Special Report: SoCRA Conference Coverage

How to obtain fully informed consent

Start with knowing the patient’s knowledge

[Editor’s note: This issue of Clinical Trials Administrator contains a story about how research sites can work toward obtaining fully informed consent. This is a continuation of the special coverage that began in last month’s issue of the 14th annual Society of Clinical Research Associates (SoCRA) Conference, held Sept. 23-25, in Lake Buena Vista, FL.]

Through education and better strategies in discussing research with subjects, clinical trial sites can improve their informed consent process, two experts advise.

One of the most important things a clinical trial site should do in obtaining informed consent is to assess the patient’s knowledge about research and clinical trials, an expert suggests.

"How do patients perceive their disease, and how do they perceive what they’ve already learned?" says Lyndon V. Evans, CCRP, RN, research manager with CancerCenters of the Carolinas in Greenville, SC. Evans spoke about obtaining informed consent at the SoCRA Conference.

"Frequently, we want to make sure that they’ve opened their eyes, and they’re perceiving their disease correctly," Evans says.

For example, a clinical trial coordinator might want to ask the patient in a breast cancer study whether she has ever had any experience with cancer before or whether she has any relatives who’ve had cancer, Evans suggests.

This is because many patients with adjuvant breast treatment have a good prognosis, but these same patients might fear the worse if their only experience with cancer was a grandmother who died from pancreatic cancer, Evans explains.

"So you want to help them see how it will be different, and you have to clarify those misconceptions," Evans says.

"One of the strategies we have is we have a seminar that we give applicants about working toward fully informed consent," says John Wright, BS, CCRC, IRB administrator at Baylor College of Medicine in Houston.

Wright had been scheduled to speak about informed consent at the SoCRA Conference, but due to circumstances beyond his control he was unable to attend.

"The seminar’s agenda typically is an over-view of informed consent regulations, and we talk about special populations as they relate to informed consent, and we talk about quality improvement and the consent monitor process," Wright says. "And we go through informed consent scenarios where we ask for audience participation."

The seminar is offered to all principal investigators, research coordinators, and any staff who will obtain informed consent, Wright adds.

Think of the patient first

Evans and Wright offer these additional guidelines for obtaining full informed consent:

• Make the environment comfortable and understand the standard of care. "Think about the room you’re in and the environment," Evans says.

For instance, bright fluorescent lighting might make people uncomfortable, and it’s not a good idea to speak with patients while standing because the interaction should be on equal ground, Evans says.

Also, patients should be encouraged to have a family member or friend with them during the consent process so someone else will hear what is discussed, Evans says.

"The third thing is for the research staff and nurses to be knowledgeable about the standard of care, including what the physician will offer the patient off the protocol, because that’s what the consent process is," Evans says. "How is the standard-of-care treatment going to be different vs. being on a protocol?"

For example, with cancer treatment the physician will most likely offer the standard of care if the patient chooses to not go into the protocol, Evans adds.

"So we need to know how the investigational treatment will be different and how it will affect them vs. the standard of care, and in most consent forms that’s covered," Evans says. "We try to talk with the physician before consenting the patient to make sure we know what the other options are for the patient."

Once a clinical trial coordinator has covered the basics of standard of care, assessing the environment and patient’s comfort level, and understands the patient’s misconceptions about their disease and research, then it’s time to talk about what the research is all about, Evans says.

Have a process in place

• Develop a consent monitoring process. "We encourage principal investigators to develop an internal consent monitoring program which they can do with members of their team," Wright says. "Also, the IRB may ask a particular investigator to have a consent monitor be part of the informed consent process."

PIs should have a rapport with subjects and present informed consent information in a way that encourages subjects to speak up and ask questions or express concerns, Wright says.

"This process needs to go on not only at the first encounter and screening, but throughout the duration of the research subjects’ participation in that setting," Wright says.

Informed consent monitoring could involve someone from research compliance services or the IRB office, Wright suggests.

"The steps we would take is to have the investigator or informed consent designee or study nurse go through the informed consent dialogue with the potential informed consent subject," Wright explains. "Then the second step would be for the informed consent designee to leave the room and have the consent monitor enter the room, and that consent monitor would use a tool we have developed called the informed consent monitor form."

