Who determines whether an academic researchers conflict of interest can be managed?

• What Is a COI and How Is It Managed? 
• IRB Application Procedures
• Recommended Consent Form Language
• Avoidance of IRB Member or Consultant COI

What Is a COI and How Is It Managed? 

The term “conflict of interest (COI) in research” refers to situations in which financial or other personal considerations may compromise — or have the appearance of compromising — an investigator’s professional judgment in conducting or reporting research. A COI depends on the situation and not on the actions or character of an individual investigator.

It is important that researchers involved in human research do not have or appear to have a COI —including a financial interest—related to any of the studies in which they participate.

Federal regulations, state laws and University policies require that faculty members submit financial disclosure forms at the time that a proposal is submitted for funding. When a financial interest and possible COI is disclosed, the case is reviewed by an independent review committee, the Chancellor’s Conflict of Interest Advisory Committee (COIAC).

The COIAC and IRB will coordinate with the PI to ensure the study incorporates the COIAC's recommendations to manage a potential COI.

IRB Application Procedures

The IRB Application asks you to respond “yes” or “no” to the following statement: "Do you [the PI] or any other responsible personnel (or the spouse, registered domestic partner and/or dependent children thereof) have financial interests related to this study?" Additional information on financial interests is available on the COIAC website.

If the answer is "yes," take the following two actions:

• Keep all financial interest disclosures current with the COIAC office. The COIAC Office may contact you for additional information.
• Briefly describe this financial interest in the consent form. See the sample wording below.

Recommended Consent Form Language

Informed consent documents for UC research projects require that “(a) a physician must disclose personal interests unrelated to the patient’s health, whether research or economic, that may affect the physician’s professional judgment; and (b) a physician’s failure to disclose such interests may give rise to a cause of action for performing medical procedures without informed consent or breach of confidentiality.”

Briefly describe the following info in the "Why is this study being done?" or "What are the costs?" section of the consent form:

• Funder: Disclose which agencies or institutions, cooperative groups, foundations or industry sponsors are funding the research or providing study drugs or equipment for the study. If the study is not being funded by an external agency, then identify the internal funding source (i.e., department funds, personal funds). 
• Financial or proprietary interests: Also disclose the nature of any financial or proprietary interests, though this disclosure can be in general terms.

Avoidance of IRB Member or Consultant COI

It is important that the members or expert consultants of the IRB do not have or appear to have a COI related to any of the studies in which they participate in the review process. 

An IRB member is provided guidelines for considering the actual or potential COI, and also determining whether a particular role or relationship could affect his or her objectivity before reviewing, participating in the panel discussion or deliberation, and voting on a protocol. Members who have a COI on a particular protocol are required to recuse themselves from reviewing or voting on a particular protocol. Procedures are in place to make sure that this occurs at every meeting and for the review of every study.

What is a Conflict of Interest?

Conflict of interest (COI) involves circumstances where an individual's professional actions or decisions at the University could be influenced by considerations of personal gain, usually of a financial nature, as a result of interests outside his/her University responsibilities. The central theme in addressing COI is transparency, and the first step is disclosure of the interest to the appropriate University administrative office.

Financial conflict of interest in research involves situations in which a researcher has a significant financial interest that may compromise, or have the appearance of compromising, professional judgment in the design, conduct, or reporting of research. A significant financial interest could include personal compensation from industry, equity interest or a management role in a company, or royalties generated from intellectual property rights.

Financial conflicts of interest are common and even inevitable at research universities. Collaborations between academic researchers and industry can provide mutual benefit by contributing to a university's research mission and helping to focus the research directions of industry. Industry/researcher collaboration is accomplished by individual consultation and/or sponsored research.  Universities are also responsible for stimulating economic development and transferring discoveries to the private sector. Universities commercialize their technologies by licensing discoveries to industry or to companies started by academic inventors.

All of these situations can create opportunities for researchers to receive financial rewards related to their research. With the opportunities comes risks that the direction of research will be affected, the objectivity of the data will be compromised, and the interpretation of research results will be skewed. As a researcher, you might not consider that your financial interest would pose these risks, but it can create that perception. This perception of bias can be as damaging to the researcher and the institution as actual bias.

