Model language helps clinical researchers

Experts at Johns Hopkins University, Duke Universit and Wake Forest University have published new language designed to help clinical researchers better disclose their financial interests in research.

The language is designed to provide guidance for researchers seeking to properly disclose the types of financial interests most commonly found in clinical research.

"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, MD, 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 project, the 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, PhD, deputy director of the Center for Clinical and Genetic Economics at the Duke Clinical Research Institute.

"We also recognised 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."