VOICE offers model for thorough, subject–friendly consent process

Health literacy is obstacle to IC

The human subjects protection field continues to search for ways to improve the informed consent (IC) process. IRB professionals often express concern that potential research participants do not understand their rights or the true risks and benefits of a study, although they might sign the IC forms and say they have no questions. Despite a variety of solutions that have been offered and tried, none has been widely used.

So IRBs and researchers continue to struggle with a complex informed consent process and seek new approaches and strategies. One promising new model that has emerged in recent years is the Valid Optimized Informed Consent Education (VOICE) program of Dartmouth College in Hanover, NH. The program addresses concerns about the readability of IC forms and participant comprehension during the IC process.

"I've come to appreciate the fact that consent forms are extremely long, extremely complicated, and a lot of participants struggle with medical terminology and health care terminology," says Dianne Ferris, MS, CIP, human research analyst at Dartmouth College. Ferris and colleagues created VOICE several years ago.

"We go to great lengths to make consent forms readable and understandable, but that doesn't address the consent process, and I think the forms and process are equally important," Ferris says.

One way to improve the IC process is by targeting health literacy issues. This became a goal for Ferris a couple of years ago after she attended a local conference on the topic.

"The conference opened my eyes to how much of a challenge health literacy is around the U.S.," she says.

Ferris' colleague Sandra Knowlton–Soho, MS, RN, also became passionate about improving the IC process after working in the clinical trial industry for 15 years.

In 2009, Knowlton–Soho and colleagues obtained seed money to start a quality improvement (QI) project involving informed consent. The QI initiative evolved into VOICE, says Knowlton–Soho, who was the lead on VOICE and now is the practice manager of palliative care and critical care at Dartmouth Hitchcock Medical Center in Lebanon, NH.

"Each of us had another full-time job, but we felt so passionate about VOICE that we made the time and pushed ourselves to keep going with it," Knowlton–Soho says.

The Dartmouth VOICE project launched with a pilot study that had one VOICE education session, as well as new tools to improve IC forms and address health literacy issues.

Also, the VOICE educational session has been incorporated into introductory explanations about VOICE during Dartmouth Hitchcock's Clinical Trials Office (CTO) training programs for research staff.

"We have yet to conduct another full, two–hour education session with members of the research community," Ferris notes. "Our VOICE program is very young at this point; the pilot study was conducted last fall, and the first CTO introduction was in March 2012."

The goal is to have the institution offer the full VOICE education session as a required or voluntary session several times a year, she adds.

Also, they plan to provide VOICE sessions to neighboring research institutions and medical centers.

Dartmouth IRB relies on several key strategies for improving informed consent, including these:

Address health literacy issues: Researchers and IRBs should not expect potential study participants to speak up if they do not understand what the informed consent form says. The typical reaction would be to nod their heads or say nothing. So it's important for IRBs to assist investigators with making the forms more readable, Ferris and Knowlton–Soho say.

Ferris sometimes finds that IC forms use words that no lay person will understand when a much simpler word is readily available.

"A term I saw recently was 'pyrexia' instead of fever," Ferris says. "Pyrexia means fever, so why not just say 'fever'— it's ridiculous."

Addressing health literacy problems could also mean educating potential subjects about their disease, or at least assessing how much they know, she says.

"What do they understand about medicine and health care?" Ferris asks. "You should incorporate these questions in the discussion early on, and then the research coordinator can tailor the discussion, accordingly."

Design an informed consent template: A year ago, the Dartmouth IRB developed a 13–page IC template that could be adapted for any type of research informed consent, or it could be a model for other IRBs. These are its general sections:

– Introduction;

– Background Information;

– What is the purpose of this study?

– Will you benefit from taking part in this study?

– What does this study involve?

– What are the options if you do not want to take part in this study?

– If you take part in this study, what activities will be done only for research purposes?

– What are the risks involved with taking part in this study?

– Other important items you should know;

– How will your privacy be protected?

– Who may use or see your health information?

– What if you decide not to give permission to use and share your health information?

– Whom should you call about this study?

– What about the costs of this study?

– Will you be paid to take part in this study?

– What happens if you get sick or hurt from taking part in this study?

– Your responsibilities as a person taking part in this study;

– Consent signatures.

Train clinical trial (CT) staff on using the teach–back method with participants: "The teach–back method is a large part of our education program," Ferris says. "We incorporated a discussion about teach–back, how to use it, the types of questions one could use, and our education program explained what it is and provide some guidance about what sections of consent discussion would be apropos and confirm comprehension."

The initial pilot training session used volunteers to act the part of study participants. Research staff practiced using teach–back with the volunteers, and they're offered guidance as they perform the teach–back techniques.

Another technique might be to incorporate teach–back questions in a study coordinator's copy of the informed consent form, Knowlton–Soho suggests.

"One of the people in our group had a 'teacher's copy' of their consent form; it had questions embedded in the form so when they went through the informed consent process they had notices to themselves to ask questions here and tips on what to ask," she says. "This is very helpful when starting a new study."

It's every IRB administrator and member's goal to make the informed consent process as strong and fair as possible, Ferris says.

"Obtaining true informed consent, like Dr. Henry Beecher said, may not be entirely possible in the truest sense, but it's a goal to which we all strive," Ferris says. A prominent investigator, Henry Beecher shed light in the 1960s on how 20 major research studies did not obtain informed consent from subjects despite significant risks. His findings were published in 1966 in the New England Journal of Medicine.