At the University of Iowa, we seek to minimize the adverse affects of conflict of interest in research and to advise faculty and staff on how to mitigate, manage, or if necessary, eliminate those conflicts. We are committed to complying with federal regulations and University policies related to disclosure, review and management of financial interests.

What is an Institutional Conflict of Interest?

As a steward of the public trust, The University of Iowa is obligated to ensure its research involving human subjects is carried out with integrity, open inquiry, and rigorous analysis, free from potential financial conflicts of interest that might affect the sound judgment of its faculty, staff, and students. When financial interests of the University or its University officials exist and create real or potential bias to the outcome of its research, an institutional conflict of interest exists.

For example, the University or one of its officials may have a financial interest in a company sponsoring research covered by this policy or may hold a proprietary interest in a product that is the subject of the research. When such research involves human subjects and the institution maintains its financial interest, the conflict of interest is presumed to be unacceptable. Such research will only be allowed to proceed at the University if there are compelling circumstances justifying the research to be conducted despite the presence of the financial conflict.

Unlike the Conflict of Interest in Research Policy, this policy requires University officials to disclose all financial interests, regardless of relatedness to his or her University responsibilities, in the eCOI disclosure portal. These interests are to be reported because a University official acting within his or her authority on behalf of the institution, could directly and significantly affect, or reasonably appear to directly and significantly affect, institutional processes for the design, conduct, reporting, review, or oversight of human subjects research that is designed to answer questions about the effects or impact of particular drugs, treatments, or diagnostic/therapeutic devices.

"University Official" includes all individuals in the following roles:

• University President
• Provost
• Vice Presidents
• Associate Provost
• Associate Vice Presidents
• Treasurer
• Controller
• Deans
• Associate and Assistant Deans
• Departmental Executive Officers
• Heads of Regental Centers and Institutes

University officials should report the following interests:

• Royalties or other payments from licenses or other technology transfer agreements related to University intellectual property rights from a for-profit company
• Payments (e.g. salary, consulting fees, honoraria, gifts, etc.) received from a for-profit company
• Any equity or other ownership in a non-publicly traded company
• Any position giving rise to a fiduciary duty in a for-profit company

The University of Iowa, as an institution, may also have significant financial interests. These financial interests include:

• Royalties or other payments from licenses or other technology transfer agreements related to University intellectual property rights from a for-profit company
• Gifts/gifts-in-kind and donations received from a for-profit company
• Equity or ownership interest (other than a mutual fund) in a publicly traded company
• Any equity interest or an entitlement to equity of any value, including options or warrants, in a non-publicly traded company

These interests will be reported to the Conflict of Interest in Research Office by the University of Iowa Research Foundation and the University of Iowa Foundation. This data will also be entered into the eCOI disclosure system by the Conflict of Interest in Research staff.

While this policy is under the authority of the Office of the President, administrative aspects of this policy will be carried out by the Conflict of Interest in Research Office. This means that the Conflict of Interest in Research Office will collect and assess financial interest disclosures submitted in the eCOI portal. Assessment includes determining if a reported financial interest reaches certain thresholds and creates a significant financial interest, and then whether or not that significant financial interest is related to human subjects research that is being conducted at the University of Iowa.

The Conflict of Interest in Research Office determines, with the consultation of the Conflict of Interest in Research Officer, whether or not an institutional conflict of interest in human subjects research exists. If the interest exists with a University official, that official will be asked to recuse him/herself from all business decision related to the interest, or to divest from the interest. If neither of these are practical options, then the institutional conflict of interest in research committee will review the case and determine a) if the interest can reasonably be managed, and if so, b) recommend management strategies to mitigate the impact of the interest on the research. In the case of a financial interest held by the University itself, the case will go directly to the committee where the same determinations will be made.

The institutional conflict of interest committee is comprised of the Conflict of Interest in Research Committee plus two additional members – the President or his/her designee and an unaffiliated member of the greater community.

Who determines a conflict of interest?

How do you resolve conflict of interest in research?

Which of following is true about the management of conflicts of interest?

What constitutes a conflict of interest in research?

Why is it important to disclose a conflict of interest in research?

What is true about conflict of interest?