CASE STUDY #1: POLARITY

DESCRIPTION OF EXTERNAL RELATIONSHIP

Dr. Mychals has a royalty agreement with NovaGnu based on the sales of their Gnums, an anti-inflammatory agent for gums. Dr. Mychals has submitted an IRB application to investigate. Dr. Mychals' role in the study is the surgical placement of the implants. His contact with patients ends after follow-up, four - five months after surgical placement. Dr. Mychals does not hold an executive position at NovaGnu nor does he serve on the Board of Directors.

Dr. Mychals’ potential conflict arises because he expects to receive more than $10,000 in royalty income. NovaGnu is sponsoring the above-mentioned research, and Dr. Mychals has requested to be the Principal Investigator (PI) of the research performed at the University.

Dr. Mychals attended the CRC meeting and requested to retain his financial interest and be the PI of the above-mentioned research at the University of Minnesota. The Committee agreed to allow him to retain his royalty agreement and be the PI of the research. The Committee considered the following factors when making their decision:

1. The study involves low risk to human subjects.
2. Since the research is a multi-center trial, the data collected at this University site will not have the sole influence on study outcomes.
3. The outcome of the clinical trial will not be determined until three years after completion of Dr. Mychal’s surgical phase of the clinical trial, thus minimizing the impact his participation would have on the sales of the implant.
4. The financial investment by NovaGnu in this research project is minimal.

Due to the above safeguards currently in place, as well as those implemented by the following management plan, the Committee felt there was a low risk that Dr. Mychal’s ’s financial interest in NovaGnu would compromise the objectivity of his University research or the safety of the research subjects.

AREAS OF POTENTIAL CONFLICT OF INTEREST

The Committee finds that Dr. Mychals has a financial interest in NovaGnu which represents a potential conflict of interest under the following provision of the Regents Policy:

> An employee participating in clinical trials or evaluation or development of a technology, process, or product owned or controlled by a business in which the employee, an immediate family member or an associated entity has a financial or business interest. Regents Policy on Financial or Business Conflict of Interest (July 10, 1998), art. 5, sec.III, subds.1(a), p. 13

CONFLICT MANAGEMENT PLAN

Dr. Mychals will not be involved in patient recruitment or the informed consent process. Those tasks will be performed by a Co-PI without a financial or business interest in NovaGnu.

- Dr. Mychals will not be involved in the data analysis of the study. Dr. Mychals has relinquished his role to an implant care coordinator, whom Dr. Mychals does not supervise, and who does not report to Dr. Mychals.
- Dr. Mychals will disclose to all students and postdocs involved in this research that he has a financial interest in NovaGnu, and that he has designated Professor Joyce within the School of X as the person students may contact if they believe their research efforts are improperly directed toward commercial areas. In addition, he will assure that the majority of faculty on the students' thesis committees have no financial or business interests in NovaGnu.
- As required under the Regents Policy, art.2 sec. II, subd. 7, p. 6 regarding disclosure to external entities, Dr. Mychals will disclose his financial interests with NovaGnu when submitting articles for publication and when making public presentations about this research.
- Dr. Mychals must disclose his financial interest in NovaGnu to his research subjects via the consent form. The wording of this disclosure is at the discretion of the IRB.
- Dr. Mychals has agreed to the conditions of the above management plan in a letter to the Committee on October, 23, 200X, as well as verbally at the Committee meeting on October 20, 200X.

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