The monitoring tool is used as a guide for monitoring what took place during the informed consent conversation, and it has 16 questions, Wright says.

"The discussion between the monitor and research subject is respectful, and it’s intended to see if the subject is conversant in the information contained in the consent form they just read and signed," Wright says. "It’s intended to demonstrate whether the subject can locate certain key information within the consent form."

For example, some questions are as follows:

— Will you benefit from the study and, if so, how?

— If you decide to not participate or if you withdraw from the study what are your treatment options?

— Why do you want to be in the study?

— Do you have a copy of the consent form?

— Do you have any questions about the research study?

Subjects should be able to have the consent form in hand and be able to guide themselves to locate the answers, Wright notes.

"The consent monitor would jot down notes that the subject found the benefits of the study or were able to tell what the benefits were," Wright says. If the subject asks questions, these are recorded on the tool, Wright adds.

"The next step would be that the monitor documents this conversation and provides the information to the researcher or consent designee who obtained informed consent," Wright says. "It’s a tool to give feedback to the investigator."

So the monitor might inform the PI that there were some parts of the informed consent process that were not understood very well by the subject and these need to be repeated or cleared up by answering additional questions, Wright says.

Provide background information

• Provide context for human subjects research. Often it’s helpful to put the research process into historical context for patients, Evans says.

"If you’re knowledgeable about the history of trials that led up to the one that you’re conducting now, it gives patients a good sense of learning about the benefits of participating in a clinical trial," Evans says.

For example, if a patient at CancerCenters of the Carolinas had a lumpectomy and is considering enrolling in a clinical trial of a new chemotherapy agent, Evans can tell her that she was able to have her lumpectomy instead of a mastectomy because of clinical trials in the late 1980’s.

"I tell her what we learned in the past in research that has improved her treatment," Evans adds. "You think about how brave those women were who were randomized to one surgical procedure to another, and this provides a historical timeline for patients."

Also, while it’s not necessary to bring up the subject of research controversies, it’s not a bad idea to use the term "guinea pig" to give a patient the chance to vocalize any misgivings, Evans says.

"I just say, Do you think it seems like you’re a guinea pig?’ and if they say, Yes,’ then that’s a lead into historical trials," Evans explains. "So I say, Yes,’ in a sense they’re a guinea pig, but look at what we’ve learned from research."

This approach breaks the tension and gives the patient permission to be open about his or her feelings and concerns, Evans notes.

Sometimes, clinical trial staff will encounter subjects who know about the Tuskegee trials and their tragic abuse of human subjects, Evans says.

"We had a prostate cancer prevention trial and were encouraging having African American men enroll," Evans says.

"The people who enrolled knew about Tuskegee and the tragedy of how African Americans were treated in that trial, so I found when we had information sessions on the prostate cancer prevention trial that we needed to mention it."

Keep the process ongoing

• Have a follow-up strategy. "We tell investigators and personnel attending a trial to keep in mind that subjects’ participation is voluntary and make sure subjects speak up if they have any questions," Wright says.

"We encourage them to foster that rapport and that environment where subjects will feel comfortable about asking a question during the study."

It’s important to stress that informed consent is a process of communication and dialogue and not just a form to sign, Wright adds.

"Make sure you follow up with people and encourage them to come back in with questions," Evans suggests. "One important thing is to assess their understanding by having them verbalize to you that they understand the protocol and treatment options."

One way to handle this is to say: "I understand you’ve talked with Dr. Smith about your treatment options. Please explain to me what your options are," Evans says.

"At all meetings with subjects they’re reminded they’re on a trial and can drop out," Evans says. "Frequently, we have to re-consent when new information is available."

Sometimes the re-consent is handled with a letter and other times the patient is called, she says. "Often they have to sign a whole new consent document with new information," Evans says.

"The investigator and physician are responsible for consenting the patient, but the research staff work in tandem with the physician and follow up and go through the process again," Evans says. "In one sense the research staff is a delegate of the physician."