New language regarding informed consent in the revised Common Rule seems benign enough at first reading, but actually accomplishing the directives in a scientifically valid manner is a formidable undertaking.

“It is difficult to take complex information and write it in a concise and very understandable way,” said Christine Grady, MSN, PhD, chief of bioethics at the National Institutes of Health (NIH) Clinical Center. “Easy reading is damn hard writing.”

Grady recently gave a talk at the NIH on the challenges of informed consent, citing this new requirement in the revised Common Rule: “Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate, organized in a way that facilitates comprehension.”

“So this is now a regulatory requirement,” Grady said. “The interesting question — something that I have been thinking about quite a bit — what is key information? What is the key information that somebody needs to be able to decide whether they want to participate or not? Does it include purpose, risk, benefits, and alternatives? Maybe it includes all of those things. If that is the case, how do you put that in the front and then what goes in the rest of the consent form?”

One approach would be to include an executive summary at the beginning of the consent form, she said.

“Other people have said, ‘No, you don’t repeat information. Whatever you put up front, you don’t repeat later on. You just build on it,’” Grady said. “Also, making something concise and focused is something people have been trying to do in research studies, but I don’t think we have actually nailed down what that looks like.”

Reading Comprehension

Multiple studies have raised issues about the length and comprehension of consent forms currently used in human research.

“When studies have looked at consent forms, the reading level is high,” she said. “Most of the analyses that have been done on consent forms come in at around the 11th grade or higher reading level. The average reading level in the U.S. is in the sixth to eighth [grade] range — it is not 11th, that’s for sure.”

Unlike clinical care in which the goal is to improve the patient’s medical condition, the goal of research is to produce knowledge, she said.

“In research, our goal is not to benefit the patient — even though patients often benefit from research,” Grady said. “The goal is to answer a research question. Therefore, sometimes we ask people to do things that are not necessarily in their own interests, but for the benefit of others.”

That heightens the ethical stakes, in a manner of speaking, because human research must ensure informed consent to research that may not be of immediate benefit to the participant.

“There is a constant debate about what information should be disclosed,” she said. “I say that recognizing that the Common Rule and the FDA regulations have a long list of things that need to be included in an informed consent document. There are lots of stories of people struggling with the degree of information or the degree of complexity of the information that they provide to participants.”

In any case, the consent and any supplemental materials must be approved by an IRB, whose members may be tempted to add other information they feel is important.

“It is interesting and ironic in a certain way that the IRBs more often than not make consent forms more complicated,” Grady said. “I did a study a few years ago that had 82 IRBs and we asked them not to change the consent form, or to change it as little as possible. Ninety-some-percent of the IRBs changed the consent form, all in the direction of being longer and more complicated. So, IRBs are part of this problem.”

The upshot is that consent forms tend to get longer under increased contemplation, and one reason is that the document serves more than one purpose.

“Consent actually has other functions besides helping people understand what the study is about and making informed decisions,” she said. “Consent also protects the institution and the sponsor. There is a balancing act. What goes in the consent form is documentation of what the person was basically informed about. So, you are balancing understandability with protection of the institution.”

By the time all bases are covered, a consent document may have considerable heft.

“Consent forms are long, and have actually, over time, gotten longer,” she said. “If you go through the consent forms that are available here, some of them are 25 to 30 pages. It’s very rare to see a consent form that is two pages.”

Despite the trend toward information overload, some studies have found that even long consent forms leave out required elements.

“You can see the challenge here is that you may be missing things, but it may also be too long and complex,” she said. “How do you balance those two things when are writing a consent form?”

Showing slides of consent forms that varied in reading level and the detail of information given, Grady elaborated on this conundrum.

“The question is, are we making it more understandable for all, or are we sacrificing information that they may really want?” she said. “And here’s the answer: We don’t know. We don’t have enough data to know whether or not a person who is deciding whether to participate in a study would make a different decision if they read one [consent form] versus the other.”

There also are a variety of approaches in the way the form itself is used in discussions with a potential research subject.

“Some people use it as a very detailed script, and they go over one section after another with the prospective participant,” she said. “Some people hand it to participants and say, ‘Read it and ask me questions.’ There’s a whole range of behaviors in between.”

Another new part to the Common Rule states that “informed consent must present information in sufficient detail, but it must be organized and presented in a way that does not merely provide lists of isolated facts but, rather, facilitates understanding.”

That certainly sounds rational in theory, but again, the devil appears in the details.

“I applaud the idea of this,” she said. “I think the challenge is, how do we do it? That is the struggle. How do you balance sufficient detail with understanding?”

One could presumably begin by dropping the laundry list approach, which may present a long scroll of information with little explanation or context.

“The one that drives me crazy is list of possible side effects,” she said. “One will say diarrhea, and the next one down will say constipation. How do you have any idea of what this drug is going to do, other than mess up your stomach in some way?”

Grady concluded with the following tips for creating an easy-to-read informed consent document:

• familiar, consistent words, active verbs, and personal pronouns;

• short, simple, and direct sentences with limited line length;

• short paragraphs, with one idea per paragraph;

• clear and logically sequenced ideas;

• highlight important points;

• avoid acronyms and abbreviations.

“All of this needs to be reviewed and approved by an IRB,” she said. “Writing consent forms is an art. They need to be readable, understandable, and they need to explain the study to the targeted participants. There are a lot of reasons to be careful about the length, the format, the reading level, and the complexity of the information.”