conflicts related to research are referred to the Conflict of Interest Committee. Not all disclosures constitute a conflict that requires resolution, and sometimes the disclosure itself is all that will be required. The Conflict of Interest Committee will seek additional information to determine whether a management plan should be put in place. Management plans may include any of the following:

modification of the research plan to help ensure scientific objectivity
public disclosure of financial interests in publications and presentations
placement of holdings in an escrow account
referral to the KUMC Data and Safety Monitoring Board for monitoring by independent reviewers
referral to the KUMC Human Subjects Committee if the potential conflict relates to human subjects protection
disclosure of financial interests to research volunteers
divestiture of significant financial interests
disqualification from participation in all or a portion of the research activity <
divestiture of decision-making positions in outside
auditing of the consent and enrollment processes in clinical research
notification to federal funding agencies, if applicable

Proposed management plans are reviewed with the individual, Chair and Dean prior to finalization.

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10. What is the requirement for ad hoc reporting?

Regent's policy requires ad hoc reporting of any new situations that may raise questions about conflict of interest. These activities should be reported as soon as they become known. If the issue pertains to federally funded research, government regulations require that the newly-disclosed conflict be managed, reduced, or eliminated, at least on an interim basis, within sixty (60) days of its identification. To submit an ad hoc report, complete and submit a new Conflict of Interest Disclosure Form with the new information. Dates of submission for your annual report and any ad hoc reports will be listed on your site. The most recent date will be considered the current form.

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11. Are there other conflict of interest disclosures?

Department chairs and some KUMC administrators are required to file a separate Statement of Substantial Interests for the State of Kansas in early spring. These forms are administered by the EVC's office and are sent to Topeka. Additionally, sponsors of clinical trials will require study personnel to submit disclosures prior to the sponsor's filing of an FDA marketing application. More professional journals are now requiring conflict of interest disclosure prior to acceptance of manuscripts for publication.

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12. What if I notice a mistake after I've submitted my form to the database and printed a copy?

Complete a new form making the necessary corrections. Then submit and print it for signatures. Dates of both forms will be listed on your site. The most recent date will be considered the correct form.

13. Where do I submit my form after I have printed it and signed it?

Submit your form to your Department Chair, Director or Unit Head. Forms received by the Department Chair, Director and Unit Heads will be forwarded to their reporting unit, ie: Dean, Vice-Chancellor, President of KUPI or KUHA (or their representative.) After the two levels of required signatures are obtained, forms are sent to the Office of Compliance, 1040 Wescoe, Mail Stop 2014.

14. Where can I get more information?

For questions, contact:
Tom Field, MSEd, Manager
Office of Compliance
Phone: 913-588-0949
TDD: 913-588-7963
tfield@kumc.edu