Researchers and officials charged with the ethical oversight of research are often reluctant to fully disclose financial interests to potential clinical research participants, according to the latest Conflict-of-Interest Notification Study (COINS), just published in the Fall 2006 issue of the Journal of Law, Medicine and Ethics. Instead, those interviewed suggest a better approach for such disclosures would be to offer potential research participants a range of dollars or even use adjectives such as a "substantial investment" to describe the extent of a researcher's financial interest.
The study, a survey of attitudes, beliefs and practices among members of institutional review boards, conflict-of-interest committees and researchers, reveals a key reason for the reluctance among researchers to share the full dollar amount: the belief that because potential research subjects may lack the sophistication to put conflicts of interest in context, they may overestimate the influence of money on the researcher's behavior and possibly refuse to participate.
"The findings raise important questions about the informed consent process," said principal investigator Jeremy Sugarman, M.D., the Harvey M. Meyerhoff Professor of Bioethics and Medicine at The Berman Bioethics Institute at Johns Hopkins University. "Some researchers appear to believe that because disclosing any dollar amount could influence a person's decision of whether or not to participate in a clinical trial, the dollar amount shouldn't be revealed at all. Instead, the person should only be told that a financial interest exists, but there's widespread disagreement on how to do it. Should researchers name the source of their funds? Should the disclosure highlight potential consequences of the financial relationship? When and how should all of that be disclosed?"
The ongoing Conflict of Interest Notification Study (COINS) was initiated to establish a framework for developing policy and practices for disclosing conflict 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. Respondents in the study's latest results were solicited from 40 academic medical centers, independent hospitals, independent institutional review boards, and unaffiliated research entities. The study is conducted by Duke University Medical Center, Wake Forest University and Johns Hopkins University.
All 40 of the researchers, conflict-of-interest committee chairs, and institutional review board chairs interviewed for the study say that when a financial interest does exist, that interest should be disclosed, albeit in limited ways short of full disclosure. For example, some participants in the COINS study believed that the sheer complexity required by full disclosures could detract attention away from the actual decision of whether or not to participate in the trial itself. Such financial interests often range from intellectual property interests to consulting fees to other special arrangements. Others believe that full disclosure should be made to include the dollar amount and source of funding, but in a straightforward, simple manner to minimize confusion among potential clinical trial participants.
"The ultimate goal of the project is to provide a framework for establishing sound policy and practices for disclosing conflict of interest in clinical research," said Kevin Weinfurt, Ph.D., deputy director of the Center for Clinical and Genetic Economics at the Duke Clinical Research Institute. "We are hoping that the data we're collecting will benefit officials who are struggling with the best ways of minimizing potential risks to study subjects and advancing the cause of clinical science."
Many of the study's respondents suggest that disclosure of financial interests take place at the beginning of the informed consent process, when information about the risks and benefits of participation are initially presented. While there are concerns about disclosing the full dollar amounts of financial interests, respondents said that the disclosure of the existence of such financial interests should occur because it:
- enables informed decision-making,
- promotes trust in researchers and research institutions, and
- reduces the risk of legal liability.
"The previous COINS study demonstrated a variety of conflict-of-interest policies at medical institutions across the United States, but no real settled opinion on how to move forward. Now the latest results tell us that researchers and their officials charged with oversight want to disclose financial conflicts of interest, and almost always for the right reasons, they just disagree on how to do it," said Jeremy Sugarman. "There is a clear need to next gather data on exactly how potential research participants would use different forms of disclosure in their decision-making. That way, we might better respect the integrity of the research enterprise while better protecting the rights and interests of research participants."
Institutional review boards are panels of experts at research institutions that evaluate and approve studies involving humans, while conflict of interest committees ensure that individual researchers and institutions do not have financial conflicts.
About the Berman Bioethics Institute at Johns Hopkins University: One of the largest centers of its kind in the world, the Berman Bioethics Institute is the home for collaborative scholarship and teaching on medical and public health ethics at the Johns Hopkins University. Since 1995, the institute has applied a deep, multidisciplinary pool of bioethics expertise to help government agencies, non-governmental organizations, and private sector organizations all over the world. Using various methods of inquiry drawn from the biological, behavioral, and social sciences, the institute's faculty members help reveal complex moral challenges on the horizon, develop new frameworks for decision-making and ethical analysis, and work toward ethically acceptable alternatives in medical, scientific, and public health policy. The institute also runs numerous academic training programs and fellowships to prepare the next generation of bioethics experts, and hosts various educational events throughout the year to help elevate the public discourse on bioethics. The institute is funded by individual donors, foundations, and public research grants. More information is available at www.bioethicsinstitute.org.