University of Colorado Denver

• Faculty
• UC Denver Officers
• Staff who participate in basic or clinical research, this includes PRAs, (or anyone who can bias the design, conduct or data analysis for the project).
• Research Committee Members
  (i.e. IRB members, DSMB Members and/or other research review committees).
• Staff who negotiate or execute research agreements on behalf of UC Denver

• All financial interests regardless of amount, for a faculty member and his/her family member with a financially interested entity that has commercial activities with UC Denver related to your research or area of expertise.
• An Executive Position or Membership on a Board of Directors where a covered individual and his/her family member holds any position that includes responsibilities for a material segment of the operation or management of a business, including Board membership.

Means anything of monetary value, including, but not limited to:

• Salary or payment for services, Consulting fees, honoraria (including honoraria from a third party, if the original source is a financially interested company), gifts, or other emoluments, or “in kind” compensation from a financially interested company (or entitlement to the same including professional organizations such as AAMC), whether for consulting, lecturing, travel, service on an advisory board, or for any other purpose not directly related to the reasonable costs of conducting research or activity (as specified in the research agreement) that in the aggregate have in the prior calendar year exceeded the de minimus amount of a value equal to or greater than $5,000, or are expected to exceed that amount in the next twelve months.
• Equity interests, including stock options, of any amount (or entitlement to the same) in a non-publicly-traded (privately held) financially interested company.
• Equity interests, including stock options (or entitlement to the same) in a publicly traded financially interested company of either a value equal to or greater than $5,000 or 5% equity ownership which ever is less.
• Royalty income or the right to receive future royalties under a patent license or copyright, where the research is directly related to the licensed technology or work.
• Compensation from a financially interested company (or entitlement to interests (e.g. stocks, stock options, or other ownership interests); and intellectual property rights (e.g. patents, copyrights, and royalties from such rights) that in the aggregate have in the prior calendar year exceeded the de minimus amount of a value equal to or greater than $5,000, or are expected to exceed that amount in the next twelve months.
• Membership on a Board of Director’s.
• Proprietary interest related to the research of any value.
• No arrangement has been entered into where the amount of compensation or the value of the ownership interests will be affected by the outcome of the research.
• Anything of Value.

• Salary, royalties, or other compensation from UC Denver;
• Income from seminars, lectures, or teaching engagements sponsored by public entities (Denver Public Schools, income from review boards, and NIH peer review boards);
• Income from service on an advisory committee or review panel for public entities (Denver Public Schools, income from review boards, and NIH peer review boards);
• Interest in mutual funds where the individual has no control over the selection of holdings.

Situations in which financial or other personal considerations may adversely affect, or have the appearance of adversely affecting, an employee’s professional judgment in exercising any University duty or responsibility in administration, management, instruction, research and other professional activities. The bias such conflicts could conceivably impart may inappropriately affect the goals of research, instructional, or administrative programs. The education of students, the methods of analysis and interpretation of research data, the hiring of staff, procurement of materials, and other administrative tasks at the University must be free of the undue influence of outside interests.

The mere appearance of a conflict may be as serious and potentially damaging as an actual distortion of instructional, research, or administrative goals, processes, or outcomes. Reports of conflicts based on appearances can undermine public trust in ways that may not be adequately restored even when the mitigating facts of a situation are brought to light. Apparent conflicts, therefore, should be disclosed and evaluated with the same vigor as actual conflicts.

The term conflict of commitment refers to situations in which outside relationships or activities (such as consulting or outside employment) directly and significantly affect, or have the appearance of directly and significantly affecting, an employee’s ability or perception of ability to exercise any UC Denver duty or responsibility or in the conducting or reporting or research. Such activities are encouraged insofar as they are conducted in accordance with University policy (including the one-sixth rule), promote professional development of faculty, and student employees, and enrich their contributions to the institution, to their profession and to the community. Consulting relationships, for example, may serve to create conduits for the exchange of information and technologies that enhance the University environment and permit faculty to test the soundness of their ideas. Regent action 6/12/48. Separate policies apply to faculty in the School of Medicine, who are subject to separate guidelines and required to direct all outside professional activities through University Physicians Incorporated (UPI).

