Communication skills and PI involvement are crucial to improving site's informed consent

IRB approval is just the beginning

Investigators are responsible for ensuring the informed consent process is done properly, but too often they delegate the task to clinical trial staff, an expert says.

"The informed consent process is not just a form and being told, 'Read this, if you like it, sign it,'" says Michael Hamrell, PhD, of MORIAH Consultants in Yorba Linda, CA.

"There needs to be a better attitude about the process," Hamrell adds. "Investigators should sit down with subjects, talk about the study and things related to it, and document the process."

Instead of spending most of their effort on getting consent forms approved by the IRB, investigators should consider the actual informed consent form as documentation of the complete informed consent process, Hamrell explains.

"The last thing you should do is say, 'This reiterates what we've discussed, and you may sign it,'" he says.

"The investigator is legally responsible for the informed consent process and has to be involved," Hamrell says.

"It's fine if a site has someone who is really good at talking with people, a patient educator or patient advocate," he notes. "But since many studies involve highly technical and scientific issues, the person who is most knowledgeable needs to be available to answer questions as part of the consent process, and this should be documented."

Hamrell has seen cases where complex studies are explained by a nurse, who obtains the participant's consent.

"They will say the doctor came in and answered the patient's questions," he adds. "Then, shouldn't the doctor be the one who got the consent; shouldn't the investigator's name be on the form?"

There are many other situations where investigators' names should be on consent forms, but they are missing, Hamrell says.

"While the regulations do not require the investigator to personally obtain consent or sign the form, investigators are responsible for making sure things are done right," Hamrell explains.

"The way some people who wrote the regulations envisioned it is to have investigators be involved in the consent and seeing that it's obtained," Hamrell adds. "But what's happened over the years is that medicine is much busier, and clinical research is more complex, so informed consent gets delegated."

Once investigators change their attitude about the informed consent process and realize that their responsibility continues long after the form is approved, then they might be less inclined to delegate the process. Or, if they do have an experienced clinical research educator sit with subjects, then the investigator also will be available to answer any specific questions about the study, Hamrell says.

Physician investigators have an additional burden when speaking with clinical trial participants than they do with their patients, he notes.

"It's not that they shouldn't explain medical issues in detail to patients but, when you have a clinical trial, there's an additional regulatory burden," Hamrell explains. "Without it you'd say, 'Did you understand? Yes or No?' and then they'd sign their name, and that's all you'd need."

However, the trust physicians expect from patients when they prescribe a medication or suggest a procedure can be a problem in clinical trials because they need participants to be fully informed and not make a decision based on their trust of the physician, Hamrell says.

"In our society, the layperson would say, 'If this is what my doctor recommends, he wouldn't recommend something that's not good for me,'" Hamrell says. "They say they trust their doctor and if he recommends a study then it's okay with them."

The other problem is that physician investigators need to learn how to speak about complex medical terms in simpler language than they're accustomed to using.

"Part of this is making sure there's a process that goes on and includes a discussion in which someone is spending time with the patient and explaining things, answering questions," Hamrell says.

Since patients are often overwhelmed by their own disease, some research suggests the best strategy is to have an initial discussion with the patient about the study and then suggest the patient think about it and come back in a couple of days with questions, and then make a decision, Hamrell says.

If the process is truncated to a single presentation then a site runs the risk of the patient saying, 'I don't know what to ask, but I think it sounds okay,' Hamrell says.

Clinical trial sites should stress better communication skills in both face-to-face discussions with participants and in the informed consent document, he notes.

In the informed consent document it is important to translate medical terms into layman words, and the actual sentences need to be structured more simply, Hamrell says.

"I work with sites and say to them, 'This language looks awfully complex,' and they say, 'We've dummied it down,'" Hamrell explains. "Then they check the reading level [such as MS Word's readability check] and discover their text is written at an 11th or 12th grade level, which shocks them."

Another strategy for improving informed consent is to help patients use available educational tools to facilitate the process, Hamrell suggests.

For example, some sites or study sponsors might prepare a videotape that describes the procedure and shows a model undergoing the process, he says.

Then the clinical trial staff can sit down with the participant and explain the study, answer questions, and ask the person to sign the consent form, Hamrell adds.

There has been interactive educational material available, as well.

"All of these things are good; anything that explains the process is good," he says. "Any of these tools help the understanding process."