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Model language unveiled to help clinical researchers disclose financial conflicts

disclosure language that's to be made available to everyone. We then added an explicit invitation for potential research participants to ask for more detail."

After extensive focus group testing and multiple rounds of review by representatives of Institutional Review Boards, the COINS project team has unveiled the following generic disclosure for situations in which a financial interest exists but does not present a measurable risk to a research participant.

***The person leading this medical research study might benefit financially from this study. The Institutional Review Board and a committee at ABC University have reviewed the possibility of a financial benefit. They believe that the possible financial benefit to the person leading the research is not likely to affect your safety and/or the scientific quality of the study. If you would like more information, please ask the researchers or the study coordinator.***

The new model language also includes specific language for situations in which there may be risks to participants. The team categorized this additional language by the nine types of financial interests most commonly encountered in clinical research, including:

  • Salary support
  • Money received outside of the study
  • Per capita payments
  • Finders' fees restricted to research uses
  • Unrestricted finders' fees
  • Researchers holding a patent
  • Universities holding a patent
  • Researchers owning equity
  • University owning equity

"The determination of risk to potential research participants can be complex, and varies by research institution. Individual institutions using the new language may want to modify key phrases to suit their purposes," said Jeremy Sugarman. "This is language that can help these institutions craft better written materials. It can also help serve as a model for how to accurately phrase disclosure in discussions with
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Contact: Ed Bodensiek
ebodensiek@jhu.edu
410-516-8523
Johns Hopkins University
19-Jan-2007


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