The term institutional conflict of interest means whenever the financial interests of the institution, or of Institutional Official acting within his or her authority on behalf of the institution, might affect – or reasonably appear to affect – institutional processes for the conduct, review, or oversight of research or for exercising any UC Denver duty or responsibility.

Yes, any changes, additions or elimination of activities and/or interest must be reported by submitting an updated evaluation form within 30 days of the change, addition or elimination to the COI Manager.

The total of all relationships with a single financially interested company exceeds $5,000 or 5% equity ownership. For example, two consulting agreements with Company ABC for $2,500 and $3,000 for the same annual period would “aggregate” to $5,500 and would be considered a significant financial interest. However, one consulting agreement with Company ABC for $2,500 and one consulting agreement with Company XYZ for $3,000 for the same period would NOT be “aggregated” and NOT considered a significant financial interest. However, both relationships are reportable on the Conflict of Interest Disclosure Form.

• Yes, individuals must complete and sign the annual evaluation form. If you have no activities or your interest are less than the amounts as defined in “significant financial interest”, you should respond accordingly to the questions on the form.
• All financial interests (i.e. dollar value > $1.00 or number of equity shares/options > share/option) for a covered individual and his/her family member with a financially interested entity that has commercial activities with UC Denver related to your field of work must be reported annually.

Human Subjects Research includes all research meeting the definition of “research” performed with ‘human subjects” as these terms are defined in the federal Common Rule (45 C.F.R. part 46 and 21 C.F.R. part 56), regardless of the source of research funding or whether the research is otherwise subject to federal regulation.

Conducts research means, with respect to a research protocol, designing research, conducting research , analyzing research data or serving as the principal investigator, enrolling research subjects, Professional Research Associates (PRA) and/or other research positions who’s responsibilities include, obtaining subject’s informed consent or making decisions related to eligibility to participate in research, analyzing and/or reporting research data, or submitting manuscripts concerning the research for publication.

Means a faculty members or UC Denver employees, spouse/domestic partner, and/or dependent children.

Instances of deliberate breach of policy including, but not limited to, failure to file or knowingly filing an incomplete, erroneous, or misleading disclosure form, violations of the guidelines or failure to comply with prescribed monitoring procedures, will be adjudicated in accordance with applicable disciplinary policies and procedures for each covered individual. Possible sanctions may include some of the following actions:

• termination of activity that is a conflict of interest;
• divestiture of significant financial interest;
• disciplinary action against the faculty member/staff member/employee up to and including termination;
• in the case of a violation of criminal or civil law, violators may be subject to civil or criminal penalties.

To appeal a negative decision of the COI Committee, you pay present your appeal to the appropriate Dean or Vice Chancellor, within 45 days of the negative decision. If the Dean or Vice Chancellor approves the appeal, the appeal will be forwarded to the UC Denver Chancellor. The UC Denver Chancellor will have final approval as to whether to permit the activity or to uphold the decision of the COI Committee.

Yes, the forms will be considered sensitive and treated confidentially. The information disclosed in the forms will be available only to individuals duly charged with the responsibility for review. However, the information may be released in accordance with and as required by Colorado law or lawful court order.

Martha Stewart has been in the news the last few years because the US Securities and Exchange Commission believed that she was told by her friend Sam Waksal that his company’s ImClone’s cancer drug application for Erbitux had been rejected by the Food and Drug Administration before the review was made public. Stewart dumped her 3,928 shares of ImClone on December 27, 2001– the day before the stock sank (over 1 month period the stock sank 70%, Martha would have lost almost $50,000) on the negative review. Since the FDAs review and rejection of the application was not yet available to the public or in the public domain, it was considered “insider information”. The testimony by Mariana Pasternak was perhaps the most damaging against the Ms. Stewart, who told investigators three months later she had no memory of being tipped about Waksal. Pasternak, a friend of Stewart for more than 20 years, said she had the conversation with Stewart on Dec. 30, 2001, on a terrace at a Mexican resort where they were vacationing.

