Informed consent kits improve process globally
Idea is to make informed consent user-friendly
Investigators conducting HIV prevention research among married women in developing countries have found that standard informed consent forms and methods do not work for both cultural and comprehension reasons. A more creative approach to informed consent could help improve comprehension, says behavioral scientist Cynthia Woodsong, PhD.
"The concepts associated with research, such as randomization, placebo, and blinding are difficult concepts to provide to people in these settings where people don’t have any notion of research design," Woodsong, a scientist in behavioral and social sciences division of Family Health International (FHI) of Research Triangle Park, NC, says.
FHI has been conducting clinical trials of topical microbicides that are inserted in the vagina to prevent HIV transmission during sexual intercourse. Even the concept of putting a gel or product in the vagina is alien to women in some of the countries in which the microbicide is being studied, she says.
Another problem with traditional informed consent is it’s based on the ethical principle of respect for persons and their autonomy in making decisions about their own bodies, and in some of the cultures in which FHI is conducting research, women traditionally are not permitted to make these kinds of decisions, Woodsong notes.
When FHI discussed the study with community leaders and others to find out what would need to be done to improve its acceptability among the population being recruited for the trials, investigators kept hearing that the women’s husbands needed to be informed and involved, she says.
"What often comes back is the women want their husbands to approve it or the community leaders say, You can’t enroll women without their husbands,’" Woodsong says.
So FHI developed a creative informed consent kit that included information that could be provided to husbands or boyfriends and would explain the clinical trial process in a way that is easily understood by women from various cultures, including women in the United States.
The result is an informed consent process, with 10 versions of materials in eight languages, which has been used in a clinical trial involving 3,200 women at seven sites in six countries, including the United States and five nations in Africa, Woodsong reports.
"In the United States, increasingly, we have health research done amongst minority and marginalized populations, folks who are not tuned into the mainstream concept of research," she says. "Even though women are able to read the words on a consent form, they may not understand."
Through the use of illustrations and consent materials, women subjects of the HIV-prevention studies have a better understanding of what to expect, and there is more of a dialogue in discussions with research coordinators who initiate the informed consent process, Woodsong explains.
"We’re seeing that this was developed in response to a particular need in one microbicide trial, and now three different groups are using it in microbicide trials," she says.
Here are some of the chief features of FHI’s creative informed consent process:
• An illustrated booklet: Researchers developed a 20-page booklet, made from 8.5-inch by 11-inch paper folded in half.
"I call it the user-friendly version of informed consent," Woodsong says.
"For each clinical trial the consent forms are lengthy with 10-plus pages of typed information," she notes. "The user-friendly version hits on the basic elements of informed consent, but not the nitty-gritty details."
Research professionals meet with subjects to discuss informed consent, giving them the booklet to review as they talk about the various elements of the trial, Woodsong says.
"There are pictures and text on each page of the booklet, with lots of white space," she describes. "The text is consistent with everything in the informed consent form, and all of it has to be approved by an ethics committee."
In the U.S. version of the booklet, there are illustrations depicting these scenes, among others:
— A calendar with a day circled to show that women in the study will see a nurse each month;
— A picture of a woman leaning close to another woman who is pointing to papers, which is intended to illustrate how participants will be counseled and treated;
— A picture showing four different women, smiling and sitting comfortably close together, above another picture of four women in white coats; this is intended to show how the medical/ research team will compare the experiences of the different women involved in the study;
— A picture of a medical professional putting a key in a filing cabinet to show how all information collected about each woman is kept confidential;
— A picture of a woman holding up her hand in a "stop" sign to show how one method of prevention is to say "No" to having sex; another illustration shows two hands pulling a condom out of a package.
Other illustrations feature a hand holding a small blood tube to demonstrate how a little blood would be drawn as part of the study, Woodsong says.
"We know from previous work that people are concerned about how much blood you are taking, so we have the hand holding a blood draw vial so they can see it’s a small amount," she explains.
While text explains the same information on each page of the booklet, researchers expect that most women will not read the text, so the illustrations serve as a memory device, as well, Woodsong says.
