Here or abroad, informed consent is still a process
Here or abroad, informed consent is still a process
Three-phase approach proves effective
As IRBs move to improve the quality of human subjects protection in international research, they should pursue a model of informed consent that begins long before an individual signs a consent document — and continues afterward.
That’s the message from a researcher who has conducted HIV prevention trials in Africa, India, and the United States. Cynthia Woodsong, PhD, a senior scientist with Family Health International in Research Triangle Park, NC, is among a group of researchers participating in the HIV/AIDS Prevention Trials Network, which collaborates to develop and test HIV preventative approaches.
She and others involved in the network have used their experiences in cross-cultural research to develop a three-phase model of informed consent that is designed to better educate individuals and communities about research before, during, and after the official consent is obtained. The approach includes getting input from the community to understand cultural mores before recruitment begins; using props and other aids to ensure that subjects understand the study and all that is involved; and following up regularly to ensure that participants still understand the study and to dispel any myths or misinformation that may have arisen since the start of the study.
Woodsong notes that while their model may seem more labor-intensive, it’s both ethically stronger and scientifically smarter than a more perfunctory get-the-signature-on-the-form approach.
"We argue that yes, it does take more time, but you get better recruitment eligibility ratios, and you get better eligible-to-enrolled ratios," she says. "If you pay attention to things on the front end, you’ll get people coming to enroll who are better suited to the study and will stay in the study. We argue that it improves retention and adherence. So it should make a study tighter — make it run more smoothly and avoid problems."
Her group published the model in a recent issue of the American Journal of Public Health [2005; 95(3):412-419]. Woodsong has been presenting the proposal at conferences of research ethics groups over the past year. Her hope is that IRBs will begin to adopt all or parts of the model when they review international research — or even research in the United States that involves different cultural groups.
Getting community input
The informed consent model Woodsong advocates attempts to take into account the relationship between participants and their community. This is particularly important, she says, in cultures that have a different concept of personal autonomy.
During a pre-enrollment stage, researchers would work with community leaders, possibly in the form of an advisory board. The board would represent different facets of the community, especially any groups being targeted in the study, such as women.
"You sort of do a general stakeholder assessment — who are the stakeholders, people who have a stake in the outcome of the research, and gatekeepers, people whose permission you have to have before you go into a community," Woodsong explains. "That may be a village chief; if you’re going to recruit in a clinic setting, you’re going to have both the director of the hospital and maybe the matron of the nursing ward."
Working with community members can help identify problems as early as possible so they can be addressed.
For example, Woodsong’s research deals with the use of vaginal gel microbicides to be used by women to prevent transmission of HIV. In some sub-Saharan African communities where she conducted the research, women expect to ask their husbands for permission to participate.
"Respecting persons means if in their culture, they don’t want to do something without asking their husband, you have to respect that," she says. So as part of the pre-enrollment process, researchers developed materials specifically to explain the study to male partners.
Community input also can identify what forms of recruitment might be most successful, perhaps prompting the use of illustrated booklets, videos or drama skits in populations with low literacy.
Community advisers can educate researchers about the best way to translate materials for optimal understanding, provide insight into local practices, and help shape informed consent materials, particularly to explain difficult research concepts such as randomization and placebos.
The pre-enrollment process can be eased significantly if a researcher has prior experience with the community, or has good local contacts, notes Woodsong.
"If you’re working with an established site and local researchers, they know what kinds of recruitment strategies work," she says. "Working with experienced teams, you can cut to the chase on a lot of this."
Using props and aids
During the enrollment phase, Woodsong says she relies on a whole array of aids and props to help women understand the studies for which they’re being recruited.
A woman might be shown a speculum to help explain a vaginal exam. Instead of simply being told that blood will be collected, she’s shown the actual vials that must be filled, so that she knows how much blood will be taken (this came in response to rumors during one study that the five "vials" to be filled were Coke bottles).
To explain an abstract concept such as use of placebo and blinding, Woodsong says researchers can use glasses of orange juice, explaining that one is vitamin-enriched and that it’s impossible to know from drinking them which has been enhanced. Or a researcher could use hair creams, with and without curl relaxer, to explain the idea that you can’t tell from looking at a treatment which one is active.
Some cultures don’t understand the idea of flipping a coin or playing the lottery to describe randomization, so the idea of drawing straws or casting lots might be more appropriate, she says.
"The idea is to spend some time with your local staff and local community advisory board members or community stakeholders to find out what mechanism of explaining would help," Woodsong says.
She says it’s vital at this point to understand how the community views individual decision-making, particularly when research involves women, who may have limited individual autonomy to make decisions about participation.
While it’s important to respect cultural norms, the informed consent process still must respect an individual’s absolute right to decide for herself whether to participate — or to let others in on the process.
In her work with vaginal microbicides, "a woman may want to use them without her husband knowing about them," Woodsong points out. "Asking a husband’s permission may be tantamount to accusing him of fooling around or suggesting that she herself is unfaithful.
"So you may want to help give women the opportunity of making a decision without involving their husband," she says. "However, if they want a husband’s or partner’s involvement, it’s incumbent on the research team to make that information available."
Comprehension drift
Once a subject is enrolled, the job of informed consent isn’t over, particularly in longitudinal studies where comprehension can drift over time, Woodsong says. Researchers must keep in touch, both at the individual and community levels, to make sure that the study is still well understood and to counter any rumors that might have taken hold and could threaten continued participation.
"If word gets out, for example, that they’re selling the blood [drawn in the study] to Satanists, then people might drop out," she says. "This happens a lot with HIV studies where blood is taken. All kinds of rumors get going about what’s being done with the blood — that it’s being sold or being used in inappropriate ways."
She says in another study that measured children, rumors cropped up that the children were being measured for coffins, since the children who were randomized into the active ingredient were expected to sicken and die.
Woodsong says quizzing participants periodically on informed consent information can have a dual benefit — reinforcing any issues that participants are unclear about, and identifying problems in the informed consent process.
For example, if follow-up quizzes show that women don’t realize the gel they’re using comes with a risk of skin rash, researchers can be prompted to remind them at their next visit. Or they can monitor which staff seem to have trouble explaining details about the study to see if they need help.
"So it becomes a quality improvement tool as well as a good ethics documentation tool," says Woodsong.
She says the three-phase informed consent model currently is in full use in a clinical trial being conducted by the HIV/AIDS Prevention Trials Network. Parts of it are being used in other clinical trials, and Woodsong says she’s gotten a lot of positive feedback from her discussions of the model at various conferences.
"People are saying yeah, this will help, it makes sense," she says. "People may be reluctant to do all of it. They may want to do the visual aids, but won’t do much with the rumor monitoring."
She hopes that as more information is generated about the model’s effectiveness, more IRBs will ask for this type of enhanced informed consent from researchers.
"If this approach catches hold, an ethics committee might say to someone going in front of their IRB, Have you thought about having any visual aids handy to explain randomization?’ IRBs might start asking for how things are going to be translated, how things are going to be explained," Woodsong says.
While all of these ideas aren’t necessary for every study, Woodsong says they are particularly useful in large longitudinal studies of populations other than the researchers’ own.
"With those types of studies, it’s a solid front-end investment of a little extra time that would pay off with better science as well as stronger ethics," she says.
As IRBs move to improve the quality of human subjects protection in international research, they should pursue a model of informed consent that begins long before an individual signs a consent document and continues afterward.Subscribe Now for Access
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