Making readable consent forms can be difficult task
Here are some layman dictionary strategies
Some principal investigators have a perfect knack for finding the right language and tone to describe their study and ask for consent from adult participants. Most others, however, have difficulty turning precise scientific and medical jargon into sixth- to eighth-grade layperson language. While IRB administrators have too little time to coach each investigator about the best strategies for writing an understandable consent form, some experts have found that with the right guidance and resources, all consent forms can be written appropriately for the layperson.
"Getting a consent form down to a lower grade level isn’t just a matter of playing the game to shorten sentences and words," says Patricia A. Bass, JD, MPH, associate general counsel for Boston Medical Center and a nonvoting member of Boston University Medical Center IRB. "They need to go back and ask, Does this flow as basic English?’ That’s what I look for in consent forms — basic high school English; things like having a topic sentence and using connectors," says Bass.
The IRB at Christiana Care Health System in Wilmington, DE, used to offer researchers the use of a lay language dictionary that they could use as a reference while writing consent forms, but it proved to be very difficult to maintain, says Jerry Castellano, PharmD, CIP, CCIP, corporate director, institutional review board for Christiana Care Health System. "It’s not as comprehensive as we’d like it to be," Castellano explains. "And part of the problem was it was only available to our internal audience, but not to those based in the community."
Eventually this problem was resolved, although the main problem of maintaining the dictionary persisted. "We had started to create the additions list, and it just got to the point where either the definitions in the lay language dictionary that we developed needed to be revised, or we needed to keep adding so many things that we abandoned updating it," he says. Finally Castellano found an alternative, a lay language dictionary that all researchers freely can access on the Internet at the web site www.medterms.com/Script/Main/hp.asp. The on-line dictionary permits searches by alphabetized terms or categorized lists, and while it doesn’t include every term a researcher might use, it is fairly comprehensive, Castellano says.
Keep it simple
Bass and Castellano suggest IRBs use these strategies to instruct researchers about creating consent forms that the average adult subject can understand:
• Offer investigators tools and resources for creating simpler language.
An IRB could create its own lay dictionary or a supplemental dictionary, but this likely would be a daunting project, Castellano says. "For us to develop a supplemental dictionary, I don’t believe it is worth the effort it would take," Castellano says. Rather, Castellano recommends that researchers access the Internet dictionary mentioned above or that an IRB purchase a comparable dictionary either in hard-copy or electronic format.
A basic resource for creating consent forms can be found on the Indian Health Services (IHS) web site, which lists sample consent forms and other consent form information, Bass says. The web site, www.ihs.gov/nonmedicalprograms/research/irb.htm, includes eight model volunteer forms for different hypothetical situations. It incorporates the applied literacy standards of the National Adult Literacy Survey (NALS) of 1993, which include three types: prose, document, quantitative. And the IHS consent form information lists factors that decrease comprehension of prose.
| The Five Levels of Prose Literacy* | |
| Level 1: | not able to read at all; or "read a relatively short text to locate a single piece of information." |
| Level 2: | "integrate two or more pieces of information to compare and contrast easily identifiable information;" locate a single piece of information but the passage had several "distracters" ("plausible but incorrect pieces of information"). |
| Level 3: | "make matches that require low-level inferences" "integrate information from dense or lengthy text that contains no organizational aids such as heading." |
| Level 4: | "integrate or synthesize information from complex or lengthy passages" "[c]onditional information is frequently present." |
| Level 5: | "search for information in dense text which contains a number of plausible distracters" readers must "use specialized background knowledge" to understand part of the text. |
| *Note: | According to the National Adult Literacy Survey (1993), only 3% of U.S. adults could understand language written at Level 5, and 20% of adults could understand language written at Level 4. |
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| Kirsch IS, Jungeblut A, Jenkins L, et al. Adult Literacy in America: A First Look at the Results of the National Adult Literacy Survey. Washington, DC: National Center for Education Statistics, U.S. Dept. Education; 1993. | |
| Source: Indian Health Services of the Department of Health and Human Services, Washington, DC; web site www.ihs.gov. | |
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Factors That Decrease Comprehension
Factors That Increase Comprehension
Source: Indian Health Services of the Department of Health and Human Services, Washington, DC; web site: www.ihs.gov. |
Another good resource is the National Cancer Institute in Bethesda, MD, which has information on readability and sample consent forms, Bass suggests.
