Risk management begins with informed consent  

Here’s how to avoid common pitfalls

Risk management issues that result in lawsuits often involve misunderstandings among subjects and clinical trials staff and investigators. By improving the informed consent process, these risks could be reduced, and here’s how, according to experts:

• Make certain the informed consent process does what is needed. Informed consent cannot be handled in a generic way. For instance, informed consent for phase I clinical trials should be drafted differently than informed consent for trials that look at efficacy, says Allison Weber Shuren, MSN, JD, health care attorney for Arent Fox in Washington, DC.

Also, when there are problems with subjects that result in civil suits, a common complaint is that the subjects thought that the trial drug, device, or intervention offered to them was one that had a proven outcome rather than that there were some risks and potential benefits that are yet unproven, says Jeffrey Trunzo, RPh, MBA, CIP, vice president of the Chesapeake Research Review Inc. of Columbia, MD.

"Our IRB review process is one where we look at the form for overall comprehensibility and having terminology that most people can understand," he says. "And the form should have a font type with enough white space so that a person can read through a very long document. It’s not uncommon for the document to be eight to 10 pages long."

One best practice is to allow potential subjects time to read the document and then to discuss it with their families before returning to have all of their questions answered, Trunzo suggests.

"We think there should be pressure-free time," he says. "They need to know it’s part altruism — they are contributing to a body of knowledge — and that there’s a chance they may not get better."

Clinical staff should spend a lot of time talking with subjects about their expectations, Shuren notes. It’s acceptable to delegate some of the informed consent process to clinical trials staff, including nurses and coordinators, but at some point the investigator or physician will need to be a part of the process, she says.

"Even if the coordinator provides the initial explanation of the trial and informed consent document and gives the subject some time to think about it, potential subjects still should be offered the opportunity to meet with the investigator to ask any questions,’" Shuren explains. "That’s part of being an investigator, part of their duty."

Also, a good risk management strategy is to make certain the informed consent process continues throughout the trial, Trunzo says.

"If it comes to light that there are unexpected serious events, it’s important to have a program so those risks that weren’t known when the study began are communicated back to people in the study, so they’ll know what those risks are and can decide whether to continue," he says.

"The whole goal of clinical trials, if designed right, is that they hope to discover problems during the clinical trial process, rather than have a drug approved and then yanked off the market," Trunzo explains.

"I think all data in humans should be shared with subjects," he says.

Some sponsors are so conscientious that they’ll require investigators to share all safety data, including animal data that might be inconclusive, Trunzo adds.

• Be vigilant with placebo-controlled trials. From a statistical standpoint of proving a hypothesis, a study that proves that a product or intervention is effective against placebo is the gold standard for research, he points out.

"That’s where you get the most clear results with a study population of a reasonable size," Trunzo says. The flip side of the argument is that if clinicians feel that there is an adequate treatment for the condition on the market and the company is creating another treatment, then they shouldn’t perform placebo-controlled trials."

Instead they should compare the new product with an old product, he suggests.

Also, placebo-controlled trials may pose risk management problems when subjects do not fully understand that they may or may not receive the drug or intervention under study, Trunzo notes.

Another strategy is to create a trap door in which a patient will be taken out of the study and given an existing treatment if their condition worsens during the trial, he reports.

"There needs to be monitoring, and there’s no need for human suffering," Trunzo says.