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Conflict-of-Interest makes headlines  Controversy heightened in the recent death of a patient during a viral gene therapy trial when it was revealed that the principal investigator on the study was receiving personal monetary benefits from the company sponsoring the study. Conflict-of-interest issues like this one are the expected result of an increase in collaboration between academic scientists and commercial enterprises. At MUSC the Compliance Council, chaired by Ed Conradi, M.D., oversees the Conflict of Interest Committee and other offices and committees involved in complying with federal regulations. Appointed by the provost, the Conflict of Interest Committee meets monthly to consider submitted grants and contracts in which a conflict of interest may exist. The committee is chaired by Kay Meier, Ph.D., and includes members of the MUSC Research Office as well as faculty members from all of the schools on campus. What is conflict-of-interest as it pertains to academic research and practice?  Conflict of interest refers to any situation in which the objectivity of a person involved in the study could potentially be compromised by the prospect of personal gain.  Common examples include the following:  investigator holds stock in the company sponsoring the research,  investigator is paid as a consultant by the sponsor,  investigator is on the governing board of the sponsoring compay,  investigator's family member(s) have a financial stake in the company Even the appearance of a conflict of interest can have an adverse effect on public opinion in the event a problem arises in a study.  For example, in a clinical study, the public perception might be that the investigator took risks with study subjects in order to bring the study to a satisfactory endpoint.  To address these concerns, and as part of federal research compliance requirements, all academic research centers must have a procedure in place for the review of conflict of interest issues.  How are potential conflict of interest issues identified?  The procedure is based on an honor system, but one that is mandated by the conflict of interest policy included in the MUSC Faculty Handbook. When principal investigators fill out their institutional blue sheets for submission of a new project, they are asked whether a potential conflict of interest exists.  Current criteria are that an interest of greater than $10,000, or greater than 5 percent ownership interest in a company, may constitute conflict of interest and requires further disclosure. This interest of $10,000 may be as equity in a company, or may represent salary, royalties, or other payments.  A unique category of conflict of interest arises when a student is performing corporate research under the mentorship of a faculty member who has significant financial interest.  If the principal investigator discloses significant financial interest by any of these criteria, then the Office of Research and Sponsored Programs will require that a Financial Interest Disclosure Form must be filled out. This form asks for further details concerning the nature of the financial interest, the nature of the study, and possible strategies to reduce or manage the conflict of interest.  On occasion, a principal investigator may be requested to fill out a disclosure form even if the blue sheets did not indicate a potential conflict of interest. This can occur if information in the institutional database suggests that a conflict of interest may exist. This mode of disclosure is more problematic since there is the potential for disruption of an ongoing program. In addition, the policy in the Faculty Handbook (section 9.8.1) states that “all Significant Financial Interests must be disclosed prior to the time a proposal is submitted.” While disclosure of financial interest undoubtedly presents an extra bureaucratic hurdle to the principal investigator, the process should not be excessively time-consuming. Once a disclosure form has been filled out, the issue is presented in a confidential manner at the monthly Conflict of Interest Committee meeting.  Members of the committee discuss whether the case appears to constitute conflict of interest, and whether further information is needed.  It is acknowledged that conflict of interest is a relatively common occurrence in the current academic environment, and the existence of a conflict of interest does not mean that the research project cannot be carried out.  For example, a project involving an investigator with a potential conflict of interest, but which is a component of a blinded multi-site study, is likely to be exempt from further consideration since the principal investigator cannot influence the outcome of the results.  The main goal of the committee is to formulate ways to resolve potential conflicts of interest.  In many cases, a sub-committee is assigned to meet with the principal investigator and discuss approaches to achieve resolution. For example, one approach could be that the principal investigator would oversee the study while another investigator (not in conflict) handled data collection. Another approach would be to establish an oversight committee to monitor the research project. In summary, attention to conflict of interest issues is a responsibility for every investigator to take seriously. Assessment and resolution of conflict of interest issues at the institutional level are intended to protect the investigator, research personnel, the university, and human subjects, while maintaining compliance with evolving federal regulations. Members of the MUSC Conflict-of-Interest Committee Kathryn Meier, chair; Julie Acker; Robert Boackle; Ron Brown; Edward Conradi; Daniel Fernandes; Gary Gilkeson; Joseph Good; Tom Higerd; Dillard Marshall; Kenneth Roozen; and Cynthia Wright