Differentiating between doctors and researchers
Beyond presenting the consent statement itself, the underlying challenge may be addressing the public perceptions about the people and institutions involved in the research process. "They want to trust that the doctor is doing only things that would improve their health," Weinfurt says about patients who might enroll in a clinical trial. "It's also confusing for patients because they have a hard time differentiating between a doctor and a researcher…; [the latter's] primary goal is to generate generalizable knowledge…, not to improve the health of this patient right here."
Doctors are also often presumed to already be well-paid, which, like an independently wealthy politician, could theoretically render them immune to financially driven conflicts of interest, a notion that some focus group conversations supported, Weinfurt says.
Disclosure can increase that trust, but it could also give researchers a moral carte blanche to take more risks in search of financial riches, according to research published in 2003 in JAMA The Journal of the American Medical Association. "Look, it's not enough to say, 'disclose, disclose, disclose.' You have to have some good idea of what effect disclosing will have, because it could be counterproductive," Kim says.
Weinfurt acknowledges that it is extremely difficult to pinpoint the financial relationship as a cause of poor patient outcome. Many point to the Jesse Gelsinger case, in which a teenager died during a gene therapy clinical trial. But, as Weinfurt notes, "That trial had one of the better disclosure statements." And the resulting lawsuit was settled out of court, leaving a dearth of precedent to establish the legal strength of financial disclosure's role in the safety or consent for a clinical trial.
Finding the best way to present financial information will require more research into patient decision-making and interests, but, Kim notes, in the bigger picture, the topic of informed consent is "a very narrow focus."
"What really matters," he says, is "that we understand conflict in the conception, design and implementation of the research—and the presentation of the data."
"Society has put so much trust into academia as a disinterested, objective, honorable, above-the-fray institution—and researchers are like that, too," he continues. But, he notes, "most people don't realize that these institutions have tremendous incentives to behave like for-profit institutions." And changing that perception—and current regulation—could take a major overhaul. "Do we need to now reconceive these institutions and individuals? Where do we draw the line?"
Recent hullabaloo over drug companies paying for ghostwritten medical journal articles—that doctors later sign their names to—has raised questions about a wealth of hidden financial arrangements in the medical research community. "Nonprofit academic institutions and individuals now have a tangled web of incentives that we had not had 30 years ago," Kim says.
Reining in all of these manifestations of conflict of interest that have surfaced will take distinct approaches for mitigating them, Weinfurt says, adding, "They…stem from a profit-driven medical technology industry, but I think they're fairly separate in how we manage them."
In most cases, Weinfurt asserts, financial conflicts of interest have no need to be in clinical trials in the first place. Letting someone who doesn't have equity in a company conduct the trial is an alternative that shouldn't present "a big challenge in terms of getting the science done," he says. On rare occasions, someone who has perfected the techniques of using a new surgical device might be the best and safest candidate for operating on patients, but, he explains, that's for institutional review boards to decide.
The bottom line is that "virtually everybody wants to know," Kim says. "That's just nature." But figuring out how people use that information? "It's going to be tricky," he adds.