Model Language Unveiled To Help Clinical Researchers Disclose Financial Conflicts

"There is near-universal agreement about the need for clinical researchers to disclose financial interests to research participants, but until now there has been little guidance available on exactly how to do it," said principal investigator Jeremy Sugarman, M.D., the Harvey M. Meyerhoff Professor of Bioethics and Medicine at the Johns Hopkins Berman Institute of Bioethics. "Our team looked beyond the need for disclosure. We researched how it should be done. Using an empirically-based approach, we have helped create the right tools to do the right thing. The new language is a model for others to use, test, and improve upon."

Developed as part of an ongoing, $3 million-dollar project called the Conflict of Interest Notification Study (COINS), the new disclosure statements are designed to be used in written materials provided to potential research participants before giving their informed consent.

"If you are thinking about participating in a clinical research trial, you should understand what you are getting yourself into, and that includes any financial interests involved," said Kevin Weinfurt, Ph.D., deputy director of the Center for Clinical and Genetic Economics at the Duke Clinical Research Institute. "We also recognized that people vary in their informational needs. So to provide adequate disclosure to all people, we included a core statement in the new 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 potential research participants. It could even be expanded and presented in other formats, such as stand-alone pamphlets or videos about clinical research."

"The COINS project is about providing a framework for establishing sound policy and practices for the disclosure of conflicts of interest in clinical research," said Kevin Weinfurt. "Toward that end, we have developed something practical: working disclosure language. We hope that others will want to use the new language as a template to further refine the options for appropriate disclosure, and ultimately, minimize potential risks to research subjects."

The Conflict of Interest Notification Study (COINS) was initiated to establish a framework for developing policy and practices for disclosing conflicts of interest in research. The $3 million dollar, five-year study is funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. The new disclosure language for researchers' use was developed through the use of focus group testing, cognitive pre-testing to evaluate participants' understanding, and numerous, subsequent expert panel reviews and revisions.

About the Johns Hopkins Berman Institute of Bioethics

One of the largest centers of its kind in the world, the Johns Hopkins Berman Institute of Bioethics is the home for collaborative scholarship and teaching on the ethics of clinical practice, public health, and biomedical science at Johns Hopkins University. Since 1995, the Institute has worked with governmental agencies, non-governmental organizations, and private sector organizations to address and resolve ethical issues. Institute faculty represent such disciplines as medicine, nursing, law, philosophy, public health, and the social sciences. Their works helps anticipate and inform debates on complex moral challenges; discerns ethically acceptable alternatives in medical, scientific, and public health policy; and helps to prepare the next generation of bioethicists. More information is available at http://www.bioethicsinstitute.org.