• Research subject mascot: FHI had a graphic designer draw illustrations of a woman, called Serena, who is featured throughout the booklet and shown in various scenes that highlight different parts of the clinical trial process. For each culture in which the trial is conducted, Serena may look a little different, reflecting that culture’s typical woman, Woodsong says.
"We pilot-tested the pictures in communities to make sure the illustrations are appropriate for each cultural setting," she explains.
Through the pilot-testing process, investigators discovered that one image of Serena that was slated for the cover of the booklet would not work. In that image, Serena had her hand on her chin, which was intended to suggest she was contemplating joining the study, Woodsong explains.
"I was told if you have your hand on your face, that means something is wrong in the African cultures we were studying," she says. "So we moved that picture to a page about the trial’s risks to show she was concerned."
In the U.S.’ illustrations, Serena’s features have been changed to reflect a multicultural woman who could be a combination of African American, Hispanic, or white race, Woodsong says.
"Serena is of nebulous race because both trials in the U.S. are enrolling blacks, whites, and Hispanics," she explains.
The venues in which Serena is depicted also vary according to where the trial is being held. For instance, for the Philadelphia trial, Serena is shown in a storefront clinic; for African trials, Serena is shown in a marketplace setting, Woodsong says.
• Additional consent materials: The informed consent kit includes items that help demonstrate the way the clinical trial intervention works.
Since many of the women in the developing world were unfamiliar with the concept of inserting a tampon or gel into their vaginas, study coordinators use props to demonstrate how the microbicide gel is applied, Woodsong says.
Investigators took a pelvic model and added a plastic vagina to demonstrate how the microbicide gel application device works, she explains.
"This allows the people doing the consent to demonstrate how to do an application, and it’s used during the consent process to allay concerns and fears," Woodsong says. "It’s intended to show how the applicator won’t hurt you or get lost in the vagina, so there’s nothing to fear."
Even in the United States, certain minority groups are unfamiliar with tampon use, so the kit could be used in conjunction with the booklet and its illustrations, which also explain how to insert the applicator, she adds.
The kit also uses flip charts for a table top and other visual aids, Woodsong adds.
• Fact sheets: The trial uses fact sheets with information similar to what is on the consent documents to describe aspects of the trial that may be of special interest to male partners of the women participants, she says. The fact sheet designed for husbands is one page, front and back, and it’s written in the spirit of "Men, here’s what you need to know," Woodsong says. It uses the same illustrations of Serena and includes a male character named Sam, she adds.
At African trial sites, where most of the women participating are married, Sam is portrayed with his arm protectively around Serena; while in the U.S. where the female participants typically are not married, Sam is portrayed casually strolling alongside her, Woodsong says.
Interestingly, although the fact sheets were created in response to feedback from pilot studies in Africa, they also have been popular in the United States, she says.
"At the U.S. sites, women want to hand the men something to read," Woodsong notes. "It’s less of an expressed need because women can make their own choice about this; but if they have a steady boyfriend, they often want to give him the fact sheet."
The fact sheets help to alleviate male concerns about how the microbicide might affect the penis when it is exposed to the product, and it’s been a gesture of good will in the African communities, Woodsong notes.
"We do a fair amount of social and behavioral work before we start trials, and that’s how we learned that you’ve got to get men involved," she says. "So in a number of country settings, we also developed male informational sessions for a Saturday afternoon when men can come and learn more about the study."
In the microbicide’s Phase II trial in New York, investigators have encouraged women to bring their partners to the consent visits so the men also can receive some safety explanations, says Woodsong.
Sometimes men will say that they feel like they need to give consent as well because their penises are going to be exposed to the product, she says.
"Because in Phase II trials we have less safety data than we do for Phase III trials, we feel a little more inclined to go out of our way to answer men’s needs for information," Woodsong says.
If it’s a Phase III trial and men have questions, study coordinators will explain that the product has been tested extensively for safety, and there’s nothing to be worried about, she says.
Investigators conducting HIV prevention research among married women in developing countries have found that standard informed consent forms and methods do not work for both cultural and comprehension reasons. A more creative approach to informed consent could help improve comprehension, says behavioral scientist Cynthia Woodsong, PhD.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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