Thursday, August 27, 2009

Study provides guidelines for conflict of interest notices
by Kelly Shaw, DCRI Communications

The COINS team has been working for five years on how to improve the ethics of research and making sure that financial disclosures are clearly understandable for patients. A new paper published in the August 27 issue of the New England Journal of Medicine offers the first guidelines based on empirical data to help institutions better address disclosure issues.

The DCRI's Kevin Weinfurt, PhD, was the lead author of the paper. Kevin Schulman, MD, Associate Director of the DCRI and Director of the Center for Clinical and Genetic Economics, and Joelle Friedman were also authors on the paper.

To date, there haven't been clear guidelines about how to disclose financial interests to patients who want to participate in trials, or what information should be disclosed.

Over the course of the five-year grant from the National Heart, Lung and Blood Institute, Weinfurt and fellow COINS researchers learned two critical things about patients and financial disclosures.

One is that patients want to know about researchers' financial interests in the trial, even if the patients don't weigh that information heavily in their decision about whether to participate in the study. Weinfurt notes that a number of patients said they would feel as though they had been morally wronged if they learned after the fact that researchers had a financial interest in the study and didn't disclose that information.

The other thing that Weinfurt et al discovered was that even though patients want financial interests disclosed, they don't necessarily understand the information nor do they have a sense of how a researcher's role might be compromised depending on the type of financial relationship.

“The assumption has been that conflict-of-interest disclosures allow patients to make better decisions about trials, but we found this to be questionable,” said Weinfurt. “We do not feel that patients should be the primary decision makers about the risks of financial relationships, and instead conflict-of-interest oversight committees should be involved with what is acceptable and should be disclosed.”

Weinfurt also noted that making financial disclosures clear and simple for patients to understand could help increase transparency in the research process and help foster trust. The COINS researchers have previously released examples of disclosure statements for nine types of financial relationships; the statements were reviewed by patients and modified by researchers as needed to improve clarity.

“This is a great body of work that has been done at the DCRI over the last several years, and we've been able to provide unique data on these ethical questions,” said Schulman. “We have a unique opportunity here to not only conduct research but to help shape the ethical framework around how studies are conducted. Other institutions look to the DCRI to provide guidance for these tricky questions.”

Click here to read the full findings.