"I remember Martha saying Sam was talking funny at the Christmas party, that he was selling or trying to sell his stock, that his daughter was selling or trying to sell her stock," Pasternak testified.

She said Stewart added: "Isn't it nice to have brokers who tell you those things?"

Martha was convicted of conspiracy, obstruction of justice, and two counts of making false statements.

Insider trading probe in the Senate.

WASHINGTON – August 2005 - The chairman of the Senate Finance Committee called Monday for a federal investigation into whether doctors are supplying investment firms with information about clinical drug trials before companies announce the results.

The Seattle Times reported Sunday that, despite confidentiality agreements, doctors are divulging details about ongoing research for a fee. The newspaper’s investigation cited 26 cases in which doctors leaked confidential details of their research, including 24 in which firms issued reports to select clients that advised whether to buy or sell a drug stock.

“The serious nature of the reported findings and allegations, coupled with the grave implications if these allegations are meritorious, compel me ... to refer these matters to the Department of Justice and to the Securities Exchange Commission for consideration,” wrote Sen. Charles Grassley, R-Iowa.

The Times said that elite investors pay up to $1 million a year to firms known as matchmakers, which pair Wall Street firms with doctors involved in ongoing drug research. Gerson Lehrman Group, the largest matchmaker, claims to have 60,000 doctors available to speak to Wall Street, double the number from three years earlier.

Those who know in advance whether a drug is going to succeed or fail can buy stock low or sell it high to those who don’t know, making quick fortunes by taking advantage of unwitting investors.

There is a broader cost to society: Leaking details about ongoing research can introduce bias into drug trials and possibly halt development of potentially lifesaving drugs, biotech executives said.

The trade group representing prescription drug manufacturers responded to the report by saying it condemned the practice of providing investors with inside information about clinical drug trials.

“If a doctor breaks securities laws or his or her confidentiality agreement with a pharmaceutical research company to gain financially, they should be severely punished,” said Ken Johnson, senior vice president of The Pharmaceutical Research and Manufacturers of America.

In accordance with the UCD COI policies and procedures document, the institution must review each project to determine if the significant financial interest could potentially connect to the project, protocol or other administrative role at the institution.

The COIC Office in collaboration with the COI Committee will review the SFI and the project then develop a management plan to mitigate the conflict. You must sign and return a copy of the management plan to the COI Office to affirm your agreement to the proposed mitigation. If the project is PHS funded then a signed copy of the management plan must be submitted to NIH before any money is drawn from the award.

Any travel paid by a commercial company or professional organization that is not for training on a research study under a grant or contract to the institution.

The Institutional Travel form available at this website or on your electronic disclosure form must be completed within 30 days of returning from each trip.

Faculty and key personnel, who may potentially bias the design, conduct or analysis of a study must have conflict of interest training prior to grant submission and this training must be updated at least every 4 years. Current mandatory training at UCD is part of the disclosure form but additional COI training is available. See training calendar here

The UCD Conflict of Interest Office must make approved management plans available to a member of the public within 5 days of the request for a plan

You cannot submit for PHS funding unless the PI and anyone on the project who may potentially bias the design, conduct or analysis of the study has completed a disclosure including the training. Failure to follow UCD policy may lead to disciplinary action being taken. If a financial conflict of interest is determined to be in place and not reported then PHS regulations require a remedial review process. If the institution and/or funding agency determines the financial conflict of interest has biased the study then grant money may need to be returned and the study stopped.

Conflict of Interest Manager
Office of Regulatory Compliance
Phone: 303-724-0034
Fax: 303-724-1019
www.coi@uchsc.edu

Conflict of Interest and Commitment Administrative Policy Statement: https://www.cu.edu/policies/aps/hr/5012.html