What are the convincing reasons that will be considered when contesting the rebuttable presumption?
• The nature of the research • Whether the research could be performed at another institution • The degree of risk that the research protocol poses for its human subjects • Unique qualifications of the individual and/or Mount Sinai to perform the study • The size and type of the financial interest • The degree to which the financial interest is related to the research • The extent of the potential financial gains for the investigator and/or Mount Sinai • The potential for effective oversight and management to minimize the financial interest Based on evaluation of such factors, if the Committee is persuaded that there is a sufficiently strong rationale for investigator and/or institutional participation, it will develop a management plan with safeguards to protect both the subjects and the data collected and analyzed in the study. Conflicted individuals are invited to propose management plans for the Committee to consider.
