Audiotaping consent sessions seen thwarting lawsuits.(Informed consent)

BOSTON -- Audiotaping the taking of informed consent could provide a helpful backup tool in case a subject or family sues after the trial, the chief of Coast Independent Review Board told the RAPS annual meeting here last month.

Darren McDaniel, CEO of the Lake Forest, CA, for-profit IRB, said there is provision for audiotaping in the regulations, and such a tape will provide objective evidence in the case of a later lawsuit.

Arguing the time to take consent is inadequate, and that more than 90 million Americans are not very literate, McDaniel urged his audience to revise the forms they use.

"Informed consent documents are written at a graduateschool level. We need to change it all--to totally revamp the system."

He also noted that 51% of FDA warning letters deal with consent-taking issues. So, in addition to taping, he suggested issuing a survey to the end-user, allowing for learning on the part of investigators and more documentation of patient/subject experiences.

By making these changes, McDaniel said trial sponsors can bring more accountability to the process, and hence, more collaboration.

He said that if a number of different people in the informed consent chain were to work together, many of the problems currently inherent in the system could be shortcircuited. This means that relationships are vital to the process: There is too much of a tendency for everything to move quickly, so there has to be trust among members of the team, as well as between the team and the participants in the clinical trials.

"Look at the process," McDaniel said. "Are we getting the best, or the easiest-the best we can get quickly?"

He gave as an example the IRB selection meetings. "They're 20 minutes long," he points out. "That's not adequate. Request the minutes of the meetings--the FDA guidance allows for it--and look for time spent."

Investigator meetings are equally poorly run. "They all have the same, one-day agenda," McDaniel argued. "There's a protocol review, then the docs leave, and the meeting goes into GCP discussion and other issues. No training, no learning happens in these meetings. We need to think differently about the meeting process."

McDaniel proposed having doctors stay through the meeting, perhaps even have them draft the consent on the spot. People who are involved in the process, he argued, will remember it better. "Allow investigators to take more ownership of the language in the informed consent form."

He said the National Cancer Institute offers this information to potential participants in its clinical trials: "Researchers and health professionals know that a written document alone may not ensure that you fully understand what participation means. Therefore, before you make your decision, the research team will discuss with you the trial's purpose, procedures, risks and potential benefits, and your rights as a participant."

McDaniel suggested that some simple modifications to the process could make all the difference in terms of accountability, and that collaboration between different team members can ensure that everyone is on the same page about informed consent in clinical trials.

He said the price paid for that inadequacy is high. Deficient informed consent represents the number-one site finding in warning letters issued to IRBs. Moreover, the press and the American public already do not have a high view of the industry, with numerous stories circulating accusing FDA and other scientists of breaches of ethics: retractions in peer-reviewed journals, sales forces told to lie, and product liability lawsuits.

He concluded that the process of enrolling subjects should be as follows:

Obtain consent, give subject time to decide, do not coerce, use understandable language, do not waive legal rights, give subject a copy, and answer his or her questions. This vagueness around issues such as time (how long is long enough to decide?), coercion (what precisely constitutes coercion?), and language (how do you know whether or not the subject "understands"?) are what makes the current requirement inadequate.

By Jeannette Cezanne New England Correspondent

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