Study offers insight into how subjects feel about standard IC language

Rights section earns many negative comments

IRBs that desire to improve their informed consent (IC) forms might learn a great deal from questions and comments from people reviewing these forms.

One of the largest studies to look at participants' opinions of a mock IC form reveals many negative impressions of some of the more common language and sections.

"We don't have anything from our data that would allow us to say what should or should not be in an informed consent form, but what's clear is there are some very negative reactions and confusion to the section on rights and confidentiality," says Kevin Weinfurt, PhD, an associate professor of psychiatry and psychology at Duke University in Durham, NC. The research was presented at the 2007 Annual Public Responsibility In Medicine & Research (PRIM&R) Human Research Protection Programs Conference.

The researchers developed a six-page, mock IC form, with standard language used in IC forms at Duke University. It's similar to the language used at other academic research institutions. It was based on a hypothetical study with a hypothetical sponsor company, and 470 participants were interviewed about their impressions.

"Several study coordinators at Duke University were involved in the development of the consent form," Weinfurt says. "So we had a lot of input and tried to make this as realistic as possible in all respects."

The people participating in the trial had ample time to look over the IC form, and the mock IC form was reviewed by the IRB chair.

"When participants were recruited, they were verbally consented and then sent the real consent document for this study," says Alice Fortune-Greeley, BA, a research assistant at Duke Clinical Research Institute of Duke University Medical Center in Durham.

The mock IC form was watermarked and printed in yellow so participants could see the difference between it and the real IC form they signed, she notes.

"It looked like a consent document other than the watermark that said 'Pretend ICD,' marked in yellow," Fortune-Greeley says.

"We gave participants a chance to look over the informed consent documents before we talked about it with them, and this is standard," Fortune-Greeley says.

"Then we went over the informed consent document section by section, which also is standard," she adds. "This was done over the telephone and face-to-face."

Most negative feedback to participants' rights

The section of the IC form that received the most negative feedback involved participants' rights in the study. It received one positive comment, 45 negative comments, and 15 comments in which the participant said he or she would hesitate to participate, Fortune-Greeley says.

"We asked participants if they understood each part of the document and what was the likelihood that they'd participate in the study, using a scale from one to five," Fortune-Greeley says.

When investigators used a multivariable model to compare the negative comments in each section with the reported likelihood to participate, they found that the sections involving rights, confidentiality, and financial disclosure were uniquely associated with the reported likelihood of participating in the study, she explains.

"So if people made negative comments in those sections, they reported a lower likelihood to participate," Fortune-Greeley says.

Legalese = ill at ease

Several participants commented that the rights section of the form seemed like legal mumble jumble, Fortune-Greeley says.

"Some participants expressed the feeling that it was something written by lawyers," Fortune-Greeley adds.

Investigators created a mock IC document, using standard language from Duke University. They made sure the form was realistic and had it broken into six sections, including an introduction, comments about how the study worked, risks to participants, benefits to participants, financial disclosure comments and questions, and confidentiality and subject's rights, Fortune-Greeley says.

"The primary issue in the 'Your rights' section was we had a statement in the informed consent document that's standard for many research projects, saying that the university medical center is not responsible for payments for injury," she explains.

Participants made comments after each section, and this particular section elicited these types of comments:

  • "Why can't the university medical center pay for my treatment?"
  • "How long will they pay for my treatment if I'm injured as a result of this study?"
  • "That's the section where I'd have concerns if I read it because it looks like they're not guaranteeing they'll keep you whole if something happens."
  • "I'd be hesitant to participate. Anyone would be crazy to get into a study if they said 'What we're going to do is harm you, but we won't give you any help if it happens.'"

Most of the negative comments regarding this section focused on the lack of payments for an injury and the lack of long-term health insurance in the case of an injury, Fortune-Greeley notes.

The mock IC form's rights and confidentiality section is very similar to what actual clinical trial participants will find when reading informed consent forms.

"These contain legal language that institutions put in the documents for their own protection," Weinfurt says. "Our data should encourage institutions to reconsider why they are putting those kinds of statements in the consent documents and whether they want to continue to do so."

For instance, in the mock consent form, researchers included language that says the study team will try to keep the study records confidential as much as is possible, but there can be no guarantee of absolute confidentiality of the study records, says Chantelle Hardy, BA, a research assistant with the Duke Clinical Research Institute in Durham, NC.

"So we received a lot of questions about why there was no guarantee of absolute confidentiality of study records," Hardy says.

Participants asked these sorts of questions:

  • "Why isn't there a 100% guarantee?"
  • "Who outside of the hypothetical medical center would see the patient's records?"
  • "Why would the study sponsor need to see their entire records?"
  • "Would names be sent out outside the university medical center?"

"And there were more questions about how data are collected and stored," Hardy says. "But only nine participants actually stated they'd be hesitant to participate because of the confidentiality section."

Overall there were 40 negative comments about the confidentiality disclosure, which indicates this section was important to some people, Weinfurt says.

"Many people have done studies where they asked people specific questions about whether this section bothered them," he notes. "But we provided a mock consent process and only recorded instances where participants volunteered something spontaneously and said, "This doesn't sound right; I have a problem with this.'"

When 40 people out of 470 have such strong negative feelings about a section that they will interrupt the interview to say something about it, then that is significant, Weinfurt says.

Use data to facilitate consent process

The study is the largest one conducted that uses the mock consent method, Weinfurt notes.

"The size of the study allowed us for the first time to record the spontaneous reactions of patients to a consent process," Weinfurt says. "For all of us involved in this study, and that includes the chair of the IRB, this was seen as an opportunity to evaluate the practices here at Duke."

In fact, the IRB chair at Duke is enthusiastic about presenting the data to the IRB and using the information to reassess consent language, Weinfurt says.

"We are very excited about that, and we can see it will have some impact on the way we do research here at Duke," Weinfurt says. "It's our hope it will get other people thinking along similar lines."

With a study this large, the data collected will show how common it is for people to have certain perceptions of IC document language.

"I think our data will help prepare study coordinators in facilitating the consent process and in anticipating the types of concerns that come up," Weinfurt says. "It may not be that 75 percent of people will have trouble with the confidentiality section, and maybe the way it's worded in most documents will stay that way for a while, but the study coordinator can at least know the types of questions people have."

So the research will inform study coordinators and IRBs and help them find ways to assist study participants in making better decisions, Weinfurt adds.

"For the confidentiality section and the 'Your rights' section, I think we're aware that the content is determined in part by federal policy with regard to HIPAA and the larger institutional legal policies," Weinfurt says. "So while the IRB may want to change what's in there, they may not be able to do so immediately."

Still, it's Weinfurt's hope that the research will give IRBs an opportunity to try changing the language.