• Keep in mind that it’s not all about word and sentence length.
Readability measurements may not have anything to do with coherence because the electronic versions often rely solely on word and sentence length, Bass says. For example, the sentence "The quick brown fox jumped over the lazy dog" measures a grade level of 2.3 and a readability of 94.3 on the Flesch-Kincaid scale, Bass notes from some of her own research. However, the same results can be obtained from this far less readable sentence: "Fox jumped brown over quick the dog lazy."
"Those formulas don’t sense coherence," Bass says. "You can sort those words in any order and readability statistics are the same." So it’s a good idea to remind researchers that in addition to running their consent forms through a readability formula they will need to have it proofread for coherence, and this also is the job of the IRB’s diverse membership.
Adversely, consent forms that have long but very common words, such as the words "institution" and "university," may draw higher grade level scores on a readability index because the words have greater than three syllables. "The word institution’ can blow it off the board, so you have to strike a balance between understanding the consent form and getting it to the point where you have all the necessary elements required by federal regulation," Castellano says.
Bass suggests a strategy of taking these types of common, but long words out of the consent form before running it through a readability index. Once the score is obtained, those types of words can be reinstalled. Another factor to consider is the tone of a consent form, Bass says. Does it use an active or passive voice, which would be better suited for the tone the researcher is trying to convey? "We need to think about those kinds of matters as well, and then see how the tone strikes people," Bass says.
Also, consent forms do not have to be written in the same dry format as a legal document. Their format could include bullets, bold-faced sentences, italics, double spaces between paragraphs, and other techniques that could make it easier to read. "Look at advertising and other written things and see how people are presenting messages in a way that you can see them, with white-faced bullets and captions," Bass says. "The Indian Health Service has an interesting model that uses a bolding format that looks like an outline with an explanation in short paragraphs or bullet points," Bass adds. "They show how you can get a good number of elements on one page." The IHS offers, on its web site, an example of how to format a consent form so that it is easier to comprehend. (See "Sample volunteer consent for domestic violence study" in this issue.)
• Watch for common medical terms that need translation.
It might be helpful for IRB members and researchers to keep in mind that some common medical terms and words may not be as well known by lay people. For instance, medical professionals and investigators commonly use the acronym ECG as a short term for electrocardiogram. However, before the word was anglicized, it was commonly called EKG, which was after the German spelling of the word, and that’s the acronym that most lay people remember, Bass says. "The lay person knows, I have to get an EKG,’ and he or she knows what that means," Bass says.
Also, keep in mind that even when volunteer subjects are highly educated and are professionals, they may still benefit from seeing simplified medical language on the consent form. "They’re not scientists or medically informed, so they might need a sixth-grade explanation of something that has to do with medicine, even though the person might be a lawyer," Bass says. "Somebody who did a study of simplifying consent forms found out that the educated people are not insulted by simplified consent forms."
• IRB director and members can assist researchers with consent form comprehension.
At Christiana Care Health System, research coordinators know they can call Castellano if they have a description or phrase they have difficulty in translating into layperson terms. "We pick up the telephone and try to come up with something," Castellano says. "Either they will call me, or if I’m unavailable, they might try another research coordinator."
IRBs have members who can bring different perspectives to whether a particular consent form is comprehensible, and they should make full use of their resources, Castellano says. "We find it absolutely critical and invaluable to have one member of the clergy, nurses, and physicians look at the consent form from different perspectives," Castellano says.
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