Medical research can have big rewards—both in gratifying discoveries and in potentially turning them into profitable treatments. To achieve the former, researchers work hard. Very hard. To obtain the latter, they can start companies or sign commercial funding agreements—well before testing is over. So, do patients undergoing clinical trials for new treatments have a right to know about these monetary interests?

Legally, no. And no empirical data has tied researchers' financial interests in a study to negative outcomes for patients. In the past several years, however, more findings suggest that, ethically, patients should be informed prior to participating in a trial.

Various federal agencies, including the U.S. Food and Drug Administration and the Department of Healthe and Human Services, have made general recommendations that institutions review and consider conflict-of-interest notification policies. More pragmatic guidelines remain elusive.

A new letter, published yesterday in The New England Journal of Medicine, brings together data from the five-year Conflict of Interest Notification Study backed by the National Heart, Lung and Blood Institute, along with broader reports on conflict of interest in medicine released by the Institute of Medicine (IOM) and the Association of American Medical Colleges (AAMC) to examine the practical goals and challenges of presenting this information to possible trial participants. The paper's lead author is Kevin Weinfurt, an associate professor at Duke University in Durham, N.C. He asserts that making this information available to patients should help achieve the following: ensure patient welfare, promote informed decisions, respect assumed right to know, create trust, decrease legal liability, and ultimately discourage financial conflict of interest.

The impact of being informed
After finding out about a conflict of interest, who would trust a coach who was betting on the game?

Most patients, it turns out.

A 2003 survey, led by Scott Kim, an associate professor in the bioethics program at the University of Michigan at Ann Arbor, showed that if participants were told that a researcher or institution testing a treatment was being funded by the pharmaceutical company that made the drug, 40 percent would be more willing to participate—a finding Kim chalks up to an appreciation for up-front honesty. If the financial arrangement were switched, however, and a researcher had an equity investment in a company that owned the treatment method (and their share of earnings would increase if a treatment went to market and did well), more than a third of patients said they would be less willing to participate.

That sizable minority alone, says Kim, should indicate that investigators and institutions have an ethical obligation to disclose financial information to patients.

Making such a disclosure beneficial to all involved might be trickier than simply adding a line to the informed consent forms, the authors of the new paper point out. Some worry that bogging down already lengthy consent documents with details about financial arrangement could confuse patients. Weinfurt and others note that there's "a worry that patients already tune out and don't pay attention to what's there," he says. "Any decision to add length to the consent form is potentially going to make patients tune out even more." In focus groups, he found that many patients still weren't entirely clear on the implications of certain financial arrangements after hours of discussion, and he worries that even simple statements might not be understood or taken into account properly when patients are deciding whether or not to participate in a clinical trial.

"Informed consent is a huge problem," Kim also says. "The language is written by lawyers, [not] by psychologists. [And] rather than an opportunity to truly help people make difficult decisions, it mostly operates on institutional efforts to comply with federal regulations."

5 Comments

1. 1. andreanis 03:28 PM 8/27/09

   Well, I mean I know this may sound cynical and unethical_" it depends on the importance of the specific patient compared to their right/ obligation (of every socialised human being ) to take part in scientific trials for the sake of scientific improvement of medical technology"..of course different ethical principles often conflict in this area ..the best bet in my view is to compromise,since a perfect solution may be hardly if at all be found..who works in this field must also be a good communicator with a flair for conflict-solutions strategies..

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2. 2. notslic 07:16 PM 8/27/09

   Not a word about WHO is deciding to be in a clinical trial. I'll say it if they won't...people agree to be test subjects for one reason...MONEY. Nobody in their right mind would take part in a clinical test unless they were getting paid. Full disclosure would only mean that a higher fee would be collected by the guinea pigs, and therefore a higher financial risk for big pharm. Can you say "LOBBY"?

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3. 3. sjd0218 in reply to notslic 10:24 PM 8/27/09

   Yeah, Notslic - please take better notes on what it happening in the world. MANY People take part in clinical trials because they are sick and desperate.
   I have a friend who has an incurable disease. He has taken part in 7 separate drug trials in the last 15 years. He does it because he is sick and he wants to get better.
   I suggest that each subject would be assigned or obtain on their own an advocate doctor to monitor the patient and a separate researcher who is running the test.
   The advocate doctor has the main responsibility for monitoring the health of the patient and has NO relationship to the outcome of the research.
   
   
   

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4. 4. notslic 10:52 PM 8/27/09

   Ok...thank you for making a point. But the reality is that the people of whom you speak are desperate and will take part despite any conflicts that may exist. Just like those who do it for the money. The big pharm lobby will make sure that it costs them as little as possible, no matter who the guinea pig is. I agree that having advocate doctors is a great idea. But the desperate and the needy can't afford it, and big pharm won't provide it unless lawyers step in and protect the test subjects. This is an area that needs more regulation. In a time when the CDC is saying that 50% of the U.S. population may get H1N1, they are rushing a vaccine that may cause enormous damage, or may help stop an epidemic. I hope it works, and I hope your friend finds a miracle cure.

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5. 5. alanmous 12:37 AM 8/28/09

   Yes. Yes. Yes. The world would be a better place if OPEN was THE policy. Doctors, Governments, Drug Trials, Data

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